As filed with the Securities and Exchange Commission on ~~October~~February 93, ~~2025~~ 2026.

Registration No. 333-________

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

PROFUSA, INC.

(Exact name of registrant as specified in its charter)

Delaware		3841		2686-~~4589529~~3437271
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

626 Bancroft Way
Suite A
Berkeley, CA 94710
(925) 997-6925
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Ben C. Hwang

Chief Executive Officer

626 Bancroft Way
Suite A

Berkeley, CA 94710

(925) 997-6925

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Ralph V. De Martino, Esq.
Marc Rivera, Esq.
ArentFox Schiff LLP
1717 K Street, NW
Washington, DC 20006
Phone: (202) 724-6847

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

~~This~~The Registrant ~~registration~~hereby ~~statement~~amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall ~~hereafter~~file ~~become~~a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with the provisions of Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. The selling ~~stockholder~~stockholders may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell, nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED ~~october 8~~FEBRUARY 3, ~~2025~~2026.

PRELIMINARY PROSPECTUS

PROFUSA, INC.

429,~~594~~487,~~048~~ 500 Shares of Common Stock Issuable Upon Exercise of Public Warrants, and

~~This prospectus relates to the resale~~43, ~~from time to time~~489,926 byShares ~~the Selling Stockholders identified in this prospectus under the caption “Selling Stockholders,”~~ of ~~up to 42,594,048 shares of common stock, par value $0.0001 per share, of the Company (the “~~Common Stock”) ~~comprising: (a) up to 42,211,548 shares of~~for ~~Common~~Resale ~~Stock~~ by Ascent Partners Fund LLC, whom we refer to in this prospectus as “Ascent,” pursuant to a common stock purchase agreement, dated as of July 28, 2025, we entered into with Ascent, which we refer to in this prospectus as the ~~Purchase~~Selling Agreement; and (b) up to 382,500 shares of Common Stock issued to certain parties in satisfaction of transaction costs incurred in connection with the Business Combination we completed on July 11, 2025.Stockholders

~~In our registration statement,~~This ~~filed~~prospectus onrelates ~~August~~to ~~22,~~the ~~2025~~issuance ~~and~~by ~~declared~~us ~~effective~~of onup ~~August~~to ~~25,~~an ~~2025,~~aggregate ~~we previously registered the resale~~ of up to 89,~~970~~487,~~830~~500 shares byof ~~Ascent pursuant~~common tostock, ~~the~~par ~~Purchase~~value ~~Agreement~~$0.0001 ~~This~~per ~~prospectus~~share, of ~~registers~~the Company (the ~~resale~~“Common ofStock”), upthat toare anissuable ~~additional~~upon ~~42,211,548~~the ~~shares~~exercise of ~~Common~~9,487,500 ~~Stock~~warrants (the ~~“Purchase~~ ~~Shares~~“Public Warrants”) ~~that~~issued ~~we may,~~ in ~~our~~connection ~~sole~~with ~~discretion,~~the ~~elect~~Company’s toinitial ~~sell~~public tooffering ~~Ascent,~~(the ~~from~~“IPO”). ~~time~~Each toPublic ~~time~~Warrant ~~over~~exercisable for aone ~~period~~share of upCommon ~~to 36~~Stock ~~months~~at ~~from~~an ~~and~~exercise ~~after~~price ~~the~~of ~~Effective~~$11.50 ~~Date~~per ~~(defined~~share. ~~below)~~The ~~pursuant~~Public toWarrants ~~the~~are ~~Purchase~~exercisable ~~Agreement.~~30 ~~Ascent~~days isafter ~~deemed~~the toclosing of bethe anBusiness ~~“underwriter” within~~Combination ~~the~~and ~~meaning~~will ofexpire ~~Section~~five ~~2(a)(11)~~years offrom the ~~Securities~~closing ~~Act~~ of ~~1933, as amended, or~~ the ~~Securities~~Business ~~Act~~Combination.

This prospectus also relates to the resale, from time to time, by the Selling Stockholders identified in this prospectus under the caption “Selling Stockholders,” of up to 43,489,926 shares of Common Stock, comprising:

Up to 25,000,000 shares of Common Stock by Ascent Partners Fund LLC, whom we refer to in this prospectus as “Ascent,” pursuant to a common stock purchase agreement, dated as of July 28, 2025, we entered into with Ascent, which we refer to in this prospectus as the ELOC Purchase Agreement;

ii.

Up to 4,743,750 shares of Common Stock issued to NorthView Sponsor I, LLC (the “Sponsor”) pursuant to certain securities subscription agreements (the “Founder Shares”);

iii.

Up to 7,347,500 shares of Common Stock that are issuable upon the exercise of 7,347,500 private placement warrants of the Company (the “Private Placement Warrants”), each initially exercisable at $11.50 per share, issued to the Sponsor, I-Bankers Securities, Inc. (“I-Bankers”), and Dawson James Securities, Inc. (“Dawson James”) in a private placement transaction that closed simultaneously with the Company’s initial public offering (the “IPO”);

iv.

Up to 569,250 shares of Common Stock that are issuable upon the exercise of 569,250 private placement warrants of the Company (the “Representative Warrants,” together with the Public Warrants and Private Placement Warrants, the “Warrants”), each initially exercisable at $11.50 per share, issued to I-Bankers and Dawson in a private placement transaction that closed simultaneously with the Company’s IPO;

Up to 150,000 shares of Common Stock (the “Inducement Shares”) issued to certain investors as an inducement for such investors to lend the Company an aggregate of $300,000 on a short-term basis prior to the completion of the Business Combination (the “Short-Term Bridge Loans”); and

vi.

Up to 5,679,426 shares of Common Stock issued in connection with the business combination we completed on July 11, 2025 (the “Business Combination”) with Profusa, Inc., a California company whom we refer to as “Legacy Profusa,” to certain shareholders of Legacy Profusa.

In our registration statement, filed on August 22, 2025 and declared effective on August 25, 2025, and our registration statement filed on October 9, 2025 and automatically effective on October 29, 2025 pursuant to Section 8(a) of the Securities Act of 1933, we previously registered the resale of up to 8,970,830 and 42,211,548 shares, respectively, by Ascent pursuant to the ELOC Purchase Agreement. This prospectus registers the resale of up to an additional 25,000,000 shares of Common Stock (the “Purchase Shares”) that we may, in our sole discretion, elect to sell to Ascent, from time to time over a period of up to 36 months from and after the Effective Date (defined below) pursuant to the ELOC Purchase Agreement. Ascent is deemed to be an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended, or the Securities Act.

We are registering the offer and sale and/or resale of these securities to satisfy certain registration obligations we have and certain registration rights we have granted. The Selling Stockholders may offer all or part of the Resale Securities for resale from time to time through public or private transactions, at either prevailing market prices or at privately negotiated prices. The Resale Securities are being registered to permit the Selling Stockholders to sell Resale Securities from time to time, in amounts, at prices and on terms determined at the time of offering. The Selling Stockholders may sell the Resale Securities through ordinary brokerage transactions, in underwritten offerings, directly to market makers of our securities or through any other means described in the section entitled “Plan of Distribution” herein. In connection with any sales of Resale Securities offered hereunder, the Selling Stockholders, any underwriters, agents, brokers or dealers participating in such sales may be deemed to be “underwriters” within the meaning of the Securities Act, or the Exchange Act. We are registering the Resale Securities for resale by the Selling Stockholders, or their donees, pledgees, transferees, distributees or other successors-in-interest selling our Common Stock received after the date of this prospectus from the Selling Stockholders as a gift, pledge, partnership distribution or other transfer.

~~The~~We will not receive any of the proceeds from the sale of Common Stock by the Selling ~~Stockholders~~Shareholders. However, we may receive up to $100,000,000 ~~sell~~in ~~the~~aggregate ~~shares~~gross proceeds from sales of ~~our~~the ~~common~~Purchase ~~stock~~Shares ~~offered~~to byAscent ~~this~~that ~~prospectus~~we may, in our discretion, elect to make, from time to time after onthe ~~terms~~date toof bethis ~~determined~~prospectus, atpursuant to the ~~time~~Purchase ofAgreement. ~~sale~~Additionally, ~~through ordinary~~we ~~brokerage~~will ~~transactions~~receive orproceeds ~~through~~from any ~~other~~cash ~~means~~exercise of ~~described~~the Warrants, which, if exercised in ~~this~~cash ~~prospectus~~with ~~under~~respect to all of the ~~caption~~17,404,250 ~~“Plan~~Warrants ofwould ~~Distribution.”~~result in aggregate gross proceeds ~~The~~to ~~shares~~us of ~~common~~$200,148,875; ~~stock~~however, ~~may~~we becannot ~~sold~~predict atwhen ~~fixed~~and ~~prices,~~in atwhat ~~market~~amounts ~~prices~~or ~~prevailing~~if atthe Warrants will be exercised and it is possible that the ~~time~~Warrants ofmay ~~sale~~expire and never be exercised, atin ~~prices~~which ~~related~~case towe ~~prevailing market~~would ~~price~~not orreceive atany ~~negotiated~~cash ~~prices~~proceeds.

WeThe ~~will~~Selling ~~pay~~Stockholders may sell the ~~expenses~~shares ~~incurred~~of our Common Stock offered inby ~~registering~~this ~~under~~prospectus ~~the~~from ~~Securities~~time ~~Act~~to ~~the~~time ~~offer~~on ~~and~~terms ~~sale~~to ofbe determined at the ~~shares~~time of ~~Common~~sale ~~Stock~~through toordinary ~~which~~brokerage ~~this~~transactions ~~prospectus~~or ~~relates~~through any byother ~~the~~means ~~Selling Stockholders,~~described ~~including~~in ~~legal~~this ~~and~~prospectus ~~accounting~~under ~~fees.~~the ~~See~~caption “Plan of Distribution ~~— Offer~~.” ~~and~~The ~~Resale~~shares of Common Stock may bybe sold at fixed prices, at market prices prevailing at the ~~Selling~~time ~~Stockholders”~~of ~~beginning~~sale, onat ~~page 145~~prices related to prevailing market price or at negotiated prices.

~~Our~~We will ~~common~~pay ~~stock~~the isexpenses ~~listed on~~incurred in registering under the ~~Nasdaq~~Securities ~~Global~~Act ~~Market~~the ~~under~~offer and sale of the ~~symbol~~shares ~~“PFSA.”~~of OnCommon ~~October~~Stock 7,to ~~2025,~~which this prospectus relates by the ~~last~~Selling ~~sale~~Stockholders, ~~price~~including ~~for~~legal ~~our~~and ~~common~~accounting ~~stock~~fees. asSee ~~reported~~“Plan of Distribution — Offer onand Resale of Common Stock by the ~~Nasdaq~~Selling ~~Global~~Stockholders” ~~Market~~beginning ~~was~~on ~~$0.33~~page ~~per share~~136.

Our Common Stock is listed on the Nasdaq Global Market under the symbol “PFSA.” On February 2, 2026, the last sale price for our Common Stock as reported on the Nasdaq Global Market was $0.09 per share. We intend to apply to transfer the listing of our Common Stock from the Nasdaq Global Market to the Nasdaq Capital Market. No assurance can be given that such application to transfer the Common Stock from the Nasdaq Global Market to the Nasdaq Capital Market will be approved.

We intend to effect a reverse stock split of all our outstanding shares of Common Stock at a ratio within a range of 1-for-30 to 1-for-200 (the “Reverse Stock Split”). Unless the context expressly indicates otherwise, all references to share and per share amounts referred to herein reflect the amounts prior to giving effect to the Reverse Stock Split, which was approved by our shareholders at a special meeting of our stockholders we held on January 27, 2026.

We are a “smaller reporting company” as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and may elect to do so in future filings.

~~Investing~~We inare ~~our~~an ~~securities~~“emerging ~~involves~~growth acompany,” ~~high~~as ~~degree~~defined ofin ~~risk.~~the ~~See~~Jumpstart ~~the~~Our ~~section~~Business ~~entitled~~Startups Act of 2012 (“~~Risk~~JOBS ~~Factors~~Act”). ~~appearing~~As ona ~~page 5 of this~~result, ~~prospectus~~we ~~for~~are aeligible to ~~discussion~~take advantage of ~~information~~certain ~~that~~reduced ~~should~~disclosure beand ~~considered~~other inrequirements ~~connection~~that ~~with~~are anotherwise ~~investment~~applicable into ~~our~~public ~~securities~~companies. See further discussion below.

Investing in our securities involves a high degree of risk. See the section entitled “Risk Factors” appearing on page 12 of this prospectus for a discussion of information that should be considered in connection with an investment in our securities.

Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

The date of this prospectus is__________, ~~2025~~2026

TABLE OF CONTENTS

		Page
ABOUT THIS PROSPECTUS		ii
PROSPECTUS SUMMARY		1
THE OFFERING		49
RISK FACTORS		512
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS		6973
THE COMMITTED EQUITY FACILITY		7074
USE OF PROCEEDS		7579
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION		76
CAPITALIZATION		80
DIVIDEND POLICY		9081
MARKET INFORMATION		9081
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		9182
BUSINESS		~~104~~94
MANAGEMENT		~~131~~121
EXECUTIVE COMPENSATION		~~136~~126
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT		~~138~~128
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS		~~139~~129
SELLING STOCKHOLDERS		~~143~~132
PLAN OF DISTRIBUTION		~~145~~136
DESCRIPTION OF SECURITIES		~~150~~141
LEGAL MATTERS		~~154~~148
EXPERTS		~~154~~148
WHERE YOU CAN FIND MORE INFORMATION		~~154~~148
INDEX TO FINANCIAL INFORMATION		F-1

You should rely only on the information contained in this prospectus or any amendment or supplement to this prospectus. This prospectus is an offer to sell only the securities offered hereby, but only under the circumstances and in jurisdictions where it is lawful to do so. Neither we nor the Selling Stockholders have authorized anyone to provide you with information different from that contained in this prospectus or any amendment or supplement to this prospectus. Neither we nor the Selling Stockholders take any responsibility for, or can provide any assurance as to the reliability of, any information other than the information in this prospectus or any amendment or supplement to this prospectus. The information in this prospectus or any amendment or supplement to this prospectus is accurate only as of its date, regardless of the time of delivery of this prospectus or any amendment or supplement to this prospectus, as applicable, or any sale of the securities offered by this prospectus. Our business, financial condition, results of operations and prospects may have changed since that date.

For Investors Outside the United States: The Selling Stockholders are offering to sell, and seeking offers to buy, the securities offered by this prospectus only in jurisdictions where offers and sales are permitted. Neither we nor the Selling Stockholders have done anything that would permit this offering or the possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities offered by this prospectus and the distribution of this prospectus outside the United States.

ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement that we filed with the SEC. The Selling Stockholders may, from time to time, sell the securities offered by it described in this prospectus through any means described in the section titled “Plan of Distribution.” We will not receive any proceeds from the sale by the Selling Stockholders of the securities offered by it described in this prospectus. However, we may receive up to $100,000,000 in aggregate gross proceeds from Ascent under the ELOC Purchase Agreement in connection with sales of our shares of Common Stock to Ascent pursuant to the ELOC Purchase Agreement after the date of this prospectus. Additionally, we will receive proceeds from any cash exercise of the Warrants, which, if exercised in cash with respect to all of the 17,404,250 Warrants would result in aggregate gross proceeds to us of $200,148,875; however, we cannot predict when and in what amounts or if the Warrants will be exercised and it is possible that the Warrants may expire and never be exercised, in which case we would not receive any cash proceeds.

We may also file a prospectus supplement or post-effective amendment to the registration statement of which this prospectus forms a part that may contain material information relating to these offerings. The prospectus supplement or post-effective amendment may also add, update or change information contained in this prospectus with respect to that offering. If there is any inconsistency between the information in this prospectus and the applicable prospectus supplement or post-effective amendment, you should rely on the prospectus supplement or post-effective amendment, as applicable. Any statement so modified will be deemed to constitute a part of this prospectus only as so modified, and any statement so superseded will be deemed not to constitute a part of this prospectus. Before purchasing any securities, you should carefully read this prospectus, any post-effective amendment, and any applicable prospectus supplement, together with the additional information described under the heading “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.”

This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed, or will be incorporated by reference as exhibits to the registration statement of which this prospectus forms a part, and you may obtain copies of those documents as described below under “Where You Can Find More Information.” You should assume that the information in this prospectus is accurate only as of the date on the front of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any sale of a security.

The distribution of this prospectus and the issuance of the securities in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the issuance of the securities and the distribution of this prospectus outside the United States. This prospectus does not constitute, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy, the securities offered by this prospectus by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.

Unless the context otherwise requires, references in this prospectus to “Profusa,” “the Company,” “we,” “us” and “our” refer to Profusa, Inc. Our logo and all product names are our common law trademarks. Solely for convenience, trademarks and tradenames referred to in this prospectus may appear without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and tradenames.

PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before deciding to invest in our securities. You should read this entire prospectus carefully, including the “Risk Factors” section in this prospectus and under similar captions in the documents incorporated by reference into this prospectus. The terms the “Company”, “our”, or “we” refer to Profusa, Inc. and its subsidiaries.

Overview

On July 11, 2025, Profusa, Inc., a Delaware corporation formerly known as NorthView Acquisition Corporation (the “Company”), consummated ~~its~~a ~~previously announced~~ business combination (the “Business Combination”) with Profusa, Inc., a California corporation (“Profusa”), pursuant to that certain Merger Agreement and Plan of Reorganization, dated as of November 7, 2022 (as the same has been amended, supplemented or otherwise modified from time to time, the “Merger Agreement”), between the Company, Profusa, and NV Profusa Merger Sub Inc., a Delaware corporation and a direct, wholly-owned subsidiary of the Company (“Merger Sub” and, collectively, the “Parties”). The consummation of the Business Combination involved the merger (the “Merger”) of Merger Sub with and into Profusa, pursuant to which, at the closing of the transactions contemplated by the Merger Agreement (the “Closing”), the separate corporate existence of Merger Sub ceased, with Profusa as the surviving corporation becoming a wholly-owned subsidiary of the Company, pursuant to the terms of the Merger Agreement and in accordance with the ~~Delaware~~ General Corporation Law of the State of Delaware (the “DGCL”). As a result of the Business Combination, the Company owns 100% of the outstanding ~~common~~Common ~~stock~~Stock of Profusa. In connection with the closing of the Business Combination, the Company changed its name from “NorthView Acquisition Corporation” to “Profusa, Inc.”

Profusa, ~~Inc.~~ was incorporated in the state of California on May 11, 2009 and operates as a digital health technology company based in Berkley, California. The Company is engaged in the development of a new generation of biointegrated sensors that potentially empowers the individual with the ability to monitor their unique body chemistry. Profusa has invested over the last twelve years more than $100 million from sophisticated venture investors as well as the most sophisticated research institutions in the U.S. (including approximately $30 million from Defense Advance Research Projects Agency (“DARPA”) and the National Institutes of Health (“NIH”)) to develop a unique biosensor platform that is easily injected subcutaneously to provide, for the first time, real-time, individual biochemistry, that is cost effective while functioning for more than six times longer than known best in class solutions on the market today.

The Company’s technology enables the development of bioengineered sensors that are designed to become one with the body to detect and continuously transmit actionable, clinical-grade data for personal and medical use. The Company’s first offering in the European Union, the Lumee™ Oxygen Platform, is designed to report reliable tissue oxygen levels at various regions of interest, both acutely and long-term. The Lumee™ Oxygen Platform has been designed for use in applications where monitoring of compromised tissue is beneficial, such as peripheral artery disease that results in narrowing of blood vessels and reduced blood flow to the lower limbs; chronic wounds (diabetic ulcers, pressure sores) that do not heal properly; and reconstructive surgery.

The Company’s research and development efforts are primarily focused on its Lumee™ Glucose Platform, which is a system designed to monitor glucose levels in interstitial fluid, continuously and long-term. A tiny, biocompatible gel injected under the skin acts as a continuous glucose monitor (CGM) for several months. The ability of Lumee™ Glucose to provide continuous glucose monitoring with only an initial single injection, is an attractive alternative for people with diabetes to manage their disease without the need for frequent finger sticks required by standard glucometers, or the need for weekly sensor replacement as required by current short-term needle-type CGMs.

Profusa’s sensor platform has the potential to generate an individualized real time biochemistry data stream, with a substantially better user-friendly form factor, accessibility for a broad user base, lower burden of healthcare costs, and significantly increased total addressable user base compared to current market solutions. Profusa believes that the combination of the potential advantages of this platform will enable it to generate both short-term revenue in the high-value clinical applications of wound care and diabetes management, but to also leverage core technology and develop and add to Profusa’s product portfolio to potentially tackle the management of other chronic conditions, while in the future creating the foundation for the technology-enabled health care where the large volume of biomarker data aligns with up-to-the-minute actions and choices of the individual. Therefore, Profusa’s data stream could become a key enabler for high-growth healthcare sectors such as telemedicine and health and wellness coaching, and sophisticated evaluation of biomarkers for both molecular diagnostics and potentially therapeutic purposes.

Profusa’s overall strategy has been to robustly invest and therefore develop and protect its technology as a private company, first in Europe where the barriers to regulatory approval traditionally are not as great as they are in the U.S. Accordingly, Profusa has validated its technology and gained approval of its first product, Lumee Oxygen, with CE approval in the EU and in the process of migrating to meet new MDR requirements in Europe. Following validation of Profusa’s technology and application via Lumee Oxygen in the EU, Profusa’s next step in the development process is to seek approval of both Lumee Oxygen as well as Lumee Glucose from the U.S. Food and Drug Administration (the “FDA”). Profusa believes that the generation of additional clinical data, which it plans to collect in connection with obtaining regulatory approval, combined with Profusa’s sophisticated patent protection, will expand partnership interest from prospective medical partners in the U.S. and worldwide. Profusa’s plan is to gain approval of Lumee Oxygen in the U.S. by-early 2026 followed by approval of Lumee Glucose in late 2026 or early 2027. While Lumee Oxygen is authorized for commercialization in the EU pending migration of CE approval to new MDR regulations, Lumee Glucose is not yet authorized for commercial sale in any jurisdiction and Profusa does not yet have regulatory approval for the sale of any of its products in the U.S. Profusa’s plans for commercialization of its products are dependent upon obtaining regulatory approval in relevant jurisdictions on a timely basis, which cannot be assured. See “Government Regulation - FDA Premarket Clearance and Approval Requirements.”

Private Placement

Simultaneously with the closing of the Company’s IPO, pursuant to certain subscription agreements, the Company completed the private sale of an aggregate of 7,347,500 warrants (the “Private Placement Warrants”) to NorthView Sponsor I, LLC, I-Bankers Securities, Inc., and Dawson James Securities, Inc. at a purchase price of $1.00 per Private Placement Warrant, generating gross proceeds to the Company of $7,347,500. The Private Placement Warrants are identical to the Warrants sold in the Company’s IPO except that the Private Placement Warrants: (i) will not be redeemable by the Company and (ii) may be exercised for cash or on a cashless basis, in each case so long as they are held by the initial purchasers or any of their permitted transferees. If the Private Placement Warrants are held by holders other than the initial purchasers or any of their permitted transferees, the Private Placement Warrants will be redeemable by the Company and exercisable by the holders on the same basis as the warrants included in the units sold in the IPO. No underwriting discounts or commissions were paid with respect to such sale. The issuance of the Private Placement Warrants was made pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as amended.

Lock-Up and Registration Rights Agreements

On or about November 7, 2022, NorthView Acquisition Corp. (“Northview”), the NorthView initial stockholders (the “NorthView Initial Stockholders”), and certain shareholders of Profusa prior to the business combination (the “Legacy Profusa Holders”) entered into a Lock-Up Agreement and an Amended and Restated Registration Rights Agreement. The Lock-Up Agreement and Amended and Restated Registration Rights Agreement provide customary demand and piggyback registration rights.

Pursuant to the Lock-Up and Registration Rights Agreements, we agreed to, as soon as practicable, but in any event within 45 calendar days after the closing date of the business combination (the “Closing Date”), use our reasonable best efforts to file a registration statement with the SEC registering the resale of certain shares of our Common Stock held by the NorthView Initial Stockholders and Legacy Profusa Holders. We further agreed to use our reasonable efforts to have the registration statement declared effective as soon as practicable after the filing thereof, but no later than the 90th calendar day (or 120th calendar day if the SEC notifies us that it will “review” the registration statement) following the Closing Date.

In addition, pursuant to the Lock-Up and Registration Rights Agreements, our Common Stock to be issued to the NorthView Initial Stockholders in exchange for shares of our Common Stock that constituted founder shares will be locked-up for 8 months after the Closing Date, subject to earlier release on (i) the last consecutive trading day where the sale price of our Common Stock equals or exceeds $12.50 per share for any 20 trading days within any 30-trading day period commencing at least 180 days after the Closing Date or (ii) such date on which we complete a liquidation, merger, stock exchange or other similar transaction that results in all of our stockholders having the right to exchange their shares of our Common Stock for cash, securities, or other property.

The Committed Equity Facility

On July 28, 2025, we entered into the ELOC Purchase ~~Agreement~~ Agreement and a related registration rights agreement (the “ELOC Registration Rights Agreement”), with Ascent. Pursuant to the terms and conditions set forth in the ELOC Purchase Agreement, we may, from time to time and at our discretion, issue and sell to Ascent ~~shares~~ shares of its ~~common~~Common ~~stock~~Stock (the “Purchased Securities”) for an aggregate purchase price of up to $100,000,000 (the “Maximum Aggregate Purchase Price”), subject to certain limitations and conditions.

Under the ELOC Purchase Agreement, we may deliver advance notices (each, an “Advance Notice”) to the Purchaser to request the purchase of shares of common stock, with each closing (a “Closing”) to occur on a trading day following the end of a 10 or fewer trading day valuation period commencing on the trading date immediately following the delivery of the Advance Notice, or as determined by the Purchaser. The purchase price per share at each Closing will be equal to 97% of the lowest volume-weighted average price (“VWAP”) of the Company’s common stock during the applicable valuation period, subject to a floor price and other adjustments as set forth in the ELOC Purchase Agreement. The maximum purchase price at any single Closing is limited to the lower of (a) $5,000,000 or (b) 100% of the average daily traded value of the common stock for the five trading days immediately preceding such Closing.

The ELOC Purchase Agreement contains certain limitations, ~~including~~ including that the aggregate number of shares issued under the ELOC Purchase Agreement may not exceed the number of shares registered under ~~the~~ the applicable registration statement or the exchange cap (generally 19.9% of the Company’s outstanding common stock as of the ~~effective~~Effective ~~date~~Date), unless stockholder approval is obtained or as otherwise permitted by the rules of the principal trading market. On August 29, 2025, at the special meeting of stockholders, the stockholders of the Company approved the Equity Line of Credit (“ELOC”) transaction with Ascent, to permit issuances of the Company’s common stock in excess of 19.99% to Ascent pursuant to the ELOC Purchase Agreement. In addition, the Purchaser’s beneficial ownership of the Company’s common stock is limited to 9.99% of the outstanding shares immediately after giving effect to any issuance.

The Company is required to deliver the Purchased Securities as DWAC shares to the Purchaser on the date that it delivers the applicable Advance Notice. If the Company fails to timely deliver the shares, the Purchaser may, among other remedies, deem the Advance Notice rescinded or require the Company to pay certain cover costs. The Purchaser may resell the Purchased Securities during the valuation period, and the Company is obligated to return any surplus shares if the Maximum Aggregate Purchase Price is exceeded.

In the event that the value of all of the Purchase Shares delivered to Ascent exceeds $100,000,000, then Ascent shall return to the to the Company the surplus amount of Purchase Shares.

In accordance with our obligations under the ELOC Registration Rights Agreement, we filed a registration statement that was declared effective on August 25, 2025 to register under the Securities Act, the offer and resale by Ascent of up to 8,970,830 shares of Common Stock, consisting of (i) up to 8,070,830 shares of Common Stock (the “Purchase Shares”) that we may, in our sole discretion, elect to sell to Ascent, from time to time over a period of up to 36 months from and after the Effective Date (defined below) pursuant to the Purchase Agreement and (ii) 900,000 Commitment Warrant Shares issuable upon the exercise of the Commitment Warrants we issued to Ascent, upon our execution of the term sheet relating to the Purchase Agreement on July 20, 2025, as consideration for its commitment to purchase shares of our Common Stock that we may, in our sole discretion, direct Ascent to purchase from us pursuant to the Purchase Agreement. This registration statement registers an additional 42,211,548 Purchase Shares that we may, in our sole discretion, elect to sell to Ascent, from time to time over a period of up to 36 months from and after the Effective Date (defined below) pursuant to the Purchase Agreement

We will control the timing and amount of any sales of Common Stock to Ascent that we may elect, in our sole discretion, to effect from time to time from and after the Effective Date and during the term of the Purchase Agreement. Actual sales of shares of Common Stock to Ascent under the Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among other things, market conditions, the trading price of the Common Stock and determinations by us as to the appropriate sources of funding for our business and operations.

We may not issue or sell any shares of Common Stock to Ascent under the Purchase Agreement which, when aggregated with all other shares of Common Stock then beneficially owned by Ascent and its affiliates (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 13d-3 thereunder), would result in Ascent beneficially owning more than 9.99% of the outstanding shares of Common Stock (the “Beneficial Ownership Limitation”).

The net proceeds to us from sales that we elect to make to Ascent under the Purchase Agreement, if any, will depend on the frequency and prices at which we sell shares of our Common Stock to Ascent. We expect that any proceeds received by us from such sales of Common Stock to Ascent will be used solely for the purchase of Bitcoin (which can be used for debt repayment) provided that the Company’s cash balance on the date of the applicable sale exceeds $5,000,000. If the cash balance is less than $5,000,000, proceeds to the Company shall be allocated first to bring the balance to $5,000,000 and the remaining proceeds to purchase Bitcoin.

There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or ELOC Registration Rights Agreement.

~~Ascent~~In ~~has~~accordance ~~agreed~~with ~~that,~~our ~~during~~obligations under the ~~term~~ELOC ofRegistration ~~the~~Rights ~~Purchase~~ Agreement, ~~none~~we offiled ~~Ascent~~registration statements on August 22, ~~any~~2025 of(declared ~~its~~effective ~~officers~~on August 25, or2025), ~~any~~and ~~entity~~October ~~managed~~8, or2025, ~~controlled~~to register under the Securities Act, the offer and resale by Ascent ~~will~~of ~~engage~~up into ~~or effect~~8,070,830 ~~directly or~~shares ~~indirectly~~and 42,211,548 ~~for~~shares, ~~its~~respectively, ~~own~~of ~~principal~~Common ~~account~~Stock (the or“Purchase ~~for~~Shares”) ~~the~~that ~~principal~~we ~~account~~may, ofin ~~any~~our ~~such~~sole ~~entity~~discretion, ~~managed~~elect orto ~~controlled~~sell byto Ascent, ~~any~~from ~~short~~time to time over a period of up ~~sales~~to ~~(as~~36 months ~~such~~from ~~term~~and isafter ~~defined~~the date that certain specified conditions in ~~Rule~~the ELOC Purchase Agreement were satisfied (the “Effective Date”) and (ii) ~~200~~900,000 Commitment Warrant Shares issuable upon the exercise of ~~Regulation SHO~~the Commitment Warrants we issued to Ascent, upon our execution of the ~~Exchange~~term sheet relating to the ELOC Purchase Agreement on July ~~Act)~~20, of2025, as consideration for its commitment to purchase the ~~Common~~Purchase ~~Stock~~Shares orthat ~~hedging~~we ~~transaction~~may, in our sole discretion, direct Ascent to purchase from us pursuant to the ELOC Purchase Agreement. This registration statement registers an additional 25,000,000 Purchase Shares that ~~establishes~~we may, in our sole discretion, elect to sell to Ascent, from time to time over a ~~net~~period ~~short~~of ~~position~~up into 36 months from and after the ~~Common~~Effective ~~Stock.~~Date pursuant to the ELOC Purchase Agreement

~~The~~We ~~Purchase~~will ~~Agreement~~control ~~will~~the ~~automatically~~timing ~~terminate on~~and ~~the~~amount ~~earliest~~of toany ~~occur~~sales of ~~(i) July 27,~~Common ~~2028~~Stock to Ascent that we may elect, ~~(ii) the~~in ~~date~~our onsole ~~which~~discretion, ~~Ascent~~to ~~shall~~effect ~~have~~from ~~purchased~~time to time from usand ~~under~~after the ~~Purchase~~Effective Date and during the term of the ELOC Purchase Agreement. Actual sales of shares of Common Stock ~~for~~to anAscent ~~aggregate~~under ~~gross~~the ~~purchase~~ELOC ~~price~~Purchase Agreement will depend on a variety of ~~$100~~factors to be determined by us from time to time,~~000~~ including,~~000~~ among other things, ~~and~~market ~~(iii)~~ conditions, the ~~date~~trading ~~either~~price ~~party~~of ~~effectively~~the Common ~~delivers~~Stock ~~notice~~and determinations by us as to the ~~other~~appropriate ~~party~~sources of ~~such~~funding ~~termination~~for our business and operations.

AsWe ~~consideration~~may ~~for~~not ~~Ascent’s~~issue ~~commitment~~or tosell ~~purchase~~any shares of Common Stock ~~at our direction upon the terms and subject~~ to ~~the~~Ascent ~~conditions set forth in the Purchase Agreement, upon our execution~~under of the ~~term~~ELOC ~~sheet relating to the~~ Purchase Agreement which, wewhen ~~issued~~aggregated ~~Ascent~~with ~~Commitment~~all ~~Warrant~~other ~~to purchase 900,000~~ shares of Common Stock ~~(the~~ ~~“Commitment~~then ~~Warrant~~beneficially ~~Shares”).~~owned ~~The~~by ~~Commitment~~Ascent ~~Warrants~~and ~~have~~its anaffiliates (as ~~exercise~~calculated ~~price~~pursuant to Section 13(d) of ~~$0.01~~the ~~and~~Securities ~~may~~Exchange Act of 1934, beas ~~exercised~~amended ~~for~~(the ~~cash or~~“Exchange Act”), ifand atRule 13d-3 thereunder), ~~the~~would ~~time~~result ofin ~~exercise~~Ascent ~~there~~beneficially isowning nomore ~~effective~~than ~~registration~~9.99% ~~statement~~of ~~covering~~ the ~~resale~~outstanding shares of Common Stock (the ~~Commitment~~“Beneficial ~~Warrant~~Ownership ~~Shares, on a cashless basis~~Limitation”).

InThe ~~addition,~~net weproceeds ~~have~~to ~~agreed~~us from sales that we elect to ~~reimburse~~make to Ascent ~~for~~ under the ~~reasonable~~ELOC ~~legal~~Purchase ~~fees~~Agreement, if any, will depend on the frequency and ~~disbursements~~prices at which we sell shares of ~~Ascent’s~~our ~~legal~~Common ~~counsel~~Stock into ~~connection~~Ascent. ~~with~~We expect ~~the~~that ~~transactions~~any ~~contemplated~~proceeds received by us from such sales of Common Stock to Ascent will be used solely for the purchase of Bitcoin (which ~~Purchase~~can ~~Agreement~~be ~~and~~used for debt repayment) provided that the ~~Registration~~Company’s ~~Rights~~cash ~~Agreement~~balance inon anthe ~~amount~~date ~~not~~of tothe ~~exceed~~applicable sale exceeds $305,000,000. If ~~upon~~the ~~our~~cash ~~execution~~balance ofis less than $5,000,000, proceeds to the ~~Purchase~~Company ~~Agreement~~ shall be allocated first to bring the balance to $5,000,000 and ~~Registration~~the remaining ~~Rights~~proceeds ~~Agreement~~to purchase Bitcoin.

~~The~~There ~~Purchase~~are ~~Agreement~~no ~~and~~restrictions ~~the~~on ~~Registration~~future ~~Rights Agreement~~financings, ~~contain~~rights ~~customary~~of ~~representations,~~first ~~warranties~~refusal, participation ~~conditions~~rights, ~~and~~penalties ~~indemnification~~or ~~obligations~~liquidated ofdamages ~~the~~in ~~parties. Copies of~~ the ~~agreements have~~ELOC ~~been~~Purchase ~~filed~~Agreement asor ~~exhibits~~ELOC toRegistration ~~the~~Rights ~~registration statement that includes this prospectus and are available electronically on the SEC’s website at www~~Agreement.~~sec.gov.~~

~~Because the per share purchase price that~~ Ascent ~~will~~has ~~pay~~agreed ~~for Purchase Shares in any Purchase~~ that, ~~we may elect to effect pursuant to the Purchase Agreement will be determined by reference to the VWAP~~ during the ~~applicable~~term ~~Valuation~~of ~~Period on~~ the ~~applicable~~ELOC ~~Closing~~Purchase ~~Date~~Agreement, none as of ~~the~~Ascent, ~~date~~any of ~~this~~its ~~prospectus~~officers, we ~~cannot~~or ~~determine~~any ~~the~~entity ~~actual~~managed ~~purchase~~or ~~price~~controlled ~~per~~by ~~share that~~ Ascent will beengage ~~required to pay for any Purchase Shares that we may elect to sell to Ascent under the Purchase Agreement from and after Commencement and, therefore, we cannot be certain how many Purchase Shares,~~ in ~~the~~or ~~aggregate~~effect, wedirectly ~~may~~or ~~issue and sell to Ascent under the Purchase Agreement from and after Commencement. As of October 8~~indirectly, ~~2025, there~~for ~~were~~its ~~41,759,307~~own ~~shares~~principal ofaccount ~~our~~or ~~Common~~for ~~Stock~~the ~~outstanding,~~principal ofaccount ~~which 34,982,922 shares were held by non-affiliates~~ of ~~our~~any ~~Company. If~~such ~~all~~entity ofmanaged ~~the~~or ~~42,211,548~~controlled ~~Purchase Shares offered for resale~~ by Ascent, ~~under~~any ~~this~~short ~~prospectus~~sales ~~were issued and outstanding~~ (as ofsuch ~~the date~~term ~~hereof,~~is ~~such~~defined ~~shares~~in ~~would~~Rule 200 ~~represent~~of ~~approximately~~Regulation SHO ~~50.3%~~ of the ~~total~~Exchange Act) ~~number~~ of ~~outstanding~~the ~~shares of~~ Common Stock ~~and~~or ~~approximately~~hedging ~~54.7% of~~transaction ~~the~~that ~~total~~establishes a ~~number~~net ofshort ~~outstanding~~position ~~shares~~in ofthe Common Stock ~~held by non-affiliates of our Company, in each case as of October 8, 2025~~.

~~Although~~The ~~the~~ELOC Purchase Agreement ~~provides~~will ~~that~~automatically weterminate ~~may~~on ~~sell up to $100,000,000 of our Common Stock to Ascent, only an additional 42,211,548 Purchase Shares are being registered under~~ the ~~Securities Act for resale~~earliest ~~by Ascent under the registration statement which includes this prospectus. This amount is in addition~~ to ~~the~~occur ~~8,970,830~~of ~~shares previously registered for resale in our prior registration statement, which was declared effective on August 25, 2025, including 900,000 Commitment Warrant Shares~~ (~~for which we have not and will not receive any cash consideration~~i)~~. If we were to issue and sell all of such 42~~ July 27,~~211,548 Purchase~~ ~~Shares to Ascent at an assumed purchase price per share of $0.34~~2028, ~~representing~~ (ii) the ~~closing~~date ~~sale price of our Common Stock~~ on ~~Nasdaq~~ onwhich ~~October~~Ascent 7,shall ~~2025,~~have wepurchased ~~would only receive approximately $14.4 million in aggregate gross proceeds~~ from ~~the~~us ~~sale of such Purchase Shares to Ascent~~ under the ~~Purchase~~ELOC ~~Agreement. Depending on the market prices of our Common Stock on the~~ Purchase ~~Dates on which we elect to sell such Purchase Shares to Ascent under the Purchase~~ Agreement~~, we may in the future need to register under the Securities~~ ~~Act additional~~ shares of ~~our~~ Common Stock for ~~resale~~an byaggregate ~~Ascent~~gross ~~which,~~purchase ~~together~~price ~~with~~of ~~the 42~~$100,~~211~~000,~~548 Purchase Shares included in this prospectus~~000, ~~will~~ ~~enable us to issue~~ and ~~sell to Ascent such aggregate number of shares of Common Stock under~~ (iii) the ~~Purchase~~date ~~Agreement~~either asparty ~~will~~effectively ~~be necessary~~delivers innotice ~~order for us~~ to ~~receive~~the ~~aggregate~~other ~~proceeds~~party ~~equal~~of tosuch ~~Ascent’s $100,000,000 maximum aggregate purchase commitment available to us under the Purchase Agreement~~termination.

~~The~~As ~~number~~consideration ~~of Purchase Shares ultimately offered~~ for ~~resale by~~ Ascent’s ~~through~~commitment ~~this~~to ~~prospectus~~purchase ~~is dependent upon the number of~~ shares of Common Stock, ifat ~~any,~~our wedirection ~~elect~~upon tothe ~~issue~~terms and~~/or sell~~ subject to ~~Ascent under~~ the ~~Purchase~~conditions ~~Agreement~~set ~~from~~forth ~~and~~in ~~after~~ the ~~Effective~~ELOC ~~Date.~~Purchase ~~The~~Agreement, ~~issuance~~upon of our ~~Common~~execution of ~~Stock~~the toterm ~~Ascent~~sheet ~~pursuant~~relating to the ELOC Purchase Agreement, ~~will~~we ~~not~~issued ~~affect~~Ascent ~~the~~Commitment ~~rights~~Warrant orto ~~privileges~~purchase ~~of our existing stockholders~~900,000 shares ~~except~~of ~~that~~Common Stock (the ~~economic~~“Commitment ~~and~~Warrant ~~voting~~Shares”). ~~interests of~~The ~~each~~Commitment ofWarrants ~~our~~have ~~existing~~an ~~stockholders~~exercise ~~will~~price beof ~~diluted~~$0.01 ~~Although~~and ~~the~~may ~~number~~be ofexercised ~~shares of our Common Stock that our existing stockholders~~for ~~own~~cash ~~will~~or, ~~not~~if ~~decrease,~~at the ~~shares~~time of ~~our~~exercise ~~Common~~there ~~Stock~~is ~~owned~~no byeffective ~~our~~registration ~~existing~~statement ~~stockholders~~covering ~~will~~the ~~represent~~resale aof ~~smaller~~the ~~percentage~~Commitment ofWarrant ~~our total~~Shares, ~~outstanding~~on ~~shares~~a ofcashless ~~our Common Stock after any such issuance~~basis.

~~Corporate~~In ~~Information~~addition, we have agreed to reimburse Ascent for the reasonable legal fees and disbursements of Ascent’s legal counsel in connection with the transactions contemplated by the ELOC Purchase Agreement and the Registration Rights Agreement in an amount not to exceed $30,000 upon our execution of the ELOC Purchase Agreement and Registration Rights Agreement.

Our principal executive offices are located at 626 Bancroft Way, Suite A, Berkeley, CA 94710, and our telephone number is (925) 997-6925. Our website address is www.profusa.com. Information on our website is not part of this prospectus. We have included our website address as an inactive textual reference only. The information on or accessible through our website is not part of this prospectus supplement and the accompanying prospectus.

~~THE~~The ~~OFFERING~~ELOC Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions, and indemnification obligations of the parties. Copies of the agreements have been filed as exhibits to the registration statement that includes this prospectus and are available electronically on the SEC’s website at www.sec.gov.

Shares of common stock offered by the Selling Stockholders		Up to 42,594,048 shares of common stock comprising (i) 42,211,548 shares of Common Stock by Ascent of which we may, at our election, issue and sell to Ascent pursuant to the Purchase Agreement from time to time after the date of this prospectus, subject to the satisfaction of specified conditions and (ii) 382,500 shares issued to certain parties in satisfaction of transaction costs incurred in connection with the Business Combination we completed on July 11, 2025.
Shares of common stock outstanding (as of October 8, 2025)		41,759,307 shares of Common Stock
Shares of common stock outstanding after giving effect to the issuance of the shares registered hereunder:		83,453,355 shares of Common Stock
Use of proceeds		We will not receive any proceeds from the sale of the Resale Securities by the Selling Stockholders. However, we may receive up to $100,000,000 in aggregate gross proceeds from sales of the Purchase Shares to Ascent that we may, in our discretion, elect to make, from time to time after the date of this prospectus, pursuant to the Purchase Agreement. The net proceeds from sales, if any, under the Purchase Agreement, will depend on the frequency and prices at which we sell the Purchase Shares to Ascent after the date of this prospectus. To the extent we sell Purchase Shares to Ascent, we intend to use any proceeds therefrom for the purchase of Bitcoin (which can be used for debt repayment) provided that the Company’s cash balance on the date of the applicable sale exceeds $5,000,000. If the cash balance is less than $5,000,000, proceeds to the Company shall be allocated first to bring the balance to $5,000,000 and the remaining proceeds to purchase Bitcoin. See “Use of Proceeds” on page 75 of this prospectus.
Terms of this offering		The Selling Stockholders, including their transferees, donees, pledgees, assignees and successors-in-interest, may sell, transfer or otherwise dispose of any or all of the shares of common stock offered by this prospectus from time to time on The Nasdaq Global Market or any other stock exchange, market or trading facility on which the shares are traded or in private transactions. The shares of common stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market price or at negotiated prices.
Nasdaq symbol		Our common stock is listed on the Nasdaq Global Market under the symbols “PFSA” and “PFSAW,” respectively.
Risk Factors		Investing in our securities involves a high degree of risk and purchasers of our securities may lose their entire investment. See “Risk Factors” for a discussion of factors you should carefully consider before deciding whether to invest in our securities.

Because the per share purchase price that Ascent will pay for Purchase Shares in any Purchase that we may elect to effect pursuant to the ELOC Purchase Agreement will be determined by reference to the VWAP during the applicable Valuation Period on the applicable Closing Date, as of the date of this prospectus, we cannot determine the actual purchase price per share that Ascent will be required to pay for any Purchase Shares that we may elect to sell to Ascent under the ELOC Purchase Agreement from and after Commencement and, therefore, we cannot be certain how many Purchase Shares, in the aggregate, we may issue and sell to Ascent under the ELOC Purchase Agreement from and after Commencement. As of February 3, 2026, there were 92,414,296 shares of our Common Stock outstanding, of which 86,537,911 shares were held by non-affiliates of our Company. If all of the 25,000,000 Purchase Shares offered for resale by Ascent under this prospectus were issued and outstanding as of the date hereof, such shares would represent approximately 21.3% of the total number of outstanding shares of Common Stock and approximately 22.4% of the total number of outstanding shares of Common Stock held by non-affiliates of our Company, in each case as of February 3, 2026.

Although the ELOC Purchase Agreement provides that we may sell up to $100,000,000 of our Common Stock to Ascent, only an additional 25,000,000 Purchase Shares are being registered under the Securities Act for resale by Ascent under the registration statement which includes this prospectus. This amount is in addition to the 8,970,830 and 42,211,548 shares previously registered for resale in our prior registration statements, including 900,000 Commitment Warrant Shares (for which we have not and will not receive any cash consideration). If we were to issue and sell all of such 25,000,000 Purchase Shares to Ascent at an assumed purchase price per share of $0.09, representing the closing sale price of our Common Stock on Nasdaq on February 2, 2026, we would only receive approximately $2.25 million in aggregate gross proceeds from the sale of such Purchase Shares to Ascent under the ELOC Purchase Agreement. Depending on the market prices of our Common Stock on the Purchase Dates on which we elect to sell such Purchase Shares to Ascent under the ELOC Purchase Agreement, we may in the future need to register under the Securities Act additional shares of our Common Stock for resale by Ascent which, together with the 25,000,000 Purchase Shares included in this prospectus, will enable us to issue and sell to Ascent such aggregate number of shares of Common Stock under the ELOC Purchase Agreement as will be necessary in order for us to receive aggregate proceeds equal to Ascent’s $100,000,000 maximum aggregate purchase commitment available to us under the ELOC Purchase Agreement.

The number of Purchase Shares ultimately offered for resale by Ascent through this prospectus is dependent upon the number of shares of Common Stock, if any, we elect to issue and/or sell to Ascent under the ELOC Purchase Agreement from and after the Effective Date. The issuance of our Common Stock to Ascent pursuant to the ELOC Purchase Agreement will not affect the rights or privileges of our existing stockholders, except that the economic and voting interests of each of our existing stockholders will be diluted. Although the number of shares of our Common Stock that our existing stockholders own will not decrease, the shares of our Common Stock owned by our existing stockholders will represent a smaller percentage of our total outstanding shares of our Common Stock after any such issuance.

Amendment No. 1 to ELOC Purchase Agreement

On December 22, 2025, the Company entered into Amendment No. 1 (the “SPA Amendment”) to the ELOC Purchase Agreement. Pursuant to the SPA Amendment, Section 1.1 of the ELOC Purchase Agreement was amended and restated to modify the definition of Floor Price to provide for a Floor Price at or above $0.111 per share during the period commencing on the date of the SPA Amendment and ending on, but excluding, the effective date of the reverse stock split presented to the Company’s stockholders in January 2026 for their approval, when such reverse stock split becomes effective (the “Modification Period”). The “Floor Price” as amended and restated means, during the Modification Period, solely with respect to an aggregate number of shares of Common Stock issued and sold as Purchased Securities not to exceed 13,650,000 shares, to be sold at or above $0.111 per share and below $0.14. Upon the earliest to occur of (x) the issuance of such aggregate number of 13,650,000 shares as Purchased Securities during the Modification Period or (y) the end of the Modification Period, the Floor Price shall thereafter mean $0.14, the price per share of Common Stock equal to the product obtained by multiplying (x) twenty percent (20%) by (y) the Official Closing Price on July 25, 2025, in each case as further adjusted to reflect any reduction (but excluding any increase) in the price per share of Common Stock caused by any reorganization, recapitalization, non-cash dividend, share split or other similar transaction, all as provided in this Agreement. The modified Floor Price of $0.111 per share applies only during the Modification Period and only up to the 13,650,000 share cap relating to shares issued and sold below 14 cents ($0.14), and the unmodified definition applies to all other times and shares. Since our Form 10-Q filing for the period ended September 30, 2025, the Company has drawn $6.7 million under the ELOC Purchase Agreement, and has made loan repayments with these proceeds of $1.3 million through December 31, 2025 and as of the date of this filing.

~~RISK~~Founder Shares ~~FACTORS~~

~~Investing in our securities~~In ~~includes~~April a2021, ~~high~~the ~~degree~~Sponsor ofpaid ~~risk. Prior to making a decision about investing in our securities~~$25,000, ~~you~~or ~~should~~approximately ~~consider~~$0.005 ~~carefully~~per ~~the specific factors discussed below~~share, ~~together~~to ~~with~~cover ~~all~~certain of the ~~other~~offering ~~information~~costs ~~contained~~ in ~~this~~exchange ~~prospectus.~~for Ifan ~~any~~ aggregate of ~~the following risks actually occurs~~5, ~~our business~~175,000 ~~financial~~shares ~~condition, results~~ of ~~operations~~common ~~and~~stock, ~~future~~par ~~prospects~~value ~~would likely be materially and adversely affected~~$0. ~~This~~0001 ~~could~~per ~~cause~~share (the ~~market~~“Founder ~~price of our Common Stock to decline and could cause you to lose all or part of your investment~~Shares”).

~~Summary~~In October 2021, the Sponsor irrevocably surrendered to the Company for cancellation and for no consideration 862,500 shares of ~~Risk~~common ~~Factors:~~stock. On December 20, 2021, the Company effected a 1.1- for-1 stock dividend of its common stock, resulting in the Sponsor holding an aggregate of 4,743,750 shares of common stock.

The Sponsor agreed not to transfer, assign or sell any of their Founder Shares until the earlier to occur of: (A) July 11, 2026 or (B) the date on which the Company completes a liquidation, merger, stock exchange or other similar transaction after the initial Business Combination that results in all of the Company’s public stockholders having the right to exchange their shares of common stock for cash, securities or other property (the “Lock-up”). Notwithstanding the foregoing, if the last sale price of the Company’s common stock equals or exceeds $12.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading day period commencing at least 150 days after the initial Business Combination, the Founder Shares will be released from the Lock-up.

Inducement Shares

In connection with the Business Combination, we issued shares of our common stock to certain investors as an inducement (the “Inducement Shares”) for such investors to provide an aggregate of $300,000 in short-term financing to the Company prior to the completion of the Business Combination (the “Short-Term Bridge Loans”). The Inducement Shares were issued as equity consideration, without cash proceeds to the Company. We are registering the resale of up to 150,000 of these outstanding Inducement Shares. The Company will not receive any proceeds from the sale of the Inducement Shares by the selling stockholders.

Business Combination Shares

In connection with the Business Combination, each share of Legacy Profusa common stock (including shares issued upon conversion of Legacy Profusa preferred stock) that was issued and outstanding immediately prior to the effective time of the Business Combination (other than shares held as treasury stock) was canceled and converted into the right to receive approximately 0.75 shares of our Common Stock, with each share of our Common Stock deemed to have a value of $10.00 per share, based on the parties’ then current assumptions and subject to the adjustments set forth in the merger agreement. Based on the number of shares of Legacy Profusa common stock outstanding, the total number of shares issued in connection with the Business Combination was approximately 19.9 million, and Legacy Profusa equity holders also received the right to receive up to an additional 3,875,000 shares of our Common Stock upon the achievement of specified milestones. We are registering the resale of up to 5,679,426 of the shares issued to certain former shareholders of Legacy Profusa in the Business Combination. We will not receive any proceeds from the sale of the Business Combination Shares by the selling stockholders.

Summary of Risk Factors

Below is a summary of the principal factors that make an investment in our company speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below, after this summary, and should be carefully considered, together with other information in this prospectus and our other filings with the SEC before making an investment decision in our securities.

Risks Related to the Committed Equity Facility

● It is not possible to predict the actual number of shares of Common Stock, if any, we will sell under the ELOC Purchase Agreement to Ascent, or the actual gross proceeds resulting from those sales.

●

The sale and issuance of our Common Stock to Ascent will cause dilution to our existing stockholders, and the sale of Purchase Shares acquired by Ascent, or the perception that such sales may occur, could cause the price of our Common Stock to fall.

●

Investors who buy Purchase Shares from Ascent at different times will likely pay different prices.

● We may use the net proceeds from sales of shares of our Common Stock made pursuant to the ELOC Purchase Agreement, if any, in ways with which you may not agree or in ways which may not yield a significant return.

●

We will primarily use the net proceeds from this offering to purchase Bitcoin, the price of which has been, and will likely continue to be, highly volatile.

●

If our common stock trades below the $0.111 floor price, we will be unable to sell shares, which could materially limit our access to capital.

Risks Related to Our Business and Operations

●

We have substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain further financing.

●

Issuance of a Material Number of Additional Shares of Common Stock Pursuant to Outstanding Warrants Could Result in Significant Dilution and Depress the Market Price of Our Common Stock.

●

We have a limited operating history on which to assess the prospects for our business and we have incurred losses since inception. We anticipate that we will continue to incur significant losses for at least the next several years as we continue to commercialize our existing products and services and seek to develop and commercialize new products and services.

●

We have been notified by The Nasdaq Stock Market LLC (“Nasdaq”) of our failure to comply with certain Nasdaq Global Market continued listing requirements and, if we are unable to regain compliance with all applicable continued listing requirements and standards of the Nasdaq Global Market, our Common Stock could be delisted from the Nasdaq Global Market.

●

We operate in a highly competitive market and face competition from large, well-established companies with significant resources, and, as a result, we may not be able to compete effectively.

●

We are subject to a variety of risks due to our international operations that could adversely affect our business, our operations or profitability and operating results.

●

There are a variety of oxygen monitoring and CGM products and technologies, and consumer confusion about product features and technology could lead consumers to purchase competitive products instead of our products, or to conflate any adverse events or safety issues associated with oxygen monitoring and CGM products with our products, which could adversely affect our business, financial condition and results of operations.

●

We expect the commercialization of the Lumee Oxygen Platform to generate nearly all our commercial revenue until we obtain regulatory approval for additional products.

●

We depend upon third-party suppliers and outsource to other parties, making us vulnerable to supply disruptions, suboptimal quality, noncompliance and/or price fluctuations, which could harm our business.

Risks Related to Healthcare Industry Shifts and Changing Regulations

●

There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our products, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.

●

If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating results.

●

Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.

●

Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

● Our current or future products may be subject to product recalls even after receiving FDA clearance or approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.

● Changes to the regulatory landscape may impact our ability to obtain marketing authorization for future product developments.

● Our failure to comply with laws, regulations and contract requirements relating to reimbursement of health care goods and services may subject us to penalties and adversely impact our reputation, business, financial condition and cash flows.

● We are subject to complex and evolving U.S. and foreign laws and regulations and other requirements regarding privacy, data protection, security, and other matters. Many of these laws and regulations are subject to change and uncertain interpretation, and could result in claims, changes to our business practices, monetary penalties, increased cost of operations, or declines in user growth or engagement, or otherwise harm our business.

● Cybersecurity risks and cyber incidents could result in the compromise of confidential data or critical data systems and give rise to potential harm to customers, remediation and other expenses, expose us to liability under HIPAA, consumer protection laws, or other common law theories, subject us to litigation and federal and state governmental inquiries, damage our reputation, and otherwise be disruptive to our business and operations.

Risks Related to Intellectual Property Protection and Use

●

We may become subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages and injunctive relief. We may also be subject to other claims or suits.

● We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

● We may not be able to protect our intellectual property rights throughout the world, which could materially, negatively affect our business.

● If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed.

● We may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of our current or future products, and we cannot provide any assurances that we would be able to obtain such licenses.

● Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submission, fee payment and other requirements imposed by government patent agencies and our patent protection could be reduced or eliminated for non-compliance with these requirements.

● If we do not obtain patent term extension and/or data exclusivity for any product candidates we decide to develop as drug product candidates, our business may be materially harmed.

General Risks of Profusa’s Business

● If we are unable to successfully remediate our existing material weaknesses and maintain effective internal control over financial reporting, investors may lose confidence in our reported financial information and our stock price and our business may be adversely impacted.

●

Environmental, social and corporate governance, or ESG regulations, policies and provisions may make our supply chain more complex and may adversely affect our relationships with customers.

● Current uncertainty in domestic and global economic and political conditions makes it particularly difficult to predict product demand and other related matters and makes it more likely that our actual results could differ materially from expectations.

● Changes in financial accounting standards or practices or existing taxation rules or practices may cause adverse unexpected revenue and/or expense fluctuations and affect our reported results of operations.

●

We identified material weaknesses in our internal control over financial reporting. These material weaknesses could continue to adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner.

● If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired, which may adversely affect investor confidence in our Company and, as a result, the market price of our ~~common~~Common ~~stock~~Stock.

Risks Related to our Bitcoin Treasury Strategy and Holdings

●

Our bitcoin treasury strategy exposes us to various risks associated with bitcoin.

● Bitcoin is a highly volatile asset, and fluctuations in the price of bitcoin are likely to influence our financial results and the market price of our ~~common~~Common ~~stock~~Stock.

● Bitcoin and other digital assets are novel assets, and are subject to significant legal, commercial, regulatory and technical uncertainty.

● Our historical financial statements do not reflect our acquisition of bitcoin, the fact that our bitcoin holdings could be a substantial part of our assets, or the potential variability in earnings that we may experience in the future relating to our bitcoin holdings.

● The concentration of our bitcoin holdings will enhance the risks inherent in our bitcoin treasury strategy.

● Our bitcoin holdings are less liquid than our existing cash and cash equivalents and may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents.

● Regulatory change reclassifying bitcoin as a security could lead to our classification as an “investment company” under the Investment Company Act of 1940, as amended, or the 1940 Act, and could adversely affect the market price of bitcoin and the market price of our common stock.

●

We may be subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect our business, financial condition, and results of operations.

●

Our custodially-held bitcoin may become part of the custodian’s insolvency estate if one or more of our custodians enters bankruptcy, receivership or similar insolvency proceedings.

~~Additional~~ Risks Related to Ownership of ~~Profusa~~ ~~Common~~Our ~~Stock Following the Business Combination~~Securities

● There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq, a failure of which could result in a de-listing of our ~~common~~Common ~~stock~~Stock.

●

Future sales, or the perception of future sales, by Profusa shareholders in the public market could cause the market price for Profusa Common Stock to decline.

● The grant and future exercise of registration rights may adversely affect the market price of Profusa shares.

●

The grant and future exercise of registration rights may adversely affect the market price of Profusa shares.

●

In addition, the shares of Profusa Common Stock reserved for future issuance under the Equity Incentive Plan will become eligible for sale in the public market once those shares are issued.

●

Because there are no current plans to pay cash dividends on Profusa Common Stock for the foreseeable future, you may not receive any return on investment unless you sell Profusa Common Stock for a price greater than that which you paid for it.

●

We may issue additional shares of its common stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of Profusa Common Stock.

●

We may redeem the unexpired NorthView Public Warrants prior to their exercise at a time that is disadvantageous to you, thereby making your warrants worthless.

Corporate Information

Our principal executive offices are located at 626 Bancroft Way, Suite A, Berkeley, CA 94710, and our telephone number is (925) 997-6925. Our website address is www.profusa.com. Information on our website is not part of this prospectus. We have included our website address as an inactive textual reference only. The information on or accessible through our website is not part of this prospectus supplement and the accompanying prospectus.

We are an “emerging growth company” as defined in the JOBS Act. We will remain an emerging growth company until the earlier of (i) December 31, 2026, the last day of the fiscal year following the fifth anniversary of the date of the first sale of our Common Stock pursuant to an effective registration statement under the Securities Act; (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under applicable SEC rules.

We are also a “smaller reporting company” as defined in Rule 12b-2 of the Exchange Act, and have elected to take advantage of certain of the scaled disclosure available for smaller reporting companies.

THE OFFERING

Shares of common stock offered by us		9,487,500 shares of Common Stock issuable upon exercise of the Public Warrants.

Shares of common stock offered by the Selling Stockholders		Up to 43,489,926 shares of common stock by the Selling Stockholders comprising:

Up to 25,000,000 shares of Common Stock by Ascent pursuant to the ELOC Purchase Agreement;

ii.

Up to 4,743,750 Founder Shares issued to the Sponsor pursuant to certain securities subscription agreements;

iii.

Up to 7,347,500 shares of Common Stock that are issuable upon the exercise of the Private Placement Warrants issued to the Sponsor, I-Bankers, and Dawson James in a private placement transaction that closed simultaneously with the Company’s IPO;

iv.

Up to 569,250 shares of Common Stock that are issuable upon the exercise of the Representative Warrants issued to I-Bankers and Dawson in a private placement transaction that closed simultaneously with the Company’s IPO;

Up to 150,000 Inducement Shares issued to certain investors as an inducement for the Short-Term Bridge Loans; and

vi.

Up to 5,679,426 shares of Common Stock issued in connection with the Business Combination to certain shareholder of Legacy Profusa.

Shares of common stock outstanding (as of February 3, 2026)		92,414,296 shares of Common Stock

Shares of common stock outstanding after giving effect to the issuance of the shares registered hereunder:		134,968,546 shares of Common Stock (assuming the full exercise of the Warrants)

Terms of this offering		The Selling Stockholders, including their transferees, donees, pledgees, assignees and successors-in-interest, may sell, transfer or otherwise dispose of any or all of the shares of common stock offered by this prospectus from time to time on The Nasdaq Global Market or any other stock exchange, market or trading facility on which the shares are traded or in private transactions. The shares of common stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market price or at negotiated prices.

Warrants exercisability		Each whole warrant is exercisable to purchase one share of our common stock.

Warrants exercise price		$11.50 per share, subject to adjustments.

Warrants exercise period		The warrants are currently exercisable. The warrants will expire at 5:00 p.m., New York City time, on July 11, 2030 or earlier upon redemption or liquidation.

Redemption of warrants

We may redeem the outstanding warrants (except as described herein with respect to the private placement warrants):

	●	in whole and not in part;

	●	at a price of $0.01 per warrant;

	●	upon a minimum of 30 days’ prior written notice of redemption, which we refer to as the 30-day redemption period; and

	●	if, and only if, the last sale price of our common stock equals or exceeds $18.00 per share for any 20 trading days within a 30-trading day period ending on the third trading day prior to the date on which we send the notice of redemption to the warrant holders.

		We will not redeem the warrants unless an effective registration statement under the Securities Act covering the shares of common stock issuable upon exercise of the warrants is effective and a current prospectus relating to those shares of common stock is available throughout the 30-day redemption period, except if the warrants may be exercised on a cashless basis and such cashless exercise is exempt from registration under the Securities Act. We may not redeem the warrants when a holder may not exercise such warrants.

		If we call the warrants for redemption as described above, our management will have the option to require all holders that wish to exercise warrants to do so on a “cashless basis.” In determining whether to require all holders to exercise their warrants on a “cashless basis,” our management will consider, among other factors, our cash position, the number of warrants that are outstanding and the dilutive effect on our stockholders of issuing the maximum number of shares of common stock issuable upon the exercise of our warrants. In such event, each holder would pay the exercise price by surrendering the warrants for that number of shares of common stock equal to the quotient obtained by dividing (x) the product of the number of shares of common stock underlying the warrants, multiplied by the difference between the exercise price of the warrants and the “fair market value” (defined below) by (y) the fair market value. The “fair market value” shall mean the average reported last sale price of the common stock for the 10 trading days ending on the third trading day prior to the date on which the notice of redemption is sent to the holders of warrants. Please see the section entitled “Description of Securities — Warrants — Public Warrants” for additional information.

		None of the private placement warrants will be redeemable by us so long as they are held by the initial purchasers of the private placement warrants or their permitted transferees.

Founder shares		In April 2021, the Sponsor paid $25,000, or approximately $0.005 per share, to cover certain of the offering costs in exchange for an aggregate of 5,175,000 shares of common stock, par value $0.0001 per share. In October 2021, the Sponsor irrevocably surrendered to the Company for cancellation and for no consideration 862,500 shares of common stock. On December 20, 2021, the Company effected a 1.1- for-1 stock dividend of its common stock, resulting in the Sponsor holding an aggregate of 4,743,750 shares of common stock.

		The founder shares are identical to our shares of Common Stock, except that:

	●	the founder shares are subject to certain transfer restrictions, as described in more detail below,

	●	our sponsor, officers and directors entered into a letter agreement with us, pursuant to which they agreed to waive their redemption rights with respect to their founder shares and public shares in connection with the completion of our initial business combination, and

	●	the founder shares are subject to registration rights.

Transfer restrictions on founder shares		In connection with our initial public offering, our sponsor agreed not to transfer, assign or sell any of its founder shares until the earlier to occur of: (A) one year after the completion of our initial business combination or (B) the date on which we complete a liquidation, merger, stock exchange or other similar transaction after our initial business combination that results in all of our public stockholders having the right to exchange their shares of common stock for cash, securities or other property. Notwithstanding the foregoing, if the last sale price of our common stock equals or exceeds $12.00 per share (as adjusted for stock splits, stock dividends, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading day period commencing at least 150 days after our initial business combination, the founder shares will be released from the lock-up.

Use of proceeds		We will not receive any proceeds from the sale of the Resale Securities by the Selling Stockholders. However, we may receive up to $100,000,000 in aggregate gross proceeds from sales of the Purchase Shares to Ascent that we may, in our discretion, elect to make, from time to time after the date of this prospectus, pursuant to the ELOC Purchase Agreement. Any sales of Purchase Shares will be executed at or above the floor or otherwise in compliance with applicable exchange rules, at prevailing market prices or as otherwise permitted.

		The net proceeds from sales, if any, under the ELOC Purchase Agreement, will depend on the frequency and prices at which we sell the Purchase Shares to Ascent after the date of this prospectus. To the extent we sell Purchase Shares to Ascent, we intend to use any proceeds therefrom for the purchase of Bitcoin (which can be used for debt repayment) provided that the Company’s cash balance on the date of the applicable sale exceeds $5,000,000. If the cash balance is less than $5,000,000, proceeds to the Company shall be allocated first to bring the balance to $5,000,000 and the remaining proceeds to purchase Bitcoin. See “Use of Proceeds” on page 79 of this prospectus.

		Additionally, we will receive proceeds from any cash exercise of the Warrants, which, if exercised in cash with respect to all of the 17,404,250 Warrants would result in aggregate gross proceeds to us of $200,148,875; however, there is no assurance that the holders of the Warrants will elect to exercise any or all of the Warrants. To the extent that Warrants are exercised on a “cashless basis,” the amount of cash we would receive from the exercise of the Warrants will decrease, potentially to zero. On February 2, 2026, the last reported sales price of our Common Stock was $0.09 and the exercise price per share of the Warrants was $11.50. The exercise price of the Warrants is significantly higher than the current market price of our Common Stock and accordingly, it is highly unlikely that Warrant holders will exercise their Warrants in the foreseeable future. Cash proceeds associated with the exercises of the Warrants are dependent on our stock price and given the recent price volatility of our Common Stock and relative lack of liquidity in our stock, there is no certainty that Warrant holders will exercise their Warrants and, accordingly, we may not receive any cash proceeds in relation to our outstanding Warrants. See “Description of Securities” for additional information regarding the Warrants.

Nasdaq symbol		Our common stock is listed on the Nasdaq Global Market under the symbol “PFSA.” Our Public Warrants are quoted on OTC Pink Limited under the symbol “NVACW.”

Risk Factors		Investing in our securities involves a high degree of risk and purchasers of our securities may lose their entire investment. See “Risk Factors” for a discussion of factors you should carefully consider before deciding whether to invest in our securities.

RISK FACTORS

Investing in our securities includes a high degree of risk. Prior to making a decision about investing in our securities, you should consider carefully the specific factors discussed below, together with all of the other information contained in this prospectus. If any of the following risks actually occurs, our business, financial condition, results of operations and future prospects would likely be materially and adversely affected. This could cause the market price of our Common Stock to decline and could cause you to lose all or part of your investment.

In addition to the other information contained in (or incorporated by reference into) this prospectus, including the matters addressed under the heading “Cautionary Note Regarding Forward-Looking Statements,” you should carefully consider the following risk factors. The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may have a material adverse effect on Profusa’s business, reputation, revenue, financial condition, results of operations and future prospects, in which event the market price of Profusa Common Stock could decline, and you could lose part or all of your investment. There may be additional risks that we do not presently know, or that we believe are immaterial as of the date hereof.

You should consider carefully the following risk factors, together with all of the other information included in this prospectus. If any of the following risks, either alone or taken together, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of our ~~common~~Common ~~stock~~Stock could decline, and stockholders may lose all or part of their investment.

Risks Related to Profusa

Unless the context otherwise requires, references in this subsection to “we,” “us,” “our” and the “Company” refer to Profusa, Inc.

Risks Related to the Committed Equity Facility

It is not possible to predict the actual number of shares of Common Stock, if any, we will sell under the ELOC Purchase Agreement to Ascent, or the actual gross proceeds resulting from those sales.

On July 28, 2025, we entered into the ELOC Purchase Agreement with Ascent, pursuant to which Ascent has committed to purchase up to $100,000,000 of shares of our Common Stock, subject to certain limitations and conditions set forth in the ELOC Purchase Agreement. The shares of our Common Stock that may be issued under the ELOC Purchase Agreement may be sold by us to Ascent at our discretion from time to time for a period of up to 36 months (unless the ELOC Purchase Agreement is earlier terminated) beginning on the Effective Date.

We generally have the right to control the timing and amount of any sales of our shares of Common Stock to Ascent under the ELOC Purchase Agreement. Sales of our Common Stock, if any, to Ascent under the ELOC Purchase Agreement will depend upon market conditions and other factors to be determined by us. We may ultimately decide to sell to Ascent all, some or none of the shares of our Common Stock that may be available for us to sell to Ascent pursuant to the ~~Purchase~~ELOC Purchase Agreement.

Although the ELOC Purchase Agreement provides that we may sell up to $100,000,000 of our Common Stock to Ascent, only an additional 4225,~~211~~000,~~548~~000 Purchase Shares are being registered under the Securities Act for resale by Ascent under the registration statement in addition to the previously registered shares of, 8,970,830 shares, declared effective on on August 25, 2025, including 900,000 Commitment Warrant Shares (for which we have not and will not receive any cash consideration)., ~~The~~and ~~total ELOC registered Purchase Shares of~~ 42,211,548 ~~may or may not cover all of the~~ shares, ofwhich ~~Common~~became ~~Stock~~effective wepursuant ~~ultimately sell~~ to ~~Ascent under~~Section ~~the~~8(a) ~~Purchase Agreement. Shares issuable upon exercise~~ of the ~~Commitment~~Securities ~~Warrants~~Act ~~that~~of we1933 ~~issued~~on toOctober ~~Ascent~~29, ~~upon~~2025. ~~our~~The ~~execution~~total ~~of the~~ELOC ~~term sheet relating to the~~ registered Purchase ~~Agreement~~Shares onof ~~July 20~~25, ~~2025~~000,000 asmay ~~consideration~~or ~~for~~may ~~its~~not ~~commitment~~cover toall ~~purchase~~of the shares of ~~our~~ Common Stock atwe ~~our~~ultimately ~~direction~~sell ~~from time~~ to ~~time~~Ascent under the ~~Purchase~~ELOC Purchase Agreement. If it becomes necessary for us to issue and sell to Ascent under the ELOC Purchase Agreement more than the total 4225,~~211~~000,~~548~~ 000 Purchase Shares being registered under the Securities Act for resale by Ascent under the registration statement that includes this prospectus in order to receive aggregate gross proceeds equal to $100,000,000 under the ELOC Purchase Agreement, we must file with the SEC one or more additional registration statements to register under the Securities Act the resale by Ascent of any such additional shares of our Common Stock we wish to sell from time to time under the ELOC Purchase Agreement, which the SEC must declare effective, in each case before we may elect to sell any additional shares of our Common Stock to Ascent under the ELOC Purchase Agreement. Any issuance and sale by us under the ELOC Purchase Agreement of a substantial amount of shares of Common Stock in addition to the total 4225,~~211~~000,~~548~~000 Purchase Shares being registered for resale by Ascent under the registration statement that includes this prospectus could cause additional substantial dilution to our stockholders. The number of Purchase Shares ultimately offered for resale by Ascent through this prospectus is dependent upon the number of shares of Common Stock, if any, we elect to sell to Ascent under the ELOC Purchase Agreement from and after the Effective Date.

812

The purchase price for the shares that we may sell to Ascent under the ELOC Purchase Agreement will fluctuate based on the price of our Common Stock. Depending on a number of factors, including market liquidity, sales of such shares may cause the trading price of our Common Stock to fall.

Ascent may resell all, some, or none of shares that we sell to Ascent subsequent to the date of this prospectus at its discretion, subject to the terms of the ELOC Purchase Agreement. Therefore, sales to ~~Ascent~~ Ascent by us could result in dilution to the interests of other holders of our Common Stock. Additionally, the sale of a substantial number of of shares of our Common Stock to Ascent, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a desirable time and price.

Investors who buy Purchase Shares from Ascent at different times will likely pay different prices.

Pursuant to the ELOC Purchase Agreement, we will have discretion, subject to market demand, to vary the timing, price and number of shares of Common Stock sold to Ascent. If and when we elect to sell Common Stock to Ascent pursuant to the ELOC Purchase Agreement, after Ascent has acquired Purchase Shares, Ascent may resell all, some or none of such shares at any time or from time to time in its sole discretion and at different prices. As a result, investors who purchase shares from Ascent in this offering at different times will likely pay different prices for those shares, and so may experience different levels of dilution and in some cases substantial dilution and different outcomes in their investment results. Investors may experience a decline in the value of the shares they purchase from Ascent in this offering as a result of future sales made by us to Ascent at prices lower than the prices such investors paid for their shares in this offering. In addition, if we sell a substantial number of shares to Ascent under the ELOC Purchase Agreement, or if investors expect that we will do so, the actual sales of shares or the mere existence of our arrangement with Ascent may make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales.

We will use the net proceeds from this offering exclusively to purchase additional Bitcoin, the price of which has been, and will likely continue to be, highly volatile.

The proceeds from the sale of the Purchase Shares are to be used exclusively for the purchase of Bitcoin (which may be used for repayment of indebtedness), provided the Company’s cash balance on any Closing Date exceeds $5,000,000. If the cash balance is less than $5,000,000, proceeds must first be used to bring the cash balance to that amount, with the remainder used to purchase Bitcoin. The Company is prohibited from using proceeds for executive compensation, distributions, or repayment of indebtedness to security holders. Bitcoin is a highly volatile asset that has traded below $53,000 per bitcoin and above $123,000 per bitcoin on Coinbase in the 12 months preceding the date of this prospectus supplement. In addition, Bitcoin does not pay interest or other returns and so the ability to generate a return on investment from the net proceeds from this offering will depend on whether there is appreciation in the value of Bitcoin following our purchases of Bitcoin with the net proceeds from this offering. Future fluctuations in Bitcoin trading prices may result in our converting Bitcoin purchased with the net proceeds from this offering into cash with a value substantially below the net proceeds from this offering.

~~Risks~~If ~~Related~~our common stock trades below the floor price under our ELOC Purchase Agreement with Ascent, we will be unable to ~~Profusa~~sell shares, which could materially limit our access to capital.

~~Unless~~Pursuant to the ~~context~~ELOC ~~otherwise~~Purchase ~~requires~~Agreement, ~~references~~if inthe ~~this~~market ~~subsection~~price toof our common stock is below the floor price per share of $0.111 (the “Floor Price”), we will be unable to sell shares under our purchase arrangements. As a result,” ~~“us~~our ability to raise capital when needed could be materially reduced or delayed. We may be forced to seek alternative financing on less favorable terms,” “including at higher cost or with greater dilution to existing stockholders, or to curtail or delay our” operational and strategic plans. Given the ~~“Company”~~volatility ~~refer~~and tolow trading volume of ~~Profusa~~our common stock, ~~Inc~~the risk that our stock trades at or below the Floor Price may be heightened and may persist for extended periods.

There can be no assurance that our increased stock price following the Reverse Stock Split will remain at a price that will be sufficient in order to meet any continued requirements and policies of Nasdaq or that our Common Stock will remain listed on Nasdaq.

There is no guarantee that, following the Reverse Stock Split, the price of our Common Stock will stay above the minimum listing requirements required by Nasdaq. Further, there can be no assurance that the market price of our Common Stock will remain at the level required for continuing compliance with the minimum price requirements. It is not uncommon for the market price of a company’s Common Stock to decline in the period following a reverse stock split. If the market price of our common were to experience such a decline, or if other factors unrelated to the number of shares of our Common Stock outstanding, such as negative financial or operational results, adversely affect the market price of our Common Stock, that may jeopardize our ability to meet or maintain the minimum bid price requirement of the exchange on which our Common Stock is listed.

Risks Related to Our Business and Operations

We have a history of net losses, and we may not achieve or maintain profitability in the future.

We have incurred net losses and negative cash flows from operations and we expect to continue to incur net losses and negative cash flows from operations for the foreseeable future, due in part to our continued investment in our business. We incurred a net loss of $27.3 million and $7.0 million for the nine months ended September 30, 2025 and 2024, respectively, and $9.2 million and $10.3 million for the years ended December 31, 2024 and 2023, respectively, and had an accumulated deficit of $152.2 million and $124.9 million as of September 30, 2025 and December 31, 2024, respectively. We expect our costs to increase in future periods as we continue to expend substantial resources on research and development, expansion into new markets, marketing and general administration (including expenses related to being a public company). The net losses we incur may fluctuate significantly from quarter to quarter.

Our long-term success is dependent upon our ability to generate increased revenue, obtain additional capital when needed and, ultimately, to achieve and maintain profitable operations. We will need to generate significant additional revenue and successfully manage our research and development and other expenses to achieve and maintain profitability. It is possible that we will not achieve profitability or that, even if we do achieve profitability, we may not maintain or increase profitability in the future. Our failure to achieve or maintain profitability could negatively impact our stock price.

We have substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain further financing.

Our recurring losses from operations raise substantial doubt about our ability to continue as a going concern. As a result, management has included disclosures in Note 1 of the financial statements and our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements for the year ended December 31, 2024 with respect to this uncertainty. Additionally, management has disclosed in Note 1 of the unaudited financial statements for the three and ~~six~~nine months ended ~~June~~September 30, 2025 that there continues to be factors which raise substantial doubt about our ability to continue as a going concern. Our audited 2024 financial statements and unaudited ~~June~~September 30, 2025 interim financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. Our ability to continue as a going concern will require us to obtain additional funding. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate certain of our operations, and our stockholders could lose all, or a significant portion, of their investment in us.

9Issuance of a Material Number of Additional Shares of Common Stock Pursuant to Outstanding Warrants Could Result in Significant Dilution and Depress the Market Price of Our Common Stock.

We have a significant number of warrants outstanding to purchase shares of our common stock. The exercise of these warrants, and the potential issuance of a material number of additional shares of common stock upon such exercise, could result in substantial dilution to existing stockholders, adversely affect the market price of our common stock, and create an “overhang” on the market for our shares.

The issuance of a large number of additional shares upon warrant exercise will dilute the ownership interests of existing stockholders and may reduce our earnings per share and the per share book value of our common stock. Even the potential for such issuance—regardless of whether or when the warrants are exercised—may adversely affect the trading price of our common stock as market participants factor in the likelihood of increased supply. This “overhang” may become more acute during periods when our stock price approaches or exceeds the applicable warrant exercise price, thereby increasing the probability of exercise and further sales into the market.

If holders elect to exercise warrants for cash, we will receive the exercise price and issue additional shares, increasing the public float and potentially exerting downward pressure on our stock price. If the warrants are exercisable on a cashless basis under certain circumstances, we could issue a significant number of shares without receiving corresponding cash proceeds, which would result in dilution without a commensurate increase in our capital resources. In addition, certain warrants may contain anti-dilution or price-protection provisions, reset mechanics, or adjustments for dividends, splits, reorganizations, or other corporate actions. These features could result in the issuance of additional shares or a reduction in the effective exercise price, compounding dilution and potentially leading to further declines in the market price of our common stock.

The timing and magnitude of warrant exercises are outside of our control and may occur at times when we would otherwise seek to limit equity issuance, such as during periods of low trading prices, limited liquidity, or heightened volatility. Sales of substantial amounts of our common stock in the public market following any warrant exercises, or the perception that such sales could occur, could adversely affect the market price of our common stock and make it more difficult for us to raise additional capital through future equity or equity-linked offerings on acceptable terms, if at all. Moreover, if a substantial number of warrants are exercised within a short period, the resulting influx of freely tradable shares could exacerbate short-term volatility, amplify price declines, and impair the investment value of our common stock.

If the exercise of warrants requires us to obtain stockholder approval under applicable stock exchange rules or results in issuances that approach or exceed exchange thresholds, we may be constrained in our ability to manage the timing and structure of issuances. In addition, if our stock price remains below the applicable exercise price of some or all of the warrants, such warrants may not be exercised for cash and we may not realize any proceeds from them, limiting our liquidity and financial flexibility while the potential dilutive overhang persists.

Any of the foregoing could materially and adversely affect your investment, including through dilution of your ownership interest, reduced earnings per share, increased share count, and a decline in the trading price of our common stock. The effects of these risks may be magnified if market conditions are unfavorable or if our business performance does not meet investor expectations.

Since inception, we have devoted substantially all of our financial resources to developing our products and related services. We have financed our operations primarily through the issuance of equity and debt securities. We have incurred significant losses. The amount of our future net losses will depend, in part, on regulatory approval, commercialization and on-going development of our products and related services, the rate of our future expenditures and our ability to obtain funding through the issuance of our securities, strategic collaborations or grants. We expect to continue to incur significant losses for several years as we continue to commercialize our Lumee Oxygen and Glucose Platform and seek to develop and commercialize new products and services. We anticipate that our expenses will increase substantially if and as we:

●

continue to build our sales, marketing and distribution infrastructure to commercialize our products and services;

●

continue to develop our products and services;

●

as we continue to conduct clinical studies;

●

seek to identify, assess, acquire, license and/or develop other products and services and subsequent generations of our current products and services;

●

seek to maintain, protect and expand our intellectual property portfolio;

●

seek to attract and retain skilled personnel; and

●

support our operations as a public company.

Our ability to generate future revenue from product and service sales depends heavily on our success in many areas, including, but not limited to:

●

launching and commercializing current and future products and services;

●

obtaining and maintaining marketing authorization with respect to each of our products and maintaining regulatory compliance throughout relevant jurisdictions;

●

maintaining clinical and economical value for end-users and customers in changing environments;

●

addressing any competing technological and market developments;

●

negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;

●

establishing and maintaining manufacturing facilities;

●

establishing and maintaining distribution relationships with third-parties that can provide adequate (in amount and quality) infrastructure to support market demand for our products; and

●

maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how.

Profusa does not intend to pay cash dividends for the foreseeable future.

Profusa currently intends to retain its future earnings, if any, to finance the further development and expansion of its business and does not intend to pay cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors and will depend on its financial condition, results of operations, capital requirements and future agreements and financing instruments, business prospects and such other factors as its board of directors deems relevant.

We have been notified by Nasdaq of our failure to comply with certain Nasdaq Global Market continued listing requirements and if we are unable to regain compliance with all applicable continued listing requirements and standards of the Nasdaq Global Market, our Common Stock could be delisted from the Nasdaq Global Market.

Our Common Stock is listed on the Nasdaq Global Market and to maintain our listing, we are required to satisfy continued listing requirements. There can be no assurance we will continue satisfying such continued listing requirements, which include among other requirements, that the closing bid price of our Common Stock be at least $1.00 per share and that that the market value of our publicly held shares of Common Stock be at least $1 million.

On September 11, 2025, we received a letter from the Staff notifying the Company that, for the previous 30 consecutive business days, the closing bid price for the Common Stock had been below the minimum $1.00 per share required for continued listing on the Nasdaq Global Market under the Minimum Bid Price Requirement. The Staff provided the Company with an initial period of 180 calendar days, or until March 10, 2026, to regain compliance with the Minimum Bid Price Requirement. In order to regain compliance with such requirement, the Company held a special meeting of shareholders on January 27, 2026 and obtained shareholder approval for a Reverse Stock Split of its Common Stock at a ratio between 1-for-30 to 1-for-200.

In addition, on October 27, 2025, the Company received a letter from the Staff notifying the Company that, for the previous 30 consecutive business days, the Company’s market value of publicly held shares was below the $15,000,000 threshold required for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5450(b)(2)(C). The Staff provided the Company with an initial period of 180 calendar days, or until April 27, 2026, to regain compliance with the Market Value Requirement.

There can be no assurance that the Company will be able to comply with all of the obligations placed on us by Nasdaq in order to regain compliance with such Nasdaq Global Market continued listing standards, and, assuming that we are able to comply with such obligations, that we will be able to continue to comply with such Nasdaq Global Market listing standards in the future, including the Minimum Bid Price Requirement and the Market Value Requirement. If we fail to regain compliance by the initial 180-day periods set forth above, we may not be successful in any appeal to Nasdaq to grant additional extensions, or in the event that we are successful, we may not be able to regain compliance by such additional extension date. In the event that we are not successful in such appeal or we are not able to regain compliance with such requirements by any applicable date, our Common Stock will be subject to delisting from Nasdaq. Additionally, assuming we are able to comply with all such obligations, if we fail to comply with all applicable Nasdaq listing requirements now or in the future, our Common Stock may be subject to delisting from Nasdaq.

In the event of such a delisting and that the Common Stock is not eligible for trading on another national securities exchange, trading of our Common Stock could be conducted in the over-the-counter market operated by the OTC Markets Group, Inc. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our Common Stock, and it would likely be more difficult to obtain coverage by securities analysts and the news media, which could cause the price of our Common Stock to decline further. Also, it may be difficult for us to raise additional capital if we are not listed on a national exchange. Additionally, in the event of such delisting, we may be subject to penalties or defaults under certain of our material agreements, which could materially and adversely affect our business, operating results and financial condition.

In order to retain its Common Stock listing, the Company intends to apply to transfer from the Nasdaq Global Market to the Nasdaq Capital Market. There can be no assurance that the Company will be able to successfully transfer to Nasdaq Capital Market or be able to comply with all of the listing requirements of Nasdaq Capital Market. In the event of such unsuccessful transfer or a delisting, and that the Common Stock is not eligible for trading on another national securities exchange, trading of our Common Stock could be conducted in the over-the-counter market operated by the OTC Markets Group, Inc.

We have incurred significant losses in the past and will likely incur losses in the future.

We have incurred significant operating losses in the past. We have financed our operations primarily through the issuance of equity and debt. We have devoted substantial resources to:

●

research and development relating to our Lumee Oxygen and Glucose Platform;

●

clinical studies for our Lumee Oxygen and Glucose Platform;

●

execution and maintenance of our intellectual property portfolio;

●

expenses associated with the commercialization of our Lumee Oxygen Platform; and

●

expansion of our workforce.

We expect our research and development expenses to increase in connection with our continued clinical trials and other development activities related to our products. We also expect that our general and administrative expenses will continue to increase due, among other things, to our expansion of commercialization for the Lumee Oxygen and Glucose Platform and the additional operational and regulatory burdens applicable to public healthcare and medical device companies. As a result, we will likely continue to incur operating losses in the future. These losses, among other things, may have an adverse effect on our stockholders’ equity.

We may need to raise additional funding to expand the commercialization of our products and services and to expand our research and development efforts. This additional financing may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product commercialization or development efforts or other operations.

Our operations have consumed substantial amounts of cash since inception. We expect to expend substantial additional amounts to commercialize our products and services and to develop new products and services. We expect to use the funds received in connection with the Business Combination to scale our operations, develop new products and services, expand internationally, and for working capital and general corporate purposes. We may require additional capital to conduct clinical trials, expand the commercialization of our existing product and services and to develop new products and services. In addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned.

The amount of funding we may need will depend on many factors, including:

●

the revenue generated by our products;

●

the costs, timing and risks of delay of regulatory approvals;

●

the expenses we incur in manufacturing, developing, selling and marketing our products;

●

our ability to scale our manufacturing operations to meet demand for our current and any future products;

●

the costs to produce our continuous glucose monitoring systems;

●

the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

●

the rate of progress and cost of our clinical trials and other development activities;

●

the success of our research and development efforts;

●

the emergence of competing or complementary technologies;

●

the terms and timing of any collaborative, licensing and other arrangements that we may establish;

●

the cost of ongoing compliance with legal and regulatory requirements, and third-party payors’ policies;

●

the cost of obtaining and maintaining regulatory or payor clearance or approval for our current or future products including those integrated with other companies’ products; and

●

the acquisition of business, products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions.

If adequate funds are not available, we may not be able to commercialize our products at the rate we desire and/or we may have to delay the development or commercialization of our products or license to third parties the rights to commercialize products or technologies that we would otherwise seek to commercialize. We also may have to reduce sales, marketing, customer support or other resources devoted to our products. Any of these factors could harm our business and financial condition.

The clinical trial process is lengthy and expensive with uncertain outcomes. Results of earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such products.

We may not sell any of our products in any jurisdiction until we have obtained marketing authorization in such jurisdiction. None of our products are approved for commercial sale in the United States. In order to obtain marketing approval for our products in the United States and in other jurisdictions, we will be required to conduct additional clinical trials. Clinical testing is difficult to design and implement, can take many years, can be expensive and carries uncertain outcomes. The long-term effects of using our products in a large number of patients have not been studied and the results of short-term clinical use of such products do not necessarily predict long-term clinical benefits or reveal long-term adverse effects.

The results of preclinical studies and clinical trials of our products conducted to date and ongoing or future studies and trials of our current, planned or future products may not be predictive of the results of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Regulatory authorities may disagree with our interpretation of data and results from our clinical trials, and favorable results do not ensure that we will achieve similar results in future clinical trials. Preclinical and clinical data are often susceptible to various interpretations and analyses, and many companies that have believed their products performed satisfactorily in preclinical studies and earlier clinical trials have nonetheless failed to replicate results in later clinical trials. Failure can occur at any stage of clinical testing. Our clinical studies may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and nonclinical testing in addition to those we have planned. In addition, it is possible that FDA will impose, as a condition of marketing authorization for future products, requirements that we conduct post-market surveillance studies or clinical studies as a condition of clearance or approval, which may reduce or delay our ability to obtain profitability with such products.

The initiation and completion of any clinical studies may be prevented, delayed or halted for numerous reasons. We may experience delays in our ongoing clinical trials for a number of reasons, which could adversely affect the costs, timing or successful completion of our clinical trials, including related to the following:

●

we may be required to submit an investigational device exemption application, or IDE, to the FDA, which must become effective prior to commencing certain human clinical trials of medical devices, and the FDA may reject our IDE and notify us that we may not begin clinical trials;

●

regulators may disagree as to the design or implementation of our clinical trials; regulators and/or institutional review boards, or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site;

●

we may not reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

●

clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

●

the number of subjects required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time may be high and result in fewer available subjects for any given clinical trial, or subjects may drop out of these clinical trials at a higher rate than we anticipate;

●

our third-party contractors, including those manufacturing products or conducting clinical trials or preclinical studies on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

●

we might have to suspend or terminate clinical trials for various reasons, including a finding that the subjects are being exposed to unacceptable health risks;

●

we may have to amend clinical trial protocols or conduct additional studies to reflect changes in regulatory requirements or guidance, which we may be required to submit to an IRB and/or regulatory authorities for re-examination;

●

regulators, IRBs or other parties may require or recommend that we or our investigators suspend or terminate clinical research for various reasons, including safety signals or noncompliance with regulatory requirements;

●

the cost of clinical trials may be greater than we anticipate;

●

clinical sites may not adhere to the clinical protocol or may drop out of a clinical trial;

1218

●

we may be unable to recruit a sufficient number of clinical trial sites or study participants;

●

regulators, IRBs or other reviewing bodies may find fault with our manufacturing processes or facilities of third-party manufacturers with which we enter into agreement for clinical and commercial supplies, the supply of devices or other materials necessary to conduct clinical trials may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply;

●

approval policies or regulations of FDA or applicable foreign regulatory agencies may change in a manner rendering our clinical data insufficient for approval;

●

our current or future products may have undesirable side effects or other unexpected characteristics; and

● impacts of regional or global public health crises ~~including the recent COVID-19 pandemic~~ could adversely affect any clinical trials we are conducting or plan to conduct, including by causing delays or difficulties in enrolling or onboarding patients, initiating clinical sites, or obtaining the requisite regulatory approvals, interruption of key clinical trial activities, or supply chain disruptions that delay or make it more difficult or costly to obtain the supplies and materials we need for clinical trials.

Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

Patient enrollment in clinical trials and completion of patient follow up depend on many factors, including the size of the patient population, the nature of the trial protocol, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, patient compliance, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the product being studied in relation to other available therapies, including any new treatments that may be approved for the indications we are investigating. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post treatment procedures or follow up to assess the safety and efficacy of a product candidate, or they may be persuaded to participate in contemporaneous clinical trials of a competitor’s product candidate. In addition, patients participating in our clinical trials may drop out before completion of the trial or experience adverse medical events unrelated to our products. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial may delay commencement or completion of the clinical trial, cause an increase in the costs of the clinical trial and delays, or result in the failure of the clinical trial.

Clinical trials must be conducted in accordance with the laws and regulations of the FDA and other applicable regulatory authorities’ legal requirements, regulations or guidelines, and are subject to oversight by these governmental agencies and IRBs at the medical institutions where the clinical trials are conducted. In addition, clinical trials must be conducted with supplies of our devices produced under applicable current good manufacturing practice, or cGMP, requirements and other regulations. Furthermore, we rely on CROs, investigators and clinical trial sites to ensure the proper and timely conduct of our clinical trials and while we have agreements governing their committed activities, we have limited influence over their actual performance. We depend on our collaborators and on medical institutions and CROs to conduct our clinical trials in compliance with good clinical practice, or GCP, requirements. To the extent our collaborators or the CROs fail to enroll participants for our clinical trials, fail to conduct the study to GCP standards or are delayed for a significant time in the execution of trials, including achieving full enrollment, we may be affected by increased costs, program delays or both. Investigators may also be subject to disqualification, which may impact their ability to participate in clinical studies. In addition, clinical trials that are conducted in countries outside the United States may subject us to further delays and expenses as a result of increased shipment costs, additional regulatory requirements and the engagement of non-U.S. CROs, as well as expose us to risks associated with clinical investigators who are unknown to the FDA, and different standards of diagnosis, screening and medical care.

Even if our future products are cleared or approved in the United States, commercialization of our products in foreign countries would require clearance or approval by regulatory authorities in those countries. Clearance or approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials. Any of these occurrences could have an adverse effect on our business, financial condition and results of operations.

1319

Our products may not achieve or maintain market acceptance.

We have developed, and we are engaged in the development of, continuous glucose monitoring (CGM) systems, and we are in the early stages of commercializing the Lumee Oxygen Platform in the EU (in addition to ongoing clinical development of the Lumee Oxygen Platform) in the United States. Our success will depend on the acceptance of our products and services in the U.S., if approved, and international healthcare markets. We are faced with the risk that the marketplace will not be receptive to our products and services over competing products and that we will be unable to compete effectively. Factors that could affect our ability to successfully commercialize our current products and services and to commercialize any potential future products and services include:

●

challenges of developing (or acquiring externally-developed) technology solutions that are adequate and competitive in meeting the requirements of next-generation design challenges;

●

anticipation and responsiveness to our competitors’ development of new products and services and technological innovations; and

●

dependence upon physicians’ and other healthcare practitioners’ acceptance of our products.

We cannot assure investors that our current products and services or any future products and services will gain broad market acceptance or that treatment guidelines will promote the market acceptance of our products. If the market for our current products and services or any future products and services fails to develop or develops more slowly than expected, or if any of the services and standards supported by us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.

We operate in a highly competitive market and face competition from large, well-established companies with significant resources, and, as a result, we may not be able to compete effectively.

The industry in which we operate in general, and the market for products like the Lumee Oxygen and Glucose Platform and glucose monitoring devices in particular, are intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants, including enhanced software capabilities, and related data and IT platforms. Our CGM products are based on our proprietary technology, but a number of companies and medical researchers are pursuing new technologies for the monitoring of glucose levels. FDA or other regulatory approval of a commercially viable continuous glucose monitor or sensor produced by one of our competitors could significantly reduce market acceptance of our systems. In addition, certain development efforts throughout the diabetes industry, including that of the National Institutes of Health and other supporters of diabetes research are continually seeking ways to prevent, cure or improve treatment of diabetes. Therefore, our products may be rendered obsolete by technological breakthroughs in diabetes monitoring, treatment, prevention or cure.

If our CGM systems are approved for commercial sale, we will compete directly with the Diabetes Care division of, among others, Abbott Laboratories; Medtronic plc’s Diabetes Group; Roche Diabetes Care, a division of Roche Diagnostics; privately-held LifeScan, Inc.; and Ascensia Diabetes Care, each of which manufactures and markets products for the single-point finger stick device market. Collectively, these companies currently account for a significant amount of the worldwide sales of self-monitored glucose testing systems.

Several companies are developing and/or commercializing products for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin that compete directly with our products. Abbott has their Libre family of CGM products and Medtronic markets and sells a standalone glucose monitoring product called Guardian Connect both internationally and in the United States.

Medtronic and other third parties have developed or are developing insulin pumps integrated with CGM systems that provide, among other things, the ability to suspend insulin administration while the user’s glucose levels are low and to automate basal and bolus insulin dosing.

We also have begun to become aware of companies outside the traditional medical device sector that are attempting to develop competitive products and services, including for the general health and wellness, or population health space.

1420

Our Lumee Oxygen Platform primarily faces competition from Siemens Healthineers, Perimed AB, SenTec AG, Radiometer Medical, MESI, ATYS Medical, among other related companies.

Some of the companies developing or marketing competing devices are large and well-known publicly traded companies, and these companies may possess competitive advantages over us, including:

●

greater name recognition;

●

established relations with healthcare professionals, customers and third-party payors;

●

established distribution networks;

●

additional lines of products, and the ability to bundle products to offer higher discounts or incentives to gain a competitive advantage;

●

greater experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products and marketing approved products;

●

duration of sensor life;

●

the ability to integrate multiple products to provide additional features beyond CGM systems; and

●

greater financial and human resources for product development, manufacturing, sales and marketing, and patent litigation.

As a result, we may not be able to compete effectively against these companies or their products, which may adversely impact our business.

The research and development efforts we undertake independently, and in some instances in connection with our collaborations with third parties, may not result in the development of commercially viable products, the generation of significant future revenues or adequate profitability.

In order to address the anticipated needs of our customers, pursue new markets for our existing products, and remain competitive, we focus our research and development efforts and strategic third-party collaboration activities on the enhancement of our current products, the development of next-generation products and the development of novel technologies and services.

The development of new products, or novel technologies and services and the enhancement of our current products (including seeking and obtaining new indications for use), requires significant investment in research and development, intellectual property protection, clinical trials, regulatory approvals and third-party reimbursement. The results of our product development and commercialization efforts may be affected by a range of factors, including our ability to anticipate customer needs, innovate and develop new products, determine a feasible or timely regulatory pathway or approach, and launch those products cost effectively into multiple markets and geographies. If we are unable to successfully anticipate customer needs, innovate, develop new products and successfully launch them, we may not be able to generate significant future revenues or profits from these efforts. Failing to timely launch our products may cause them to become obsolete and materially and adversely affect our business and financial position.

The development and commercial launch timelines for our products depend a great deal on our ability to achieve clinical endpoints and regulatory requirements and to overcome technology challenges, and may be delayed due to scheduling issues with patients and investigators, requests from institutional review boards, or inquiries from regulators about our independent and collaborative product development activities, product performance and manufacturing supply constraints, among other factors. In addition, support of these clinical trials requires significant resources from employees involved in the production of our products, including research and development, manufacturing, quality assurance, and clinical and regulatory personnel. Even if our development and clinical trial efforts succeed, the FDA may not approve the products or may require additional product testing and clinical trials before approving the products, which would result in product launch delays and additional expense. If approved by the FDA, the products may not be accepted in the marketplace by physicians or users.

We may enter into collaborative arrangements to develop new products and to pursue new markets. As a result of these relationships, our operating results depend, to some extent, on the ability of our partners to successfully commercialize their systems or products. Any factors that may limit our partners’ ability to achieve widespread adoption of their systems, including competitive pressures, technological breakthroughs for the treatment or prevention of diabetes, adverse regulatory or legal actions relating to their products, or changes in reimbursement rates or policies of third-party payors relating to these products, could have an adverse impact on our operating results.

1521

Many of the companies that we collaborate with are also competitors or potential competitors who may decide to terminate our collaborative arrangement. In the event of such a termination, we may be required to devote additional resources to product development and commercialization, we may need to cancel some development programs and we may face increased competition. Additionally, collaborations may not result in the development of products that achieve commercial success and could be terminated prior to developing any products. Former collaborators may use the experience and insights they develop in the course of their collaborations with us to initiate or accelerate their development of products that compete with our products, which may create competitive disadvantages for us. Accordingly, we cannot provide assurance that any of our collaborations will result in the successful development of a commercially viable product or result in significant additional future revenues.

Medical device development is costly and involves continual technological change, which may render our current or future products obsolete.

The market for medical devices is characterized by rapid technological change, medical advances and evolving industry standards. Any one of these factors could reduce the demand for our devices or services or require substantial resources and expenditures for research, design and development to avoid technological or market obsolescence.

Our success will depend on our ability to enhance our current technology, services and systems and develop or acquire and market new technologies to keep pace with technological developments and evolving industry standards, while responding to changes in customer needs. A failure to adequately develop or acquire device enhancements or new devices that will address changing technologies and customer requirements adequately, or to introduce such devices on a timely basis, may have a material adverse effect on our business, financial condition and results of operations.

We might have insufficient financial resources to improve existing devices, advance technologies and develop new devices at competitive prices. Technological advances by one or more competitors or future entrants into the field may result in our current devices becoming non-competitive or obsolete, which may decrease revenues and profits and adversely affect our business and results of operations.

We may encounter significant competition across our existing and future planned products and services and in each market in which we sell or plan to sell our products and services from various companies, many of which have greater financial and marketing resources than we do.

In addition, our competitors, which are well-established manufacturers with significant resources, may engage in aggressive marketing tactics. Competitors may also possess the ability to commercialize additional lines of products, bundle products or offer higher discounts and incentives to customers in order to gain a competitive advantage. If the prices of competing products are lowered as a result, we may not be able to compete effectively.

If we are unable to successfully develop and effectively manage the introduction of new products, our business may be adversely affected.

We must successfully manage introductions of new or advanced products and associated management services. Introductions of new or advanced products could also adversely impact the commercialization of Lumee™ Oxygen Platform or other existing products to consumers. For instance, the introduction or announcement of new or advanced products may shorten the life cycle of our existing products or reduce demand, thereby reducing any benefits of successful new product introductions and potentially lead to challenges in managing write-downs or write-offs of inventory of existing products. In addition, any new products may have higher manufacturing costs than legacy products, which could negatively impact our gross margins and operating results. Accordingly, if we fail to effectively manage introductions of new or advanced products, our business may be adversely affected.

We may experience challenges managing the inventory of monitors and other items, which can lead to excess inventory and discounting of our products, or alternatively insufficient inventory levels. Inventory levels in excess of consumer demand may result in inventory write-downs or write-offs, product expiration and the sale of inventory at discounted prices, which would affect our gross margin and could impair the strength of our brand. Reserves and write-downs for rebates, promotions and excess inventory will be recorded based on our forecast of future demand.

Actual future demand could be less than our forecast, which may result in additional reserves and write-downs in the future, or actual demand could be stronger than our forecast, which may result in a reduction to previously recorded reserves and write-downs in the future and increase the volatility of our operating results.

1622

If we are unable to establish and maintain adequate sales and marketing capabilities or enter into and maintain arrangements with third parties to sell and market our products, our business may be harmed.

We must continue to develop and grow our sales and marketing organization and enter into partnerships or other arrangements to market and sell our products and/or collaborate with third parties, including distributors and others, to commercialize the Lumee™ Oxygen Platform and to achieve commercial success for any of our future products. Developing and managing a direct sales organization is a difficult, expensive and time-consuming process.

To continue to develop our sales and marketing organization to successfully achieve market awareness and sell our products, we must:

●

continue to recruit and retain adequate numbers of effective and experienced sales and marketing personnel;

●

effectively train our sales and marketing personnel in the benefits and risks of our products;

●

establish and maintain successful sales, marketing, training and education programs that educate health care professionals so they can appropriately inform their patients about our products;

● manage geographically dispersed sales and marketing operations; ~~and~~

● effectively train our sales and marketing personnel on the applicable fraud and abuse laws that govern interactions with healthcare practitioners as well as current and prospective patients and maintain active oversight and auditing measures to ensure continued compliance.; and

We● ~~may not be able to~~ successfully manage our sales force or increase our product sales at acceptable rates.

We have limited experience in marketing and selling our products and related services, and if we are unable to successfully commercialize our products and related services, our business and operating results will be adversely affected.

We only recently received CE Mark approval in the EU for our first product, the Lumee Oxygen Platform, and accordingly we have limited experience marketing and selling our products and related services. Sales of our Lumee Oxygen Platform in the EU will depend on our ability to maintain CE Mark approval, including requirements to comply with European Medical Devices Regulation and renew the CE Mark as required. Sales of Lumee Oxygen Platform outside of the EU, including in the U.S., and sales of Lumee Glucose in any jurisdiction, will depend on our ability to obtain and maintain applicable regulatory approvals in such jurisdictions. Following regulatory approvals, future sales of our products will depend in large part on our ability to effectively market and sell our products and services, successfully manage and expand our sales force, and increase the scope of our marketing efforts. We may also enter into distribution arrangements in the future. Because we have limited experience in marketing and selling our products, our ability to forecast demand, the infrastructure required to support such demand and the sales cycle to customers is unproven. If we do not build an efficient and effective marketing and sales force, our business and operating results will be adversely affected.

We are subject to a variety of risks due to our international operations that could adversely affect our business, our operations or profitability and operating results.

We are not currently generating revenues in international countries. We currently operate clinical trial studies internationally in Vietnam, Germany and Austria and intend to continue to pursue growth opportunities outside the United States and we may increase our use of administrative and support functions from locations outside the United States, which could expose us to greater risks associated with our sales and operations. As we pursue opportunities outside the United States, we may become more exposed to these risks and our ability to scale our operations effectively may be affected.

Additionally, our international expansion efforts may not be successful and we may experience difficulties in scaling these functions from locations outside the United States and may not experience the expected cost efficiencies.

1723

Our profitability and international operations are, and will continue to be, subject to a number of risks and potential costs, including:

●

local product preferences and product requirements;

●

longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;

●

fluctuations in foreign currency exchange rates;

●

less intellectual property protection in some countries outside the United States than exists in the United States;

●

trade protection measures and import and export licensing requirements;

●

trade relations among the United States and foreign countries in which our customers or future customers, distributors, manufacturers and suppliers may have operations;

●

required compliance with foreign regulatory requirements and laws;

●

required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act, data privacy requirements, labor laws and anti-competition regulations;

●

workforce instability;

●

political and economic instability; and

●

the potential impact of tariffs and the resulting impact of administration changes in the U.S. government.

Changes in foreign currency exchange rates may reduce the reported value of our foreign currency denominated revenues, expenses, and cash flows. We cannot predict changes in currency exchange rates, the impact of exchange rate changes, nor the degree to which we will be able to manage the impact of currency exchange rate changes.

We believe that many individuals do not have full information regarding the types of oxygen monitoring and CGM products and available in the market, in part due to the lack of consumer education regarding these types of products. Consumers may not have sufficient information about oxygen monitors or CGMs generally or how these products and technologies compare to each other.

This lack of information may result in consumers purchasing devices from our competitors, even if our product would provide consumers with their desired product features. In addition, any adverse events or safety issues relating to competitive products and related negative publicity, even if such events are not attributable to our products, could result in reduced purchases of our products by consumers generally. Any of these occurrences could lead to reduced sales of our products and adversely affect our business, financial condition and results of operations.

We expect the commercialization of the Lumee Oxygen Platform to generate nearly all our commercial revenue until we obtain regulatory approval for additional products.

Our first offering is the Lumee Oxygen Platform, from which we expect to continue to derive nearly all our commercial revenue until such time as we obtain regulatory approval for additional products, such as Lumee Glucose, which may never occur. Accordingly, our ability to continue to generate revenue is highly reliant on our ability to market and sell the Lumee Oxygen Platform and to retain consumers using the product. We have not yet established that our commercial model will be successful. We cannot control the completion or timing of our distribution partners’ protocols or other internal processes or procedures, and the timing and execution of our expanded launch is dependent on our ability to distribute our products pursuant to our agreements with them.

The outbreak of the SARS-CoV-2 virus and its variants and the COVID-19 disease that it causes, or similar public health crises, could have a material adverse impact on our business, financial condition and results of operations, including our manufacturing, commercial operations and sales.

In December 2019, a novel strain of coronavirus (SARS-CoV-2) was reported and it has since spread throughout the world. The COVID-19 pandemic caused by SARS-CoV-2 has had significant impacts on our business operations, and any future outbreak of contagious diseases, or other adverse public health developments, could have a material adverse effect on our business operations. These impacts to our operations have included, and could again in the future include, disruptions or restrictions on the ability of our employees and customers to travel or of us to pursue collaborations and other business transactions, travel to customers and/or conduct live demonstrations of our products at promotional events, maintain our presence in medical schools and other educational institutions, oversee the activities of our third-party manufacturers and suppliers and make shipments of materials. The COVID-19 pandemic may also continue to cause financial strain on our customer base due to decreased funding and other revenue shortfalls.

Travel restrictions and business closures have and may in the future adversely impact our operations locally and worldwide, including our ability to manufacture, market, sell or distribute our products, and such restrictions and closure have caused or may cause temporary closures of facilities of suppliers, manufacturers or customers. Disruptions in the operations of our suppliers, customers, and manufacturers and access to customers have and may in the future adversely impact our sales and operating results. In addition, travel restrictions have made it more difficult for us to monitor the quality of our third-party manufacturing operations when we are unable to conduct in-person quality audits of those facilities.

In addition, the issues originally brought on by COVID-19 continue to have an ongoing adverse impact on global supply chains, including ours. We have experienced constraints in availability, increasing lead times and costs required to obtain some inventory components. As a result of the COVID-19 pandemic and the measures designed to contain its spread, our suppliers may not have the materials, capacity, or capability to supply our components according to our schedule and specifications. Further, there may be logistics issues, including our ability and our supply chain’s ability to maintain production, as well as transportation demands that may cause further delays. If our suppliers’ operations are curtailed, we may need to seek alternate sources of supply, which may be more expensive. Alternate sources may not be available or may result in delays in shipments to us from our suppliers and subsequently to our customers. In addition, the COVID-19 pandemic and the measures designed to stop the spread of the virus may have similar effects on our customers. The current pandemic may also give rise to force majeure contractual protections being asserted by customers and/or suppliers that we maintain contracts with, potentially relieving contractual obligations these parties have to us. In any case, any disruption of our suppliers’ or customers’ businesses would likely negatively impact our sales and operating results.

Our business, financial condition and results of operations could be adversely affected by disruptions in the global economy caused by the ongoing conflict between Russia and Ukraine.

The global economy has been negatively impacted by the military conflict between Russia and Ukraine. Furthermore, governments in the U.S., United Kingdom, and European Union have each imposed export controls on certain products and financial and economic sanctions on certain industry sectors and parties in Russia. Although we have no operations in Russia or Ukraine, we may experience shortages in materials and increased costs for transportation, energy, and raw materials due in part to the negative impact of the Russia-Ukraine military conflict on the global economy. The scope and duration of the military conflict in Ukraine is uncertain, rapidly changing and hard to predict. Further escalation of geopolitical tensions related to the military conflict, including increased trade barriers or restrictions on global trade, could result in, among other things, cyberattacks, supply disruptions, lower consumer demand, and changes to foreign exchange rates and financial markets, any of which may adversely affect our business and supply chain.

We may face risks associated with acquisitions of companies, products and technologies and our business could be harmed if we are unable to address these risks.

We may in the future seek to acquire or invest in businesses, applications or technologies that we believe could complement or expand our portfolio, enhance our technical capabilities or otherwise offer growth opportunities. However, we cannot assure you that we would be able to successfully complete any acquisition we choose to pursue, or that we would be able to successfully integrate any acquired business, product or technology in a cost-effective and non-disruptive manner. The pursuit of potential acquisitions may divert the attention of management and cause us to incur various costs and expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated. We may not be able to identify desirable acquisition targets or be successful in entering into an agreement with any particular target or obtain the expected benefits of any acquisition or investment.

1925

To date, the growth of our operations has been largely organic, and we have limited experience in acquiring other businesses or technologies. We may not be able to successfully integrate any acquired personnel, operations and technologies, or effectively manage the combined business following an acquisition. Acquisitions could also result in dilutive issuances of equity securities, the use of our available cash, or the incurrence of debt, which could harm our operating results. In addition, if an acquired business fails to meet our expectations, our operating results, business and financial condition may suffer.

Our success will depend on our ability to attract and retain our personnel and manage our human capital, while controlling labor costs.

Our future success depends on our ability to attract, recruit, train, retain, motivate and integrate key personnel, including Ben Hwang, our Chief Executive Officer, as well as other members of our management team and our research and development, manufacturing, software engineering and sales and marketing personnel. Competition for qualified personnel is intense. The loss or incapacity of existing members of our executive management team could adversely affect our operations if we experience difficulties in hiring qualified successors. Our executive officers have signed offer letters or employment agreements with us, but their service is at-will and may end at any point in time. In addition, all of our employees are at-will, which means that either we or the employee may terminate their employment at any time.

We believe that our management team must be able to act decisively to apply and adapt our business model in the rapidly changing markets in which we will compete. In addition, we rely upon technical and scientific employees or third-party contractors to effectively establish, manage and grow our business. Consequently, we believe that our future viability will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical personnel. In order to do so, in the future we may need to pay higher compensation or fees to our employees or consultants than we currently expect, and such higher compensation payments may have a negative effect on our operating results. Competition for experienced, high-quality personnel is intense, and there is no assurance that we will be able to recruit and retain such personnel. Our growth depends, in particular, on attracting and retaining highly-trained sales personnel with the necessary technical background and ability to understand our products and services at a technical level to effectively identify and sell to potential new customers and develop new products. Because of the technical nature of our products and the dynamic market in which we compete, any failure to attract, recruit, train, retain, motivate and integrate qualified personnel could materially harm our operating results and growth prospects. Recruiting, training and retention difficulties can limit our ability to support our research and development and commercialization efforts.

We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations.

We are required to comply with export and import control laws, which may affect our ability to enter into or complete transactions with certain customers, business partners, and other persons. In certain circumstances, export control regulations may prohibit the export of certain products, services, and technologies. We may be required to obtain an export license before exporting a controlled item, and granting of a required license cannot be assured. Compliance with the import laws that apply to our businesses may restrict our access to, and may increase the cost of obtaining, certain products and could interrupt our supply of imported inventory.

Exported technologies necessary to develop and manufacture certain products are subject to U.S. export control laws and similar laws of other jurisdictions. We may be subject to adverse regulatory consequences, including government oversight of facilities and export transactions, monetary penalties, and other sanctions for violations of these laws. In certain instances, these regulations may prohibit us from developing or manufacturing certain of our products for specific applications outside the United States. Failure to comply with any of these laws and regulations could result in civil and criminal, monetary, and nonmonetary penalties; disruptions to our business; limitations on our ability to import and export products and services; or damage to our reputation.

2026

Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability.

As of the year ended December 31, 2024, we had federal net operating loss carryforwards (“NOLs”) to offset future taxable income of approximately $114.8 million, subject to certain limitations (including the limitations described below). If not utilized, U.S. federal net operating loss carryforward amounts generated prior to January 1, 2018 will begin to expire 20 years after the tax year in which such losses originated. State net operating loss carryforward amounts may also be subject to expiration. A lack of future taxable income would adversely affect our ability to utilize these NOLs.

In addition, under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change NOLs and other pre-change tax attributes (such as research tax credits) to offset post-change taxable income. For these purposes, an ownership change generally occurs where the equity ownership of one or more stockholders or groups of stockholders considered by the rules as owning, directly or indirectly, 5% or more of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a three-year period (calculated on a rolling basis) as well as changes in ownership arising from new issuances of stock by us. Our existing NOLs may be subject to limitations arising out of previous ownership changes or in connection with the Business Combination and we may be limited as to the amount that can be utilized each year as a result of such ownership changes and related transactions. In addition, future changes in our stock ownership, including future offerings, as well as other changes that may be outside of our control, could result in additional ownership changes under Section 382 of the Code. There are additional limitations found in Sections 269, 383 and 384 of the Code that may also limit the use of NOL carryforwards that may apply and result in increased tax liability to us. Our NOLs may also be impaired under similar provisions of state law.

We have recorded a full valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits of those assets.

If our manufacturing capabilities are insufficient to produce an adequate supply of product at appropriate quality levels, our growth could be limited and our business could be harmed.

Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts on commercialization of our products, including growth of our manufacturing capacity, on research and development, and conducting clinical trials for our CGM sensors and systems. We may need funds to continue the commercialization of our current products and to develop and commercialize our sensors and systems or pursue other strategic initiatives. Additional financing may not be available on a timely basis on terms acceptable to us, or at all. Any additional financing may be dilutive to stockholders or may require us to grant a lender a security interest in our assets. The amount of funding we may need will depend on many factors, including:

●

the revenue generated by sales of our products and other future products;

●

the costs, timing and risks of delay of additional regulatory approvals;

●

the expenses we incur in manufacturing, developing, selling and marketing our products;

●

our ability to scale our manufacturing operations to meet demand for our current and any future products;

●

the costs to produce the Lumee™ Oxygen Platform or our CGM systems;

●

the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

●

the rate of progress and cost of our clinical trials and other development activities;

●

the success of our research and development efforts;

●

the emergence of competing or complementary technologies;

●

the terms and timing of any collaborative, licensing and other arrangements that we may establish;

●

the cost of ongoing compliance with legal and regulatory requirements, and third-party payors’ policies;

2127

●

the cost of obtaining and maintaining regulatory or payor clearance or approval for our current or future products including those integrated with other companies’ products; and

●

the acquisition of business, products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions.

We manufacture our products and procure important third-party services at numerous facilities worldwide. We purchase many of the components, materials and services needed to manufacture these products from numerous suppliers in various countries. We have generally been able to obtain adequate supplies of such materials, components and services. However, we also rely on single and/or sole sources for certain components and materials used in manufacturing our products. For example, currently we purchase all of the microbeads used in our Lumee Oxygen hydrogel from Microbeads AS, all of our glucose sensing dye from Laurus Labs, all of our reference dye from Biotium and all of our bacterial catalase from Roche. In some cases, our agreements with these and other suppliers can be terminated by either party upon short notice. Our contract manufacturers may also rely on single- or sole-source suppliers to manufacture some of the components used in our products.

Although we work with our suppliers to try to ensure continuity of supply while maintaining quality, timeliness and reliability, the supply of these components, materials and services has in some cases been, and may continue to be impacted, interrupted or insufficient. Our manufacturers and suppliers may also encounter problems during manufacturing for a variety of reasons. They may fail to follow specific protocols and procedures, fail to comply with applicable regulations, or be the subject of FDA or other regulatory authority audits or inspections that result in allegations of non-compliance (for example, resulting in Form 483 Observations, Warning Letters, or other FDA enforcement actions). Our manufacturers and suppliers may also experience or be impacted by equipment malfunction, environmental factors, and public health emergencies ~~including but not limited to the COVID-19 pandemic~~, any of which could delay or impede their ability to meet our demand.

Further, if our sole- or single-source suppliers shift their manufacturing and assembly sites to other locations, depending on the circumstances and nature of the item supplied, in addition to quality system activities such as verification and validation, there could be a need for FDA notifications or submissions, and the new locations could be subject to regulatory inspections. If there are regulatory delays or impediments impacting our suppliers or us for any reason, we may not be able to quickly establish additional or replacement suppliers, particularly for our single-source components, in part because of the custom nature of various parts we design. Any interruption or delay in the supply of components or materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders or switch to competitive products. For supply risks related to the COVID-19 pandemic see our Risk Factor entitled, “The outbreak of the SARS-Cov-2 virus and its variants and the COVID-19 disease that it causes, or similar public health crises, could have a material adverse impact on our business, financial condition and results of operations, including our manufacturing, commercial operations and sales.”

Our reliance on these outside manufacturers and suppliers also subjects us to other risks that could harm our business, including:

●

we may experience a reduction or interruption in supply, and may not be able to obtain adequate supply in a timely manner or on commercially reasonable terms from additional or replacement sources;

●

our products are technologically complex and it is difficult to develop alternative supply sources;

●

we are not a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours;

2228

●

our suppliers may make errors in manufacturing components that could negatively affect the quality, effectiveness or safety of our products or cause delays in shipment of our products;

●

we may have difficulty locating and qualifying alternative suppliers for our single-source supplies;

●

switching components may require product redesign and submission to the FDA of new applications (such as new 510(k) submissions or PMA supplements) which could significantly delay production;

●

our suppliers manufacture products for a range of customers, and fluctuations in demand for the products these suppliers manufacture for others may affect their ability to deliver components to us in a timely manner or at the current pricing;

●

our suppliers may discontinue the production of components that are critical to our products; and

●

our suppliers may encounter financial and/or other hardships unrelated to our demand for components, including those related to changes in global economic conditions and/or disease outbreaks, which could inhibit their ability to fulfill our orders and meet our requirements.

We also outsource certain services to other parties, including inside sales, certain transaction processing, accounting, information technology, manufacturing, and other areas. Outsourcing of services to third parties could expose us to suboptimal quality of service delivery or deliverables and potentially result in repercussions such as missed deadlines or other timeliness issues, erroneous data, supply disruptions, non-compliance (including with applicable legal or regulatory requirements and industry standards) and/or reputational harm, with potential negative effects on our results. Closure of non-essential businesses and shelter-in-place orders that may reoccur in the U.S. and globally as a result of ~~the~~epidemics ~~COVID-19 pandemic~~ or ~~other~~pandemics ~~epidemics~~ may also adversely impact our outsourced operations. We continue to monitor this situation closely.

We also require the suppliers, service providers and business partners of components or services for our products and related services to comply with law and certain of our policies regarding sourcing practices, but we do not control them or their practices. If any supplier, service provider or business partner violates laws or implements unethical practices, there could be disruptions to our supply chain, cancellation of our orders, a termination of the relationship with the partner or damage to our reputation, and the FDA or other regulators could seek to hold us responsible for such violations.

We will need to expand our organization, and we may experience difficulties in recruiting needed additional employees and consultants, which could disrupt our operations.

As our development and commercialization plans and strategies develop, we will need additional managerial, operational, sales, marketing, financial, legal and other resources. The competition for qualified personnel in the medical device industry is intense. Due to this intense competition, we may be unable to attract and retain the qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.

Our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of additional products. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenue could be reduced and we may not be able to implement our business strategy. Our future financial performance and our ability to commercialize products and services and compete effectively will depend, in part, on our ability to effectively manage any future growth.

2329

The failure to comply with U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws in non-U.S. jurisdictions could materially adversely affect our business and result in civil and/or criminal sanctions.

We are currently subject to certain provisions of the U.S. Foreign Corrupt Practices Act, or FCPA, and as a public company we will be subject to additional provisions of the FCPA. The FCPA prohibits companies and their intermediaries from making payments in violation of law to non-U.S. government officials for the purpose of obtaining or retaining business or securing any other improper advantage. Our planned future reliance on independent distributors to sell our products internationally demands a high degree of vigilance in enforcing our policy against participation in corrupt activity, because these distributors could be deemed to be our agents, and we could be held responsible for their actions. Other U.S. companies in the medical device and pharmaceutical fields have faced criminal penalties under the FCPA for allowing their agents to deviate from appropriate practices in doing business with such non-U.S. government officials. We are also subject to similar anti-bribery laws in the jurisdictions in which we operate.

Any violations of these laws, or allegations of such violations, could disrupt our operations, involve significant management distraction, involve significant costs and expenses, including legal fees, and could result in a material adverse effect on our business, prospects, financial condition, or results of operations. We could also incur severe penalties, including criminal and civil penalties, disgorgement, and other remedial measures.

Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets, including changes in inflation, interest rates and overall economic conditions and uncertainties. To the extent inflation or other factors increase our business costs, it may not be feasible to pass price increases on to our customers or offset higher costs through manufacturing efficiencies. Inflation could also adversely affect the ability of our customers to purchase our products. An economic downturn could result in a variety of risks to our business, including weakened demand for our products and our inability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also result in further constraints on our suppliers or cause future customers to delay making payments for our products. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

We may experience pricing pressures from contract suppliers or manufacturers on which we rely.

We expect that there will be supply constraints and our suppliers may continue to raise prices, which we may not be able to offset through manufacturing efficiencies or pricing actions. Pricing pressures from third parties could increase our costs and force us to increase the prices of our products if we are unable to enter into alternative arrangements with other suppliers or manufacturers, potentially leading to decreased customer demand.

Manufacturing difficulties and/or any disruption at our facilities may adversely affect our manufacturing operations and related product sales, and increase our expenses.

Our products are manufactured at two facilities located in California, with limited alternate facilities. If an event occurs at one of our facilities that results in damage to, or closure of, one or more of such facilities, or if our distributions from those facilities are limited or restricted in any way, we may be unable to manufacture the relevant products at the previous levels or at all. Because of the time required to approve and lease a manufacturing facility, an alternate facility and/or a third-party may not be available on a timely basis to replace production capacity in the event manufacturing capacity is lost.

We take precautions to safeguard our facilities, which include manufacturing protocols, insurance, health and safety protocols, and off-site storage of data. However, a natural or man-made disaster, such as fire, flood, earthquake, act of terrorism, cyber-attack or other disruptive event, ~~such~~a ~~as the COVID-19~~ pandemic or another public health emergency, could cause substantial delays in our operations, damage, destroy or limit our manufacturing equipment, inventory, or records and cause us to incur additional expenses. Earthquakes and fires are of particular significance since our manufacturing facilities in California are located in an earthquake-prone area. In the event our existing manufacturing ~~facilities~~ facilities or equipment are affected by man-made or natural disasters, we may be unable to manufacture products for sale or meet customer ~~demands~~ demands or sales projections. If our manufacturing operations were curtailed or ceased, it would seriously harm our business. The insurance we we maintain against fires, floods, earthquakes and other natural disasters and similar events may not be adequate to cover our losses in in any particular case. ~~Further, insurance coverage may not be available or successfully secured for loss profits or business interruption relating to the COVID-19 pandemic and its impacts.~~

2430

Customer or third-party complaints or negative reviews or publicity about our company or our products could harm our reputation and brand.

We expect to rely on customers who use our products to provide good reviews and word-of-mouth recommendations to contribute to our future growth. Customers who are dissatisfied with their experiences with our products or services may post negative reviews. We may also be the subject of blog, forum or other media postings that include inaccurate statements and create negative publicity. Any negative reviews or publicity, whether real or perceived, disseminated by word-of-mouth, by the general media, by electronic or social networking means or by other methods, could harm our reputation and brand and could severely diminish consumer confidence in our products.

The size and expected growth of our addressable market has not been established with precision, and may be smaller than we estimate.

Our estimates of the addressable market for our current products and future products are based on a number of internal and third-party estimates and assumptions, including the prevalence of diabetes across income levels and demographic profiles. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct. In addition, the statements in this prospectus relating to, among other things, the expected growth in the market for our products, are based on a number of internal and third-party estimates and assumptions and may prove to be inaccurate. For example, although we expect that the prevalence of diabetes will increase in the general population, demographic trends could shift and the prevalence of diabetes could decrease. Furthermore, even if the prevalence of diabetes increases as we expect, technological or medical advances could provide alternatives to address diabetes and reduce demand for automatic glucose monitoring. As a result, our estimates of the addressable market for our current or future products may prove to be incorrect.

Another key element of our business strategy is utilizing market research and ad hoc user feedback from our clinical studies to understand and improve our products. This strategy underlies our entire product design, marketing and customer support approach and is the basis on which we developed our current products and are pursuing the development of new products. However, our market research participants may represent only a small percentage of the overall market. As a result, the responses we receive may not be reflective of the broader market and may not provide us accurate insight into the desires of our potential customers. In addition, understanding the meaning and significance of such market research responses necessarily requires that analysis be conducted and conclusions be drawn. We may not be able to perform an analysis that yields meaningful results, or the conclusions we draw from the analysis could be misleading or incorrect. Moreover, even if our market research has allowed us to better understand the features and functionality consumers are seeking in our products, there can be no assurance that consumers will actually purchase our products or that our competitors will not develop products with similar features.

If the actual number of consumers who would benefit from our products, the price at which we can sell future products or the addressable market for our products is smaller than we estimate, it could have a material adverse effect on our business, financial condition and results of operations.

We or the third parties upon whom we depend may be adversely affected by disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster. Any interruption in the operations of our or our suppliers’ manufacturing or other facilities may have a material adverse effect our business, financial condition and results of operations.

Our corporate headquarters are located near the San Francisco Bay Area, which has experienced both severe earthquakes and wildfires. We do not carry earthquake insurance. Severe weather, natural disasters and other calamities, such as pandemics ~~(including the COVID-19 pandemic)~~, earthquakes, tsunamis and hurricanes, fires and explosions, accidents, mechanical failures, unscheduled downtimes, civil unrest, strikes, transportation interruptions, unpermitted discharges or releases of toxic or hazardous substances, other environmental risks, sabotage or terrorist attacks, could severely disrupt our operations, or our third-party manufacturers’ and suppliers’ operations, and have a material adverse effect on our business, financial condition and results of operations.

If a natural disaster, power outage or other event occurs that prevents us from using all or a significant portion of our headquarters or other facilities, or those of our third-party manufacturers or suppliers, that damages critical infrastructure, such as our enterprise financial systems or manufacturing resource planning and enterprise quality systems, or that otherwise disrupts operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time. A mechanical failure or disruption affecting any major operating line may result in a disruption to our ability to supply customers, and standby capacity may not be available. The disaster recovery and business continuity plans we have in place currently are limited and are unlikely to prove adequate in the event of a serious disaster or similar event. The potential impact of any disruption would depend on the nature and extent of the damage caused by a disaster. There can be no assurance that alternative production capacity will be available in the future in the event of a major disruption or, if it is available, that it could be obtained on favorable terms. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business, financial condition and results of operations.

2531

Furthermore, integral parties in our supply chain are similarly vulnerable to natural disasters or other sudden, unforeseen and severe adverse events. If such an event were to affect our supply chain, it could have a material adverse effect on our business, financial condition and results of operations.

Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.

Our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results. These fluctuations may occur due to a variety of factors, many of which are outside our control, including, but not limited to:

●

the timing and amount of expenditures that we may incur to develop, commercialize or acquire additional products and technologies or for other purposes, such as the expansion of our sales team and our facilities;

●

changes in governmental funding of life sciences research and development or changes that impact budgets or budget cycles;

●

the timing of when we recognize any revenues;

●

future accounting pronouncements or changes in our accounting policies;

●

the outcome of any future litigation or governmental investigations involving the Company, our industry or both;

●

higher than anticipated service, replacement and warranty costs;

● the impact of the COVID-19 pandemic on the economy, investment in the life sciences and medical technology industries, our business operations, and resources and operations of our suppliers, future distributors and current and potential customers;

●

the impact of political instability and military conflict, such as the conflict in Ukraine, which has resulted in instability in the global financial markets and export controls, and which could result in supply disruptions for us; and

●

general industry, economic and market conditions and other factors, including factors unrelated to our operating performances or the operating performance of our competitors.

The cumulative effects of the factors discussed above could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful.

This variability and unpredictability could also result in us failing to meet the expectations of industry or financial analysts or investors for any period. If we are unable to further commercialize products or generate revenue, or if our operating results fall below the expectations of analysts or investors or below any guidance we may provide, or if the guidance we provide is below the expectations of analysts or investors, the market price of our ~~common~~Common ~~stock~~Stock could decline.

2632

If our financial performance fails to meet the expectations of investors and public market analysts, the market price of our ~~common~~Common ~~stock~~ Stock could decline.

Our revenues and operating results may fluctuate significantly from quarter to quarter. We believe that period-to-period comparisons of our operating results may not be meaningful and should not be relied on as an indication of our future performance. If quarterly revenues or operating results fall below the expectations of investors or public market analysts, the trading price of our ~~common~~Common ~~stock~~Stock could decline substantially. Factors that might cause quarterly fluctuations in our operating results include:

●

our inability to manufacture an adequate supply of product at appropriate quality levels and acceptable costs;

●

possible delays in our research and development programs or in the completion of any clinical trials;

●

a lack of acceptance of our products in the marketplace;

●

the inability of customers to receive reimbursements from third-party payors;

●

the purchasing patterns of our customers;

●

failures to comply with regulatory requirements, which could lead to withdrawal of products from the market;

●

our failure to continue the commercialization of any of our products;

●

competition;

●

inadequate financial and other resources; and

●

global political and economic conditions, political instability and military hostilities.

In the unlikely event that payment of certain outstanding promissory notes issued by Profusa to its founders and insiders is demanded at an inopportune time for Profusa, Profusa’s management believes it would still have sufficient funds to operate its business, but may need to adjust certain expenditures or raise additional funds to operate at its currently planned levels.

We have issued a number of promissory notes and convertible notes to founders, insiders and other parties, many of which are payable on demand, past due or nearing maturity, which could adversely affect our liquidity. Profusa has issued a number of promissory notes and convertible notes to its founders, insiders and ~~insiders~~related parties, as well as other third parties, a number of which are ~~either~~ payable on demand, or past due, or have matured. As of ~~December 31~~September 30, ~~2024~~2025, we had approximately $0.9 million in promissory notes outstanding, with approximately $0.3 million of accrued and unpaid interest. Many of these promissory notes ~~had~~do annot ~~aggregate~~have a stated maturity and certain notes are past due. As a result, we are currently in default under certain of these notes, and the related balances are classified as current liabilities on our condensed consolidated balance sheets. In addition, as of September 30, 2025, we had outstanding ~~amount~~convertible promissory notes issued to related parties, including ~~principal~~a convertible note held by Tasly, which has matured and is payable at its principal amount plus accrued interest. We also assumed certain related-party debt and note obligations in connection with the July 2025 business combination with Northview, including convertible and non-convertible notes originally issued by Northview or its affiliates. Further, at the closing of ~~approximately~~the business combination, we issued a $~~910~~10.0 million convertible note (reflecting a 10% original issue discount),~~000~~ and on September 30, 2025, issued an additional $2,222,222 in principal amount of convertible notes pursuant to the same financing arrangement. These notes may be converted into shares of our Common Stock or, in certain circumstances, may require repayment in cash. Profusa has an understanding with the holders of certain of these ~~noteholders~~promissory notes and convertible notes that they will ~~withhold~~refrain from demanding or pursuing repayment until a date to be agreed upon by the parties. ~~that~~However, these arrangements are informal ~~will~~and not legally binding, and there can be ~~subsequent~~no toassurance that the ~~closing~~noteholders ofwill ~~the~~continue ~~Business~~to ~~Combination.~~forbear ~~However,~~from inexercising ~~the~~their ~~unlikely~~rights. ~~event~~If one ~~that~~or ~~the~~more noteholders were to demand or pursue repayment of these ~~promissory~~obligations ~~notes~~ at ana ~~inopportune~~ time ~~for~~when Profusa lacks sufficient liquidity, itwe could isbe ~~Profusa~~required to divert cash from operations, renegotiate the terms of our indebtedness, seek additional financing on unfavorable terms, or curtail or delay planned activities. Although management’s ~~belief~~believes that, iteven in such an event, Profusa would ~~still~~likely have sufficient funds to ~~operate~~continue ~~its~~operations ~~business,~~for ~~but~~the ~~may~~near ~~need~~term, our ability to ~~adjust~~operate ~~certain~~our ~~expenditures~~business orat ~~raise~~currently ~~additional~~planned ~~funds~~levels tocould ~~operate~~nevertheless atbe materially ~~its~~and ~~currently~~adversely ~~planned levels~~affected.

Risks Related to Healthcare Industry Shifts and Changing Regulations

Before a new medical device, or a significant modification of a medical device, including a new use of or claim for an existing product, can be marketed in the United States, it must first receive either 510(k) clearance or pre-market approval, or PMA, from the FDA, unless an exemption applies. In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a device legally on the market, known as a “predicate” device, with respect to intended use, technology and safety and effectiveness, in order to clear the proposed device for marketing. Clinical data is sometimes required to support substantial equivalence. Further, if a previously unclassified new medical device does not qualify for the 510(k) pre-market notification process because no predicate device to which it is substantially equivalent can be identified, the device is automatically classified into Class III. If such a device would be considered low or moderate risk (in other words, it does not rise to the level of requiring the approval of a PMA), it may be eligible for the De Novo classification process.

2733

The FDA or other regulators could delay, limit, or deny clearance or approval of a device for many reasons, including:

●

Our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that any of our devices (including any future devices) and any of our device accessories is substantially equivalent to a legally marketed predicate device or safe or effective for the proposed intended use;

●

the disagreement of the FDA with the design or implementation of any clinical trials or the interpretation of data from preclinical studies or clinical trials;

●

serious and unexpected adverse device effects experienced by participants in our clinical trials;

●

the insufficiency of the data from preclinical studies or clinical trials to support clearance or approval, where required;

●

our inability to demonstrate that the clinical and other benefits of the device outweigh the risks;

●

the failure of our manufacturing process or facilities to meet applicable requirements; and

●

the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval.

Obtaining 510(k) clearance, De Novo classification, or PMA approval for medical devices can be expensive and time-consuming, and entails significant user fees, unless an exemption is available. The FDA’s process for obtaining 510(k) clearance usually takes three to 12 months, but it can last longer. In the PMA approval process, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including but not limited to, technical, non-clinical, clinical trial, manufacturing and labeling data. The process for obtaining a PMA is more costly and uncertain than for a 510(k), and approval can take anywhere from at least one year to, in some cases, multiple years from the time the application is initially filed with the FDA. Modifications to products that are approved through a PMA application generally require further FDA approval. Some of our products may require PMA approval. In addition, the FDA may require that we obtain a PMA prior to marketing future changes of our existing products. Further, we may not be able to obtain additional 510(k) clearances or PMAs for new products or for modifications to, or additional indications for, our products in a timely fashion or at all. Delays in obtaining future clearances or approvals could adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn could harm our revenue and future profitability.

Some of our new or modified products will require FDA clearance of a 510(k) notification or FDA approval of a PMA application or supplement, or potentially a grant of a De Novo classification. The FDA may refuse our requests for 510(k) clearance or PMA of new products or may not clear or approve these products for the indications that are necessary or desirable for successful commercialization. Early stage review may also result in delays or other issues. For example, the FDA has issued guidance intended to explain the procedures and criteria used in assessing whether 510(k) and PMA submissions should be accepted for substantive review. Under the “Refuse to Accept” guidance, the FDA conducts an early review against specific acceptance criteria to inform 510(k) and PMA submitters if the submission is administratively complete, or if not, to identify the missing element(s). Submitters are given the opportunity to provide the FDA with any information identified as missing. If the information is not provided within a specified time, the submission will not be accepted for FDA review. The FDA may also change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions that may prevent or delay approval or clearance of our products under development or impact our ability to gain clearance or approval for modifications to our currently approved or cleared products in a timely manner. Significant delays in receiving clearance or approval, or the failure to receive clearance or approval for our new products, would have an adverse effect on our ability to expand our business.

Further, even in instances where we determine modifications to our cleared or approved products do not require a new 510(k) clearance or a PMA, the FDA may review our decision and disagree, or otherwise determine on its own initiative that a new clearance or approval is required. In this case, we may ultimately be required to make additional changes to our products, we may need to submit a new 510(k) application or a PMA and obtain clearance or approval, we may be required to temporarily suspend shipment of, withdraw or recall our products until such clearance or approval is obtained (which may not happen in a timely manner or at all), and/or we may be subject to other enforcement actions or proceedings and litigation, all of which would materially and adversely disrupt and harm our business and future growth. Where we determine that modifications to our approved or cleared products do require a new 510(k) clearance from the FDA or PMA approval, we may not be able to obtain such clearance or approval in a timely manner, or at all. Obtaining clearances or approvals can be a time-consuming and costly process, which may in some cases require us to conduct clinical trials, and delays in obtaining required future clearances or approval could adversely affect our ability to make updates and enhancements to our products in a timely manner, which in turn would harm our future growth.

We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could become subject to penalties, be excluded from participation in government programs, and/or be required to make significant changes to our operations.

Our products and associated services are subject to extensive pre-market and post-market regulation by the FDA and various other federal, state, local and foreign government authorities. Government regulation of medical devices is meant to assure their safety and effectiveness, and includes requirements for, among other things:

●

design, development and manufacturing processes;

●

labeling, content and language of instructions for use and storage;

●

product testing, non-clinical studies and clinical trials;

●

regulatory authorizations, such as pre-market clearance or pre-market approval;

●

establishment registration, device listing and ongoing compliance with the QSR requirements;

●

advertising and promotion;

●

marketing, sales and distribution;

●

conformity assessment procedures;

●

product traceability and record-keeping procedures;

●

review of product complaints, complaint reporting, recalls and field safety corrective actions;

●

post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury;

●

post-market studies (if applicable); and

●

product import and export.

The laws and regulations to which we and our products are subject are complex and subject to periodic changes. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales.

To support current and any future additional PMA, 510(k), De Novo applications or supplements, we together with our partners, must successfully complete pre-clinical studies, bench-testing, and in some cases clinical trials that will demonstrate that the product is safe and effective. Product development, including pre-clinical studies and clinical trials, is a long, expensive and uncertain process and is subject to delays ~~(including any potential delays due to the ongoing COVID-19 pandemic)~~ and failure at any stage. Furthermore, the data obtained from the studies and trials may be inadequate to support approval of an application and the FDA may request additional clinical data in support of those applications, which may result in significant additional clinical expenses and may delay product approvals.

While we have in the past obtained, and may in the future obtain, an investigational device exemption, or IDE, prior to commencing clinical trials for our products, FDA approval of an IDE application permitting us to conduct testing does not mean that the FDA will consider the data gathered in the trial to be sufficient to support approval of a PMA, De Novo or 510(k) application or supplement, even if the trial’s intended safety and effectiveness endpoints are achieved.

2935

Failure to obtain any required regulatory authorization in foreign jurisdictions will prevent us from marketing our products abroad.

We conduct limited commercial and marketing efforts in Europe with respect to our Lumee Oxygen Platform systems and may seek to market our products in other regions in the future. Outside the United States, we can market a product only if we receive a marketing authorization and, in some cases, pricing approval, from the appropriate regulatory authorities. The marketing authorization procedures vary among countries and can involve additional testing, and the time required to obtain any required authorization or approval may differ from that required to obtain FDA marketing authorization(s). Foreign regulatory authorization or approval processes may include all of the risks associated with obtaining FDA marketing authorization(s) in addition to other risks. We may not obtain foreign regulatory authorizations or approvals on a timely basis, if at all. Obtaining a marketing authorization from the FDA does not ensure authorization or approval by regulatory authorities in other countries will follow, and authorization or approval by one foreign regulatory authority does not ensure authorization or approval by regulatory authorities in other foreign countries or by the FDA. In addition, in order to obtain the authorization to market our products in certain foreign jurisdictions, we may need to obtain a Certificate to Foreign Government from the FDA. The FDA may refuse to issue a Certificate to Foreign Government in certain instances, including without limitation, during the pendency of any outstanding warning letter. As a result, we may not be able to file for regulatory approvals or marketing authorizations and may not receive necessary approvals or authorizations to commercialize our products in any market outside the United States on a timely basis, or at all.

Potential long-term complications from our current or future products under development may not be revealed by our clinical experience to date.

Based on our experience, complications from use of our products may include sensor errors, sensor failures, broken sensors, lodged sensors or skin irritation under the adhesive dressing of the sensor. Inflammation or redness, swelling, minor infection, and minor bleeding at the sensor insertion site are also possible risks with an individual’s use of our products. However, if unanticipated long-term side-effects result from the use of our products systems we have under development, we could be subject to liability and the adoption of our systems may become more limited. It is possible that the data from our clinical studies and trials may not be indicative of long-term patient outcomes. We cannot assure you that repeated, long-term use would not result in unanticipated adverse effects, potentially even after the sensor is removed.

If our products are approved or cleared, we will be subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. Manufacturers are also expected to maintain certain policies, procedures, and records regarding complaints and medical device reporting. If we fail to comply with our reporting and recordkeeping obligations, the FDA could take action, including warning letters, untitled letters, it has come to our attention letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance or approval, seizure of our products or delay in clearance or approval of future products.

3036

The FDA and foreign regulatory bodies have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to require a recall must be based on a finding that there is reasonable probability that the device could cause serious injury or death. We may also choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or failures to comply with applicable regulations. Product defects or other errors may occur in the future.

Depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new clearances or approvals for the device before we may market or distribute the corrected device. Seeking such clearances or approvals may delay our ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.

Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

Quality is very important to us and our customers due to the serious and costly consequences of product failure, and our business exposes us to potential product liability risks that are inherent in the design, manufacture, and marketing of medical devices. To comply with the FDA’s medical device reporting requirements, for example, we have are required to file reports of applicable field failures. Although we believe we have taken and are taking appropriate action aimed at reducing and/or eliminating field failures, we may have other product failures in the future. Product or component failures, manufacturing nonconformances, design defects, off-label use, or inadequate disclosure of product-related risks or product-related information with respect to our products, if they were to occur, could result in an unsafe condition or injury to, or death of, a patient. These problems could lead to recalls, corrections or removals of, or issuance of a safety alert relating to, our products, and could result in product liability claims and lawsuits.

Additionally, the production of our products must occur in a highly controlled and clean environment to minimize particles and other yield- and quality-limiting contaminants. Weaknesses in process control or minute impurities in materials may cause a substantial percentage of defective products. If we are not able to maintain stringent quality controls, or if contamination problems arise, our clinical development and commercialization efforts could be delayed, which would harm our business and our results of operations.

If we fail to meet any applicable product quality standards and our products are the subject of recalls or safety alerts, our reputation could be damaged, we could lose customers, our reputation could be harmed and our revenue and results of operations could decline.

If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market.

Our products, if cleared or approved, would be subject to extensive regulation as medical devices in the United States and elsewhere, including by the FDA and its foreign counterparts. Any product for which we obtain marketing approval, clearance or authorization (and the activities related to its production, distribution, and promotion, sale, and marketing) will be subject to continual review and periodic inspections by the FDA and other regulatory bodies, which may include inspection of our manufacturing processes, complaint handling and adverse event reporting, post-approval clinical data and promotional activities for such product. The FDA’s Medical Device Reporting, or MDR, regulations require that we report to the FDA any incident in which our product may have caused or contributed to a death or serious injury, or in which our product malfunctioned and, if the malfunction were to recur, it would likely cause or contribute to a death or serious injury.

In addition, government regulations specific to medical devices are wide ranging and govern, among other things:

●

product design, development, manufacture, and release;

●

laboratory and clinical testing, labeling, packaging, storage and distribution;

3137

●

product safety and efficacy;

●

premarketing clearance or approval;

●

record keeping;

●

product marketing, promotion and advertising, sales and distribution;

●

post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals;

●

post-market approval studies; and

●

product import and export.

If the FDA determines that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the agency may issue a cease distribution and notification order and a mandatory recall order. We may also decide to recall a product voluntarily if we find a material deficiency, including unacceptable risks to health, manufacturing defects, design errors, component failures, labeling defects, or other issues. Recalls of our products could divert the attention of our management and have an adverse effect on our reputation, financial condition, and operating results.

We and certain of our suppliers are also required to comply with the FDA’s Quality System Regulation, or QSR, and other regulations which cover the methods and documentation of the design, testing, production, control, selection and oversight of suppliers or contractors, quality assurance, labeling, packaging, storage, complaint handling, shipping and servicing of our products. The FDA may enforce the QSR through announced (through prior notification) or unannounced inspections.

Compliance with ongoing regulatory requirements can be complex, expensive and time-consuming. Failure by us or one of our suppliers or distributors to comply with statutes and regulations administered by the FDA, competent authorities and other regulatory bodies, or failure to take adequate response to any observations, could result in, among other things, any of the following actions:

●

warning letters or untitled letters that require corrective action;

●

delays in approving, or refusal to approve, our systems;

●

fines and civil or criminal penalties;

●

unanticipated expenditures;

●

FDA refusal to issue certificates to foreign governments needed to export our products for sale in other countries;

●

suspension or withdrawal of clearance or approval by the FDA or other regulatory bodies;

●

product recall or seizure;

●

administrative detention;

●

interruption of production, partial suspension, or complete shutdown of production;

●

interruption of the supply of components from our key component suppliers;

●

operating restrictions;

●

court consent decrees;

●

FDA orders to repair, replace, or refund the cost of devices;

●

injunctions; and

●

criminal prosecution.

3238

The potential effect of these events can in some cases be difficult to quantify. If any of these actions were to occur, it would harm our reputation and cause our product sales and profitability to suffer. In addition, we believe events that could be classified as reportable events pursuant to MDR regulations are generally underreported by physicians and users, and any underlying problems could be of a larger magnitude than suggested by the number or types of MDRs filed by us. Furthermore, while we select and monitor our key component suppliers to ensure key quality objectives are met and maintained, and performance of each key component supplier is continually re-evaluated based on objective evidence gathered by our quality assurance department, we cannot be certain that our key component suppliers currently are or will always continue to be in compliance with all applicable regulatory requirements.

Even if regulatory approval or clearance of a product is granted, the approval or clearance may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for costly post-marketing testing or surveillance to monitor the safety or effectiveness of the product. Later discovery of previously unknown problems with our products, including software bugs, unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as the QSR, MDR reporting, or other post-market requirements may result in restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, fines, suspension of regulatory approvals, product seizures, injunctions, the imposition of civil or criminal penalties, or criminal prosecution. In addition, our distributors have rights to create marketing materials for their sales of our products, and may not adhere to contractual, legal or regulatory limitations that are imposed on their marketing efforts.

We may be subject to fines, penalties and injunctions if we are determined to be promoting the use of our products for unapproved or improper off-label uses or determined to have made claims that are untruthful or misleading or not adequately substantiated.

We believe our marketing, promotional and educational materials and practices comply with FDCA, Federal Trade Commission Act, and other applicable laws and regulations, as may be amended from time to time. If the FDA, FTC or other regulatory body with competent jurisdiction over us, our activities or products takes the position that our marketing, promotional or other materials or activities constitute improper promotion or marketing of an unapproved or improper use, or that they contain untruthful, misleading, or inadequately substantiated statements or claims, such regulatory body could request that we modify our materials or practices, or subject us to regulatory enforcement actions, including the issuance, depending on the regulatory body and the nature of the alleged violation, of a warning letter, injunction, seizure, civil fine and criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider promotional, marketing or other materials or activities to constitute improper promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. Recent court decisions have impacted the FDA’s enforcement activity regarding off-label promotion in light of First Amendment considerations; however, there are still significant risks in this area in part due to the potential False Claims Act exposure and the FDA’s continued focus on ensuring devices are marketed in a manner consistent with their FDA-required labeling.

It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our educational and promotional activities or training methods to constitute promotion of an off-label use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged, and adoption of the products could be impaired. Although our policy is to refrain from statements that could be considered off-label promotion of our products, if cleared or approved, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. It is also possible that other federal, state or foreign enforcement authorities might take action, including, but not limited to, through a whistleblower action under the FCA, if they consider our business activities to constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil or administrative penalties, treble damages, fines, disgorgement, exclusion from participation in government healthcare programs, reporting requirements and compliance oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations. In addition, the off-label use of any products for which we receive approval or clearance may increase the risk of product liability claims. Product liability claims are expensive to defend and could divert our management’s attention, result in substantial damage awards against us, and harm our reputation.

3339

Our current or future products may be subject to product recalls even after receiving FDA clearance or approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.

Medical devices can experience performance problems in the field that require review and possible corrective action. The occurrence of component failures, manufacturing errors, software errors, design defects or labeling inadequacies affecting a medical device could lead to a government-mandated or voluntary recall by the device manufacturer, in particular when such deficiencies may endanger health. The FDA and similar governmental bodies in other countries have the authority to require the recall of our products if we or our third-party manufacturers fail to comply with relevant regulations pertaining to, among other things, manufacturing practices, labeling, advertising or promotional activities, or if new information is obtained concerning the safety or efficacy of these products. For example, under the FDA’s MDR regulations, we are required to report to the FDA any incident in which our products may have caused or contributed to a death or serious injury or in which our products malfunctioned in a manner likely to cause or contribute to death or serious injury if that malfunction were to recur. Repeated adverse events or product malfunctions may result in a voluntary or involuntary product recall, or administrative or judicial seizure or injunction, when warranted. A government-mandated recall may be ordered if the FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. A voluntary recall by us could occur as a result of any material deficiency in a device, such as manufacturing defects, labeling deficiencies, packaging defects or other failures to comply with applicable regulations, such as a failure to obtain marketing approval or clearance before launching a new product. In general, if we decide to make a change to our product, we are responsible for determining whether to classify the change as a recall. It is possible that the FDA could disagree with our initial classification. The FDA requires that certain classifications of recalls be reported to the FDA within 10 working days after the recall is initiated. If a change to a device addresses a violation of the federal Food, Drug, and Cosmetic Act, or FDCA, that change would generally constitute a medical device recall and require submission of a recall report to the FDA. A future recall announcement could harm our reputation with customers, potentially lead to product liability claims against us and negatively affect our sales. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, will distract management from operating our business and may harm our reputation and financial results.

Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our reputation, results of operations and financial condition, which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be subject to product liability claims, be required to bear other costs, or be required to take other actions that may have a negative impact on our future sales and our ability to generate profits. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA. We may initiate voluntary recalls involving our products in the future that we determine do not require notification to the FDA. If the FDA disagrees with our determinations, the FDA could require us to report those actions as recalls. A future recall, withdrawal, or seizure of any product could materially and adversely affect consumer confidence in the Profusa brand, lead to decreased demand for our products and negatively affect our sales. In addition, the FDA could take enforcement action for failing to report recalls when they were conducted by us or one of our agents.

Health care policy changes, including U.S. health care reform legislation, may have a material adverse effect on our business.

Although we do not currently have a product on the market in the U.S. and do not make patient referrals or bill Medicare, Medicaid, or other government or commercial third-party payors, we may be subject to a number of healthcare statutory and regulatory requirements, and therefore may be affected by changes in health care laws and regulations. In response to increases in health care costs in recent years, there have been and continue to be proposals by the federal government, state governments, regulators, and third-party payors to control these costs and, more generally, to reform the U.S. health care system. Certain of these proposals could limit the prices we are able to charge for the products we may commercialize or the amounts of reimbursement available for the products we may commercialize and could limit the acceptance and availability of our products. Further, while the United States has begun shifting to pay-for-performance rather than fee-for-service models and has been embracing many shared-risk arrangements, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services, Office of Inspector General (OIG) specifically excluded medical device manufacturers from utilizing the new, more flexible Stark Law exceptions and Anti-Kickback Statute safe harbors under the Final Rules, part of the U.S. Department of Health and Human Services’ Regulatory Sprint to Coordinated Care, which were published on December 2, 2020 in the Federal Register and were largely effective January 19, 2021. The exclusion of manufacturers from utilizing these exceptions and safe harbors may not allow us to avail ourselves of immunity from liability under the laws, potentially inviting greater scrutiny over any potential shared risk arrangements.

3440

On November 16, 2020 the OIG published a Special Fraud Alert addressing manufacturer Speaker Programs signaling both a narrower government view of AKS compliance with respect to such programs as well as the potential for increased enforcement in this space by government oversight agencies such as the OIG and the Department of Justice (DOJ). We continue to assess industry response to the Special Fraud Alert and have and may continue to make modifications to certain aspects of our speaker programs, which may have a detrimental impact on our ability to educate healthcare providers about our products and to promote use of our products, which may lead to decreased product sales and negatively impact our business, financial condition and results of operations.

Comprehensive healthcare legislation, signed into law in the United States in March 2010, titled the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, collectively, the ACA, imposes certain stringent compliance, recordkeeping, and reporting requirements on companies in various sectors of the life sciences industry, and enhanced penalties for non-compliance. There have been numerous legal and Congressional challenges to the law’s provisions. On June 17, 2021, the U.S. Supreme Court dismissed a legal challenge to the law brought by several states arguing that, without the individual mandate, the entire Affordable Care Act ACA was unconstitutional. The Supreme Court dismissed the lawsuit without ruling on the merits of the states’ constitutionality arguments.

Other legislative changes have been proposed and adopted in the U.S. since the ACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by the U.S. Congress. This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013. As a result of the COVID-19 pandemic, this reduction was temporarily suspended from May 1, 2020 through March 31, 2022, with subsequent reductions to 1% from April 1, 2022 until June 30, 2022. The 2% reduction was then reinstated and has been in effect since June 30, 2022, and will remain in effect (with additional reductions of 2.25% in the first half of 2030 and 3% in the second half of 2030 to offset the COVID-19 suspension) until 2031 unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was enacted which, among other things, further reduced Medicare payments to several providers, including hospitals and outpatient clinics, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

We cannot predict what additional new legislation, agency priorities, and rulemakings may be on the horizon as the United States continues to reassess how it pays for healthcare. As a result, we cannot quantify or predict what impact any changes might have on our business and results of operations. However, any changes that lower reimbursement for our products could materially and adversely affect our business, financial condition and results of operations.

Other legal, regulatory and commercial policy influences are subjecting our industry to significant changes, and we cannot predict whether new regulations or policies will emerge from U.S. federal or state governments, foreign governments, or third-party payors. Third-party payors in the United States often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. There may be significant delays in obtaining coverage and reimbursement for products we are able to commercialize, as the process of determining coverage and reimbursement is often time consuming and costly which will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage or adequate reimbursement will be obtained. It is difficult to predict at this time what government authorities and third-party payors will decide with respect to coverage and reimbursement for our products. Government and third-party payors may, in the future, consider healthcare policies and proposals intended to curb rising healthcare costs, including those that could significantly affect reimbursement for healthcare products such as our systems. These policies have included, and may in the future include: basing reimbursement policies and rates on clinical outcomes, the comparative effectiveness, and costs, of different treatment technologies and modalities; imposing price controls and taxes on medical device providers; and other measures. Future significant changes in the healthcare systems in the United States or elsewhere could also have a negative impact on the demand for our current and future products. These include changes that may reduce reimbursement rates for our products and changes that may be proposed or implemented by the current or future laws or regulations.

3541

We are subject to federal, state and foreign laws prohibiting “kickbacks” and false or fraudulent claims, and other fraud and abuse laws, transparency laws, and other health care laws and regulations, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.

Although we do not currently have an approved or commercialized product in the U.S., our relationships with customers and third-party payors for our products, once approved and commercialized, may be subject to broadly applicable fraud and abuse and other health care laws and regulations that may constrain our sales, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs and certain customer and product support programs, we may have with hospitals, physicians or other purchasers of medical devices. Other federal and state laws generally prohibit individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, or are for items or services that were not provided as claimed. These laws include, among others, the federal Anti-Kickback Statute, the federal civil False Claims Act, other federal health care false statement and fraud statutes, the federal Physician Payments Sunshine Act, the Civil Monetary Penalties Law, and analogous fraud and abuse and transparency laws in most states. While the federal laws generally apply only to products or services for which payment may be made by a federal healthcare program, state laws often apply regardless of whether federal funds may be involved.

While we believe and make every effort to ensure that our business arrangements with third parties and other activities and programs comply with all applicable laws, these laws are complex, and our activities may be found not to be compliant with one or more of these laws, which may result in significant civil, criminal and/or administrative penalties, fines, damages and exclusion from participation in federal health care programs. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity, and be costly to respond to, and thus could have a material adverse effect on our business, financial condition and results of operations. Our compliance with Medicare and Medicaid regulations may be reviewed by federal or state agencies, including the OIG, CMS, and DOJ, or may be subject to whistleblower lawsuits under federal and state false claims laws. To ensure compliance with Medicare, Medicaid and other regulations, government agencies conduct periodic audits of the Company to ensure compliance with various supplier standards and billing requirements.

Similarly, our international operations are subject to the provisions of the FCPA, which prohibits U.S. companies and their intermediaries from making payments in violation of law to non-U.S. government officials for the purpose of obtaining or retaining business or securing any other improper advantage. In many countries, the healthcare professionals that medical device distributors regularly interact with may meet the definition of a foreign official for purposes of the FCPA. International business operations are also subject to various other international anti-bribery laws such as the U.K. Anti-Bribery Act. Despite meaningful measures that we undertake to facilitate lawful conduct, which include training and compliance programs and internal policies and procedures, we may not always prevent unauthorized, reckless or criminal acts by our employees or agents, or employees or agents of businesses or operations we may acquire. Violations of these laws, or allegations of such violations, could disrupt operations, involve significant management distraction and have a material adverse effect on our business, financial condition and results of operations, among other adverse consequences.

Changes to the regulatory landscape may impact our ability to obtain marketing authorization for future product developments.

Development or changes to the FDA or foreign regulatory approval standards and processes, including both legal and policy changes, could also delay or prevent the approval of our products submitted for review. For example, as part of the 21^st Century Cures Act passed in 2016, Congress enacted several reforms that further affect medical device regulation both pre- and post-approval, and FDA implementation and development of guidance in many areas is still ongoing. In addition, the FDA is in the process of reviewing the 510(k) approval process and criteria and has announced initiatives to improve the current pre- and post-market regulatory processes and requirements associated with infusion pumps and other home-use medical devices. As part of this effort, the FDA is reviewing the adverse event reporting and recall processes for insulin pumps. Any change in the laws or regulations that govern the clearance and approval processes relating to our current and future products could make it more difficult and costly to obtain clearance or approval for new products, or to produce, market and distribute existing products. The data contained in our submissions, including data drawn from our clinical trials, may not be sufficient to support clearance or approval of our products or additional or expanded indications.

3642

Medical device company stock prices have declined significantly in certain circumstances where companies have failed to meet expectations in regard to the timing of regulatory approval. If the FDA’s response causes product approval delays, or is not favorable for any of our products, our stock price (and the market price of our senior convertible notes) could decline substantially. It is uncertain how these potential changes may impact our ability to gain clearance or approval from FDA for our products in the future.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval or clearance of our future products under development or impact our ability to modify our currently cleared products on a timely basis. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of planned or future products. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be.

FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products or make it more difficult to obtain clearance or approval for, manufacture, market or distribute our products. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require: additional testing prior to obtaining clearance or approval; changes to manufacturing methods; recall, replacement or discontinuance of our products; or additional record keeping.

The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay regulatory clearance or approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.

Any change in the laws or regulations that govern the clearance and approval processes relating to our current, planned and future products could make it more difficult and costly to obtain clearance or approval for new products or to produce, market and distribute existing products. Significant delays in receiving clearance or approval or the failure to receive clearance or approval for any new products would have an adverse effect on our ability to expand our business. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing clearance that we may have obtained and we may not achieve or sustain profitability.

Our failure to comply with laws, regulations and contract requirements relating to reimbursement of health care goods and services may subject us to penalties and adversely impact our reputation, business, financial condition and cash flows.

We are subject to laws, regulations and contractual requirements regulating the provision of, and reimbursement for, health care goods and services, both in our capacity as a medical device manufacturer and/or as a supplier of covered items and services to federal health care program beneficiaries, with respect to which items and services we submit claims for reimbursement from such programs. The laws and regulations of health care goods and services that apply to us, including those described above, are subject to evolving interpretations and enforcement discretion. As part of our compliance program, we have reviewed our sales contracts, marketing materials, referral source relationships, programmatic offerings, and billing practices (among others) to reduce the risk of non-compliance with these and other foreign, federal and state laws. If a governmental authority was to conclude that we are not in compliance with applicable laws and regulations, we and our officers, directors and employees could be subject to criminal and civil penalties, including, for example, exclusion from participation as a supplier of product to beneficiaries covered by federal healthcare programs, including but not limited to Medicare and Medicaid. Any failure to comply with laws, regulations or contractual requirements relating to reimbursement and health care goods and services could adversely affect our reputation, business, financial condition and cash flows.

3743

We are subject to complex and evolving U.S. and foreign laws and regulations and other requirements regarding privacy, data protection, security, and other matters. Many of these laws and regulations are subject to change and uncertain interpretation, and could result in claims, changes to our business practices, monetary penalties, increased cost of operations, or declines in user growth or engagement, or otherwise harm our business.

We are subject to a number of foreign, federal and state laws and regulations protecting the use, disclosure and confidentiality of certain patient health and personal information, including patient records, and restricting the use and disclosure of that protected information. These laws include foreign, federal and state medical privacy laws, breach notification laws and consumer protection laws. As our customer base grows to include U.S. federal government agencies, Profusa may also need comply with Federal Risk and Authorization Management Program and Cybersecurity Maturity Model Certification requirements. These frameworks impose stringent cybersecurity standards and potentially significant non-compliance penalties.

In addition, foreign data protection, privacy, and other laws and regulations can be more restrictive than those in the United States. For example, data localization laws in some countries generally mandate that certain types of data collected in a particular country be stored and/or processed within that country. We may be subject to inquiries, investigations and audits in Europe and around the world, particularly in the areas of consumer and data protection, which will arise in the ordinary course of business and may increase in frequency as we continue to grow and expand our operations. Legislators and regulators may make legal and regulatory changes, or interpret and apply existing laws, in ways that make our products less useful to our customers, require us to incur substantial costs, expose us to unanticipated civil or criminal liability, or cause us to change our business practices. These changes or increased costs could negatively impact our business and results of operations in material ways.

In the ordinary course of our business, we collect and store sensitive data, such as our proprietary business information and that of our clients, contractors, vendors and others as well as personally identifiable information of our customers, vendors and others, which data may include full names, social security numbers, addresses, and birth dates, in our data centers and on our networks. Our employees, contractor and vendors may also have access to and may use personal health information in the ordinary course of our business. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our security measures and business controls, our information technology and infrastructure may be vulnerable to attacks by hackers, breaches due to employee, contractor or vendor error, or malfeasance or other disruptions or subject to the inadvertent or intentional unauthorized release of information. Any such occurrence could compromise our networks and the information stored thereon could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, and liability under laws that protect the privacy of personal information and regulatory penalties, disrupt our operations and the services we provide to our clients or damage our reputation, any of which could adversely affect our profitability, revenue and competitive position.

As we grow and expand our administrative, customer support or IT support services, we may also utilize the services of personnel and contractors located outside of the United States to perform certain functions. While we make every effort to review our applicable contracts and other payor requirements, a local, state, or federal government agency or one of our customers may find the use of offshore resources to be a violation of a legal or contractual requirement, which could result in termination of the contractual relationship, penalties, or changes in our business operations that could adversely affect our business, financial condition, and results of operations. Additionally, while we have implemented industry standard security measures for offshore access to protected health information and other personal information, unauthorized access or disclosure of such information by offshore personnel could result in legal claims or proceedings, and liability under laws that protect the privacy of personal information and regulatory penalties, disrupt our operations and the services we provide to our clients, damage to our reputation or result in the termination of contractual relationships, penalties or the loss of coverage, any of which could adversely affect our profitability, revenue and competitive position.

Security breaches and other disruptions that compromise our information and expose us to liability, could cause our business and reputation to suffer and could subject us to substantial liabilities.

The Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act of 1996, as amended, and implementing regulations, or HIPAA, extensively regulate the use and disclosure of individually identifiable health information, known as “protected health information,” and require covered entities, including health plans and most health care providers, to implement administrative, physical and technical safeguards to protect the security of such information. Certain provisions of the security and privacy regulations apply to business associates (entities that handle protected health information on behalf of covered entities), and business associates are subject to direct liability for violation of these provisions. In addition, a covered entity may be subject to penalties as a result of a business associate violating HIPAA, if the business associate is found to be an agent of the covered entity. Profusa is a covered entity under HIPAA and may also function in a business associate capacity to other covered entities.

3844

Covered entities must report breaches of unsecured protected health information to affected individuals without unreasonable delay and notification must also be made to the U.S. Department of Health & Human Services, Office for Civil Rights, or OCR and, in certain situations involving large breaches, to the media. Various U.S. state laws and regulations may also require us to notify affected individuals and state agencies in the event of a data breach involving individually identifiable information.

Violations of the HIPAA privacy and security regulations may result in criminal and civil penalties. The OCR enforces the regulations and performs compliance audits. In addition to enforcement by OCR, state attorneys general are authorized to bring civil actions seeking either injunction or damages in response to violations that threaten the privacy of state residents. We follow and maintain a HIPAA compliance plan, which we believe complies with the HIPAA privacy and security regulations, but there can be no assurance that OCR or other regulators will agree. The HIPAA privacy regulations and security regulations have and will continue to impose significant costs on us in order to comply with these standards.

There are numerous other laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security concerns. We also remain subject to federal or state privacy-related laws that are more restrictive than the regulations issued under HIPAA. These laws vary and could impose additional penalties. For example, the Federal Trade Commission uses its consumer protection authority to initiate enforcement actions in response to alleged privacy and data security violations. The California Consumer Privacy Act, or CCPA, which came into effect January 1, 2020 and was amended and expanded by the California Privacy Rights Act, or CPRA, which came into effect on January 1, 2023. The CCPA, including as amended by CPRA, among other things, create new data privacy obligations for covered companies and provide new privacy rights to California residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. As of January 1, 2023, the CCPA applies broadly to California employees and personal information of business contacts, which we anticipate will increase our compliance costs. It remains unclear what, if any, additional modifications will be made to this legislation or how it will be interpreted and regulations implementing CPRA amendments will not be finalized before CPRA amendments come into effect. Therefore, the effects of the CCPA and CPRA are significant and will likely require us to modify our data processing practices, and may cause us to incur substantial costs and expenses to comply, particularly given our base of operations in California. There are also a number of other legislative proposals worldwide, including in the United States at both the federal and state level, that could impose additional and potentially conflicting obligations in areas affecting our business.

We are also subject to laws and regulations in foreign countries covering data privacy and other protection of health and employee information that may be more onerous than corresponding U.S. laws, including in particular the laws of Europe.

For instance, in the European Union, increasingly stringent data protection and privacy rules that have and will continue to have substantial impact on the use of patient data across the healthcare industry became effective in May 2018. The EU General Data Protection Regulation, or GDPR, applies across the European Union and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance. The GDPR fine framework can be up to 20 million euros, or up to 4% of the company’s total global turnover of the preceding fiscal year, whichever is higher. The GDPR also requires companies processing personal data of individuals residing in the European Union to comply with EU privacy and data protection rules, even if the company itself does not have a physical presence in the European Union. Noncompliance could result in the imposition of fines, penalties, or orders to stop noncompliant activities. Due to the strong consumer protection aspects of the GDPR, companies subject to its purview are allocating substantial legal costs to the development of necessary policies and procedures and overall compliance efforts. For example, following a decision of the Court of Justice of the EU in October 2015, the transfer of personal data to US companies that had certified as members of the US Safe Harbor Scheme was declared invalid. In July 2016, the European Commission adopted the EU-US Privacy Shield Framework, or the Privacy Shield Framework, which replaced the US Safe Harbor Scheme. On July 16, 2020, the Court of Justice of the European Union issued a decision that declared the Privacy Shield Framework invalid, and will also result in additional compliance obligations for companies that implement standard contractual clauses to ensure a valid basis for the transfer of personal data outside of Europe. We expect continued costs associated with maintaining compliance with GDPR into the future, and these provisions as interpreted by EU agencies, could negatively impact our business, financial condition and results of operations.

3945

In addition to the laws discussed above, we may see more stringent state and federal privacy legislation in 2022 and beyond, as the increased cyber attacks during the COVID-19 pandemic have once again put a spotlight on data privacy and security in the U.S. and other jurisdictions. We cannot predict where new legislation might arise, the scope of such legislation, or the potential impact to our business and operations.

Cybersecurity risks and cyber incidents could result in the compromise of confidential data or critical data systems and give rise to potential harm to customers, remediation and other expenses, expose us to liability under HIPAA, consumer protection laws, or other common law theories, subject us to litigation and federal and state governmental inquiries, damage our reputation, and otherwise be disruptive to our business and operations.

Cyber incidents can result from deliberate attacks or unintentional events. We collect and store on our networks sensitive information, including intellectual property, proprietary business information and personally identifiable information of individuals, such as our customers and employees. The secure maintenance of this information and technology is critical to our business operations. We have implemented multiple layers of security measures to protect the confidentiality, integrity and availability of this data and the systems and devices that store and transmit such data. We utilize current security technologies, and our defenses are monitored and routinely tested internally and by external parties. Additionally, we use third party products such as Amazon Cognito that provide advanced user authentication services that aim to prevent bad actors from accessing our systems. Despite these efforts, threats from malicious persons and groups, new vulnerabilities and advanced new attacks against information systems create risk of cybersecurity incidents. These incidents can include, but are not limited to, gaining unauthorized access to digital systems for purposes of misappropriating assets or sensitive information, corrupting data, or causing operational disruption. Because the techniques used to obtain unauthorized access, disable or degrade service, or sabotage systems change frequently and may not immediately produce signs of intrusion, we may be unable to anticipate these incidents or techniques, timely discover them, or implement adequate preventative measures. When we leverage third-party tools to manage security features, we add an additional potential attack surface that is capable of being exploited.

InWe ~~response to the COVID-19 pandemic, we~~ have modified our business practices and implemented telework policies wherever possible for appropriate categories of “nonessential” employees to minimize the disruption to our operations, to the extent possible. The continuation of these telework policies means additional operational risk, including increased cybersecurity risk. These cyber risks include, among other risks, greater phishing, malware, and other cybersecurity attacks, vulnerability to or disruptions of our information technology infrastructure and systems to support remote operations, increased risk of unauthorized access, use or dissemination of confidential information, limited ability to restore the systems in the event of a systems failure or interruption, greater risk of a security breach resulting in destruction, alteration or misuse of valuable information, including proprietary business information and personally identifiable information of individuals, all of which could expose us to risks of data or financial loss, litigation and liability.

These threats can come from a variety of sources, ranging in sophistication from an individual hacker to malfeasance by employees, consultants or other service providers to criminal or other unauthorized threat actors, including state-sponsored attacks. Cyber threats may be generic, or they may be custom-crafted against our information systems. Over the past several years, cyber attacks have become more prevalent and much harder to detect and defend against. These threat actors may be able to penetrate our security measures, breach our information technology systems, misappropriate or compromise confidential and proprietary information of our Company and our customers, cause system disruptions and shutdowns, or introduce ransomware, malware, or vulnerabilities into our products, systems, and networks or those of our customers and partners. Our network and storage applications, as well as those of our contractors, may be vulnerable to cyber-attack, malicious intrusion, malfeasance, loss of data privacy or other significant disruption and may be subject to unauthorized access by hackers, employees, consultants or other service providers. In addition, hardware, software or applications we develop or procure from third parties may contain defects in design or manufacture or other problems that could unexpectedly compromise information security or other problems that unexpectedly could interfere with the operation of our products. Unauthorized parties may also attempt to gain access to our systems or facilities through fraud, trickery or other forms of deceiving our employees, contractors and temporary staff.

4046

We are and may continue to be subject to cybersecurity incidents that bypass our security measures. Such incidents may impact the integrity, availability or privacy of personal health information or other data subject to privacy laws or disrupt our information systems, devices or business, including our ability to deliver services to our customers. As a result, cybersecurity, physical security and the continued development and enhancement of our controls, processes and practices designed to protect our enterprise, information systems and data from attack, damage or unauthorized access remain a priority for us. As cyber threats continue to evolve, we may be required to expend significant additional resources to continue to modify or enhance our protective measures or to investigate and remediate any cybersecurity vulnerabilities. The occurrence of any of these events could result in:

●

harm to customers;

●

business interruptions and delays;

●

the loss, misappropriation, corruption or unauthorized access of data;

●

litigation, including potential class action litigation, and potential liability under privacy, security and consumer protection laws or other applicable laws;

●

reputational damage;

●

increase to insurance premiums; and

●

foreign, federal and state governmental inquiries, any of which could have a material, adverse effect on our financial position and results of operations and harm our business reputation.

Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches, service interruptions, or data corruption could significantly disrupt our operations and adversely affect our business and operating results.

We rely on information technology and telephone networks and systems, including the Internet, to process and transmit sensitive electronic information and to manage or support a variety of business processes and activities, including sales, billing, customer service, procurement and supply chain, manufacturing, and distribution. We use enterprise information technology systems to record, process, and summarize financial information and results of operations for internal reporting purposes and to comply with regulatory financial reporting, legal, and tax requirements. System failures or outages, including any potential disruptions due to significantly increased global demand on certain cloud-based systems ~~during or as a result of the COVID-19 pandemic~~, or failures to adequately scale our data platforms and architectures support patient care could compromise our ability to perform these functions in a timely manner, which could harm our ability to conduct business or delay our financial reporting. Such failures could materially adversely affect our operating results and financial condition. Our information technology systems, some of which are managed by third parties, may be susceptible to damage, disruptions or shutdowns due to computer viruses, ransomware or other malware, attacks by computer hackers, failures during the process of upgrading or replacing software, databases or components thereof, power outages, hardware failures, telecommunication failures, user errors or catastrophic events. Although we have developed systems and processes that are designed to protect customer information and prevent data loss and other security breaches, including systems and processes designed to reduce the impact of a security breach at a third-party vendor, such measures cannot provide absolute security. In addition, certain countries have implemented or may implement legislative and technological actions that either do or can effectively regulate access to the internet, including the ability of internet service providers to limit access to specific websites or content. Other countries have attempted or are attempting to change or limit the legal protections available to businesses that depend on the internet for the delivery of their services. If our systems are breached or suffer severe damage, disruption or shutdown and we are unable to effectively resolve the issues in a timely manner, our business and operating results may significantly suffer and we may be subject to litigation, government enforcement actions and other actions for which we could face financial liability and other adverse consequences which may include:

●

additional government oversight of our operations;

●

loss of existing customers;

●

difficulty in attracting new customers;

●

problems in determining product cost estimates and establishing appropriate pricing;

4147

●

difficulty in preventing, detecting, and controlling fraud;

●

disputes with customers, physicians, and other health care professionals;

●

increases in operating expenses, incurrence of expenses, including notification and remediation costs;

●

regulatory fines or penalties;

●

individual actions or class actions for damages;

●

loss of revenues (including through loss of coverage or reimbursement);

●

product development delays;

●

disruption of key business operations; and

●

diversion of attention of management and key information technology resources.

Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, thereby preventing new products and services from being developed or commercialized in a timely manner or otherwise preventing those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve or clear new medical device products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also increase the time necessary for new products to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times, and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. Separately, in response to the COVID-19 pandemic, in March 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing facilities and provided guidance regarding the conduct of clinical trials, which has since been further updated and is being refreshed on a periodic basis. The FDA has also noted that it iswas continuing to ensure timely reviews of applications for medical products during the COVID-19 pandemic in line with its user fee performance goals and conducting “mission-critical” domestic and foreign inspections to ensure compliance of manufacturing facilities with FDA quality standards.

Subsequently, in July 2020, the FDA announced its intention to resume certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system. The FDA intends to use this risk-based assessment system to identify the categories of regulatory activity that can occur within a given geographic area, ranging from mission-critical inspections to resumption of all regulatory activities. The agency’s rating system is used to assist in determining when and where it is safest to conduct such inspections based on data about the virus’s trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. The FDA’s assessment of whether an inspection is mission-critical considers many factors related to the public health benefit of U.S. patients having access to the product subject to inspection, including whether the products are used to diagnose, treat, or prevent a serious disease or medical condition for which there is no other appropriate substitute. Both for-cause and pre-approval inspections can be deemed mission-critical. ~~The COVID-19 public health emergency determinations and declarations ended May 11, 2023.~~ This is nonetheless subject to change.

4248

Risks Related to Intellectual Property Protection and Use

Third parties may assert infringement or misappropriation claims against us with respect to our current or future products. We are aware of numerous patents issued to third parties that may relate to aspects of our business, including the design and manufacture of CGM sensors and membranes, as well as methods for oxygen and continuous glucose monitoring. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Therefore, we cannot be certain that we have not infringed the intellectual property rights of such third parties or others. Our competitors may assert that our systems or the methods we employ in the use of our systems are covered by U.S. or foreign patents held by them. This risk is exacerbated by the fact that there are numerous issued patents and pending patent applications relating to our systems in the medical technology field. Because patent applications may take years to issue, there may be applications now pending of which we are unaware that may later result in issued patents that our products infringe. There could also be existing patents of which we are unaware that one or more components of our system may inadvertently infringe. As the number of competitors in the market grows, the possibility of patent infringement by us or a patent infringement claim against us increases. If we are unable to successfully defend any such claims as they may arise or enter into or extend settlement and license agreements on acceptable terms or at all, our business operations may be harmed.

Any infringement or misappropriation claim could place significant strain on our financial resources, divert management’s attention from our business and harm our reputation. In addition, if the relevant patents are upheld as valid and enforceable and we are found to infringe such patents, we could be prohibited from selling any of our products that is found to infringe unless we could obtain licenses to use the technology covered by the patent or are able to design around the patent. We may be unable to obtain a license on terms acceptable to us, if at all, and we may not be able to redesign our products to avoid infringement. We may be unable to maintain or renew licenses on terms acceptable to us, if at all, and we may be prohibited from selling any of our products that required the technology covered by the relevant licensed patents. Even if we are able to redesign our products to avoid an infringement claim, we may not receive FDA approval for such changes in a timely manner or at all.

Any adverse determination in litigation or derivation proceedings to which we are or may become a party relating to patents or other intellectual property rights could subject us to significant liabilities to third parties or require us to seek licenses from other third parties. If we are found to infringe third-party patents, a court could order us to pay damages to compensate the patent owner for the infringement, such as a reasonable royalty amount and/or profits lost by the patent owners, along with prejudgment and/or post-judgment interest. Furthermore, if we are found to willfully infringe third-party patents, we could, in addition to other penalties, be required to pay treble damages; and if the court finds the case to be exceptional, we may be required to pay attorneys’ fees for the prevailing party. If we are found to infringe third-party copyrights or trademarks or misappropriate third-party trade secrets, based on the intellectual property at issue, a court could order us to pay statutory damages, actual damages, or profits, such as reasonable royalty or lost profits of the owners, unjust enrichment, disgorgement of profits, and/or a reasonable royalty, and the court could potentially award attorneys’ fees or exemplary or enhanced damages. Although patent and intellectual property disputes in the medical device area have often been settled through licensing or similar arrangements, costs associated with such arrangements may be substantial and would likely include ongoing royalties. We may be unable to obtain necessary intellectual property licenses on satisfactory terms. If we do not obtain any such necessary licenses, we may not be able to redesign our products to avoid infringement and any redesign may not receive FDA approval or other requisite marketing authorization in a timely manner or at all. Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary intellectual property licenses could prevent us from manufacturing and selling our products, which would have a significant adverse impact on our business. If litigation were to be initiated by intellectual property owners, there could significant legal fees and costs incurred in defending litigation (which may include filing administrative actions to attack the intellectual property) as well as a potential monetary settlement payment to the owners, even if the matter is resolved before going to trial. Moreover, the owners may take an overly aggressive approach and/or include multiple allegations in a single litigation.

4349

In addition, from time to time, we are subject to various claims, complaints and legal actions arising out of the ordinary course of business, including commercial insurance, product liability or employment-related matters.

Also, from time to time, we may bring claims or initiate lawsuits against various third parties with respect to matters arising out of the ordinary course of our business, including commercial and employment-related matters. We do not believe we are party to any currently pending legal proceedings, the outcome of which could have a material adverse effect on our business, financial condition or results of operations. There can be no assurance that existing or future legal proceedings arising in the ordinary course of business or otherwise will not have a material adverse effect on our business, financial condition or results of operations.

Our inability to adequately protect our intellectual property could allow our competitors and others to produce products based on our technology, which could substantially impair our ability to compete.

Our success and our ability to compete depend, in part, upon our ability to maintain the proprietary nature of our technologies. We rely on a combination of patent, copyright and trademark law, and trade secrets and nondisclosure agreements to protect our intellectual property. However, such methods may not be adequate to protect us or permit us to gain or maintain a competitive advantage. Our patent applications may not issue as patents in a form that will be advantageous to us, or at all. Our issued patents, and those that may issue in the future, may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products. In addition, there are numerous changes to the patent laws and proposed changes to the rules of the U.S. Patent and Trademark Office, which may have a significant impact on our ability to protect our technology and enforce our intellectual property rights.

To protect our proprietary rights, we may in the future need to assert claims of infringement against third parties. The outcome of litigation to enforce our intellectual property rights in patents, copyrights, trade secrets or trademarks is highly unpredictable, could result in substantial costs and diversion of resources, and could have a material adverse effect on our business, financial condition and results of operations regardless of the final outcome of such litigation. In the event of an adverse judgment, a court could hold that some or all of our asserted intellectual property rights are not infringed, or are invalid or unenforceable, and could award attorney fees.

Despite our efforts to safeguard our unpatented and unregistered intellectual property rights, we may not succeed in doing so or the steps taken by us in this regard may not be adequate to detect or deter misappropriation of our technology or to prevent an unauthorized third party from copying or otherwise obtaining and using our products, technology or other information that we regard as proprietary. In addition, third parties may be able to design around our patents. Furthermore, the laws of foreign countries may not protect our proprietary rights to the same extent as the laws of the United States.

We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe on our patents or the patents that we license. In the event of infringement or unauthorized use, we may file one or more infringement lawsuits, which can be expensive and time-consuming. An adverse result in any such litigation proceedings could put one or more of our patents at risk of being invalidated, being found to be unenforceable or being interpreted narrowly and could put our patent applications at risk of not issuing. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Many of our competitors are larger than we are and have substantially greater resources. They are, therefore, likely to be able to sustain the costs of complex patent litigation longer than we could. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise any funds necessary to continue our operations, continue our internal research programs, in-license needed technology, or enter into development partnerships that would help us bring our products to market.

4450

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of their other clients or former employers to us, which could subject us to costly litigation.

As is common in the medical device industry, we engage the services of consultants and independent contractors to assist us in the development of our products. Many of these consultants and independent contractors were previously employed at, or may have previously provided or may be currently providing consulting or other services to, universities or other technology, biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may become subject to claims that we, a consultant or an independent contractor inadvertently or otherwise used or disclosed trade secrets or other information proprietary to their former employers or their former or current clients. We may similarly be subject to claims stemming from similar actions of an employee, such as one who was previously employed by another company, including a competitor or potential competitor. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to our management team. If we were to be unsuccessful, we could lose access or exclusive access to valuable intellectual property.

We may not be able to protect our intellectual property rights throughout the world, which could materially, negatively affect our business.

Filing, prosecuting and defending patents on current and future products in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, regardless of whether we are able to prevent third parties from practicing our inventions in the United States, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not pursued and obtained patent protection to develop their own products, and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as it is in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Even if we pursue and obtain issued patents in particular jurisdictions, our patent claims or other intellectual property rights may not be effective or sufficient to prevent third parties from competing. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license and may adversely impact our business.

In addition, we also face the risk that our products are imported or reimported into markets with relatively higher prices from markets with relatively lower prices, which would result in a decrease of sales and any payments we receive from the affected market. Recent developments in U.S. patent law have made it more difficult to stop these and related practices based on theories of patent infringement.

If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed.

We rely heavily on trade secrets and confidentiality agreements to protect our unpatented know-how, technology and other confidential proprietary information, and to maintain our competitive position. However, trade secrets and know-how can be difficult to protect. In particular, we anticipate that with respect to our technologies, these trade secrets and know-how will over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel from academic to industry scientific positions.

4551

In addition to pursuing patents on our technology, we take steps to protect our intellectual property and proprietary technology by entering into agreements, including confidentiality agreements, non-disclosure agreements and intellectual property assignment agreements, with our employees, consultants, academic institutions, corporate partners and, when needed, our advisers. However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors or other third parties will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. For example, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Such agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements, and we may not be able to prevent such unauthorized disclosure, which could materially and adversely impact our ability to establish or maintain a competitive advantage in the market, and our business, financial condition, results of operations and prospects.

Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to enforce a claim that a third party had wrongfully obtained and was using our trade secrets, it would be expensive and time-consuming, it could distract our personnel, and the outcome would be unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets or may not recognize certain claims of intellectual property infringement.

We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached. If any of our confidential proprietary information were to be lawfully obtained or independently developed by a competitor or other third party, absent patent and copyright protection, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position. Competitors or third parties could purchase our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts, design around our protected technology, develop their own competitive technologies that fall outside the scope of our intellectual property rights or independently develop our technologies without reference to our trade secrets. If any of our trade secrets were to be disclosed to or independently discovered by a competitor or other third party, it could materially and adversely affect our business, financial condition, results of operations and prospects.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case. In some cases, our licensors may be responsible for, for example, these payments, thereby decreasing our control over compliance with these requirements.

We may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of our current or future products, and we cannot provide any assurances that third-party patents do not exist that might be enforced against our current or future products in the absence of such a license. We may fail to obtain any of these licenses on commercially reasonable terms, if at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. If we could not obtain a license, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we may be unable to develop or commercialize the affected products, which could materially harm our business and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation. Licensing intellectual property involves complex legal, business and scientific issues. Disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including:

●

the scope of rights granted under the license agreement and other interpretation-related issues;

4652

●

whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

●

our right to sublicense patent and other rights to third parties under collaborative development relationships;

●

our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our products, and what activities satisfy those diligence obligations; and

●

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.

If disputes over licensed intellectual property prevent or impair our ability to maintain the licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product, or the dispute may have an adverse effect on our results of operations.

In addition to agreements pursuant to which we in-license intellectual property, we have in the past, and we may in the future, grant licenses under our intellectual property. Like in-licenses, out-licenses are complex, and disputes may arise between us and our licensees, such as the types of disputes described above. Moreover, our licensees may breach their obligations, or we may be exposed to liability due to our failure or alleged failure to satisfy our obligations. Any such occurrence could have an adverse effect on our business.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.

The measures that we use to protect the security of our intellectual property and other proprietary rights may not be adequate, which could result in the loss of legal protection for, and thereby diminish the value of, such intellectual property and other rights.

In addition to pursuing patents on our technology, we also rely upon trademarks, trade secrets, copyrights and unfair competition laws, as well as license agreements and other contractual provisions, to protect our intellectual property and other proprietary rights. Despite these measures, any of our intellectual property rights could be challenged, invalidated, circumvented or misappropriated. In addition, we take steps to protect our intellectual property and proprietary technology by entering into confidentiality agreements and intellectual property assignment agreements with our employees, consultants, corporate partners and, when needed, our advisors. Our suppliers also have access to the patented technology owned or used by us as well as other proprietary information, and these suppliers are subject to confidentiality provisions under their agreements with us.

Such agreements or provisions may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements, and we may not be able to prevent such unauthorized disclosure. Notwithstanding any such agreements, there is no assurance that our current or former manufacturers or suppliers will not use and/or supply our competitors with our trade secrets, know-how or other proprietary information to which these parties gained access or generated from their relationship with us. This could lead to our competitors gaining access to patented or other proprietary information. Moreover, if a party to an agreement with us has an overlapping or conflicting obligation to a third party, our rights in and to certain intellectual property could be undermined. Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, it would be expensive and time-consuming, the outcome would be unpredictable, and any remedy may be inadequate. In addition, courts outside the United States may be less willing to protect trade secrets.

4753

In addition, competitors could purchase our products and attempt to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe our intellectual property rights, design around our protected technology or develop their own competitive technologies that fall outside of our intellectual property rights. If our intellectual property does not adequately protect our market share against competitors’ products and methods, our competitive position could be adversely affected, as could our business.

Our issued patents could be found invalid or unenforceable if challenged in court, which could have a material adverse impact on our business.

If we or any of our partners were to initiate legal proceedings against a third party to enforce a patent covering one of our products or services, the defendant in such litigation could counterclaim that our patent is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement, or failure to claim patent eligible subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement during prosecution. Third parties may also raise similar claims before the USPTO even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the challenged patent. Such a loss of patent protection would have a material adverse impact on our business.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products.

The America Invents Act, or AIA, introduced changes that limit where a patent holder may file a patent infringement suit and providing additional opportunities for third parties to challenge any issued patent in the USPTO. This applies to all of our owned and in-licensed U.S. patents, even those issued before March 16, 2013 (the effective date of the AIA). Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

Additionally, the U.S. Supreme Court has ruled on several patent cases in recent years, such as Impression Products, Inc. v. Lexmark International, Inc., Association for Molecular Pathology v. Myriad Genetics, Inc., Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corporation Pty. Ltd. v. CLS Bank International, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by the U.S. Congress and decisions by the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

4854

Several inventions covered by our patent portfolio were made using U.S. government funding. The U.S. government has an irrevocable, non-exclusive, royalty-free license to use such other inventions.

U.S. government grant funding was used in the inventions covered by four U.S. patents and two pending U.S. patent applications in Profusa’s patent portfolio. As a result of this funding, the government is granted an irrevocable, non-exclusive, royalty-free license to use these patents/applications. The government’s ability to practice the inventions described in these patents/applications is limited to practice for or on behalf of the United States. However, the license can be used to allow a third party to practice the invention solely for the government’s benefit.

In some circumstances, the U.S. government agency that provided the grants has the right to “march-in” and require Profusa to license its invention to a third party. These circumstances are as follows: (a) the inventing party has not tried to achieve practical application of the invention; (b) such a license is needed to alleviate health or safety concerns; (c) such a license is needed to meet public use requirements specified in federal regulations; or (d) the inventing party fails to ensure that the invention will be “manufactured substantially” in the United States.

The negative effects of march-in rights on Profusa’s business could be profound. Most importantly, Profusa could be compelled to grant licenses for its patented inventions to third parties, including competitors. This scenario could lead to increased competition, loss of market exclusivity, and diminished control over the commercialization of its innovations.

Furthermore, the forced licensing of patents under march-in rights may result in reduced revenues and profitability for Profusa. The terms and conditions of such licenses could be dictated by the government, potentially impacting the company’s ability to generate income from its intellectual property on favorable terms.

Moreover, the uncertainty surrounding the potential exercise of march-in rights creates a challenging business environment. It introduces regulatory risks and can complicate strategic planning and investment decisions for Profusa, as Profusa must navigate the possibility of government intervention in its intellectual property rights.

The invocation of March-in rights by the government could lead to increased competition, revenue reduction, loss of control over intellectual property, and heightened regulatory complexities, all of which could have a negative impact on Profusa’s business operations and financial performance.

Additionally, government support may have implications for Profusa’s right to license the inventions covered by these patents/applications. For example, generally when granting an exclusive license, the licensee must ensure that the invention will be “manufactured substantially” within the United States.

Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submission, fee payment and other requirements imposed by government patent agencies and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and applications will be due to be paid to the USPTO and various government patent agencies outside of the United States over the lifetime of our owned patents and applications. The USPTO and various foreign government agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. In some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in a partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Patent terms may be inadequate to protect our competitive position on products or product candidates for an adequate amount of time.

Patents have a limited lifespan. In most countries, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest national or international (i.e., PCT) filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. After patents expire, we may be open to competition with respect to products that were covered by the expired patents.

4955

If we do not obtain patent term extension and/or data exclusivity for any product candidates we decide to develop as drug product candidates, our business may be materially harmed.

Depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we decide to develop as product candidates, one or more of the U.S. patents we may obtain may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent term extension of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar extensions as compensation for patent term lost during regulatory review processes are also available in certain foreign countries and territories, such as in Europe under a Supplementary Protection Certificate. However, we may not be granted an extension in the United States and/or foreign countries and territories because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. We may not be eligible for patent term extension, or PTE, as it is only available in the U.S. if any component of a product candidate has never been approved as a drug substance. If we are unable to obtain patent term extension or the term of any such extension is shorter than what we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and prospects could be materially harmed.

We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

We may be subject to claims that former employees, collaborators or other third parties have an interest in our owned patent rights, trade secrets or other intellectual property as an inventor or co-inventor. For example, we may have disputes arise from conflicting obligations of employees, consultants or others who are involved in developing our products, product candidates, or other technologies. Litigation may be necessary to defend against these and other claims challenging inventorship or our ownership of our owned patent rights, trade secrets or other intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our products, product candidates, or other technologies. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

●

others may be able to make products that are similar to products and technologies we may develop or utilize similar technology that are not covered by the claims of the patents that we own or license now or in the future;

●

we, or our licensor(s), might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future;

●

we, or our licensor(s), might not have been the first to file patent applications covering certain of our or their inventions;

●

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing, misappropriating or otherwise violating our owned or licensed intellectual property rights;

●

it is possible that our pending licensed patent applications or those that we may own in the future will not lead to issued patents;

5056

●

issued patents that we own, in-license, or otherwise hold rights to may be held invalid or unenforceable or have their scope narrowed, including as a result of legal challenges by our competitors;

●

our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

●

we may not develop additional proprietary technologies that are patentable;

●

the patents of others may harm our business; and

●

we may choose not to file a patent application for certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property.

Should any of these events occur, they could materially adversely affect our business, financial condition, results of operations and prospects.

General Risks of Profusa’s Business

If we are unable to successfully ~~maintain~~remediate our existing material weaknesses and maintain effective internal control over financial reporting, investors may lose confidence in our reported financial information and our stock price and our business may be adversely impacted.

As a public company, we will be required to maintain internal control over financial reporting and our management is required to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year. If we are not successful in remediating our exiting material weaknesses and maintaining effective internal control over financial reporting, there could be inaccuracies or omissions in the financial information we are required to file with the SEC. Additionally, even if there are no inaccuracies or omissions, we will be required to publicly disclose the conclusion of our management that our internal control over financial reporting or disclosure controls and procedures are not effective. These events could cause investors to lose confidence in our reported financial information, adversely impact our stock price, result in increased costs to remediate any deficiencies, attract regulatory scrutiny or lawsuits that could be costly to resolve and distract management’s attention, limit our ability to access the capital markets or cause our ~~stock~~Common Stock to be delisted from the ~~The~~ Nasdaq ~~Stock~~Global Market or any other securities exchange on which it is then listed.

Environmental, social and corporate governance, or (“ESG”) regulations, policies and provisions may make our supply chain more complex and may adversely affect our relationships with customers.

There is an increasing focus on the governance of environmental and social risks. A number of our customers who are payors or distributors have adopted, or may adopt, procurement policies that include ESG provisions that their suppliers or manufacturers must comply with, or they may seek to include such provisions in their terms and conditions. An increasing number of participants in the medical device industry are also joining voluntary ESG groups or organizations, such as the Responsible Business Alliance. These ESG provisions and initiatives are subject to change, can be unpredictable, and may be difficult and expensive for us to comply with, given the complexity of our supply chain and the outsourced manufacturing of certain components of our products. If we are unable to comply, or are unable to cause our suppliers to comply, with such policies or provisions, a customer may stop purchasing products from us, and may take legal action against us, which could harm our reputation, revenue and results of operations.

Current uncertainty in domestic and global economic and political conditions makes it particularly difficult to predict product demand and other related matters and makes it more likely that our actual results could differ materially from expectations.

Our operations and performance depend on worldwide economic and political conditions. These conditions have been adversely impacted by continued global economic uncertainty, political instability and military hostilities in multiple geographies, concerns over the potential downgrade of U.S. sovereign debt and continued sovereign debt, monetary and financial uncertainties in Europe and other foreign countries, and global health pandemics such as the COVID-19 pandemic. These include potential reductions in the overall stability and suitability of the Euro as a single currency, given the economic and political challenges facing individual Eurozone countries. These conditions have made and may continue to make it difficult for our customers and potential customers to afford our products, and could cause our customers to stop using our products or to use them less frequently. If that were to occur, our revenue may decrease and our performance may be negatively impacted. In addition, the pressure on consumers to absorb more of their own health care costs has resulted in some cases in higher deductibles and limits on durable medical equipment, which may cause seasonality in purchasing patterns.

5157

Furthermore, during economic uncertainty, our customers have had job losses and may continue to have issues gaining timely access to sufficient health insurance or credit, which could result in their unwillingness to purchase products or impair their ability to make timely payments to us. While the potential economic impact brought by and the duration of ~~the~~a ~~COVID-19~~ pandemic may be difficult to assess or predict, it may ~~has already caused~~cause, and is likely to result in ~~further~~, significant disruption of global financial markets, which may reduce our ability to access capital on favorable terms or at all. In addition, a recession, depression or other sustained adverse market event ~~resulting from the spread of COVID-19~~ could materially and adversely affect our business and the value of our ~~common~~Common ~~stock~~Stock.

We cannot predict the reoccurrence of any economic slowdown or the strength or sustainability of the economic recovery, worldwide, in the United States, or in our industry. These and other economic factors could have a material adverse effect on our business, financial condition and results of operations.

Changes in financial accounting standards or practices or existing taxation rules or practices may cause adverse unexpected revenue and/or expense fluctuations and affect our reported results of operations.

A change in accounting standards or practices or a change in existing taxation rules or practices can have a significant effect on our reported results and may even affect our reporting of transactions completed before the change is effective. New accounting pronouncements and taxation rules and varying interpretations of accounting pronouncements and taxation practice have occurred and may occur in the future. The method in which we market and sell our products may have an impact on the manner in which we recognize revenue. In addition, changes to existing rules or the questioning of current practices may adversely affect our reported financial results or the way we conduct our business. Additionally, changes to existing accounting rules or standards, such as the potential requirement that U.S. registrants prepare financial statements in accordance with International Financial Reporting Standards, may adversely impact our reported financial results and business, and may further require us to incur greater accounting fees.

Climate change may have a long-term impact on our business.

There are inherent risks related to climate change wherever business is conducted. Access to clean water and reliable energy in the communities where we conduct our business, whether for our offices or for our vendors, is a priority. Our manufacturing sites in California are vulnerable to climate change effects. For example, in California, increasing intensity of droughts throughout the states and annual periods of wildfire danger increase the probability of planned and unplanned power outages in the communities where we work and live. While this danger has a low-assessed risk of disrupting normal business operations, it has the potential impact on employees’ abilities to commute to work or to work from home and stay connected effectively. Climate-related events, including the increasing frequency of extreme weather events and their impact on the U.S. and other major regions’ critical infrastructure, have the potential to disrupt our business, our third-party suppliers, and/or the business of our customers, and may cause us to experience higher attrition, losses, and additional costs to maintain or resume operations.

We face the risk of product liability claims and may be subject to damages, fines, penalties and injunctions, among other things.

Our business exposes us to the risk of product liability claims that is inherent in the testing, manufacturing and marketing of medical devices, including those which may arise from the misuse (including system hacking or other unauthorized access by third parties to our systems) or malfunction of, or design flaws in, our products. This liability may vary based on the FDA classification associated with our devices. We may be subject to product liability claims if our products cause, or merely appear to have caused, an injury. Claims may be made by customers, healthcare providers or others selling our products. The risk of claims may also increase if our products are subject to a product recall or seizure.

Although we have insurance at levels that we believe is appropriate, this insurance is subject to deductibles and coverage limitations. Our current product liability insurance may not continue to be available to us on acceptable terms, if at all, and, if available, the coverage may not be adequate to protect us against any future product liability claims. Further, if additional products are approved for marketing, we may seek additional insurance coverage. If we are unable to obtain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may harm our business. A product liability claim, recall or other claims with respect to uninsured liabilities or for amounts in excess of insured liabilities could result in significant costs and significant harm to our business.

5258

We may be subject to claims against us even if the apparent injury is due to the actions of others or misuse of the device or a partner device. Our customers, either on their own or following the advice of their physicians, may use our products in a manner not described in the products’ labeling and that differs from the manner in which it was used in clinical studies and approved by the FDA. Off-label use of products by customers is common, and any such off-label use of our products could subject us to additional liability, or require design changes to limit this potential off-label use once discovered.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or halt the marketing and sale of our products, if approved. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

●

decreased demand for our approved products, if any;

●

harm to our reputation;

●

initiation of investigations by regulators, which could result in enforcement action against us or our contract manufacturers;

●

costs to defend the related litigation;

●

a diversion of management’s time and our resources;

●

substantial monetary awards to trial participants or patients;

●

product recalls, withdrawals or labeling, marketing or promotional restrictions;

●

loss of revenue; and

●

exhaustion of any available insurance and our capital resources.

We will incur increased costs and become subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it more difficult to run our business.

As a public company, we will incur significant legal, accounting and other expenses that we have not incurred as a private company, including costs associated with public company reporting requirements. We also have incurred and will continue to incur costs associated with the Sarbanes-Oxley Act, and related rules implemented by the Securities and Exchange Commission, or SEC, and the exchange our securities are listed on. The expenses generally incurred by public companies for reporting and corporate governance purposes have been increasing. We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly, although we are currently unable to estimate these costs with any degree of certainty. These laws and regulations also could make it more difficult or costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. These laws and regulations could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, on our board committees or as our executive officers. Furthermore, if we are unable to satisfy our obligations as a public company, we could be subject to delisting of our ~~common~~Common ~~stock~~Stock, fines, sanctions, other regulatory action and potentially civil litigation.

We are an Emerging Growth Company

We are an “emerging growth company” as defined in the ~~Jumpstart Our Business Startups Act of 2012 (“~~JOBS Act”). We will remain an emerging growth company until the earlier of (i) December 31, 2026, the last day of the fiscal year following the fifth anniversary of the date of the first sale of our ~~common~~Common ~~stock~~Stock pursuant to an effective registration statement under the Securities Act; (ii) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under applicable SEC rules.

5359

We expect that we will remain an emerging growth company for the foreseeable future but cannot retain our emerging growth company status indefinitely and will no longer qualify as an emerging growth company on or before December 31, 2026. References herein to “emerging growth company” have the meaning associated with it in the JOBS Act.

For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from specified disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

●

being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

●

not being required to comply with the requirement of auditor attestation of our internal controls over financial reporting;

●

not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

● reduced disclosure obligations regarding executive compensation in the Company’s periodic reports and proxy statements; and

●

not being required to hold a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

For as long as we continue to be an emerging growth company, we expect that we will take advantage of the reduced disclosure obligations available to us as a result of that classification. We have taken advantage of certain of those reduced reporting burdens in this prospectus. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.

An emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected to avail ourselves of this extended transition period and, as a result, we will not be required to adopt new or revised accounting standards on the dates on which adoption of such standards is required for other public reporting companies.

As a public company, we are required to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act and make an ongoing, formal assessment of the effectiveness of our internal controls over financial reporting.

We cannot assure you that the measures we have taken to date, and actions we may take in the future, will prevent or avoid control deficiencies that could lead to material weaknesses in our internal control over financial reporting in the future. Our current controls, and any new controls that we develop, may become inadequate because of changes in conditions in our business. Further, deficiencies in our disclosure controls and internal control over financial reporting may be discovered in the future. Any failure to develop or maintain effective controls or any difficulties encountered in their implementation or improvement could harm our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements for prior periods.

We have performed a formal evaluation of our internal control over financial reporting under the supervision and with the participation of management, including our principal executive officer and principal financial officer, as required by Section 404 of the Sarbanes-Oxley Act. Based upon their evaluation, our principal executive officer and principal financial and accounting officer, concluded that our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) were not effective as of June 30, 2025 due to the existence of material weaknesses. Our internal controls were not adequately designed and appropriate to address the following material weaknesses related to (i) segregation of duties in recording journal entries, (ii) segregation of duties within the procurement business cycle, and (iii) in the procurement cycle our controls were insufficient for reviewing and reconciling accounts payable and accrued liabilities. In addition, our internal controls did not detect an error in (i) the review of the convertible promissory notes valuation and warrant valuation (ii) proper recording of accounts payable and accrued expenses, expensing or prepaid expenses, common stock subject to possible redemption, and the calculation of our income tax provision (iii) the proper safeguarding of trust assets and the monitoring process of the use of trust funds. The company plans to remediate such weaknesses. In connection with the business combination, the company has hired a new CFO with significant experience, including financial reporting and internal controls. The CFO plans to establish reporting controls consistent with a public company of this size, including segregation of duties and controls related to Sarbanes-Oxley, to the extent applicable. However, we can give no assurance that the measures we have taken, or will take, will prevent any future material weaknesses or deficiencies in internal control over financial reporting.60

54We have performed a formal evaluation of our internal control over financial reporting under the supervision and with the participation of management, including our principal executive officer and principal financial officer, as required by Section 404 of the Sarbanes-Oxley Act. Based upon their evaluation, our principal executive officer and principal financial and accounting officer, concluded that our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) were not effective as of September 30, 2025 due to the existence of material weaknesses. Our internal controls were not adequately designed and appropriate to address the following material weaknesses related to (i) segregation of duties in the financial statement close process, (ii) lack of review controls and expertise to ensure accurate valuations and accounting of financial instruments, (iii) lack of technical accounting expertise and internal controls to ensure accurate preparation of its financial statements in accordance with U.S. GAAP including complex debt and equity instruments. We have considered our prior period material weaknesses and have included these unremediated weaknesses in internal controls in our considerations above, nothing that certain internal controls related to prior period activities such as proper recording of Common Stock subject to possible redemption, and the proper safeguarding of trust assets with the monitoring process of the use of trust funds are no longer applicable. The Company plans to remediate such weaknesses. In connection with the Business Combination, the Company hired a new CFO with significant experience, including financial reporting and internal controls. The CFO has experience establishing internal reporting controls consistent with a public company of this size, including segregation of duties and controls related to Sarbanes-Oxley. The Company has made the necessary steps to add additional consultants to the accounting and finance team to ensure the preparation and review of invoices, technical accounting matters, and financial statements are being completed by two or more independent parties. However, we can give no assurance that the measures we have taken, or will take, will prevent any future material weaknesses or deficiencies in internal control over financial reporting. We are required to evaluate and disclose changes made in our internal controls and procedures on a quarterly basis. Failure to comply with the Sarbanes-Oxley Act could potentially subject us to sanctions or investigations by the SEC, the applicable stock exchange or other regulatory authorities, which would require additional financial and management resources.

We ~~have~~do not ~~engaged~~expect anthat ~~independent registered~~our ~~public~~disclosure ~~accounting~~controls ~~firm~~and toprocedures ~~perform~~will anprevent ~~audit~~all errors and all instances of ~~our~~fraud. Disclosure ~~internal~~controls ~~control~~and ~~over~~procedures, ~~financial~~no ~~reporting~~matter ashow ofwell ~~any~~conceived ~~balance~~and ~~sheet~~operated, ~~date~~can orprovide only reasonable, not absolute, assurance that ~~for~~the ~~any~~objectives ~~period~~of ~~reported~~the indisclosure ~~our~~controls ~~financial~~and ~~statements~~procedures are met. WeFurther, the design of disclosure controls and procedures must reflect the fact that there are ~~required~~resource constraints, and the benefits must be considered relative to ~~evaluate~~their ~~and~~costs. ~~disclose~~Because ~~changes~~of ~~made~~the inherent limitations in ~~our~~all ~~internal~~disclosure controls and procedures, onno aevaluation ~~quarterly~~of ~~basis.~~disclosure ~~Failure~~controls toand ~~comply~~procedures ~~with~~can ~~the~~provide ~~Sarbanes-Oxley~~absolute ~~Act~~assurance ~~could~~that ~~potentially~~we have ~~subject~~detected usall toour ~~sanctions~~control ordeficiencies ~~investigations~~and instances of fraud, if any. The design of disclosure controls and procedures also is based bypartly on certain assumptions about the ~~SEC~~likelihood of future events, ~~the~~and ~~applicable~~there ~~stock~~can ~~exchange~~be orno ~~other~~assurance ~~regulatory~~that ~~authorities,~~any ~~which~~design ~~would~~will ~~require~~succeed ~~additional~~in ~~financial~~achieving its ~~and~~stated ~~management~~goals ~~resources~~under all potential future conditions.

If we fail to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired, which may adversely affect investor confidence in our Company and, as a result, the market price of our ~~common~~Common ~~stock~~Stock.

As a public company, we are required to comply with the requirements of the Sarbanes-Oxley Act, including, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. We continue to develop and refine our disclosure controls and other procedures that are designed to ensure that information we are required to disclose in the reports that we will file with the SEC are recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and that information required to be disclosed in reports under the Exchange Act, is accumulated and communicated to our management, including our principal executive and financial officers.

In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting, we have expended, and anticipate that we will continue to expend, significant resources, including dedicated to internal resources. We may also need to engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our internal control over financial reporting. If any of these new or improved controls and systems do not perform as expected, we may experience additional material weaknesses in our controls. Moreover, our testing, or the subsequent testing by our independent registered public accounting firm, may reveal additional deficiencies in our internal control over financial reporting that are deemed to be material weaknesses.

Any failure to implement and maintain effective disclosure controls and procedures and internal control over financial reporting, including the identification of one or more material weaknesses, could cause investors to lose confidence in the accuracy and completeness of our financial statements and reports, which would likely adversely affect the market price of our ~~common~~Common ~~stock~~Stock. In addition, we could be subject to sanctions or investigations by the stock exchange on which our ~~common~~Common ~~stock~~Stock is listed, the SEC and other regulatory authorities.

Risks Related to our Bitcoin Treasury Strategy and Holdings

Our bitcoin treasury strategy exposes us to various risks associated with bitcoin.

Our bitcoin treasury strategy exposes us to various risks associated with bitcoin, including the following:

Bitcoin is a highly volatile asset. Bitcoin is a highly volatile asset that has traded below $5375,000 per bitcoin and above $~~123~~126,000 per bitcoin on the Coinbase exchange in the 12 months preceding the date of this prospectus. The trading price of bitcoin significantly decreased during prior periods, and such declines may occur again in the future. We intend to engage in hedging strategies from time to time as part of our treasury management operations if deemed appropriate. As of the date of this prospectus, the Company has purchased $12.0 million of Bitcoin as part of the Company’s ongoing treasury strategy, representing 816.5351 Bitcoins.

5561

Bitcoin does not pay interest or dividends. Bitcoin does not pay interest or other returns and we can only generate cash from our bitcoin holdings if we sell our bitcoin or implement strategies to create income streams or otherwise generate cash by using our bitcoin holdings. Even if we pursue any such strategies, we may be unable to create income streams or otherwise generate cash from our bitcoin holdings, and any such strategies may subject us to additional risks.

Our bitcoin holdings may significantly impact our financial results and the market price of our ~~common~~Common ~~stock~~Stock. Our bitcoin holdings may significantly affect our financial results and if we continue to increase our overall holdings of bitcoin in the future, they will have an even greater impact on our financial results and the market price of our ~~common~~Common ~~stock~~Stock. See “— Our historical financial statements do not reflect our acquisition of bitcoin, the fact that our bitcoin holdings will be the substantial majority of our assets, or the potential variability in earnings that we may experience in the future relating to our bitcoin holdings” below.

Our bitcoin treasury strategy has not been tested over an extended period of time or under different market conditions. We will be using the proceeds from this offering to facilitate the recent adoption our bitcoin treasury strategy and we will need to continually examine the risks and rewards of this new strategy. This new strategy has not been tested over an extended period of time or under different market conditions. For example, although we believe bitcoin, due to its limited supply, has the potential to serve as a hedge against inflation in the long term, the short-term price of bitcoin declined in recent periods during which the inflation rate increased. Some investors and other market participants may disagree with our bitcoin treasury strategy or actions we undertake to implement it. If bitcoin prices were to decrease or our bitcoin treasury strategy otherwise proves unsuccessful, our financial condition, results of operations, and the market price of our ~~common~~Common ~~stock~~Stock could be materially adversely affected.

We are subject to counterparty risks, including in particular risks relating to our custodians. Although we intend to implement various measures that are designed to mitigate our counterparty risks, including by storing substantially all of the bitcoin we own in custody accounts at U.S.-based, institutional-grade custodians and negotiating contractual arrangements intended to establish that our property interest in custodially-held bitcoin is not subject to claims of our custodians’ creditors, applicable insolvency law is not fully developed with respect to the holding of digital assets in custodial accounts. If our custodially-held bitcoin were nevertheless considered to be the property of our custodians’ estates in the event that any such custodians were to enter bankruptcy, receivership or similar insolvency proceedings, we could be treated as a general unsecured creditor of such custodians, inhibiting our ability to exercise ownership rights with respect to such bitcoin and this may ultimately result in the loss of the value related to some or all of such bitcoin. Even if we are able to prevent our bitcoin from being considered the property of a custodian’s bankruptcy estate as part of an insolvency proceeding, it is possible that we would still be delayed or may otherwise experience difficulty in accessing our bitcoin held by the affected custodian during the pendency of the insolvency proceedings. Any such outcome could have a material adverse effect on our financial condition and the market price of our ~~common~~Common ~~stock~~Stock.

The broader digital assets industry is subject to counterparty risks, which could adversely impact the adoption rate, price, and use of bitcoin. A series of recent high-profile bankruptcies, closures, liquidations, regulatory enforcement actions and other events relating to companies operating in the digital asset industry, including the filings for bankruptcy protection by Three Arrows Capital, Celsius Network, Voyager Digital, FTX Trading and Genesis Global Capital, the closure or liquidation of certain financial institutions that provided lending and other services to the digital assets industry, including Signature Bank and Silvergate Bank, SEC enforcement actions against Coinbase, Inc. and Binance Holdings Ltd., the placement of Prime Trust, LLC into receivership following a cease-and-desist order issued by Nevada’s Department of Business and Industry, and the filing and subsequent settlement of a civil fraud lawsuit by the New York Attorney General against Genesis Global Capital, its parent company Digital Currency Group, Inc., and former partner Gemini Trust Company, have highlighted the counterparty risks applicable to owning and transacting in digital assets. Although these bankruptcies, closures, liquidations and other events have not resulted in any loss or misappropriation of our bitcoin, nor have such events adversely impacted our access to our bitcoin, they have, in the short-term, likely negatively impacted the adoption rate and use of bitcoin. Additional bankruptcies, closures, liquidations, regulatory enforcement actions or other events involving participants in the digital assets industry in the future may further negatively impact the adoption rate, price, and use of bitcoin, limit the availability to us of financing collateralized by bitcoin, or create or expose additional counterparty risks.

Changes in our ownership of bitcoin could have accounting, regulatory and other impacts. While we currently plan to own bitcoin directly, we may investigate other potential approaches to owning bitcoin, including indirect ownership (for example, through ownership interests in a fund that owns bitcoin). If we were to own all or a portion of our bitcoin in a different manner, the accounting treatment for our bitcoin, our ability to use our bitcoin as collateral for additional borrowings, and the regulatory requirements to which we are subject, may correspondingly change. For example, the volatile nature of bitcoin may force us to liquidate our holdings to use it as collateral, which could be negatively affected by any disruptions in the crypto market and, if liquidated, the value of the collateral would not reflect potential gains in the market value of bitcoin, all of which could negatively affect our business and implementation of our bitcoin strategy.

5662

Changes in the accounting treatment of our bitcoin holdings could have significant accounting impacts, including increasing the volatility of our results. In December 2023, the FASB issued ASU 2023-08, ~~which~~requires ~~upon our adoption will require~~ us to measure in-scope crypto assets (including our bitcoin holdings) at fair value in our statement of financial position, and to recognize gains and losses from changes in the fair value of our bitcoin in net income each reporting period. ASU 2023-08 will also require us to provide certain interim and annual disclosures with respect to our bitcoin holdings. Due to the volatility in the price of bitcoin, the adoption of ASU 2023-08 ~~could~~ could have a material impact on our financial results in future periods, increase the volatility of our financial results, affect the ~~carrying~~ carrying value of our bitcoin on our balance sheet, and could result in tax-related adjustments, which in turn could have a material adverse effect on our financial results and the market price of our ~~common~~Common ~~stock~~Stock.

The broader digital assets industry, including the technology associated with digital assets, the rate of adoption and development of, and use cases for, digital assets, market perception of digital assets, and the legal, regulatory, and accounting treatment of digital assets are constantly developing and changing, and there may be additional risks in the future that are not possible to predict.

Bitcoin is a highly volatile asset, and fluctuations in the price of bitcoin are likely to influence our financial results and the market price of our ~~common~~Common ~~stock~~Stock.

Bitcoin is a highly volatile asset, and fluctuations in the price of bitcoin are likely to influence our financial results and the market price of our ~~common~~Common ~~stock~~Stock. Our financial results and the market price of our ~~common~~Common ~~stock~~Stock would be adversely affected, and our business and financial condition would be negatively impacted, if the price of bitcoin decreased substantially (as it has in the past, such as during 2022), including as a result of:

●

decreased user and investor confidence in bitcoin, including due to the various factors described herein;

●

investment and trading activities, such as (i) trading activities of highly active retail and institutional users, speculators, miners and investors, (ii) actual or expected significant dispositions of bitcoin by large holders, and (iii) actual or perceived manipulation of the spot or derivative markets for bitcoin or spot bitcoin ETPs;

●

negative publicity, media or social media coverage, or sentiment due to events in or relating to, or perception of, bitcoin or the broader digital assets industry, for example, (i) public perception that bitcoin can be used as a vehicle to circumvent sanctions, including sanctions imposed on Russia or certain regions related to the ongoing conflict between Russia and Ukraine, or to fund criminal or terrorist activities, such as the purported use of digital assets by Hamas to fund its terrorist attack against Israel in October 2023; (ii) expected or pending civil, criminal, regulatory enforcement or other high profile actions against major participants in the bitcoin ecosystem, including the SEC’s enforcement actions against Coinbase, Inc. and Binance Holdings Ltd.; (iii) additional filings for bankruptcy protection or bankruptcy proceedings of major digital asset industry participants, such as the bankruptcy proceeding of FTX Trading and its affiliates; and (iv) the actual or perceived environmental impact of bitcoin and related activities, including environmental concerns raised by private individuals, governmental and non-governmental organizations, and other actors related to the energy resources consumed in the bitcoin mining process;

●

changes in consumer preferences and the perceived value or prospects of bitcoin;

●

competition from other digital assets that exhibit better speed, security, scalability, or energy efficiency, that feature other more favored characteristics, that are backed by governments, including the U.S. government, or reserves of fiat currencies, or that represent ownership or security interests in physical assets;

●

a decrease in the price of other digital assets, including stablecoins, or the crash or unavailability of stablecoins that are used as a medium of exchange for bitcoin purchase and sale transactions, such as the crash of the stablecoin Terra USD in 2022, to the extent the decrease in the price of such other digital assets or the unavailability of such stablecoins may cause a decrease in the price of bitcoin or adversely affect investor confidence in digital assets generally;

5763

●

the identification of Satoshi Nakamoto, the pseudonymous person or persons who developed bitcoin, or the transfer of substantial amounts of bitcoin from bitcoin wallets attributed to Mr. Nakamoto or other “whales” that hold significant amounts of bitcoin;

●

disruptions, failures, unavailability, or interruptions in service of trading venues for bitcoin, such as, for example, digital asset exchange FTX Trading’s freezing of withdrawals and transfers from its accounts in 2022;

●

the filing for bankruptcy protection by, liquidation of, or market concerns about the financial viability of digital asset custodians, trading venues, lending platforms, investment funds, or other digital asset industry participants, such as the filing for bankruptcy protection by digital asset trading venues FTX Trading and BlockFi and digital asset lending platforms Celsius Network and Voyager Digital Holdings in 2022, the ordered liquidation of the digital asset investment fund Three Arrows Capital in 2022, the announced liquidation of Silvergate Bank in 2023, the government-mandated closure and sale of Signature Bank in 2023, the placement of Prime Trust, LLC into receivership following a cease-and-desist order issued by the Nevada Department of Business and Industry in 2023, and the exit of Binance Holdings Ltd. from the U.S. market in 2023 as part of its settlement with the Department of Justice and other federal regulatory agencies;

●

regulatory, legislative, enforcement and judicial actions that adversely affect the price, ownership, transferability, trading volumes, legality or public perception of bitcoin, or that adversely affect the operations of or otherwise prevent digital asset custodians, trading venues, lending platforms or other digital assets industry participants from operating in a manner that allows them to continue to deliver services to the digital assets industry;

●

further reductions in mining rewards of bitcoin, including block reward halving events, which are events that occur after a specific period of time that reduce the block reward earned by “miners” who validate bitcoin transactions, or increases in the costs associated with bitcoin mining, including increases in electricity costs and hardware and software used in mining, that may cause a decline in support for the Bitcoin network;

●

transaction congestion and fees associated with processing transactions on the bitcoin network;

●

macroeconomic changes, such as changes in the level of interest rates and inflation, fiscal and monetary policies of governments, trade restrictions, and fiat currency devaluations;

●

developments in mathematics or technology, including in digital computing, algebraic geometry and quantum computing, that could result in the cryptography used by the bitcoin blockchain becoming insecure or ineffective; and

●

changes in national and international economic and political conditions, including, without limitation, the adverse impact attributable to the economic and political instability caused by the current conflict between Russia and Ukraine and the economic sanctions adopted in response to the conflict, and the potential broadening of the Israel-Hamas conflict to other countries in the Middle East.

Bitcoin and other digital assets are novel assets, and are subject to significant legal, commercial, regulatory and technical uncertainty.

Bitcoin and other digital assets are relatively novel and are subject to significant uncertainty, which could adversely impact their price. The application of state and federal securities laws and other laws and regulations to digital assets is unclear in certain respects, and it is possible that regulators in the United States or foreign countries may interpret or apply existing laws and regulations in a manner that adversely affects the price of bitcoin.

The U.S. federal government, states, regulatory agencies, and foreign countries may also enact new laws and regulations, or pursue regulatory, legislative, enforcement or judicial actions, that could materially impact the price of bitcoin or the ability of individuals or ~~institutions~~ institutions such as us to own or transfer bitcoin. For example, the U.S. executive branch, SEC, the European Union’s Markets in Crypto Assets Regulation, among others have been active in recent years, and in the U.K., the Financial Services and Markets Act 2023, or FSMA 2023 became law. It is not possible to predict whether, or when, any of these developments will lead to Congress granting additional authorities to the SEC, Commodity Futures Trading Commission (“CFTC”), or other regulators, or whether, or when, any other federal, state or foreign legislative bodies will take any similar actions. It is also not possible to predict the nature of any such additional authorities, how additional legislation or regulatory oversight might impact the ability of digital asset markets to function or the willingness of financial and other institutions to continue to provide services to the digital assets industry, nor how any new regulations or changes to existing regulations might impact the value of digital assets generally and bitcoin specifically. The consequences of increased regulation of digital assets and digital asset activities could adversely affect the market price of bitcoin and in turn adversely affect the market price of our ~~common~~Common ~~stock~~Stock.

5864

Moreover, the risks of engaging in a bitcoin treasury strategy are relatively novel and have created, and could continue to create, complications due to the lack of experience that third parties have with companies engaging in such a strategy, such as increased costs of director and officer liability insurance or the potential inability to obtain such coverage on acceptable terms in the future.

The growth of the digital assets industry in general, and the use and acceptance of bitcoin in particular, may also impact the price of bitcoin and is subject to a high degree of uncertainty. The pace of worldwide growth in the adoption and use of bitcoin may depend, for instance, on public familiarity with digital assets, ease of buying, accessing or gaining exposure to bitcoin, institutional demand for bitcoin as an investment asset, the participation of traditional financial institutions in the digital assets industry, consumer demand for bitcoin as a means of payment, and the availability and popularity of alternatives to bitcoin. Even if growth in bitcoin adoption occurs in the near or medium-term, there is no assurance that bitcoin usage will continue to grow over the long-term.

Because bitcoin has no physical existence beyond the record of transactions on the bitcoin blockchain, a variety of technical factors related to the bitcoin blockchain could also impact the price of bitcoin. For example, malicious attacks by miners, inadequate mining fees to incentivize validating of bitcoin transactions, hard “forks” of the bitcoin blockchain into multiple blockchains, and advances in digital computing, algebraic geometry, and quantum computing could undercut the integrity of the bitcoin blockchain and negatively affect the price of bitcoin. The liquidity of bitcoin may also be reduced and damage to the public perception of bitcoin may occur, if financial institutions were to deny or limit banking services to businesses that hold bitcoin, provide bitcoin-related services or accept bitcoin as payment, which could also decrease the price of bitcoin. Similarly, the open-source nature of the bitcoin blockchain means the contributors and developers of the bitcoin blockchain are generally not directly compensated for their contributions in maintaining and developing the blockchain, and any failure to properly monitor and upgrade the bitcoin blockchain could adversely affect the bitcoin blockchain and negatively affect the price of bitcoin.

The liquidity of bitcoin may also be impacted to the extent that changes in applicable laws and regulatory requirements negatively impact the ability of exchanges and trading venues to provide services for bitcoin and other digital assets.

Our historical financial statements do not reflect our acquisition of bitcoin, the fact that our bitcoin holdings could be a substantial part of our assets, or the potential variability in earnings that we may experience in the future relating to our bitcoin holdings.

Our historical financial statements do not reflect our intended acquisition of bitcoin, that we intend for our bitcoin holdings to comprise most of our total assets, or the potential variability in earnings that we may experience in the future from holding or selling significant amounts of bitcoin, given our expected asset concentration. The price of bitcoin has historically been subject to dramatic price fluctuations and is highly volatile. We expect to determine the fair value of our bitcoin based on quoted (unadjusted) prices on the Coinbase exchange, and following early adoption of ASU 2023-08, will be required to measure our bitcoin holdings at fair value in our statement of financial position, and to recognize gains and losses from changes in the fair value of our bitcoin in net income each reporting period, which may create significant volatility in our reported earnings, amplified by our asset concentration in bitcoin, and decrease the carrying value of our digital assets, which in turn could have a material adverse effect on the market price of our ~~common~~Common ~~stock~~Stock. Conversely, any sale of bitcoins at prices above our carrying value for such assets creates a gain for financial reporting purposes even if we would otherwise incur an economic or tax loss with respect to such transaction, which also may result in significant volatility in our reported earnings.

Because we intend to purchase additional bitcoin in future periods and increase our overall holdings of bitcoin, we expect that the proportion of our total assets that will be represented by our bitcoin holdings will increase in the future. As a result, and in particular with respect to the quarterly periods and full fiscal year with respect to which ASU 2023-08 will apply, and for all future periods, volatility in our earnings may be significantly more than what we experienced in prior periods. As of the date of this prospectus, the Company has purchased $12.0 million of Bitcoin as part of the Company’s ongoing treasury strategy, representing 816.5351 Bitcoins.

5965

Due to the currently unregulated nature and lack of transparency surrounding the operations of many bitcoin trading venues, bitcoin trading venues may experience greater fraud, security failures or regulatory or operational problems than trading venues for more established asset classes, which may result in a loss of confidence in bitcoin trading venues and adversely affect the value of our bitcoin.

Bitcoin trading venues are relatively new and, in many cases, currently unregulated. Even if regulated, such venues may not be complying with such regulations. Furthermore, there are many bitcoin trading venues that do not provide the public with significant information regarding their ownership structure, management teams, corporate practices and regulatory compliance. As a result, the marketplace may lose confidence in bitcoin trading venues, including prominent exchanges that handle a significant volume of bitcoin trading and/or are subject to regulatory oversight, in the event one or more bitcoin trading venues cease or pause for a prolonged period the trading of bitcoin or other digital assets, or experience fraud, significant volumes of withdrawal, security failures or operational problems.

In 2019 there were reports claiming that 80-95% of bitcoin trading volume on trading venues was false or non-economic in nature, with specific focus on currently unregulated exchanges located outside of the United States. The SEC also alleged as part of its June 2023, complaint that Binance Holdings Ltd. committed strategic and targeted “wash trading” through its affiliates to artificially inflate the volume of certain digital assets traded on its exchange. Such reports and allegations may indicate that the bitcoin market is significantly smaller than expected and that the United States makes up a significantly larger percentage of the bitcoin market than is commonly understood. Any actual or perceived false trading in the bitcoin market, and any other fraudulent or manipulative acts and practices, could adversely affect the value of our bitcoin. Negative perception, a lack of stability in the broader bitcoin markets and the closure, temporary shutdown or operational disruption of bitcoin trading venues, lending institutions, institutional investors, institutional miners, custodians, or other major participants in the bitcoin ecosystem, due to fraud, business failure, cybersecurity events, government-mandated regulation, bankruptcy, or for any other reason, may result in a decline in confidence in bitcoin and the broader bitcoin ecosystem and greater volatility in the price of bitcoin. For example, in 2022, each of Celsius Network, Voyager Digital, Three Arrows Capital, FTX Trading, and BlockFi filed for bankruptcy, following which the market prices of bitcoin and other digital assets significantly declined. In addition, in June 2023, the SEC announced enforcement actions against Coinbase, Inc., and Binance Holdings Ltd., two providers of large trading venues for digital assets, which similarly was followed by a decrease in the market price of bitcoin and other digital assets. These were followed in November 2023, by an SEC enforcement action against Kraken, another large trading venue for digital assets. As the price of our ~~common~~Common ~~stock~~Stock is affected by the value of our bitcoin holdings, the failure of a major participant in the bitcoin ecosystem could have a material adverse effect on the market price of our ~~common~~Common ~~stock~~Stock.

The concentration of our bitcoin holdings will enhance the risks inherent in our bitcoin treasury strategy.

We intend to use the net proceeds from the Committed Equity Facility to purchase bitcoin and we may increase our overall holdings of bitcoin in the future. Once we complete the planned acquisition of bitcoin, a substantial majority of our treasury holdings could be bitcoin. The concentration of our bitcoin holdings may limit the risk mitigation that we could take advantage of by purchasing a more diversified portfolio of treasury assets, and the absence of diversification enhances the risks inherent in our bitcoin treasury strategy. Any future significant declines in the price of bitcoin would have a more pronounced impact on our financial condition than if we used our cash to purchase a more diverse portfolio of assets.

The emergence or growth of other digital assets, including those with significant private or public sector backing, could have a negative impact on the price of bitcoin and adversely affect our financial condition and results of operations.

As a result of our bitcoin treasury strategy, a substantial amount of our cash could be concentrated in our bitcoin holdings. Accordingly, the emergence or growth of digital assets other than bitcoin may have a material adverse effect on our financial condition. While bitcoin is the largest digital asset by market capitalization as of the date of this prospectus, there are numerous alternative digital assets and many entities, including consortiums and financial institutions, are researching and investing resources into private or permissioned blockchain platforms or digital assets that do not use proof-of-work mining like the bitcoin network. For example, in late 2022, the ethereum network transitioned to a “proof-of-stake” mechanism for validating transactions that requires significantly less computing power than proof-of-work mining. The ethereum network has completed another major upgrade since then and may undertake additional upgrades in the future. If the mechanisms for validating transactions in ethereum and other alternative digital assets are perceived as superior to proof-of-work mining, those digital assets could gain market share relative to bitcoin.

6066

Other alternative digital assets that compete with bitcoin in certain ways include “stablecoins,” which are designed to maintain a constant price because of, for instance, their issuers’ promise to hold high-quality liquid assets (such as U.S. dollar deposits and short-term U.S. treasury securities) equal to the total value of stablecoins in circulation. Stablecoins have grown rapidly as an alternative to bitcoin and other digital assets as a medium of exchange and store of value, particularly on digital asset trading platforms. As of the date of this prospectus, two of the seven largest digital assets by market capitalization are U.S. dollar-backed stablecoins.

Additionally, central banks in some countries have started to introduce digital forms of legal tender. For example, China’s CBDC project was made available to consumers in January 2022, and governments including the United States, the European Union, and Israel have been discussing the potential creation of new CBDCs. Whether or not they incorporate blockchain or similar technology, CBDCs, as legal tender in the issuing jurisdiction, could also compete with, or replace, bitcoin and other digital assets as a medium of exchange or store of value. As a result, the emergence or growth of these or other digital assets could cause the market price of bitcoin to decrease, which could have a material adverse effect on our financial condition, and operating results.

Our bitcoin holdings are less liquid than our existing cash and ~~cash equivalents and~~ may not be able to serve as a source of liquidity for us to the same extent as cash ~~and cash equivalents~~.

Historically, the bitcoin markets have been characterized by significant volatility in price, limited liquidity and trading volumes compared to sovereign currency markets, relative anonymity, a developing regulatory landscape, potential susceptibility to market abuse and manipulation, compliance and internal control failures at exchanges, and various other risks inherent in its entirely electronic, virtual form and decentralized network. During times of market instability, we may not be able to sell our bitcoin at favorable prices or at all. For example, a number of bitcoin trading venues temporarily halted deposits and withdrawals in 2022. As a result, our bitcoin holdings may not be able to serve as a source of liquidity for us to the same extent as cash ~~and cash equivalents~~. Further, bitcoin we hold with our custodians and transact with our trade execution partners does not enjoy the same protections as are available to cash or securities deposited with or transacted by institutions subject to regulation by the Federal Deposit Insurance Corporation or the Securities Investor Protection Corporation. Additionally, we may be unable to enter into term loans or other capital raising transactions collateralized by our unencumbered bitcoin or otherwise generate funds using our bitcoin holdings, including in particular during times of market instability or when the price of bitcoin has declined significantly. If we are unable to sell our bitcoin, enter into additional capital raising transactions using bitcoin as collateral, or otherwise generate funds using our bitcoin holdings, or if we are forced to sell our bitcoin at a significant loss, in order to meet our working capital requirements, our business and financial condition could be negatively impacted.

If we or our third-party service providers experience a security breach or cyberattack and unauthorized parties obtain access to our bitcoin, or if our private keys are lost or destroyed, or other similar circumstances or events occur, we may lose some or all of our bitcoin and our financial condition and results of operations could be materially adversely affected.

Substantially all of the bitcoin we will own will be held in custody accounts at U.S.-based institutional-grade digital asset custodians. Security breaches and cyberattacks are of particular concern with respect to our bitcoin. Bitcoin and other blockchain-based cryptocurrencies and the entities that provide services to participants in the bitcoin ecosystem have been, and may in the future be, subject to security breaches, cyberattacks, or other malicious activities. For example, in October 2021 it was reported that hackers exploited a flaw in the account recovery process and stole from the accounts of at least 6,000 customers of the Coinbase exchange, although the flaw was subsequently fixed and Coinbase reimbursed affected customers. Similarly, in November 2022, hackers exploited weaknesses in the security architecture of the FTX Trading digital asset exchange and reportedly stole over $400 million in digital assets from customers. A successful security breach or cyberattack could result in:

●

a partial or total loss of our bitcoin in a manner that may not be covered by insurance or the liability provisions of the custody agreements with the custodians who hold our bitcoin;

●

harm to our reputation and brand;

●

improper disclosure of data and violations of applicable data privacy and other laws; or

●

significant regulatory scrutiny, investigations, fines, penalties, and other legal, regulatory, contractual and financial exposure.

6167

Further, any actual or perceived data security breach or cybersecurity attack directed at other companies with digital assets or companies that operate digital asset networks, regardless of whether we are directly impacted, could lead to a general loss of confidence in the broader bitcoin blockchain ecosystem or in the use of the bitcoin network to conduct financial transactions, which could negatively impact us.

Attacks upon systems across a variety of industries, including industries related to bitcoin, are increasing in frequency, persistence, and sophistication, and, in many cases, are being conducted by sophisticated, well-funded and organized groups and individuals, including state actors. The techniques used to obtain unauthorized, improper or illegal access to systems and information (including personal data and digital assets), disable or degrade services, or sabotage systems are constantly evolving, may be difficult to detect quickly, and often are not recognized or detected until after they have been launched against a target. These attacks may occur on our systems or those of our third-party service providers or partners. We may experience breaches of our security measures due to human error, malfeasance, insider threats, system errors or vulnerabilities or other irregularities. In particular, we expect that unauthorized parties will attempt, to gain access to our systems and facilities, as well as those of our partners and third-party service providers, through various means, such as hacking, social engineering, phishing and fraud. Threats can come from a variety of sources, including criminal hackers, hacktivists, state-sponsored intrusions, industrial espionage, and insiders. In addition, certain types of attacks could harm us even if our systems are left undisturbed. For example, certain threats are designed to remain dormant or undetectable, sometimes for extended periods of time, or until launched against a target and we may not be able to implement adequate preventative measures. Further, there has been an increase in such activities due to the increase in work-from-home arrangements. The risk of cyberattacks could also be increased by cyberwarfare in connection with the ongoing Russia-Ukraine and Israel-Hamas conflicts, or other future conflicts, including potential proliferation of malware into systems unrelated to such conflicts. Any future breach of our operations or those of others in the bitcoin industry, including third-party services on which we rely, could materially and adversely affect our financial condition and results of operations.

We face risks relating to the custody of our bitcoin, including the loss or destruction of private keys required to access our bitcoin and cyberattacks or other data loss relating to our bitcoin

We will hold our bitcoin with regulated custodians that have duties to safeguard our private keys. Our custodial services contracts will not restrict our ability to reallocate our bitcoin among our custodians, and our bitcoin holdings may be concentrated with a single custodian from time to time, including immediately after this offering. In light of the significant amount of bitcoin we hold, we continually evaluate the need to engage additional custodians. Additional custodians could achieve a greater degree of diversification in the custody of our bitcoin as the extent of potential risk of loss is dependent, in part, on the degree of diversification. If there is a decrease in the availability of digital asset custodians that we believe can safely custody our bitcoin, for example, custodians discontinue or limit their services in the United States, we may need to enter into agreements that are less favorable than our currently anticipated agreements or take other measures to custody our bitcoin, and our ability to seek a greater degree of diversification in the use of custodial services would be materially adversely affected. In addition, holding our bitcoin with regulated custodians could affect the availability of receiving digital assets that may result from “forks” of the bitcoin blockchain if our custodians are unable to support or otherwise provide us with such digital assets, thereby reducing the amount of digital assets we may hold as a result. While our custodians will carry insurance policies to cover losses for commercial crimes and cyber and tech errors or omissions, the policy limits vary per provider and would be shared among all of their customers, and subject to various limitations and exclusions (such as if a loss arises due to our failure to protect our login credentials and devices). The insurance that covers losses of our bitcoin holdings may cover only a small fraction of the value of the entirety of our bitcoin holdings, and there can be no guarantee that such insurance will be maintained as part of the custodial services we will have or that such coverage will cover losses with respect to our bitcoin. Moreover, our use of custodians exposes us to the risk that the bitcoin our custodians hold on our behalf could be subject to insolvency proceedings and we could be treated as a general unsecured creditor of the custodian, inhibiting our ability to exercise ownership rights with respect to such bitcoin. Any loss associated with such insolvency proceedings is unlikely to be covered by any insurance coverage we maintain related to our bitcoin.

6268

Bitcoin is controllable only by the possessor of both the unique public key and private key(s) relating to the local or online digital wallet in which the bitcoin is held. While the bitcoin blockchain ledger requires a public key relating to a digital wallet to be published when used in a transaction, private keys must be safeguarded and kept private in order to prevent a third party from accessing the bitcoin held in such wallet. To the extent the private key(s) for a digital wallet are lost, destroyed, or otherwise compromised and no backup of the private key(s) is accessible, neither we nor our custodians will be able to access the bitcoin held in the related digital wallet. Furthermore, we cannot provide assurance that our digital wallets, nor the digital wallets of our custodians held on our behalf, will not be compromised as a result of a cyberattack. The bitcoin and blockchain ledger, as well as other digital assets and blockchain technologies, have been, and may in the future be, subject to security breaches, cyberattacks, or other malicious activities.

Regulatory change reclassifying bitcoin as a security could lead to our classification as an “investment company” under the Investment Company Act of 1940, as amended, or the 1940 Act, and could adversely affect the market price of bitcoin and the market price of our ~~common~~Common ~~stock~~Stock.

Under Sections 3(a)(1)(A) and (C) of the 1940 Act, a company generally will be deemed to be an “investment company” for purposes of the 1940 Act if (1) it is, or holds itself out as being, engaged primarily, or proposes to engage primarily, in the business of investing, reinvesting or trading in securities or (2) it engages, or proposes to engage, in the business of investing, reinvesting, owning, holding or trading in securities and it owns or proposes to acquire investment securities having a value exceeding 40% of the value of its total assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis. We do not believe that we are an “investment company,” as such term is defined in the 1940 Act, and are not registered as an “investment company” under the 1940 Act as of the date of this prospectus.

While senior SEC officials have stated their view that bitcoin is not a “security” for purposes of the federal securities laws, a contrary determination by the SEC could lead to our classification as an “investment company” under the 1940 Act, if the portion of our assets consists of investments in bitcoins exceeds 40% safe harbor limits prescribed in the 1940 Act, which would subject us to significant additional regulatory controls that could have a material adverse effect on our business and operations and may also require us to change the manner in which we conduct our business.

We monitor our assets and income for compliance under the 1940 Act and seek to conduct our business activities in a manner such that we do not fall within its definitions of “investment company” or that we qualify under one of the exemptions or exclusions provided by the 1940 Act and corresponding SEC regulations. If bitcoin is determined to constitute a security for purposes of the federal securities laws, we would take steps to reduce the percentage of bitcoins that constitute investment assets under the 1940 Act. These steps may include, among others, selling bitcoins that we might otherwise hold for the long term and deploying our cash in non-investment assets, and we may be forced to sell our bitcoins at unattractive prices. We may also seek to acquire additional non-investment assets to maintain compliance with the 1940 Act, and we may need to incur debt, issue additional equity or enter into other financing arrangements that are not otherwise attractive to our business. Any of these actions could have a material adverse effect on our results of operations and financial condition. Moreover, we can make no assurance that we would successfully be able to take the necessary steps to avoid being deemed to be an investment company in accordance with the safe harbor. If we were unsuccessful, and if bitcoin is determined to constitute a security for purposes of the federal securities laws, then we would have to register as an investment company, and the additional regulatory restrictions imposed by 1940 Act could adversely affect the market price of bitcoin and in turn adversely affect the market price of our ~~common~~Common ~~stock~~Stock.

We may be subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect our business, financial condition, and results of operations.

As bitcoin and other digital assets are relatively novel and the application of state and federal securities laws and other laws and regulations to digital assets is unclear in certain respects, it is possible that regulators in the United States or foreign countries may interpret or apply existing laws and regulations in a manner that adversely affects the price of bitcoin. The U.S. federal government, states, regulatory agencies, and foreign countries may also enact new laws and regulations, or pursue regulatory, legislative, enforcement or judicial actions, that could materially impact the price of bitcoin or the ability of individuals or institutions such as us to own or transfer bitcoin. For examples, see “Risk Factors-Risks Related to Our Bitcoin Treasury Strategy and Holdings-Bitcoin and other digital assets are novel assets, and are subject to significant legal, commercial, regulatory and technical uncertainty” elsewhere in this prospectus.

6369

Our bitcoin treasury strategy exposes us to risk of non-performance by counterparties

Our bitcoin treasury strategy exposes us to the risk of non-performance by counterparties, whether contractual or otherwise. Risk of non-performance includes inability or refusal of a counterparty to perform because of a deterioration in the counterparty’s financial condition and liquidity or for any other reason. For example, our execution partners, custodians, or other counterparties might fail to perform in accordance with the terms of our agreements with them, which could result in a loss of bitcoin, a loss of the opportunity to generate funds, or other losses.

We expect our primary counterparty risk with respect to our bitcoin will be custodian performance obligations under the various custody arrangements we enter into. A series of recent high-profile bankruptcies, closures, liquidations, regulatory enforcement actions and other events relating to companies operating in the digital asset industry, the closure or liquidation of certain financial institutions that provided lending and other services to the digital assets industry, SEC enforcement actions against other providers, or placement into receivership or civil fraud lawsuit against digital asset industry participants have highlighted the perceived and actual counterparty risk applicable to digital asset ownership and trading. Legal precedent created in these bankruptcy and other proceedings may increase the risk of future rulings adverse to our interests in the event one or more of our custodians becomes a debtor in a bankruptcy case or is the subject of other liquidation, insolvency or similar proceedings.

While our custodians will be subject to regulatory regimes intended to protect customers in the event of a custodial bankruptcy, receivership or similar insolvency proceeding, no assurance can be provided that our custodially-held bitcoin will not become part of the custodian’s insolvency estate if one or more of our custodians enters bankruptcy, receivership or similar insolvency proceedings. Additionally, if we pursue any strategies to create income streams or otherwise generate funds using our bitcoin holdings, we would become subject to additional counterparty risks. We will need to carefully evaluate market conditions, including price volatility as well as service provider terms and market reputations and performance, among others, prior to implementing any such strategy, all of which could effect our ability to successfully implement and execute on any such future strategy. These risks, along with any significant non-performance by counterparties, including in particular the custodian or custodians with which we will custody substantially all of our bitcoin, could have a material adverse effect on our business, prospects, financial condition, and operating results.

If bitcoin is determined to constitute a security for purposes of the federal securities laws, the additional regulatory restrictions imposed by such a determination could adversely affect the market price of bitcoin and in turn adversely affect the market price of our ~~common stock~~Common Stock. See “Risk Factors — Regulatory change reclassifying bitcoin as a security could lead to our classification as an “investment company” under the Investment Company Act of 1940, as amended, or the 1940 Act, and could adversely affect the market price of bitcoin and the market price of our ~~common~~Common ~~stock~~Stock” above. Moreover, the risks of us engaging in a bitcoin treasury strategy could create complications due to the lack of experience that third parties have with companies engaging in such a strategy, such as increased costs of director and officer liability insurance or the potential inability to obtain such coverage on acceptable terms in the future.

A temporary or permanent blockchain “fork” to bitcoin or other crypto assets could adversely affect our business.

Blockchain protocols, including bitcoin, are open source. Any user can download the software, modify it, and then propose that bitcoin or other blockchain protocols users and miners adopt the modification. When a modification is introduced and a substantial majority of users and miners consent to the modification, the change is implemented and the bitcoin or other blockchain protocol networks, as applicable, remain uninterrupted. However, if less than a substantial majority of users and miners consent to the proposed modification, and the modification is not compatible with the software prior to its modification, the consequence would be what is known as a “fork”, i.e., “split” of the impacted blockchain protocol network and respective blockchain, with one prong running the pre-modified software and the other running the modified software. The effect of such a fork would be the existence of two parallel versions of the bitcoin or other blockchain protocol network, as applicable, running simultaneously, but with each split network’s crypto asset lacking interchangeability. A “hard fork” — where there is disagreement among the users about the rules of the network — can have a significant negative impact on value of the crypto asset.

The bitcoin has been subject to “forks” that resulted in the creation of new networks, including bitcoin cash ABC, bitcoin cash SV, bitcoin diamond, bitcoin gold and others. Some of these forks have caused fragmentation among platforms as to the correct naming convention for forked crypto assets. Due to the lack of a central registry or rulemaking body, no single entity has the ability to dictate the nomenclature of forked crypto assets, causing

disagreements and a lack of uniformity among platforms on the nomenclature of forked crypto assets, and which results in further confusion to customers as to the nature of assets they hold on platforms, and which can negatively impact the value of the crypto assets. In addition, several of these forks were contentious and as a result, participants in certain communities may harbor ill will towards other communities. As a result, certain community members may take actions that adversely impact the use, adoption, and price of bitcoin, or any of their forked alternatives.

6470

Furthermore, hard forks can lead to new security concerns. For instance, when the Ethereum and Ethereum Classic networks split in July 2016, replay attacks, in which transactions from one network were rebroadcast on the other network to achieve “double-spending,” plagued platforms that traded Ethereum through at least October 2016, resulting in significant losses to some crypto asset platforms. Similar replay attacks occurred in connection with the bitcoin cash and bitcoin cash SV network split in November 2018. Another possible result of a hard fork is an inherent decrease in the level of security due to the splitting of some mining power across networks, making it easier for a malicious actor to exceed 50% of the mining power of that network, thereby making crypto assets that rely on proof-of-work more susceptible to attack, as has occurred with Ethereum Classic.

We intend to recognize forked and airdropped assets consistent with our custodians. We may not immediately or ever have the ability to withdraw a forked or airdropped bitcoin by virtue of bitcoins that we hold with our custodians. Future forks may occur at any time. A fork can lead to a disruption of networks and our information technology systems, cybersecurity attacks, replay attacks, or security weaknesses, any of which can further lead to temporary or even permanent loss of our and our assets.

The due diligence procedures conducted by us and our liquidity providers to mitigate transaction risk may fail to prevent transactions with a sanctioned entity.

We will execute trades through U.S.-based liquidity providers, and rely on these third parties to implement controls and procedures to mitigate the risk of transacting with sanctioned entities. While we expect our third party service providers to conduct their business in compliance with applicable laws and regulations and in accordance with our contractual arrangements, there is no guarantee that they will do so. Accordingly, we are exposed to risk that our due diligence procedures may fail. If we are found to have transacted in bitcoin with bad actors that have used bitcoin to launder money or with persons subject to sanctions, we may be subject to regulatory proceedings and any further transactions or dealings in bitcoin by us may be restricted or prohibited.

~~Additional~~ Risks Relating to Ownership of ~~Profusa Common~~our ~~Stock Following the Business Combination~~Securities

There can be no assurance that we will be able to transfer the listing of our securities to the Nasdaq Capital Market or that we will be able to comply with the continued listing standards of Nasdaq, the Nasdaq Capital Market, or any other exchange, a failure of which could result in a de-listing of our common stock.

We intend to transfer the listing of our securities to the Nasdaq Capital Market. The Nasdaq Capital Market requires that the trading price of its listed stocks remain above one dollar in order for the stock to remain listed. If a listed stock trades below one dollar for more than 30 consecutive trading days, then it is subject to delisting from Nasdaq. In addition, to maintain a a listing on Nasdaq, we must satisfy minimum financial and other continued listing requirements and standards, including those ~~regarding~~ regarding director independence and independent committee requirements, minimum stockholders’ equity, and certain corporate governance requirements. While we are working diligently to transfer the listing of our securities to the Nasdaq Capital Market, there can be no assurance that we will successfully transfer such listing in a timely manner or at all. If we are unable to satisfy Nasdaq ~~these~~ requirements or standards, we could be subject to delisting, which would have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we would expect to take actions to restore our compliance with the listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of ~~our~~ our common stock, prevent our common stock from dropping below the minimum bid price requirement, or prevent future non-compliance with the listing requirements.

If Nasdaq delists our shares from trading on its exchange for failure to meet the listing standards, Profusa and its stockholders could face significant negative consequences including:

●

limited availability of market quotations for Profusa’s securities;

●

reduced liquidity for Profusa’s securities;

●

a determination that Profusa Common Stock is a “penny stock” which will require brokers trading in Profusa Common Stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of Profusa Common Stock;

●

a limited amount of analyst coverage; and

●

a decreased ability to issue additional securities or obtain additional financing in the future.

The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” If Profusa’s securities were not listed on the Nasdaq, such securities would not qualify as covered securities and we would be subject to regulation in each state in which we offer our securities because states are not preempted from regulating the sale of securities that are not covered securities.

Future sales, or the perception of future sales, by Profusa shareholders in the public market could cause the market price for Profusa Common Stock to decline.

The sale of shares of Profusa Common Stock in the public market, or the perception that such sales could occur, could harm the prevailing market price of shares of Profusa Common Stock. These sales, or the possibility that these sales may occur, also might make it more difficult for Profusa to sell equity securities in the future at a time and at a price that it deems appropriate.

The grant and future exercise of registration rights may adversely affect the market price of Profusa shares.

Pursuant to the Registration Rights Agreement which is described elsewhere in this prospectus, the parties can each demand that Profusa register their registrable securities under certain circumstances and will each also have piggyback registration rights for these securities in connection with certain registrations of securities that Profusa undertakes. In addition, Profusa is required to file and maintain an effective registration statement under the Securities Act covering such securities and certain other securities of Profusa.

The registration of these securities will permit the public sale of such securities. The registration and availability of such a significant number of securities for trading in the public market may have an adverse effect on the market price of Profusa shares.

~~In addition, the shares of Profusa Common Stock reserved for future issuance under the Equity Incentive Plan will become eligible for sale in the public market once those shares are issued.~~72

A total of approximately 15% of the fully diluted shares of Profusa Common Stock common stock has been reserved for future issuance under its equity incentive plan. The compensation committee of Profusa’s board of directors may determine the exact number of shares to be reserved for future issuance under its equity incentive plan at its discretion. Profusa is expected to file one or more registration statements on Form S-8 under the Securities Act to register shares of Profusa Common Stock or securities convertible into or exchangeable for shares of Profusa Common Stock issued pursuant to Profusa’s equity incentive plan. Any such Form S-8 registration statements will automatically become effective upon filing. Accordingly, shares registered under such registration statements will be available for sale in the open market.

In the future, Profusa may also issue its securities in connection with investments or acquisitions. The amount of shares of Profusa Common Stock issued in connection with an investment or acquisition could constitute a material portion of Profusa’s then-outstanding shares of common stock. Any issuance of additional securities in connection with investments or acquisitions may result in additional dilution to Profusa’s stockholders.

Profusa may retain future earnings, if any, for future operations, expansion and debt repayment and has no current plans to pay any cash dividends for the foreseeable future. Any decision to declare and pay dividends as a public company in the future will be made at the discretion of Profusa’s board of directors and will depend on, among other things, Profusa’s results of operations, financial condition, cash requirements, contractual restrictions and other factors that Profusa’s board of directors may deem relevant. In addition, Profusa’s ability to pay dividends may be limited by covenants of any existing and future outstanding indebtedness it or its subsidiaries incur. As a result, you may not receive any return on an investment in Profusa Common Stock unless you sell your shares of common stock for a price greater than that which you paid for it.

Pursuant to the Equity Incentive Plan and the ESPP, following the completion of the proposed transactions, Profusa may issue an aggregate of approximately 15% of the fully diluted shares of Profusa Common Stock, which amount will be subject to increase from time to time. Profusa may also issue additional shares of Profusa Common Stock or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances.

The issuance of additional shares or other equity securities of equal or senior rank would have the following effects:

● existing stockholders’ proportionate ownership interest in Profusa will decrease;

● the amount of cash available per share, including for payment of dividends in the future, may decrease;

● the relative voting strength of each previously outstanding Profusa Common Stock may be diminished; and

● the market price of Profusa Common Stock may decline.

Anti-takeover provisions in our amended and restated certificate of incorporation and under Delaware law could make an acquisition of Profusa, which may be beneficial to its stockholders, more difficult and may prevent attempts by its stockholders to replace or remove Profusa’s current management.

Our amended and restated certificate of incorporation that will be in effect upon completion of the Business Combination will contain provisions that may delay or prevent an acquisition of Profusa or a change in its management. These provisions may make it more difficult for stockholders to replace or remove members of its board of directors. Because the board of directors is responsible for appointing the members of the management team, these provisions could in turn frustrate or prevent any attempt by its stockholders to replace or remove its current management. In addition, these provisions could limit the price that investors might be willing to pay in the future for shares of Profusa Common Stock. Among other things, these provisions include:

● the limitation of the liability of, and the indemnification of, its directors and officers;

● a prohibition on actions by its stockholders except at an annual or Special Meeting of stockholders;

● a prohibition on actions by its stockholders by written consent; and

● the ability of the board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by the board of directors.

Moreover, because Profusa is incorporated in Delaware, it is governed by the provisions of Section 203 of the DGCL, which prohibits a person who owns 15% or more of its outstanding voting stock from merging or combining with Profusa for a period of three years after the date of the transaction in which the person acquired 15% or more of Profusa’s outstanding voting stock, unless such merger or combination is approved in a prescribed manner. This could discourage, delay or prevent a third party from acquiring or merging with Profusa, whether or not it is desired by, or beneficial to, its stockholders. This could also have the effect of discouraging others from making tender offers for Profusa Common Stock, including transactions that may be in its stockholders’ best interests. Finally, these provisions establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings. These provisions would apply even if the offer may be considered beneficial by some stockholders. For more information, see “Description of Profusa Capital Stock”.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between Profusa and its stockholders, which could limit its stockholders’ ability to obtain a favorable judicial forum for disputes with Profusa or its directors, officers or employees.

Profusa’s amended and restated certificate of incorporation will provide that the Court of Chancery of the State of Delaware will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

● any derivative action or proceeding brought on Profusa’s behalf;

● any action asserting a breach of fiduciary duty;

● any action asserting a claim against Profusa arising under the DGCL, its amended and restated certificate of incorporation or its amended and restated bylaws; and

● any action asserting a claim against Profusa that is governed by the internal-affairs doctrine or otherwise related to Profusa’s internal affairs.

To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, Profusa’s amended and restated certificate of incorporation further provides that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, Profusa would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of its amended and restated certificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with Profusa or its directors, officers or other employees, which may discourage lawsuits against Profusa and its directors, officers and other employees. If a court were to find either exclusive-forum provision in its amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, Profusa may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which could harm its business.

We may be subject to securities litigation, which is expensive and could divert management attention.

The market price of our securities may be volatile and, in the past, companies that have experienced volatility in the market price of their securities have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert management’s attention from other business concerns, which could seriously harm its business.

Profusa does not intend to pay cash dividends for the foreseeable future.

Following the Business Combination, Profusa currently intends to retain its future earnings, if any, to finance the further development and expansion of its business and does not intend to pay cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors and will depend on its financial condition, results of operations, capital requirements and future agreements and financing instruments, business prospects and such other factors as its board of directors deems relevant.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Some of the information in this prospectus, and the documents we incorporate by reference, contain forward-looking statements within the meaning of the federal securities laws. You should not rely on forward-looking statements in this prospectus, and the documents we incorporate by reference. Forward-looking statements typically are identified by use of terms such as “anticipate,” “believe,” “plan,” “expect,” “future,” “intend,” “may,” “will,” “should,” “estimate,” “predict,” “potential,” “continue,” and similar words, although some forward-looking statements are expressed differently. This prospectus, and the documents we incorporate by reference, may also contain forward-looking statements attributed to third parties relating to their estimates regarding the markets we may enter in the future. All forward-looking statements address matters that involve risk and uncertainties, and there are many important risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements contained in this prospectus, and the documents we incorporate by reference.

You should also carefully consider the statements under “Risk Factors” and other sections of this prospectus, which address additional facts that could cause our actual results to differ from those set forth in the forward-looking statements. We caution investors not to place significant reliance on the forward-looking statements contained in this prospectus, and the documents we incorporate by reference. We undertake no obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise.

6973

THE COMMITTED EQUITY FACILITY

On July 28, 2025, we entered into the ELOC Purchase Agreement and the ELOC Registration Rights Agreement with Ascent. Upon the terms and subject to the satisfaction of the conditions contained in the ELOC Purchase Agreement, from and after the Effective Date, we will have the right, in our sole discretion, to sell to Ascent up to $100,000,000 of shares of our Common Stock, subject to certain limitations set forth in the ELOC Purchase Agreement, from time to time after the date of this prospectus and during the term of the ELOC Purchase Agreement. Sales of Common Stock by us to Ascent under the ELOC Purchase Agreement, and the timing of any such sales, are solely at our option, and we are under no obligation to sell any securities to Ascent under the ELOC Purchase Agreement. In accordance with our obligations under the ELOC Registration Rights Agreement, we previously filed a registration statements, ~~statement~~on August 22, 2025 (declared effective on August 25, 2025) and October 8, 2025 registering the resale of up to 8,970,830 shares and 42,211,548 shares, respectively, by Ascent pursuant to the ELOC Purchase Agreement. In addition, we have filed the registration statement that includes this prospectus with the SEC to register under the Securities Act the resale by Ascent of up to an additional 4225,~~211~~000,~~548~~ 000 Purchase Shares that we may, in our sole discretion, elect to sell to Ascent, from time to time over a period of up to 36 months from and after the Effective Date (defined below) pursuant to the ELOC Purchase Agreement.

Under the ELOC Purchase Agreement, we have the right, but not the obligation, from time to time at our sole discretion for a period of up to 36 months, unless the ELOC Purchase Agreement is earlier terminated, to direct Ascent to purchase up to a specified maximum amount of shares of Common Stock in one or more Purchases as set forth in the ELOC Purchase Agreement, by delivering a written Advance Notice, if any, to Ascent in accordance with the ELOC Purchase Agreement on any trading day we select.

From and after Commencement, the Company will control the timing and amount of any sales of Common Stock to Ascent. Actual sales of shares of our Common Stock to Ascent under the ELOC Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among other things, market conditions, the trading price of our Common Stock and determinations by us as to the appropriate sources of funding for our Company and its operations.

Moreover, we may not issue or sell any shares of Common Stock to Ascent under the ELOC Purchase Agreement which, when aggregated with all other shares of Common Stock then beneficially owned by Ascent and its affiliates (as calculated pursuant to Section 13(d) of the Exchange Act and Rule 13d-3 thereunder), would result in Ascent beneficially owning shares of Common Stock in excess of the 9.99% Beneficial Ownership Limitation.

The net proceeds to us from sales that we elect to make to Ascent under the ELOC Purchase Agreement, if any, will depend on the frequency and prices at which we sell shares of our Common Stock to Ascent. We expect that any proceeds received by us from such sales to Ascent will be used for working capital and general corporate purposes.

Neither we nor Ascent may assign or transfer our respective rights and obligations under the ELOC Purchase Agreement or the ELOC Registration Rights Agreement, and no provision of the ELOC Purchase Agreement or the ELOC Registration Rights Agreement may be modified or waived by us or Ascent.

70As consideration for Ascent’s commitment to purchase shares of Common Stock at our direction upon the terms and subject to the conditions set forth in the ELOC Purchase Agreement, upon our execution of the term sheet relating to the ELOC Purchase Agreement, we issued Ascent Commitment Warrants to purchase up to 900,000 Commitment Warrant Shares. The Commitment Warrants have an exercise price of $0.01 and may be exercised for cash or, if at the time of exercise there is no effective registration statement covering the resale of the Commitment Warrant Shares, on a cashless basis. If we do not require Ascent to purchase any Purchase Shares on or before the 100th day following the execution of the ELOC Purchase Agreement, the number of Commitment Warrant Shares underlying the Commitment Warrants will be reduced to 450,000.

AsIn ~~consideration~~addition, ~~for~~we ~~Ascent’s commitment~~have toagreed ~~purchase shares of Common Stock at our direction upon the terms and subject~~ to ~~the~~reimburse ~~conditions~~Ascent ~~set~~for ~~forth~~costs, infees ~~the Purchase~~and ~~Agreement,~~expenses ~~upon our execution~~ of ~~the~~up ~~term sheet relating~~ to ~~the Purchase Agreement~~$30, ~~we issued Ascent Commitment Warrants to purchase up to 900,~~000 ~~Commitment Warrant Shares. The Commitment Warrants have an exercise price~~ of ~~$0.01~~the ~~and may be exercised for cash or~~negotiation, ifpreparation ~~at the~~and ~~time~~closing of ~~exercise there is no effective registration statement covering~~ the ~~resale~~ELOC ofPurchase ~~the~~Agreement ~~Commitment~~up ~~Warrant Shares, on a cashless basis. If we do not require Ascent~~ to ~~purchase any Purchase Shares on or before~~ the ~~100th~~Effective ~~day~~Date ~~following~~and ~~the execution of the~~ELOC ~~Purchase~~Registration Rights Agreement, ~~the~~and ~~number~~additional ofcosts, ~~Commitment~~fees ~~Warrant~~and ~~Shares~~expenses ~~underlying the Commitment Warrants will be reduced to 450,000~~thereafter.

InThe ~~addition,~~ELOC wePurchase ~~have~~Agreement ~~agreed to~~and ~~reimburse~~the ~~Ascent~~ELOC ~~for~~Registration ~~costs,~~Rights ~~fees~~Agreement contain ~~and~~customary ~~expenses~~representations, ofwarranties, upconditions toand ~~$30,000~~indemnification obligations of the ~~negotiation,~~parties. ~~preparation~~Copies ~~and closing~~ of the ~~Purchase~~agreements ~~Agreement~~have upbeen filed as exhibits to the ~~Effective~~registration ~~Date~~statement ~~and~~that ~~ELOC~~includes ~~Registration~~this ~~Rights~~prospectus ~~Agreement,~~ and ~~additional~~are ~~costs,~~available ~~fees~~electronically ~~and~~on ~~expenses~~the ~~thereafter~~SEC’s website at www.sec.gov.

~~The~~Purchases ~~Purchase Agreement and the ELOC Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations~~ of ~~the parties.~~Common ~~Copies~~Stock ofUnder the ~~agreements~~ELOC ~~have been filed as exhibits to the registration statement that includes this prospectus and are available~~Purchase ~~electronically on the SEC’s website at www.sec.gov.~~Agreement

Purchases of Common Stock Under the Purchase Agreement

Purchases

We have the right, but not the obligation, from time to time at our sole discretion for a period of up to 36 months, unless the ELOC Purchase Agreement is earlier terminated, beginning on the Effective Date, to direct Ascent to purchase a specified number of shares of Common Stock, not to exceed the applicable Maximum Closing Purchase Price, in a Purchase under the ELOC Purchase Agreement, by timely delivering a written Advance Notice to Ascent to purchase a specified number of Purchase Shares. On the same date, the Company must deliver the specified number of Purchase Shares to Ascent.

Under the Purchase Agreement, we may deliver from time to time an Advance Notice to the Purchaser to request the purchase of shares of common stock, with each closing (a “Closing”) to occur on a trading day following the end of a 10 or fewer trading day valuation period commencing on the trading date immediately following the delivery of the Advance Notice, or as determined by the Purchaser. The purchase price per share at each Closing will be equal to 97% of the lowest VWAP of the Company’s common stock during the applicable valuation period, subject to a floor price and other adjustments as set forth in the Purchase Agreement. The maximum purchase price at any single Closing is limited to the lower of (a) $5,000,000 or (b) 100% of the average daily traded value of the common stock for the five trading days immediately preceding such Closing.74

~~The~~Under the ELOC Purchase Agreement, ~~contains~~we may deliver from time to time ~~certain~~an ~~limitations~~Advance Notice to the Purchaser to request the purchase of shares of common stock, ~~including~~with ~~that~~each ~~Ascent’s~~closing ~~beneficial~~(a ~~ownership~~“Closing”) to occur on a trading day following the end of a 10 or fewer trading day valuation period commencing on the trading date immediately following the delivery of the Advance Notice, or as determined by the Purchaser. The purchase price per share at each Closing will be equal to 97% of the lowest VWAP of the Company’s common stock during the applicable valuation period, subject to a floor price and other adjustments as set forth in the ELOC Purchase Agreement. The maximum purchase price at any single Closing is limited to ~~9.99~~the lower of (a) $5,000,000 or (b) 100% of the ~~outstanding~~ ~~shares~~average ~~immediately~~daily ~~after~~traded ~~giving~~value ~~effect~~of tothe ~~any~~common ~~issuance~~stock for the five trading days immediately preceding such Closing.

The ELOC Purchase Agreement contains certain limitations, including that Ascent’s beneficial ownership of the Company’s common stock is limited to 9.99% of the outstanding shares immediately after giving effect to any issuance.

In the event that the value of all of the Purchase Shares delivered to Ascent exceeds $100,000,000, then Ascent shall return to the to the Company the surplus amount of Purchase Shares.

Amendment No. 1 to ELOC Purchase Agreement

On December 22, 2025, the Company entered into Amendment No. 1 (the “SPA Amendment”) to the ELOC Purchase Agreement. Pursuant to the SPA Amendment, Section 1.1 of the ELOC Purchase Agreement was amended and restated to modify the definition of Floor Price to provide for a Floor Price at or above 11.1 cents ($0.111) per share during the period commencing on the date of the SPA Amendment and ending on, but excluding, the effective date of the reverse stock split presented to the Company’s stockholders in January 2026 for their approval, when such reverse stock split becomes effective (the “Modification Period”). The “Floor Price” as amended and restated means, during the Modification Period, solely with respect to an aggregate number of shares of Common Stock issued and sold as Purchased Securities not to exceed 13,650,000 shares, to be sold at or above 11.1 cents ($0.111) per share and below 14 cents ($0.14). Upon the earliest to occur of (x) the issuance of such aggregate number of 13,650,000 shares as Purchased Securities during the Modification Period or (y) the end of the Modification Period, the Floor Price shall thereafter mean 14 cents ($0.14), the price per share of Common Stock equal to the product obtained by multiplying (x) twenty percent (20%) by (y) the Official Closing Price on July 25, 2025, in each case as further adjusted to reflect any reduction (but excluding any increase) in the price per share of Common Stock caused by any reorganization, recapitalization, non-cash dividend, share split or other similar transaction, all as provided in this Agreement. The modified Floor Price of 11.1 cents ($0.111) per share applies only during the Modification Period and only up to the 13,650,000 share cap relating to shares issued and sold below 14 cents ($0.14), and the unmodified definition applies to all other times and shares.

Conditions Precedent to Commencement and Each Purchase

Ascent’s obligation to accept Advance Notices that are timely delivered by us under the ELOC Purchase Agreement and to purchase shares of our Common Stock in Purchases under the ELOC Purchase Agreement, are subject to (i) the initial satisfaction, at the Commencement, and (ii) the satisfaction, on the applicable Purchase Date for each Purchase after the Effective Date, of the conditions precedent thereto set forth in the ELOC Purchase Agreement, all of which are entirely outside of Ascent’s control, which conditions including the following:

● the accuracy in all material respects of the representations and warranties of the Company included in the ELOC Purchase Agreement;

71● the Company having performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the ELOC Purchase Agreement to be performed, satisfied or complied with by the Company;

● the ~~Company~~registration ~~having~~statement ~~performed,~~that ~~satisfied~~includes this prospectus (and ~~complied~~any inone ~~all~~or ~~material~~more ~~respects~~additional registration statements filed with ~~all~~the ~~covenants,~~SEC ~~agreements~~that ~~and~~include ~~conditions~~shares ~~required~~of Common Stock that may be issued and sold by the Company to Ascent under the ELOC Purchase Agreement) tohaving bebeen ~~performed~~declared effective under the Securities Act by the SEC, ~~satisfied~~and Ascent being able to utilize this prospectus (and the prospectus included in any one or ~~complied~~more additional registration statements filed with bythe SEC under the ~~Company~~ELOC Registration Rights Agreement) to resell all of the Purchase Shares included in this prospectus (and included in any such additional prospectuses);

● the registration statement that includes this prospectus (and any one or more additional registration statements filed with the SEC that include shares of Common Stock that may be issued and sold by the Company to Ascent under the Purchase Agreement) having been declared effective under the Securities Act by the SEC, and Ascent being able to utilize this prospectus (and the prospectus included in any one or more additional registration statements filed with the SEC under the ELOC Registration Rights Agreement) to resell all of the Purchase Shares included in this prospectus (and included in any such additional prospectuses);

●

trading in the Company shares of Common Stock shall not have been suspended by the SEC or Nasdaq and, at any time prior to such Closing Date (or, as the case may be, the Effective Date), trading in securities generally as reported by Bloomberg L.P. shall not have been suspended or limited, or minimum prices shall not have been established on Securities of the Company whose trades are reported by such service or on any Trading Market for such securities;

●

there shall not have occurred any breach, default or event of default under any indebtedness of the Company or any of its subsidiaries (A) having (individually or in the aggregate for all such indebtedness) an aggregate maximum principal amount or commitment greater than $150,000, or (B) any such indebtedness shall become or be declared due and payable prior to the date on which it would otherwise become due and payable;

●

there shall not have occurred any breach, default or event of default under any other contractual obligation to which the Company or any of its subsidiaries is obligated that, if determined adversely to any Company Group Member, could reasonably be expected to result in any injunction affecting the Company or any of its subsidiaries $150,000;

●

there shall not have occurred any monetary judgment, writ or similar final process shall be entered or filed against the Company of any of its subsidiaries or any of their assets for an injunction or for monetary damages of more than $150,000, and such judgment, writ or similar final process shall remain unvacated, unbonded or unstayed for a period of forty-five (45) calendar days;

●

none of the Company or its subsidiaries have commenced a case or other proceeding under any bankruptcy, reorganization, arrangement, adjustment of debt, relief of debtors, dissolution, insolvency, winding up, reorganization, arrangement, adjustment, protection, relief or composition of debts or liquidation or similar regulation of any jurisdiction relating to the Company or such subsidiary;

●

no change of control of the Company shall have occurred;

●

the Company shall not have amended its charter documents in any manner that materially and adversely affects any rights of the Ascent or change the nature of the Company’s business;

●

the Company’s Common Stock shall not have become “penny stock” as defined in Regulations for purposes of 3(a)(51) of the Exchange Act, and

●

the transfer of shares of Common Stock through the Depository Trust Company System shall remain available for the “Deposit and Withdrawal at Custodian” (DWAC) service of the Deposit Trust Corporation and shall not be subject to any restriction or limitation imposed by or on behalf of the Deposit Trust Corporation on any of its services or any other restriction or limitation on the use of the services provided by the Deposit Trust Corporation (DTC chill).

Termination of the Purchase Agreement

The Purchase Agreement will automatically terminate on the earliest to occur of (i) July 27, 2028, (ii) the date on which Ascent shall have purchased from us under the Purchase Agreement shares of Common Stock for an aggregate gross purchase price of $100,000,000, and (iii) the date either party effectively delivers notice to the other party of such termination.

No Short-Selling or Hedging by Ascent

Ascent has represented to us that at no time prior to the date of the Purchase Agreement has Ascent, any of its officers, or any entity managed or controlled by Ascent, engaged in or effected, in any manner whatsoever, directly or indirectly, for Ascent’s own principal account or for the principal account of any such entity managed or controlled by Ascent, any short sale (as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of our Common Stock or any hedging transaction, which establishes a net short position with respect to our Common Stock that remained in effect as of the date of the Purchase Agreement. Ascent has agreed that, during the term of the Purchase Agreement, none of Ascent, any of its officers, or any entity managed or controlled by Ascent will engage in or effect, directly or indirectly, any of the foregoing transactions either for Ascent’s own principal account or for the principal account of any such entity managed or controlled by Ascent.

Effect of Sales of our Common Stock under the Purchase Agreement on our Stockholders

The Commitment Warrant Shares that we issued, and the Purchase Shares to be issued or sold by us, to Ascent under the Purchase Agreement that are being registered under the Securities Act for resale by Ascent in this offering are expected to be freely tradable. The 42,211,548 Purchase Shares being registered for resale in this offering may be issued and sold by us to Ascent from time to time at our discretion over a period of up to 36 months (unless the Purchase Agreement is earlier terminated), beginning on the Effective Date. The resale by Ascent of a significant amount of Purchase Shares registered for resale in this offering at any given time, or the perception that these sales may occur, could cause the market price of our Common Stock to decline and to be highly volatile. Sales of our Common Stock, if any, to Ascent under the Purchase Agreement will depend upon market conditions and other factors to be determined by us. We may ultimately decide to sell to Ascent all, some or none of the shares of our Common Stock that may be available for us to sell to Ascent pursuant to the Purchase Agreement.

If and when we do elect to sell shares of our Common Stock to Ascent pursuant to the Purchase Agreement, after Ascent has acquired such shares, Ascent may resell all, some or none of such shares at any time or from time to time in its discretion and at different prices. As a result, investors who purchase shares from Ascent in this offering at different times will likely pay different prices for those shares, and so may experience different levels of dilution, and in some cases substantial dilution, and different outcomes in their investment results. Investors may experience a decline in the value of the shares they purchase from Ascent in this offering as a result of future sales made by us to Ascent at prices lower than the prices such investors paid for their shares in this offering. In addition, if we sell a substantial number of shares of our Common Stock to Ascent under the Purchase Agreement, or if investors expect that we will do so, the actual sales of shares or the mere existence of our arrangement with Ascent may make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales.

Because the per share purchase price that Ascent will pay for Purchase Shares in any Purchase that we may elect to effect pursuant to the Purchase Agreement will be determined by reference to the VWAP during the applicable Valuation Period on the applicable Closing Date, as of the date of this prospectus, we cannot determine the actual purchase price per share that Ascent will be required to pay for any Purchase Shares that we may elect to sell to Ascent under the Purchase Agreement from and after Commencement and, therefore, we cannot be certain how many Purchase Shares, in the aggregate, we may issue and sell to Ascent under the Purchase Agreement from and after Commencement. As of October 8, 2025, there were 41,759,307 shares of our Common Stock outstanding, of which 34,982,922 shares were held by non-affiliates of our Company. If all of the 42,211,548 Purchase Shares offered for resale by Ascent under this prospectus were issued and outstanding as of the date hereof, such shares would represent approximately 50.3% of the total number of outstanding shares of Common Stock and approximately 54.7% of the total number of outstanding shares of Common Stock held by non-affiliates of our Company, in each case as of October 8, 2025.

Although the Purchase Agreement provides that we may sell up to $100,000,000 of our Common Stock to Ascent, only an additional 42,211,548 Purchase Shares are being registered under the Securities Act for resale by Ascent under the registration statement which includes this prospectus. This amount is in addition to the 8,970,830 shares previously registered for resale in our prior registration statement, which was declared effective on August 25, 2025, including 900,000 Commitment Warrant Shares (for which we have not and will not receive any cash consideration). If we were to issue and sell all of such 42,211,548 Purchase Shares to Ascent at an assumed purchase price per share of $0.34, representing the closing sale price of our Common Stock on Nasdaq on October 7, 2025, we would only receive approximately $14.4 million in aggregate gross proceeds from the sale of such Purchase Shares to Ascent under the Purchase Agreement. Depending on the market prices of our Common Stock on the Purchase Dates on which we elect to sell such Purchase Shares to Ascent under the Purchase Agreement, we may in the future need to register under the Securities Act additional shares of our Common Stock for resale by Ascent which, together with the 42,211,548 Purchase Shares included in this prospectus, will enable us to issue and sell to Ascent such aggregate number of shares of Common Stock under the Purchase Agreement as will be necessary in order for us to receive aggregate proceeds equal to Ascent’s $100,000,000 maximum aggregate purchase commitment available to us under the Purchase Agreement.

The number of Purchase Shares ultimately offered for resale by Ascent through this prospectus is dependent upon the number of shares of Common Stock, if any, we elect to issue and/or sell to Ascent under the Purchase Agreement from and after the Effective Date. The issuance of our Common Stock to Ascent pursuant to the Purchase Agreement will not affect the rights or privileges of our existing stockholders, except that the economic and voting interests of each of our existing stockholders will be diluted. Although the number of shares of our Common Stock that our existing stockholders own will not decrease, the shares of our Common Stock owned by our existing stockholders will represent a smaller percentage of our total outstanding shares of our Common Stock after any such issuance.

The following table sets forth the amount of gross proceeds we would receive from Ascent from our sale of Purchase Shares (which are being registered for resale by Ascent under the registration statement that includes this prospectus) to Ascent as Purchase Shares under the Purchase Agreement at varying purchase prices:

Assumed Average Purchase Price Per Share	Number of Registered Purchase Shares to be Issued if Full Purchase(1)		Percentage of Outstanding Shares After Giving Effect to the Issuance to Ascent(2)			Gross Proceeds from the Sale of Purchase Shares to Ascent Under the Purchase Agreement
$0.14		42,211,548		50.3	%	$	5,909,617
$0. 34(3)		42,211,548		50.3	%	$	14,351,926
$0.50		42,211,548		50.3	%	$	21,105,774
$0.75		42,211,548		50.3	%	$	31,658,661
$1.00		42,211,548		50.3	%	$	42,211,548

(1) As the following table sets forth the amount of gross proceeds we would receive from Ascent from our sale of Purchase Shares being registered for resale by Ascent under this registration statement, it excludes both the 900,000 Commitment Warrant Shares issued upon exercise of the Commitment Warrants that we issued to Ascent upon our execution of the term sheet relating to the Purchase Agreement on July 20, 2025, as consideration for its commitment to purchase shares of Common Stock and the 8,070,830 shares previously registered under the agreement for resale. Although the Purchase Agreement provides that we may sell up to $100,000,000 of our Common Stock to Ascent, we are only registering and additional 42,211,548 shares under the registration statement that includes this prospectus, , which may or may not cover all of the shares of Common Stock we ultimately sell to Ascent under the Purchase Agreement.

(2) The denominator is based on 41,759,307 shares of Common Stock outstanding as of October 8, 2025, adjusted to include the issuance of the number of Purchase Shares set forth in the adjacent column that we would have sold to Ascent, assuming the average purchase price in the first column. The numerator is based on the number of Purchase Shares issuable under the Purchase Agreement (which are included in this prospectus) at the corresponding assumed average purchase price set forth in the first column.

(3) The closing sale price of our Common Stock on Nasdaq on October 7, 2025.

USE OF PROCEEDS

We will not receive any proceeds from the sale of Common Stock by any of the Selling Stockholders.

In addition, we may receive up to $100,000,000 aggregate gross proceeds under the Purchase Agreement from any sales we make to Ascent pursuant to the Purchase Agreement. The net proceeds from sales, if any, under the Purchase Agreement, will depend on the frequency and prices at which we sell our Common Stock to Ascent after the date of this prospectus. See the section titled “The Committed Equity Facility” in this prospectus for more information.

We expect to use any proceeds that we receive under the Purchase Agreement for the purchase of Bitcoin (which can be used for debt repayment) provided that the Company’s cash balance on the date of the applicable sale exceeds $5,000,000. If the cash balance is less than $5,000,000, proceeds to the Company shall be allocated first to bring the balance to $5,000,000 and the remaining proceeds to purchase Bitcoin. As of the date of this prospectus, we cannot specify with certainty all of the particular uses, and the respective amounts we may allocate to those uses, for any net proceeds we receive. Accordingly, we will retain broad discretion over the use of these proceeds.

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

Introduction

The following unaudited pro forma condensed combined financial information presents the combination of financial information of Northview Acquisition, Corporation (“NorthView”) and Profusa, Inc. (“Profusa”), adjusted to give effect to the Business Combination and related transactions. The following unaudited pro forma condensed combined financial information has been prepared in accordance with Article 11 of Regulation S-X.

Unless the context otherwise requires, following the Closing (as defined below), references to “we,” “us,” “our,” “New Profusa,” and the “Company” refer to Profusa, Inc., a Delaware corporation formerly known as NorthView Acquisition Corporation, and its consolidated subsidiaries.

The following unaudited pro forma condensed combined balance sheet as of June 30, 2025, assumes that the Business Combination occurred on June 30, 2025. The unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2025, and for the year ended December 31, 2024, present pro forma effect to the Business Combination as if it had been completed on January 1, 2024.

The Business Combination is accounted for as a reverse recapitalization under U.S. GAAP. Under this method of accounting, NorthView will be treated as the “acquired” company for financial reporting purposes. This determination is primarily based on Profusa Stockholders comprising a relative majority of the voting power of Profusa (the combined entity) and having the ability to nominate majority of the members of the New Profusa Board, Profusa’s operations prior to the acquisition comprising the only ongoing operations of New Profusa, and Profusa’s senior management comprising the senior management of New Profusa. Accordingly, for accounting purposes, the financial statements of New Profusa will represent a continuation of the financial statements of Profusa with the Business Combination treated as the equivalent of Profusa issuing stock for the net assets of NorthView, accompanied by a recapitalization. The net assets of NorthView will be stated at historical cost, with no goodwill or other intangible assets recorded. Operations prior to the Business Combination will be presented as those of Profusa in future reports of New Profusa.

The unaudited pro forma condensed combined financial statements have been presented for illustrative purposes only and do not necessarily reflect what the Combined Company’s financial condition or results of operations would have been had the acquisition occurred on the dates indicated. Further, the pro forma condensed combined financial information also may not be useful in predicting the future financial condition and results of operations of the Combined Company. The actual financial position and results of operations may differ significantly from the pro forma amounts reflected herein due to a variety of factors. The unaudited pro forma condensed combined financial statements give effect to the warrants issued in association with the Committed Equity Facility. Management has started drawing down on the ELOC and believes it is probable at this point that all shares registered of 8,970,830 shares will be issued. As such, the Purchase Shares and have been reflected in the unaudited pro forma condensed combined financial statements.

The historical financial information of NorthView was derived from the unaudited financial statements of Northview as of and for the six months ended June 30, 2025, and the audited financial statements of NorthView as of and for the year ended December 31, 2024, which are included in the Proxy Statement/Prospectus. The historical financial information of Profusa was derived from the unaudited financial statements of Profusa as of and for the six months ended June 30, 2025, and audited financial statements of Profusa as of and for the year ended December 31, 2024, which are included in the Proxy Statement/Prospectus. This information should be read together with NorthView’s and Profusa’s audited financial statements, and related notes, the sections titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations of NorthView” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations of Profusa” and other financial information included in the Proxy Statement/Prospectus.

Description of the Business Combination

● On November 7, 2022, NorthView entered into a Merger Agreement with Profusa and Merger Sub, pursuant to which, Merger Sub merged with and into Profusa with Profusa as the surviving corporation and becoming a wholly-owned subsidiary of NorthView. In connection with the Merger, NorthView changed its name to “Profusa, Inc.”

~~More~~Termination ~~specifically,~~of ~~and as described in greater detail below, at~~ the ~~Effective~~ELOC ~~Time~~Purchase ~~of the Merger:~~Agreement

a.The ~~each~~ELOC ~~share~~Purchase ofAgreement ~~issued~~will ~~and~~automatically ~~outstanding~~terminate ~~Profusa~~on ~~Common~~the ~~Stock~~earliest to ~~was~~occur ~~converted~~of ~~into~~(i) aJuly ~~number~~27, of2028, ~~shares~~(ii) ofthe ~~New~~date ~~Profusa~~on ~~common~~which ~~stock,~~Ascent ~~par~~shall ~~value~~have ~~$0.0001~~purchased ~~per~~from ~~share~~us ~~(“New~~under ~~Profusa~~the ~~Common~~ELOC ~~Stock”),~~Purchase ~~based~~Agreement onshares ~~the~~of Common ~~Exchange~~Stock ~~Ratio~~for ~~that reflects~~ an ~~equity~~aggregate ~~valuation~~gross ofpurchase ~~Profusa~~price of $~~155~~100,000,000 ~~(as adjusted for the Incentive Equity Value~~, ~~the Private Placement Value~~ and ~~the Aggregate Company Incentive Amount~~(iii), ~~divided~~the bydate aneither ~~assumed~~party ~~value~~effectively ofdelivers ~~New~~notice ~~Profusa~~to ~~Common~~the other ~~Stock~~party of ~~$10.00~~such ~~per share~~termination.

b.No Short-Selling ~~each~~or ~~option~~Hedging toby ~~purchase Profusa Common Stock was converted into an option to purchase New Profusa Common Stock based on the Exchange Ratio, and~~Ascent

c.Ascent ~~each~~has ~~warrant~~represented to ~~purchase~~us ~~Profusa~~that at no time prior to the date of the ELOC Purchase Agreement has Ascent, any of its officers, or any entity managed or controlled by Ascent, engaged in or effected, in any manner whatsoever, directly or indirectly, for Ascent’s own principal account or for the principal account of any such entity managed or controlled by Ascent, any short sale (as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of our Common Stock or ~~was~~any ~~converted~~hedging ~~into~~transaction, which establishes a ~~warrant~~net toshort ~~purchase~~position ~~New~~with ~~Profusa~~respect to our Common Stock ~~based~~that onremained in effect as of the date ~~Warrant~~of ~~Ratio~~the ~~(as~~ELOC ~~defined~~Purchase inAgreement. Ascent has agreed that, during the ~~Merger~~term of the ELOC Purchase Agreement), none of Ascent, any of its officers, or any entity managed or controlled by Ascent will engage in or effect, directly or indirectly, any of the foregoing transactions either for Ascent’s own principal account or for the principal account of any such entity managed or controlled by Ascent.

~~PIPE~~Effect ~~Transaction~~of Sales of our Common Stock under the ELOC Purchase Agreement on our Stockholders

●The OnPurchase ~~February~~Shares ~~11,~~to ~~2025~~be issued or sold by us, ~~NorthView~~to ~~executed~~Ascent aunder ~~Securities~~the ELOC Purchase Agreement (that are being registered under the ~~“PIPE~~Securities ~~Subscription~~Act ~~Agreement”)~~for ~~with~~resale by Ascent ~~Partners~~in ~~Fund~~this ~~LLC~~offering ~~(“Ascent”~~are expected to be freely tradable. The 25,000,000 Purchase Shares being registered for resale in this offering may be issued and ~~together~~sold ~~with~~by ~~any~~us ~~additional~~to ~~investors~~Ascent ~~who~~from ~~become~~time to ~~parties~~time at our discretion over a period of up to 36 months (unless the ~~PIPE~~ELOC ~~Subscription~~Purchase Agreement, ~~the~~is ~~“PIPE~~earlier ~~Investors”~~terminated)., ~~Pursuant~~beginning toon the Effective ~~PIPE~~Date. ~~Subscription~~The ~~Agreement~~resale by Ascent of a significant amount of Purchase Shares registered for resale in this offering at any given time, or the ~~PIPE~~perception ~~Investors~~that ~~are~~these ~~expected~~sales may occur, ~~subject~~could tocause the ~~conditions~~market ~~relating~~price of our Common Stock to ~~such~~decline ~~purchase~~and ~~set~~to ~~forth~~be inhighly ~~the~~volatile. ~~PIPE~~Sales of ~~Subscription~~our ~~Agreement~~Common Stock, if any, to ~~purchase~~Ascent ~~from~~under ~~NorthView~~the ~~senior~~ELOC ~~secured~~Purchase ~~convertible~~Agreement ~~notes~~will independ anupon ~~aggregate~~market ~~principal~~conditions ~~amount~~and ofother upfactors to ~~$22~~be determined by us. We may ultimately decide to sell to Ascent all,~~222,222~~ (some or none of the ~~“PIPE~~shares ~~Convertible~~of ~~Notes”)~~our Common Stock that may be available for aus ~~purchase~~to sell ~~price~~to ofAscent uppursuant to ~~$20,000,000,~~the ~~after~~ELOC ~~10%~~Purchase ~~OID~~Agreement.

AtIf ~~the~~and ~~Closing~~when ~~and~~we do elect to sell shares of our Common Stock to Ascent pursuant to the ~~PIPE Subscription~~ELOC Purchase Agreement, ~~New~~after ~~Profusa~~Ascent ~~issued~~has acquired such shares, Ascent may resell all, some or none of such shares at any time or from time to time in its discretion and at different prices. As a ~~PIPE~~result, ~~Convertible~~investors ~~Note~~who purchase shares from Ascent in ~~the~~this offering ~~principal~~at ~~amount~~different oftimes ~~$10~~will likely pay different prices for those shares,~~000,000~~ ~~(the~~and ~~“Initial~~so ~~Note”)~~may experience different levels of dilution, and ~~reflecting~~in asome ~~10%~~cases ~~original~~substantial ~~issue~~dilution, ~~discount~~and todifferent ~~the~~outcomes ~~face~~in ~~amount~~their ~~(“OID”)~~investment ~~thereof~~results. ~~The~~Investors ~~Initial~~may ~~Note~~experience ~~matures~~a ondecline ~~January~~in ~~11,~~the ~~2027,~~value ~~which~~of isthe ~~18-months~~shares they purchase from ~~Closing~~Ascent onin ~~July~~this ~~11,~~offering ~~2025~~as ~~(the~~a ~~“Maturity~~result ~~Date”)~~of ~~and~~future issales ~~convertible~~made atby ~~any~~us ~~time~~to Ascent at ~~the~~prices ~~holder’s option~~lower atthan the ~~lower~~prices such ofinvestors ~~$10~~paid orfor ~~95%~~their ofshares ~~the~~in ~~lowest~~this ~~daily~~offering. ~~volume-weighted~~In ~~average~~addition, ~~price~~if ~~per~~we ~~share~~sell ~~(“VWAP”)~~a substantial number of ~~New~~shares ~~Profusa~~of our Common Stock into Ascent under the ~~10 trading~~ELOC ~~days~~Purchase ~~prior~~Agreement, toor ~~the~~if ~~original~~investors ~~issue~~expect ~~date~~that ~~for~~we ~~each~~will ~~PIPE~~do ~~Convertible~~so, ~~and~~the ~~shall~~actual besales ~~adjusted,~~of ~~without~~shares ~~limitation,~~or the mere existence of our ~~based~~arrangement onwith ~~down-round~~Ascent ~~and~~may ~~most~~make it more difficult for us to sell equity or equity-~~favored~~related ~~nation~~securities ~~(MFN)~~in ~~price~~the future at a time and ~~terms~~at ~~protections~~a price ~~(the~~that ~~“Conversion~~we ~~Price”)~~might otherwise wish to effect such sales.

~~Interest~~Because ~~shall~~the ~~accrue~~per onshare purchase price that Ascent will pay for Purchase Shares in any Purchase that we may elect to effect pursuant to the ~~aggregate unconverted~~ELOC ~~and~~Purchase ~~then~~Agreement ~~outstanding~~will be ~~principal~~determined ~~amount~~by ofreference to the ~~Initial~~VWAP ~~Note~~during atthe aapplicable ~~rate~~Valuation ofPeriod ~~10%~~on ~~per~~the ~~annum~~applicable ~~and~~Closing ~~increase~~Date, ~~upon~~as anof ~~event~~the date of ~~default~~this prospectus, towe ~~24%~~cannot determine the actual purchase price per ~~annum.~~share ~~Payments~~that ~~made~~Ascent inwill ~~cash~~be required to pay for any Purchase Shares that we may elect to sell to Ascent under the ~~Initial~~ELOC ~~Note~~Purchase ~~shall~~Agreement befrom ~~subject~~and toafter aCommencement 5%and, ~~fee~~therefore, ~~which~~we ~~shall~~cannot be certain how many Purchase Shares, in ~~addition~~the aggregate, we may issue and sell to ~~any~~Ascent ~~amounts owed~~under ~~thereunder.~~the ~~The~~ELOC ~~Initial~~Purchase ~~Note~~Agreement ~~provides~~from ~~for~~and ~~certain~~after ~~events~~Commencement. As of ~~default~~February 3, ~~that~~2026, ~~are~~there ~~typical~~were ~~for~~92,414,296 ashares ~~transaction~~ of ~~this~~our ~~type~~Common Stock outstanding, ~~including~~of which 86,537,911 shares ~~among~~were held by non-affiliates of ~~other~~our ~~things,~~Company. ~~any~~If ~~breach~~all of the ~~representations~~25,000,000 orPurchase ~~warranties~~Shares ~~made~~offered byfor ~~New~~resale ~~Profusa~~by orAscent ~~its~~under ~~subsidiaries.~~this ~~The~~prospectus ~~Initial~~were ~~Note~~issued ~~also~~and ~~provides~~outstanding as ~~for~~of athe ~~10%~~date ~~late~~hereof, ~~fee~~such inshares ~~case~~would ofrepresent ~~late~~approximately ~~payments~~21.3% ~~and~~of ~~mandatory~~the ~~prepayments~~total ~~upon~~number ~~Subsequent~~of ~~Offerings~~outstanding ~~(as~~shares ~~defined~~of inCommon ~~the~~Stock ~~Initial Note)~~ and, approximately in22.4% of the ~~absence~~total number of anoutstanding ~~event~~shares of ~~default,~~Common ~~may~~Stock beheld ~~prepaid~~by ~~upon 10 business~~non-affiliates ~~day’s~~of ~~prior~~our ~~notice~~Company, ~~subject~~in toeach ~~certain~~case ~~conversion~~as ~~rights~~ of ~~the~~February 3, ~~PIPE Investors~~2026.

The Initial Note may not be converted by the PIPE Investors into shares of New Profusa Common Stock if such conversion would result in the investors or their affiliates owning in excess of 4.99% of the number of shares of New Profusa Common Stock outstanding immediately after giving effect to the issuance of all shares issuable upon conversion of the Initial Note.

The outstanding principal balance of the Profusa Senior Convertible Promissory Notes and all accrued but unpaid interest converted into Profusa Common Stock and NorthView exchanged the Profusa Common Stock for 4,170,932 shares of New Profusa, on an as converted price of $0.34 per share. The Exchange Ratio and the Company Reference Share Value were $0.94 and $9.40, respectively.

The outstanding principal balance of the Profusa Senior Secured Convertible Promissory Notes and all accrued but unpaid interest converted into Profusa Common Stock and NorthView exchanged the Profusa Common Stock for 5,542,261 shares of New Profusa, an as converted price of $0.50 per share.

●Although ~~On August 25, 2025,~~ the ~~Company~~ELOC ~~entered~~Purchase Agreement ~~into~~provides ~~Amendment~~that ~~No.~~we 1may ~~(the~~sell ~~“SPA~~up ~~Amendment”)~~ to ~~the~~$100,000,000 ~~PIPE~~of ~~Subscription~~our ~~Agreement.~~Common ~~Pursuant~~Stock to ~~the SPA Amendment~~Ascent, ~~Section~~only ~~2.1~~an ofadditional ~~the~~25,000,000 ~~PIPE~~Purchase ~~Subscription~~Shares ~~Agreement~~are being ~~was~~registered ~~amended~~under ~~and~~the ~~restated~~Securities toAct ~~provide~~ for ~~four~~resale ~~tranches~~by ofAscent ~~Notes:~~under ~~(i)~~the anregistration ~~initial~~statement ~~closing~~which ~~for~~includes ~~Notes~~this inprospectus. anThis ~~aggregate~~amount is ~~principal~~in ~~amount~~addition ofto ~~$10~~the 8,~~000~~970,~~000~~830 ~~(the~~shares ~~“First~~and ~~Tranche”)~~42,211,548 ~~which~~shares ~~already~~previously ~~occurred~~registered for resale in ~~July~~our ~~11,~~prior ~~2025;~~registration ~~(ii)~~statements, aincluding 900,000 ~~second~~Commitment ~~closing~~Warrant Shares (for ~~Notes~~which inwe anhave ~~aggregate~~not ~~principal~~and ~~amount~~will ofnot ~~$2,222,222~~receive ~~(the~~any ~~“Second~~cash ~~Tranche”~~consideration). ~~for~~If awe ~~purchase~~were ~~price~~to issue and sell all of $2such 25,000,000, ~~subject~~Purchase Shares to ~~the~~Ascent ~~satisfaction~~at ofan ~~certain~~assumed ~~conditions~~purchase ~~including~~price ~~the~~per ~~filing~~share of a$0.09, ~~registration~~representing ~~statement~~the onclosing ~~Form~~sale ~~S-1~~price ~~covering~~of ~~all~~our Common ~~conversion~~Stock ~~shares~~on ~~and~~Nasdaq noon ~~Nasdaq~~February ~~listing~~2, ~~deficiency;~~2026, ~~(iii)~~we awould ~~third~~only ~~closing~~receive ~~for~~approximately ~~Notes~~$2.25 million in an aggregate ~~principal~~gross ~~amount~~proceeds offrom ~~$5,555,556 (~~the sale ~~“Third~~of ~~Tranche”)~~such ~~for~~Purchase aShares ~~purchase~~to ~~price~~Ascent ofunder ~~$5,000,000, subject to~~ the ~~satisfaction~~ELOC ofPurchase ~~certain~~Agreement. ~~conditions~~Depending ~~including~~on the ~~full~~market ~~conversion~~prices ~~or repayment~~ of ~~the~~our ~~First~~Common ~~Tranche,~~Stock ~~effectiveness~~on ofthe aPurchase Dates ~~registration~~on ~~statement,~~which nowe ~~Nasdaq~~elect ~~listing~~to ~~deficiency,~~sell ~~and~~such ~~receipt~~Purchase ofShares ~~stockholder~~to ~~approval;~~Ascent ~~and~~under ~~(iv)~~the aELOC ~~fourth~~Purchase ~~closing~~Agreement, ~~for~~we ~~Notes~~may in anthe ~~aggregate~~future ~~principal~~need ~~amount~~to ofregister under ~~$4,444,444 (~~the ~~“Fourth~~Securities ~~Tranche”)~~Act ~~for~~additional ashares ~~purchase price~~ of ~~$4,000,000,~~our ~~subject~~Common toStock ~~the~~for ~~satisfaction~~resale ofby ~~certain~~Ascent ~~conditions~~which, ~~including~~together with the ~~full~~25,000,000 ~~repayment~~Purchase ofShares included ~~the~~in ~~First~~this ~~and Second Tranches~~prospectus, atwill ~~least~~enable ~~fifty~~us ~~percent~~to ~~(50%)~~issue ~~repayment~~and orsell ~~conversion~~to ofAscent ~~the~~such ~~Third~~aggregate ~~Tranche,~~number ~~effectiveness~~ of ashares ~~registration~~of ~~statement,~~Common ~~and~~Stock nounder ~~Nasdaq~~the ~~listing~~ELOC Purchase ~~deficiency.~~Agreement ~~The~~as ~~Amendment~~will ~~supersedes~~be ~~and~~necessary ~~replaces~~in ~~all~~order ~~prior~~for ~~provisions~~us ~~relating~~ to ~~“Additional~~receive ~~Closings”~~aggregate ~~and~~proceeds ~~“Additional~~equal ~~Notes,” and all references~~ to ~~such~~Ascent’s ~~terms~~$100,000,000 inmaximum ~~the~~aggregate purchase ~~PIPE~~commitment ~~Subscription~~available ~~Agreement and related documents are~~ to beus ~~construed~~under ~~in accordance with~~ the ~~new~~ELOC ~~tranche~~Purchase ~~structure~~Agreement.

●The ~~Concurrently,~~number onof ~~August~~Purchase ~~25,~~Shares ~~2025,~~ultimately ~~the~~offered ~~Company~~for ~~entered~~resale ~~into~~by ~~Amendment~~Ascent through ~~No.~~this 1prospectus ~~(the~~is ~~“Note~~dependent ~~Amendment”)~~upon to the ~~Initial~~number ~~Note.~~of ~~The~~shares ~~Note Amendment modifies the terms~~ of ~~the~~Common ~~Initial Note~~Stock, ~~specifically~~if ~~amending~~any, ~~Section~~we ~~4(b)~~elect to ~~revise~~issue ~~the~~and/or ~~conversion~~sell ~~price provisions on any conversion date~~ to beAscent under the ~~lower~~ELOC ofPurchase ~~(i)~~Agreement ~~the~~from ~~Conversion~~and ~~Price~~after onthe ~~such~~Effective ~~date~~Date. ~~and~~The ~~(ii)~~issuance ~~ninety-five~~of ~~percent~~our ~~(95%)~~Common ofStock ~~the~~to ~~lowest~~Ascent ~~daily~~pursuant ~~volume~~to ~~weighted~~the ~~average~~ELOC ~~price~~Purchase Agreement ~~(“VWAP”)~~will ~~for~~not affect the ~~Company’s~~rights ~~common~~or ~~stock~~privileges ~~during~~of ~~the~~our ~~ten~~existing ~~consecutive~~stockholders, ~~trading~~except ~~days~~that ~~immediately preceding~~ the ~~applicable~~economic ~~conversion~~and ~~date~~voting ~~(the~~interests ~~“Alternate~~of ~~Conversion~~each of ~~Price”),~~our ~~provided~~existing ~~that~~stockholders inwill nobe ~~event~~diluted. ~~shall~~Although the ~~conversion~~number ~~price~~of beshares ~~less~~of ~~than~~our ~~the~~Common ~~Floor~~Stock ~~Price~~that ofour ~~twenty~~existing ~~percent~~stockholders ~~(20%)~~own ofwill not decrease, the ~~closing~~shares ~~sale price~~ of ~~the~~our ~~common~~Common ~~stock~~Stock onowned ~~the~~by ~~principal~~our ~~trading~~existing ~~market~~stockholders onwill ~~the~~represent ~~trading~~a ~~day~~smaller ~~immediately~~percentage ~~preceding~~of ~~the~~our ~~Note~~total ~~Amendment’s~~outstanding shares ~~effective~~of ~~date,~~our ~~which~~Common ~~was~~Stock ~~August~~after ~~22,~~any ~~2025~~such issuance.

●The ~~NorthView’s~~following ~~Convertible~~table ~~Working~~sets ~~Capital~~forth ~~loan will be being converted subsequent to~~ the ~~close~~amount of ~~the~~gross ~~Business~~proceeds ~~Combination~~we inwould receive afrom ~~future~~Ascent ~~registration~~from ~~statement.~~our ~~The~~sale ~~principal outstanding~~ of ~~the~~Purchase ~~note~~Shares ~~was~~(which ~~$1,919,796~~are asbeing ofregistered ~~June~~for ~~30,~~resale ~~2025~~by ~~which~~Ascent ~~has~~under ~~been fair value adjusted on~~ the ~~balance~~registration ~~sheet~~statement that atincludes ~~June~~this ~~30,~~prospectus) ~~2025~~ to ~~$10,288,111~~Ascent ~~which~~as isPurchase ~~included~~Shares inunder the ~~pro~~ELOC ~~forma~~Purchase atAgreement ~~the current balance as no interest accrues on this note and will be converted into 863,908 shares of New Profusa,~~ at anvarying aspurchase ~~converted price of $2.22 per share.~~prices:

● Upon consummation of the Merger the former holders of Profusa’s common stock, senior convertible notes, junior convertible notes and vested in-the-money Profusa Options (the “Participating Securityholders”) received certain rights, under which in the future New Profusa may issue to the Participating Securityholders an aggregate of 3,875,000 shares of New Profusa’s common stock (the “Milestone Earnout Shares”) during the respective earnout periods in equal ¼ installments upon achievement of the following four Milestone Events:

Assumed Average Purchase Price Per Share	Number of Registered Purchase Shares to be Issued if Full Purchase⁽¹⁾		Percentage of Outstanding Shares After Giving Effect to the Issuance to Ascent⁽²⁾			Gross Proceeds from the Sale of Purchase Shares to Ascent Under the Purchase Agreement
$0.111⁽³⁾		25,000,000		82.4	%	$	3,186,987
$0.20		25,000,000		82.4	%	$	5,000,000
$0.09⁽⁴⁾		25,000,000		82.4	%	$	2,250,000
$0.40		25,000,000		82.4	%	$	10,000,000
$0.50		25,000,000		82.4	%	$	12,500,000

●(1) ~~Milestone~~As Ithe ~~Earnout~~following ~~Rights:~~table ~~share~~sets ~~price~~forth the amount of ~~New~~gross ~~Profusa~~proceeds ~~Common~~we ~~Stock~~would isreceive ~~equal~~from toAscent orfrom ~~greater~~our ~~than~~sale ~~$12.50~~of Purchase Shares being registered for ~~any~~resale 20by ~~trading~~Ascent ~~days~~under ~~during~~this ~~any~~registration 30statement, ~~days~~it ~~trading~~excludes ~~period~~both orthe ~~consummation~~900,000 ofCommitment aWarrant ~~Subsequent~~Shares ~~Transaction~~issued ~~where~~upon exercise of the ~~stockholders~~Commitment ofWarrants ~~New~~that ~~Profusa~~we ~~will~~issued ~~receive~~to aAscent ~~consideration~~upon our execution of atthe ~~least~~term ~~$12.50~~sheet relating to the ELOC Purchase Agreement on July 20, 2025, as consideration for ~~each~~its ~~share~~commitment ofto ~~New~~purchase ~~Profusa~~shares of Common Stock, ~~(“Milestone~~as ~~Event~~well ~~I”).~~as ~~The~~the ~~Milestone~~resale Iof ~~period~~the ~~will~~8,070,830 ~~commence~~shares and 42,211,548 shares we previously registered for resale under our registration statements filed on ~~the~~August ~~18-month~~22, ~~anniversary~~2025 and ~~end~~October on8, 2025, respectively. Although the ~~two-year~~ELOC ~~anniversary~~Purchase Agreement provides that we may sell up to $100,000,000 of our Common Stock to Ascent, we are only registering an additional 25,000,000 shares under the ~~closing~~registration ~~date~~statement that includes this prospectus, which may or may not cover all of the ~~Merger~~shares ~~(“Milestone~~of ~~Event~~Common IStock ~~Period”);~~we ultimately sell to Ascent under the ELOC Purchase Agreement.

●(2) ~~Milestone~~The IIdenominator ~~Earnout~~is ~~Rights:~~based ~~share~~on ~~price~~92,414,296 shares of ~~New Profusa~~ Common Stock isoutstanding ~~equal~~as toof orFebruary ~~greater~~3, ~~than~~2026, ~~$14.50~~adjusted ~~for~~to ~~any~~include 20the ~~trading~~issuance ~~days~~of ~~during~~the ~~any~~number ~~30 days trading period or consummation~~ of aPurchase ~~Subsequent~~Shares ~~Transaction~~set ~~where~~forth in the ~~stockholders~~adjacent ofcolumn ~~New~~that ~~Profusa~~we ~~will~~would ~~receive~~have asold ~~consideration~~to ofAscent, atassuming ~~least~~the ~~$14.50~~average ~~for~~purchase ~~each~~price ~~share~~in ofthe ~~New~~first ~~Profusa Common Stock (“Milestone Event II”)~~column. The ~~Milestone~~numerator IIis ~~period~~based ~~will commence~~ on the ~~360-day~~number ~~anniversary~~of ~~and~~Purchase ~~end~~Shares onissuable ~~the~~under ~~two-year anniversary of~~ the ~~closing~~ELOC ~~date~~Purchase ofAgreement ~~the~~(which ~~Merger~~are ~~(“Milestone~~included ~~Event~~in IIthis ~~Period”~~prospectus); ~~provided~~at ~~that such 30 days trading period does not overlap with~~ the 30corresponding ~~days~~assumed ~~trading~~average ~~period~~purchase ~~used~~price toset ~~satisfy~~forth ~~the requirements of Milestone Event I; provided, further, that~~ in the ~~event that such 30 days trading period could satisfy either Milestone Event I or Milestone Event II, then Milestone Event II shall be deemed to be satisfied~~ first; column.

●(3) ~~Milestone~~The ~~III~~$0.111 ~~Earnout:~~price ~~the~~referenced ~~closing~~herein ofis presented solely for illustrative purposes. Under the ~~APAC~~ELOC ~~Joint~~Purchase ~~Venture~~Agreement, asthe ~~described~~Company inmay ~~this~~not ~~proxy~~sell ~~statement/prospectus,~~shares ~~and~~at prices below the ~~Companies~~applicable ~~receipt~~Floor ofPrice, ~~the~~which ~~related~~is $60.111 ~~million~~per ~~funding,~~share ~~during~~for ~~the~~a ~~fiscal~~limited ~~year~~number ~~ended~~of ~~December~~shares 31of 13,650,000, ~~2025~~of ~~(“Milestone~~which ~~Event~~10,793,546 ~~III”);~~shares are remaining, and $0.14 per share thereafter.

●(4) ~~Milestone~~The IVclosing ~~Earnout:~~sale ~~achievement~~price of ~~revenue~~our ofCommon ~~$11,864,000~~Stock ~~for~~on ~~the~~Nasdaq ~~fiscal~~on ~~year~~February ~~ended December 31~~2, 2026 ~~(“Milestone Event IV,” and, together with Milestone Event I, Milestone Event II and Milestone Event III the “Milestone Events”)~~. ~~Milestone I Earnout Rights, Milestone II Earnout Rights, Milestone III Earnout Rights and Milestone IV Earnout Rights are further referred to collectively as “Milestone Earnout Rights”.~~

~~PIPE~~USE OF ~~Lock-Up Agreement~~PROCEEDS

~~On July 11, 2025, the~~We ~~PIPE~~will ~~Investors entered into a lock-up agreement (the “PIPE Lock-Up Agreement”), pursuant to which they agreed to, subject to certain customary exceptions,~~ not ~~offer,~~receive ~~sell, contract to sell, hypothecate, pledge or otherwise dispose of~~ any ~~shares~~proceeds offrom ~~New~~the ~~Profusa Common~~sale ~~Stock or securities convertible, exchangeable or exercisable into, shares~~ of ~~New Profusa~~ Common Stock ~~beneficially owned, held or acquired~~ by ~~them.~~any ~~The period for such restrictions shall apply from the Closing date until the termination~~ of the ~~PIPE~~Selling ~~Lock-Up Agreement in accordance with its terms~~Stockholders.

We may receive up to $100,000,000 aggregate gross proceeds under the ELOC Purchase Agreement from any sales we make to Ascent pursuant to the ELOC Purchase Agreement. The ~~foregoing~~net ~~description~~proceeds offrom sales, if any, under the ~~PIPE~~ELOC ~~Lock-Up~~Purchase Agreement, iswill ~~not~~depend ~~complete~~on the frequency and isprices ~~qualified~~at inwhich ~~its~~we ~~entirety~~sell byour ~~reference~~Common Stock to ~~the~~Ascent ~~text~~after the date of ~~such~~this ~~document,~~prospectus. aSee ~~form~~the ofsection ~~which is~~titled ~~filed~~“The asCommitted ~~Exhibit~~Equity ~~10.8~~Facility” ~~hereto~~in ~~and~~this ~~incorporated~~prospectus ~~herein~~for bymore ~~reference~~information.

~~PIPE~~We ~~Registration~~expect ~~Rights~~to use any proceeds that we receive under the ELOC Purchase Agreement for the purchase of Bitcoin (which can be used for debt repayment) provided that the Company’s cash balance on the date of the applicable sale exceeds $5,000,000. If the cash balance is less than $5,000,000, proceeds to the Company shall be allocated first to bring the balance to $5,000,000 and the remaining proceeds to purchase Bitcoin. As of the date of this prospectus, we cannot specify with certainty all of the particular uses, and the respective amounts we may allocate to those uses, for any net proceeds we receive. Accordingly, we will retain broad discretion over the use of these proceeds.

OnAdditionally, ~~July 11~~we will receive proceeds from any cash exercise of the Warrants, ~~2025~~which, ~~New~~if exercised in cash with respect to all of the 17,404,250 Warrants would result ~~Profusa~~in ~~and~~aggregate gross proceeds to us of $200,148,875; however, there is no assurance that the ~~PIPE~~holders ~~Investors~~of ~~entered~~the ~~into~~Warrants awill ~~registration~~elect ~~rights~~to ~~agreement~~exercise any (or all of the ~~“PIPE~~Warrants. ~~Registration~~To ~~Rights~~the ~~Agreement~~extent that Warrants are exercised on a “cashless basis,”) the amount of cash we would receive from the exercise of the Warrants will decrease, potentially to zero. On February 2, 2026, the last reported sales price of our Common Stock was $0.09 and the exercise price per share of the Warrants was $11.50. The exercise price of the Warrants is significantly higher ~~PIPE~~than ~~Registration~~the ~~Rights~~current ~~Agreement~~market ~~provides~~price ~~customary~~of ~~demand~~our Common Stock and ~~piggyback~~accordingly, ~~registration~~it ~~rights~~is highly unlikely that Warrant holders will exercise their Warrants in the foreseeable future. Cash proceeds associated with the exercises of the Warrants are dependent on our stock price and given the recent price volatility of our Common Stock and relative lack of liquidity in our stock, there is no certainty that Warrant holders will exercise their Warrants and, accordingly, we may not receive any cash proceeds in relation to our outstanding Warrants. See “Description of Securities” for additional information regarding the Warrants.

Pursuant to the PIPE Registration Rights Agreement, New Profusa will, as soon as practicable, but in any event within 20 calendar days after the Closing Date, use its reasonable best efforts to file with the SEC a registration statement registering the resale of certain New Profusa Common Stock issuable to the PIPE Investors upon conversion of the PIPE Convertible Notes. New Profusa will use its reasonable efforts to have the registration statement declared effective as soon as practicable after the filing thereof, but no later than the 45h calendar day (but in any event no later than the 60th calendar day) following the Closing.

After giving effect to the Business Combination transaction and the issuance of the Merger Consideration described above, there are 111,250,017 shares of our Common Stock issued and outstanding.

The following summarizes the pro forma Common Stock:

	Pro Forma Combined
Shareholder	Shares		%
NorthView public shareholders(3)		1,999,277		1.9
NorthView other shareholders(1)		4,483,530		4.0
Former Profusa shareholders(2)		15,500,000		13.9
Shares issued to other parties(4)		382,500		0.3
Senior secured convertible note(6)		5,542,261		5.0
Profusa bridge notes(7)		4,170,932		3.7
Northview working capital loan(8)		863,908		0.8
PIPE Subscription(5)		27,125,231		24.4
Ascent ELOC Commitment shares(9)		51,182,378		46.0
Total Common Stock shares on closing date of the Business Combination		111,250,017		100.0

(1) Includes Sponsor and Representative shares in NorthView and has been reduced by the 710,220 sponsor shares allocated to the senior secured convertible note holders.

(2) Includes 8,593,991 shares issued to existing Profusa common and preferred shareholders, 6,699,365 shares issued to the holders of Profusa’s junior convertible notes and senior convertible notes, and 206,644 shares reserved for Profusa option holders.

(3) Includes 1,897,500 shares issuable pursuant to outstanding NorthView Rights.

(4) Represents $1,325,000 of transaction costs paid in shares of New Profusa Common Stock at $10 per share to H.C. Wainwright & Co. and $500,000 of transaction costs paid in shares of New Profusa Common Stock at $2 per share to The Benchmark Company LLC.

(5) Represents 22,193,371 shares issuable upon conversion of the $10 million first tranche of the PIPE Investor convertible note facility ($22.22M total) and 4,931,860 shares issuable upon conversion of the $2.22 million second tranche of the PIPE Investor convertible note facility. Both tranches are estimated to convert at a price of $0.4506 per share which is calculated based on 95% of the VWAP rate on August 26, 2025 of $0.4743 per share.

(6) Senior secured convertible note which includes 710,220 Sponsor shares that were utilized as inducement shares for the notes.

(7) Represents 1,277,502 shares issued upon the conversion and exchange of Profusa bridge notes and 2,893,430 shares issued in exchange for the shares issued pursuant to the Bridge Note Buyout Agreement.

(8) Represents shares from the conversion of the NorthView working capital convertible loan at a $2.22 per share.

(9) The Ascent ELOC Commitment shares represent 900,000 warrants issued for common stock with an exercise price of $0.01 which are issued and expected to be exercised, and the total shares registered under the ELOC agreement through the filing of our last Form S-1 of 8,970,830 shares with an additional 42,211,548 shares which are probable to be issued

The following unaudited pro forma condensed combined balance sheet as of June 30, 2025 and the unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2025 and for the year ended December 31, 2024 are based on the unaudited and audited historical financial statements of NorthView and Profusa. The unaudited pro forma adjustments are based on information currently available, and assumptions and estimates underlying the unaudited pro forma adjustments are described in the accompanying notes. Actual results may differ materially from the assumptions used to present the accompanying unaudited pro forma condensed combined financial information.

~~UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET~~CAPITALIZATION

AsThe following table sets forth our cash and cash equivalents, and our capitalization as of ~~June~~September 30, 2025:

~~(in~~● ~~thousands,~~on ~~except~~an ~~share~~actual ~~and per share data)~~basis;

	Profusa, Inc. (Historical)		NorthView (Historical)		Transaction Accounting Adjustments				Pro Forma Combined
ASSETS
Current assets:
Cash and cash equivalents	$	44	$	—	$	1,277		B	$	14,365
						11,000		C
						(4,146	)	F
						(328	)	G
						(1,745	)	H
						(1,648	)	I
						(253	)	N
						10,164		T
Restricted cash				2		(2	)	B		—
Cash held in Trust Account				661		(661	)	P		—
Prepaid taxes				25		—				25
Prepaid expenses and other current assets		209		—		—				209
Total current assets		253		688		13,658				14,599
Cash held in Trust Account		—		1,275		(1,275	)	B		—
Deferred offering costs		4,136		—		(2,837	)	G		—
						(1,299	)	J		—
Other non-current assets		55		—		—				55
Total Assets	$	4,444	$	1,963	$	8,247			$	14,654
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable	$	6,884	$	1,745	$	—			$	8,629
Excise tax payable		—		1,953		—				1,953
Accrued expenses and other current liabilities		4,299		1,534		(1,299	)	J		2,461
						5,971		E
						(1,745	)	H
						(5,971	)	F
						(328	)	G
Convertible debt payable, net of discount		49,971		10,288		(27,594	)	N		13,844
						11,000		C
						(19,533	)	O
						(10,288	)	R
Due to redeeming stockholders		—		661		(661	)	P
Promissory notes		940		—		—				940
PPP loan		1,383		—		—				1,383
Total current liabilities		63,477		16,181		(50,448	)			29,210
Warrant liability		—		6,962		—				6,962
Total liabilities		63,477		23,143		(50,448	)			36,172

●

on a pro forma basis, after giving effect to (i) the issuance of 30,478,624 shares of Common Stock in connection with the ELOC; (ii) the repayment of $0.7 million of the outstanding principal balance of the Ascent PIPE Convertible Note and of incurred expenses of $0.1 million; (iii) the issuance of 19,954,176 shares of Common Stock pursuant to conversions of outstanding convertible notes; (iv) the issuance of 250,000 shares of Common Stock upon the exercise of outstanding warrants; and (v) the Company’s purchase of $1 million of Bitcoin; and

●

on a pro forma as adjusted basis, giving effect to the sale of shares of our Common Stock by us in this offering at an assumed public offering price of $0.09 per share (the last reported sale price of our Common Stock on the Nasdaq on February 2, 2026), after deducting discounts and commissions and estimated offering expenses payable by us.

The as adjusted information below is illustrative only, and our capitalization following the completion of this offering will be adjusted based on the actual public offering price and other terms of this offering determined at pricing. You should read this table together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the related notes appearing elsewhere in this prospectus.

	As of September 30, 2025 (unaudited)
	Actual			Pro Forma			Pro Forma As Adjusted
	(in thousands, except share and per share data)
Cash and cash equivalents	$	3,009		$	9,740			[●]
Digital assets		972			1,972			[●]
Loans payable - related party at fair value		14,359			10,394			[●]
Total stockholders’ equity:

Preferred stock, $0.0001 par value per share; 0 shares authorized, 0 shares issued or outstanding, actual, pro forma, and pro forma as adjusted		—			—			[●]
Common Stock, $0.0001 par value per share; 600,000,000 shares authorized; 41,731,496 shares issued and outstanding, actual; 92,414,296 shares issued and outstanding, pro forma; [●] shares issued and outstanding, pro forma as adjusted		4			9			[●]
Additional paid-in capital		118,250			128,941			[●]
Accumulated other comprehensive loss		—			—			[●]
Accumulated deficit		(152,214	)		(152,214	)		[●]

Total stockholders’ equity:		(33,960	)		(23,264	)		[●]
Total capitalization		(19,601	)		(12,870	)		[●]

A $[●] increase in the assumed public offering price of $[●] per share would increase cash and cash equivalents, working capital, total assets, and total stockholders’ equity by approximately $[●], assuming the number of shares of Common Stock and Pre-funded Warrants offered by us, as set forth on the cover of this prospectus, remains the same and after deducting the placement agent fees and estimated offering expenses payable by us, and assuming the sale of all shares of Common Stock offered hereby, and no issuance or exercise of any Pre-funded Warrants issued in connection with this offering. An increase (decrease) in the number of shares of Common Stock that we are offering of by [●] shares would increase (decrease) cash and cash equivalents, working capital, total assets, and total stockholders’ equity by approximately $[●], after deducting the placement agent fees and estimated offering expenses payable by us, and assuming the sale of all shares of Common Stock offered hereby and no issuance or exercise of any Pre-funded Warrants issued in connection with this offering and that the assumed public offering price of such shares of Common Stock remains as set forth on the cover page of this prospectus. The pro forma as adjusted information discussed above is illustrative only and will adjust based on the actual offering price and other terms of this offering determined at pricing.

Unless otherwise indicated, the number of shares of our Common Stock to be outstanding immediately after this offering is based on 41,731,496 shares of our Common Stock outstanding as of September 30, 2025, and excludes:

●

17,404,250 shares of Common Stock issuable upon the exercise of outstanding warrants;

●

117,010,536 shares of Common Stock issuable upon conversion of outstanding convertible notes; and

●

no exercise of any Pre-funded Warrants issued in connection with this offering.

UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET — (Continued)

As of June 30, 2025

(in thousands, except share and per share data)

	Profusa, Inc. (Historical)			NorthView (Historical)			Transaction Accounting Adjustments				Pro Forma Combined
Commitments and contingencies
Convertible Preferred Stock:		—			—			—				—
Series A convertible preferred stock: $0.0001 par value – 4,350,314 shares authorized at June 30, 2025 and December 31, 2024, and 4,350,314 shares issued and outstanding at June 30, 2025 and December 31, 2024, (Liquidation preference $5,307 at June 30, 2025 and December 31, 2024)		5,231			—			(5,231	)	K		—
Series B convertible preferred stock: $0.0001 par value – 5,293,175 shares authorized at June 30, 2025 and December 31, 2024, and 5,293,175 shares issued and outstanding at June 30, 2025 and December 31, 2024, (Liquidation preference $13,815 at June 30, 2025 and December 31, 2024)		13,701			—			(13,701	)	L		—
Series C/C-1 convertible preferred stock: $0.0001 par value – 8,907,893 shares authorized at June 30, 2025 and December 31, 2024, and 8,220,445 shares issued and outstanding at June 30, 2025 and December 31, 2024, (Liquidation preference $45,062 at June 30, 2025 and December 31, 2024)		46,217			—			(46,217	)	M		—
Common shares subject to possible redemption		—			1,331			(1,331	)	A		—
Stockholders’ equity (deficit):
Common Stock
Common stock, $0.0001 par value; 100,000,000 shares authorized; pro forma; 33,161,159 shares issued and outstanding		—			—			1		N		2
								1		T
Additional paid-in capital		5,840			—			1,331		A		106,493
								(22,511	)	D
								(5,971	)	E
								46,217		M
								5,231		K
								13,701		L
								1,825		F
								(2,837	)	G
								27,340		N
								1,920		R
								19,533		O
								3,728		Q
								983		S
								10,163		T
Accumulated deficit		(130,022	)		(22,511	)		22,511		D		(128,013	)
								(1,648	)	I
								(3,728	)	Q
								8,368		R
								(983	)	S
Total stockholders’ equity (deficit)		(124,182	)		(22,511	)		125,175				(21,518	)
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)	$	4,444		$	1,963		$	8,247			$	14,654

UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS

FOR THE SIX MONTHS ENDED JUNE 30, 2025

(in thousands, except share and per share data)

	Profusa, Inc. (Historical)			NorthView (Historical)			Transaction Accounting Adjustments				Pro Forma Combined
Revenue	$	—			—			—				—
Operating expenses:
Research and development		827		$	—		$	—			$	827
General and administrative		1,600			1,551			1,648		FF		8,527
								3,728		HH
Total operating expenses		2,427			1,551			5,376				9,354
Loss from operations		(2,427	)		(1,551	)		(5,376	)			(9,354	)
Other income (expenses)
Interest income earned on cash and marketable securities held in Trust Account		—			95			(95	)	AA		—
Change in fair value of convertible loan		(118	)		(1,380	)		1,380		DD		(118	)
Change in fair value of Securities Purchase Agreement		—			(194	)		194		KK		—
Interest expense		(2,519	)		—			2,482		BB		(1,056	)
								—		EE
								(1,019	)	II
Change in fair value of warrant liabilities		—			(6,265	)		—				(6,265	)
Other income (expense), net		—			—			(983	)	JJ		(983	)
Net (loss) before income taxes		(5,064	)		(9,295	)		(3,417	)			(17,776	)
Provision for income taxes		—			22			(22	)	CC		—
Net (loss)	$	(5,064	)	$	(9,317	)	$	(3,395	)		$	(17,776	)
Deemed dividend		—			—			(9,684	)	GG		(9,684	)
Net loss attributable to common stockholders		(5,064	)		(9,317	)		(13,079	)			(27,460	)
Basic and diluted net (loss) per share subject to possible redemption				$	(1.66	)
Basic and diluted weighted average shares outstanding, common stock subject to possible redemption					412,717
Basic and diluted net (loss) per share, common stock				$	(1.66	)
Basic and diluted weighted average shares outstanding, common stock					5,193,750
Basic and diluted net loss per share-Profusa	$	(0.90	)
Weighted average shares outstanding of Profusa Common Stock		5,604,651
Basic and diluted net loss per share of New Profusa common stock											$	(0.25	)
Weighted average shares outstanding of New Profusa common stock – basic and diluted												111,250,017

UNAUDITED PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS

FOR THE YEAR ENDED DECEMBER 31, 2024

(in thousands, except share and per share data)

	Profusa, Inc. (Historical)			NorthView (Historical)			Transaction Accounting Adjustments				Pro Forma Combined
Revenue	$	100			—			—				100
Operating expenses:
Research and development		1,608		$	—		$	—			$	1,608
General and administrative		2,992			1,351			1,606		FF		9,704
								3,755		HH
Total operating expenses		4,600			1,351			5,361				11,312
Loss from operations		(4,500	)		(1,351	)		(5,361	)			(11,212	)
Other income (expenses)
Interest income earned on cash and marketable securities held in Trust Account		—			425			(425	)	AA		—
Change in fair value of convertible loan		(311	)		(7,166	)		7,166		DD		(311	)
Interest expense		(4,424	)		—			4,349		BB		(2,216	)
								(104	)	EE
								(2,037	)	II
Change in fair value of warrant liabilities		—			(539	)		—				(539	)
Other income (expense), net		5			—			(983	)	JJ		(978	)
Net income (loss) before income taxes		(9,230	)		(8,631	)		2,605				(15,256	)
Provision for income taxes		—			81			(81	)	CC		—
Net income (loss)	$	(9,230	)	$	(8,712	)	$	2,686			$	(15,256	)
Deemed dividend		—			—			(9,684	)	GG		(9,684	)
Net loss attributable to common stockholders		(9,230	)		(8,712	)		(6,998	)			(24,940	)
Basic and diluted net (loss) per share subject to possible redemption				$	(1.47	)
Basic and diluted weighted average shares outstanding, common stock subject to possible redemption					747,644
Basic and diluted net (loss) per share, common stock				$	(1.47	)
Basic and diluted weighted average shares outstanding, common stock					5,193,750
Basic and diluted net loss per share-Profusa	$	(1.65	)
Weighted average shares outstanding of Profusa Common Stock		5,604,651
Basic and diluted net loss per share of New Profusa common stock											$	(0.23	)
Weighted average shares outstanding of New Profusa common stock – basic and diluted												110,534,620

NOTES TO UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

1. Basis of Presentation

The Business Combination will be accounted for as a reverse recapitalization under U.S. GAAP. Under this method of accounting, NorthView Acquisition Corporation (“NorthView”), will be treated as the “acquired” company for financial reporting purposes. This determination is primarily based on Profusa, Inc. (“Profusa”) Stockholders comprising a relative majority of the voting power of Profusa (the combined entity) and having the ability to nominate majority of the members of the New Profusa Board, Profusa’s operations prior to the acquisition comprising the only ongoing operations of New Profusa, and Profusa’s senior management comprising the senior management of New Profusa. Accordingly, for accounting purposes, the financial statements of New Profusa will represent a continuation of the financial statements of Profusa with the Business Combination treated as the equivalent of Profusa issuing stock for the net assets of NorthView, accompanied by a recapitalization. The net assets of NorthView will be stated at historical cost, with no goodwill or other intangible assets recorded. Operations prior to the Business Combination will be presented as those of Profusa in future reports of New Profusa.

As a result of the Business Combination, all outstanding stock of Profusa were cancelled in exchange for the right to receive newly issued shares of Common Stock of New Profusa, par value $0.0001 per share (“Common Stock”), and all outstanding options to purchase Profusa stock were exchanged for options exercisable for newly issued shares of New Profusa Common Stock.

The total consideration received by Profusa Security Holders at the Closing of the transactions contemplated by the Merger Agreement is the newly issued shares of Common Stock and securities convertible or exchangeable for newly issued shares of Common Stock with an aggregate value equal $255,958,617, with each Profusa Stockholder receiving for each share of Profusa Common Stock held (after giving effect to the exchange or conversion of all outstanding Profusa Preferred Stock for shares of Profusa Common Stock and treating all vested in-the-money Profusa Convertible Securities (including, on a net exercise basis, all vested qualified Profusa Options) as if such securities had been exercised as of immediately prior to the Merger, but excluding all unvested Profusa Options) a number of shares of Common Stock equal to a conversion ratio of approximately 0.34. As a result, the Profusa Security Holders received an aggregate of 25,595,862 shares of newly issued Common Stock as Merger Consideration.

As an additional consideration, each Profusa Stockholder is entitled to earn, on a pro rata basis, an aggregate of 3,875,000 shares of New Profusa’s common stock (the “Milestone Earnout Shares”) during the respective earnout periods in equal ¼ installments upon achievement of the following defined Milestone Events. The Milestone Earnout Shares will be placed in escrow and will be outstanding from and after the Closing, subject to cancellation if the applicable price targets are not achieved. While in escrow, the shares will be non-voting.

The unaudited pro forma combined financial information contained herein does not account for the assumption by New Profusa at the Closing of unvested Profusa Stock Options or future issuances of shares of Common Stock upon exercise thereof. The unaudited pro forma combined financial information contained herein does account for the subsequent execution of the ELOC Agreement and secondary tranche of PIPE funding.

After giving effect to the Business Combination transaction and the issuance of the Merger Consideration described above, there are 111,250,017 shares of our Common Stock issued and outstanding.

2. Basis of Pro Forma Presentation

The unaudited pro forma condensed combined balance sheet as of June 30, 2025 assumes that the Business Combination and related transactions occurred on June 30, 2025. The unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2025 and for the year ended December 31, 2024 presents pro forma effect to the Business Combination as if it had been completed on January 1, 2024.

The unaudited pro forma condensed combined balance sheet as of June 30, 2025 has been prepared using, and should be read in conjunction with, the following:

● NorthView’s unaudited condensed consolidated balance sheet as of June 30, 2025 and the related notes for the six months ended June 30, 2025, included in the Proxy Statement/Prospectus; and

● Profusa’s unaudited condensed consolidated balance sheet as of June 30, 2025 and the related notes for the six months ended June 30, 2025, included in the Proxy Statement/Prospectus.

The unaudited pro forma condensed combined statement of operations for the six months ended June 30, 2025 has been prepared using, and should be read in conjunction with, the following:

● NorthView’s unaudited condensed consolidated statement of operations for the six months ended June 30, 2025 and the related notes, included in the Proxy Statement/Prospectus; and

● Profusa’s unaudited condensed consolidated statement of operations for the six months ended June 30, 2025 and the related notes, included in the Proxy Statement/Prospectus.

The unaudited pro forma condensed combined statement of operations for the year ended December 31, 2024 has been prepared using, and should be read in conjunction with, the following:

● NorthView’s audited consolidated statement of operations for the year ended December 31, 2024 and the related notes, included in the Proxy Statement/Prospectus; and

● Profusa’s audited consolidated statement of operations for the year ended December 31, 2024 and the related notes, included in the Proxy Statement/Prospectus.

As the unaudited pro forma condensed combined financial information has been prepared based on these preliminary estimates, the final amounts recorded may differ materially from the information presented.

The unaudited pro forma condensed combined financial information does not give effect to any anticipated synergies, operating efficiencies, tax savings or cost savings that may be associated with the Business Combination. In addition, on July 28, 2025, we entered into the Committed Equity Facility with Ascent, pursuant to which Ascent has committed to purchase up to $100,000,000 of shares of our Common Stock, subject to certain limitations and conditions set forth in the Purchase Agreement. The shares of our Common Stock that may be issued under the Purchase Agreement may be sold by us to Ascent at our discretion from time to time for a period of up to 36 months (unless the Purchase Agreement is earlier terminated) beginning on the Effective Date. The proceeds from the Committed Equity Facility are to be used exclusively for the purchase of Bitcoin (which may be used for repayment of indebtedness), provided the Company’s cash balance on any Closing Date exceeds $5,000,000. If the cash balance is less than $5,000,000, proceeds must first be used to bring the cash balance to that amount, with the remainder used to purchase Bitcoin.

The unaudited pro forma condensed combined financial information is not necessarily indicative of what the actual results of operations and financial position would have been had the Business Combination taken place on the dates indicated, nor are they indicative of the future consolidated results of operations or financial position of the Combined Company. They should be read in conjunction with the historical financial statements and notes thereto of NorthView and Profusa.

The accompanying pro forma financial statements reflect the impact of transactions that are either completed or considered probable in accordance with Regulation S-X Article 11. Management has considered the impact of the Committed Equity Facility on these pro forma financial statements, and notes that the agreement is written in a manner in which the Company will issue a variable number of shares at a variable issuance price, based on the then current market rates, less a fixed discount. The number of shares registered to date related to the ELOC facility are expected to be issued, which totals 51,182,378 shares, made up of the 8,970,830 shares previously registered and an additional 42,211,548 shares being registered, which is calculated as the maximum number of shares able to be registered based on authorized shares of 300,000,000. The Company has now started to draw on the ELOC and has estimated the issuance price based on the last actual conversion price of .4743 for the first tranche of shares registered, which is based on the VWAP on August 26, 2025, and an estimated conversion price of $0.14 to align with the floor price as defined by the agreement for this next tranche of 42,211,548 shares being registered, as seen in Tickmark (T) on the unaudited pro forma balance sheet.

Pursuant to the Purchase Agreement, 900,000 Commitment Warrant Shares are issuable upon exercise of the Commitment Warrants we issued to Ascent upon our execution of the term sheet relating to the Purchase Agreement on July 20, 2025, as consideration for its commitment to purchase shares of our Common Stock that we may, in our sole discretion, direct Ascent to purchase from us pursuant to the Purchase Agreement. The Commitment Warrants have an exercise price of $0.01 and may be exercised for cash or, if at the time of exercise there is no effective registration statement covering the resale of the Commitment Warrant Shares, on a cashless basis. The warrants issued to Ascent are currently being analyzed for their accounting treatment, which the Company expects to be equity classified based on their cashless exercise option. As such, the Company will finalize the accounting conclusions on these warrants, and validate their equity classification for the upcoming September 30, 2025 financial statements. As the Company has drawn on the ELOC facility, the 900,000 warrants were issued to Ascent and have been included within the unaudited pro forma financial statements at their fair value as calculated using the Black Scholes valuation method.

3. Accounting Policies and Reclassifications

Upon consummation of the Business Combination, management has performed a comprehensive review of the two entities’ accounting policies. As a result of the review, management has not identified differences between the accounting policies of the two entities which have a material impact on the financial statements of the Combined Company. Based on its analysis, management did not identify any differences that would have a material impact on the unaudited pro forma condensed combined financial information. As a result, the unaudited pro forma condensed combined financial information does not assume any differences in accounting policies.

4. Adjustments to Unaudited Pro Forma Condensed Combined Financial Information

The unaudited pro forma condensed combined financial information has been prepared to illustrate the effect of the Business Combination and has been prepared for informational purposes only.

The following unaudited pro forma condensed combined financial information has been prepared in accordance with Article 11 of Regulation S-X as amended by the final rule, Release No. 33-10786 “Amendments to Financial Disclosures about Acquired and Disposed Businesses” to depict the accounting for the transaction (“Transaction Accounting Adjustments”) and present the reasonably estimable synergies and other transaction effects that have occurred or are reasonably expected to occur (“Management’s Adjustments”). NorthView has elected not to present Management’s Adjustments and is only presenting Transaction Accounting Adjustments in the unaudited pro forma condensed combined financial information. The historical financial statements have been adjusted in the unaudited pro forma condensed combined financial information to include all necessary Transaction Accounting Adjustments pursuant to Article 11 of Regulation S-X, including those that are not expected to have a continuing impact.

The audited historical financial statements have been adjusted in the unaudited pro forma condensed combined financial information to give pro forma effect to transaction accounting adjustments that reflect the accounting for the transaction under GAAP. All activity between Profusa and Northview has been eliminated between the companies on the pro forma statement under tickmark J.

The pro forma combined statement of operations does not reflect a provision for income taxes or any amounts that would have resulted had the Combined Company filed consolidated income tax returns during the periods presented. The pro forma condensed combined balance sheet does not reflect the deferred taxes of the Combined Company as a result of the Business Combination. Upon Closing of the Business Combination, it is likely that the Combined Company will record a full valuation allowance against the total U.S. and state deferred tax assets given the net operating losses and valuation allowance of Profusa as the recoverability of the tax assets is uncertain. The Company used the separate return method in calculating the pro forma tax provision and tax effects of our pro forma adjustments.

The pro forma basic and diluted earnings per share amounts presented in the unaudited pro forma condensed combined statement of operations are based upon the number of the Combined Company’s shares outstanding, assuming the Business Combination occurred on January 1, 2024.

Transaction Accounting Adjustments to Unaudited Pro Forma Condensed Combined Balance Sheet

The Transaction Accounting Adjustments included in the unaudited pro forma condensed combined balance sheet as of June 30, 2025 are as follows:

A. Reflects the reclassification of the remaining shares of NorthView Common Stock to permanent equity immediately prior to the Merger.

B. Reflects the liquidation and reclassification of the balance of investments held in the trust account to cash and cash equivalents that becomes available to fund the Transaction. This is the full trust account balance as of June 30, 2025, which is further adjusted for redemptions reflected in adjustment (P) below to reflect the remaining trust account balance following such redemptions which were distributed at closing.

C. Reflects the gross proceeds from the issuance and sale of PIPE Convertible Notes of NorthView that are convertible into shares of NorthView common stock at $10.00 per share pursuant to the PIPE Subscription Agreement entered into with the PIPE Investors, assuming no redemptions. The PIPE Subscription Agreement provides for a total facility up to $22.22 million which is split into tranches. The Initial Note was funded upon closing the merger for $10 million which was subject to a 10% OID ($9.0 million net). A subsequent $2.22 million subject to a 10% OID ($2.0 million net) is considered probable based on the terms of the convertible note. The notes did not convert as of the closing date. As such, the notes will remain in the pro forma balance sheet for pro forma purposes, as the notes convert at the election of the note holder until the shares are registered.

D. Reflects the recapitalization and elimination of Northview’s pre-merger accumulated deficit balance.

E. Represents direct and incremental transaction costs incurred by New Profusa related to the Merger and PIPE Subscription Agreement of approximately $6.0 million for advisory, banking, printing, legal and accounting that are incurred and anticipated to be incurred. These costs will not affect the Company’s combined statements of operations and comprehensive loss beyond 12 months after the acquisition date.

F. Represents the payment of estimated direct and incremental transaction costs that are incurred and anticipated to be incurred, of which $1.8 million is expected to be paid in shares and $4.2 million is expected to be paid in cash, including the Business Combination Marketing Fee of $2.0 million. These costs will not affect the Company’s combined statements of operations and comprehensive loss beyond 12 months after the acquisition date.

G. Represents reclassification of Profusa’s deferred offering costs to permanent equity and payment of the respective accrued and unpaid portion of the deferred offering costs.

H. Represents payment of Northview accrued offering costs and expenses.

I. Represents payment of direct and incremental transaction costs incurred by NorthView of approximately $1.6 million in advisory, banking, printing, legal, and accounting fees and other transaction related expenses in connection with the Merger and PIPE Subscription Agreement.

J. Elimination of transactions between the two companies.

K. Reflects exchange of Profusa’s Series A Convertible Preferred Stock for common stock of Profusa with $0.0001 par value.

L. Reflects exchange of Profusa’s Series B Convertible Preferred Stock for common stock of Profusa with $0.0001 par value.

M. Reflects exchange of Profusa’s Series C/C1 Convertible Preferred Stock for common stock of Profusa with $0.0001 par value.

N. Reflects conversion of Senior Notes and Senior Bridge Notes into 6,819,763 shares of Profusa in accordance with their terms.

O. Reflects conversion of Junior Notes into 2,801,697 shares of Profusa in accordance with their terms.

P. Reflects the remaining redemptions in the trust to settle all balances due to redeeming shareholders.

Q. Represents reclassification of Profusa’s transaction costs incurred in excess of proceeds received from additional paid-in capital to accumulated deficit.

R. Represents issuance of shares in New Profusa upon conversion of Northview’s convertible loan at the Closing of the Merger. The balance of the note was $1,919,796, which was fair value adjusted on the balance sheet to $10,288,111 is included in the pro forma at the current balance as no interest accrues on this note and was converted into 863,908 shares of New Profusa, at an as converted price of $2.22 per share.

S. Reflects the impact from the warrants issued to Ascent according to the ELOC Registration Rights Agreement. The warrants are equity classified and recorded at their fair value on the agreement date.

T. Reflects the cash received and the shares issued from the ELOC facility, assuming additional 42,211,548 shares issued at the floor price of $0.14 per share for approximately $5.9 million additional financing, plus the 8,970,830 previously registered shares assuming an average conversion price using the VWAP rate on August 26, 2025 of $0.4743 per share.

Transaction Accounting Adjustments to Unaudited Pro Forma Condensed Combined Statements of Operations

The Transaction Accounting Adjustments included in the unaudited pro forma condensed combined statements of operations for the six months ended June 30, 2025 and the year ended December 31, 2024 are as follows:

AA. Represents the elimination of investment income related to the investments held in the NorthView Trust Account.

BB. Represents elimination of interest expense related to Profusa’s Junior Notes, and the interest expense related to Profusa’s Senior Notes Senior Secured Notes, and Senior Bridge Notes which was incurred following the modification of the Senior Notes on September 27, 2022 which was accounted for as debt extinguishment. Interest expense incurred prior to the September 27, 2022 modification is not eliminated because prior to that date the Senior Notes did not contain conversion feature requiring conversion of the Senior Notes upon a merger with a SPAC. Accordingly, the Senior Notes were deemed to have been extinguished as of September 27, 2022, and re-issued immediately as new debt that is convertible upon the Merger. All expenses incurred with respect to the Senior Notes following the September 27, 2022 modification, including interest expense and gains or losses incurred with subsequent modifications of the Senior Notes, are eliminated.

CC. Represents the income tax impact on the elimination of investment income related to the investments held in NorthView’s Trust Account.

DD. Represents elimination of the changes in the fair value of Northview’s convertible loan upon the closing of the Business Combination.

EE. To account for the Profusa Senior Secured Working Capital Loan interest at 12.0% during the year ended December 31, 2024, for the portion not already accounted for in accrued interest. All Profusa Senior Secured Working Capital Loan interest was accounted for as of June 30, 2025 in Tickmark BB for the period. No new notes were issued between June 30, 2025 and the closing of the Business Combination on July 11, 2025.

FF. Represents the accrual of estimated Transaction related costs incurred by NorthView after June 30, 2025 and December 31, 2024, respectively.

GG. Represents issuance of the Milestone Earnout Rights and Profusa Inducement Recoupment Earnout Rights to the equity holders of Profusa, which are treated as dividend distributions and recorded in additional paid-in capital. Earnout right represents a right to receive shares in future upon meeting certain earnout targets. The issuance date fair values of Milestone Earnout Rights and Profusa Inducement Recoupment Earnout Rights was determined using Monte Carlo Simulation approach. The Company estimated the vesting and payoff of the Milestone Earnout Shares and the Inducement Shares related to Milestone I Event and Milestone II Event for each simulated stock price path, and the vesting and payoff of the Milestone Earnout Shares related to Milestone III Event and Milestone IV Event for each simulated revenue path and the correlated stock price path. The fair value is then determined by averaging the payoff across all simulated paths and discounting it to the valuation date.

HH. Reflects transaction costs incurred in excess of proceeds.

II. To account for the PIPE Investors interest at 10% related to the first tranche of the PIPE Convertible Note.

JJ. To account for the warrant expense associated to the 900,000 warrants issued to Ascent associated with the ELOC Registration Rights Agreement, calculated based on the warrant fair value on the warrant agreement date.

KK. Represents elimination of the changes in the fair value of Northview’s Securities Purchase Agreement upon the closing of the Business Combination.

5. Net Loss per Share

Represents the net loss per share calculated using the historical weighted average shares outstanding, and the issuance of additional shares in connection with the Business Combination, assuming the shares were outstanding since January 1, 2024. As the Business Combination and related transactions are being reflected as if they had occurred at the beginning of January 1, 2024, the calculation of weighted average shares outstanding for basic and diluted net loss per share assumes that the shares issuable relating to the Business Combination have been outstanding for the entire periods presented.

The unaudited pro forma condensed combined financial information has been prepared with the actual redemptions of Public Shares by NorthView Public Stockholders for the six months ended June 30, 2025 and for the year ended December 31, 2024:

	Year Ended December 31, 2024			Six Months Ended June 30, 2025
Pro forma net loss	$	(15,256	)	$	(17,776	)
Deemed dividend	$	(9,684	)		(9,684	)
Pro forma net loss used in calculation of weighted-average pro forma net loss per share	$	(24,940	)	$	(27,460	)
Basic weighted average shares outstanding		110,534,620			111,250,017
Pro forma net loss per share – Basic and Diluted	$	(0.23	)	$	(0.25	)
Weighted average shares outstanding-basic and diluted
NorthView Common shareholders		6,535,591			6,482,807
Former Profusa shareholders		15,500,000			15,500,000
Shares issued to underwriters		382,500			382,500
Senior secured convertible note		4,660,000			5,542,261
Profusa bridge notes		4,285,012			4,170,932
Northview working capital loan		863,908			863,908
PIPE Subscription		27,125,231			27,125,231
Ascent ELOC Commitment Shares		51,182,378			51,182,378
		110,534,620			111,250,017

DIVIDEND POLICY

We have never declared or paid any cash dividends on our common stock, and we do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We expect to retain future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends on our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements and any contractual restrictions.

MARKET INFORMATION

Our Common Stock is currently listed on Nasdaq under the symbol “PFSA”. Prior to the consummation of the Business Combination, our Common Stock was listed on the OTC under the symbol “NVAC”. As of ~~August~~February 282, ~~2025~~2026, there were 194 holders of record of our Common Stock and the closing sale price of our Common Stock was $0.720.09 per share. The actual number of stockholders of our Common Stock is greater than the number of of record holders and includes holders of our Common Stock whose shares of Common Stock are held in street name by brokers and other nominees.

9081

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS

~~References~~You toshould ~~“Profusa,”~~ read the ~~“Company,”~~following discussion ~~“we,”~~together ~~“us,”~~with our financial statements and ~~“our,”~~the ~~refer~~related tonotes ~~Profusa,~~included ~~Inc.~~elsewhere ~~and~~in ~~its~~this ~~subsidiaries~~prospectus. ~~The following~~This discussion and analysis contains offorward-looking ~~the~~statements ~~Company’s~~that ~~financial~~are ~~condition~~based ~~and~~on ~~results~~our ofcurrent ~~operations~~expectations ~~should~~and beprojections ~~read~~about inour ~~conjunction~~business ~~with the~~and ~~unaudited~~operations. ~~condensed~~Our actual ~~consolidated~~results ~~financial~~may ~~statements~~differ ~~and~~materially ~~the~~from ~~notes~~those ~~thereto~~currently ~~contained~~anticipated ~~elsewhere~~and expressed in ~~this~~such ~~prospectus~~forward-looking ~~(this~~statements ~~“Report”).~~as a result of ~~Certain~~a ~~information~~number ~~contained~~of infactors, ~~the~~including ~~discussion~~those ~~and~~which ~~analysis~~we ~~set~~discuss ~~forth~~under ~~below~~“Risk ~~includes~~Factors” ~~forward-looking~~and ~~statements~~elsewhere ~~that~~in ~~involve~~this ~~risks~~prospectus. ~~and~~See “Cautionary ~~uncertainties~~Note Regarding Forward-Looking Statements.”

Profusa, Inc., our wholly owned California subsidiary (“~~Old~~Legacy Profusa”), became our accounting predecessor upon the closing of the Business Combination on July 11, 2025. The results of operations discussed below ~~are~~reflect those of ~~Old~~Legacy Profusa and its consolidated subsidiaries for periods prior to July 11, 2025, and those of the combined company for periods from July 11, 2025 onward. For the quarter ended September 30, 2025, results include Legacy Profusa up to July 11, 2025 and the combined company thereafter.

Cautionary Note Regarding Forward-Looking Statements

This Prospectus includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions. Factors that might cause or contribute to such a discrepancy include, but are not limited to, those described in our other Securities and Exchange Commission (“SEC”) filings.

Business Overview

We are a clinical-stage digital health and medical technology company focused on developing biosensing solutions to improve health ~~outcomes~~ outcome for patients in a variety of different diseases and conditions. Our first product is Lumee Oxygen, which enables physicians to ascertain the extent of perfusion, or passage of blood through the circulatory system to an organ or tissue, in patients with Critical Limb Ischemia (CLI) both during and after endovascular revascularization procedures. Lumee Oxygen has already received regulatory approval in Europe through the attainment of a CE mark; however, prior to commercialization in the U.S., Lumee Oxygen must obtain FDA clearance or approval.

The latest version of Lumee Oxygen is called Wireless Lumee Oxygen System. It has multiple components, one of which is a microsensor that is injected into the tissue of the patient using a hypodermic needle. The sensor is designed so it does not need to be removed as it overcomes the foreign body response that usually inhibits the ability of permanent implants to function. The sensor contains no electronics, utilizing luminescence to send a light signal to a reader that is placed over the incision site, which in turn can send a signal to an app on a smartphone. We are in clinical trials for Lumee Glucose, our sensing solution being developed for use in continuous glucose monitoring (CGM). This system targets diabetics and pre-diabetics to allow them ~~real-time~~realtime access to their glucose data, at a price point that our management thinks is comparable or lower to existing systems.

We already sell our oxygen sensor for research use only applications, namely animal models and in vitro testing. Management is targeting the European market (those jurisdictions that accept CE mark) for early launch for both Lumee Oxygen and Lumee Glucose. Lumee Oxygen’s launch in Europe occurred in 2023 and Lumee Glucose launch is expected to occur in 2025, subject to regulatory approval. We have access to key opinion leaders (KOLs) in both Europe and the United States, who deal with peripheral arterial disease (PAD) and Critical Limb Ischemia (CLI). We will sell directly to facilities based on the endorsement of these KOLs. In Germany, Austria and France, some KOLs have already used Lumee Oxygen on a trial basis. We have worked with reimbursement consultants to develop potential Category I CPT codes for Lumee Oxygen use.

We will sell directly to facilities based on the endorsement of these KOLs. In Germany, Austria and France, some KOLs have already used Lumee Oxygen on a trial basis. We have worked with reimbursement consultants to develop potential Category I CPT codes for Lumee Oxygen use. Additionally, we have entered into commercial and clinical collaboration agreements with practitioners and hospital departments in Austria, Belgium and France.

Regarding Lumee Glucose, if and when we obtained marketing authorization, we plan to embark on a dual strategy of both direct to hospital sales, for our professional-use and personal-use CGM product, and direct to pharmacy sales for our personal use product only, thereby maximizing flexibility for the consumer. By aiming for coverage under a user’s pharmacy benefit, we believe we can diversify our user base, while accounting for any risk related to unlikely delay of attainment of a category I CPT code for sensor insertion. We feel a difference between other insertable or implantable CGMs and Lumee Glucose, is that the latter can be simply inserted with a hypodermic needle and does not require a surgical implantation, similar to how pharmacists use these needles to administer flu shots and other vaccines. At the same time, physicians can still leverage existing CPT codes related to interpretation of CGM data and we have, in parallel, initiated steps for CPT codes related to our sensor insertion. We will target both public and private payors for coverage.

Since our launch, we have significantly devoted all of our resources to research and development, as well as all clinical study activities related but not limited to Lumee Oxygen, Lumee Glucose and prototypes for sensors of at least eight other analytes. We have also invested, on a smaller scale, in making sales of Lumee Oxygen for research- use only clients, which include entities working with animal models. Furthermore, we also performed research and development under government grants.

Since inception, we have incurred recurring annual losses from operations. For the three months ended ~~June~~ September 30, 2025 and 2024, we incurred a net loss of $222.3 2 million and $2.0 5 million, respectively. For the ~~six~~ nine months ended ~~June~~ September 30, 2025 and 2024, we incurred a net loss of $527.1 3 million and $47.5 0 million, respectively. During the ~~six~~ nine months ended ~~June~~ September 30, 2025 and 2024, we have used $111.1 ~~million~~ ~~and~~million and $1.0 8 million, respectively, of cash in our operating activities. We have notes and loans payable and interest due of $526.3 7 million within twelve months of ~~June~~ September 30, 2025. Additionally, we have notes and loans payable and interest due of $14.4 million which are considered non-current and are due after September 30, 2026.

We have been able to finance our operations primarily with the proceeds from the issuance of equity and debt instruments ~~and to a lesser extent, revenues from government grants~~. For the ~~six months~~nine months ending ~~June~~ September 30, 2025, we obtained net cash from financing activities of $114.0 9 million compared to $01.9 8 million for the same period in 2024. We held cash of ~~less~~$3.0 ~~than~~million and $0.1 2 million as of ~~June~~ September 30, 2025, and ~~$0.2 million as of~~ December 31, 2024, respectively.

The Company’s condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has reviewed the relevant conditions and events surrounding its ability to continue as a going concern including among others: historical losses, projected future results, including ~~the effects of COVID-19,~~ cash requirements for the upcoming year, funding capacity, net working capital, total stockholders’ deficit and future access to capital.

On July 11, 2025 Profusa, Inc., a Delaware corporation formerly known as NorthView Acquisition Corporation, consummated its previously announced business combination with Profusa, Inc., a California corporation, pursuant to that certain Merger Agreement and Plan of Reorganization. At the Closing and pursuant to the PIPE Subscription Agreement, New Profusa issued a PIPE Convertible Note in the principal amount of $10,000,000 (the “Initial Note”) for a purchase price of $9,000,000, reflecting a 10% Original Issuance Discount (“OID”). Management believes this liquidity has not alleviated the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date the condensed consolidated financial statements are issued.

As part of the closing, the Company had cash inflows of $1.3 million from the NorthView trust account, net of redemptions, and the $9 million net PIPE convertible note. Cash outflows included marketing fees and vendor payments which totaled $3.4 million due at closing. Subsequent to the closing of the Merger, there continue to be factors which raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date the condensed consolidated financial statements are issued. The condensed consolidated financial statements do not contain any adjustments that might result from the outcome of this uncertainty.

It is our expectation to continue to make substantial investments in building its European and United States commercial infrastructure and enhancing existing products and developing new ones. Furthermore, we aim to continue discussions with potential partners in Asia.

We expect to incur additional expenses due to operating as a public company, including expenses related to compliance with the rules and regulations of the ~~U.S. Securities and Exchange Commission, or the~~ SEC, and those of the Nasdaq Stock Market LLC ~~(“NASDAQ”) Stock Market~~, additional insurance expenses, investor relations activities and other administrative, professional and consulting services. As a result of these and other factors, we expect that we will require additional financing to fund our operations and planned growth. We may seek to raise any additional capital through equity offerings or debt financings, additional credit or loan facilities or a combination of one or more of these funding sources. In the scenario that we are unable to acquire sufficient financing or financing on terms satisfactory to our management or ~~Board~~ board of ~~Directors~~directors, our ability to continue to pursue our business objectives and to respond to business opportunities, challenges or unforeseen circumstances could be significantly limited, and our business, financial condition and results of operations could be materially adversely affected. For the ~~current period and for~~ twelve months following the ~~issuance~~date of ~~these~~this ~~financial statements~~filing, our risk of going concern has been mitigated but not fully alleviated by the ~~Tranche 1~~ PIPE Convertible Note issued for a gross proceeds of $1012.0 2 million.

9283

Accounting for Business Combination

On ~~November 7~~July 11, ~~2022~~2025, the Business ~~Company~~Combination ~~entered~~was ~~into~~successfully ancompleted ~~Agreement~~ and ~~Plan~~was ofaccounted ~~Merger~~for ~~(“Merger~~as ~~Agreement”) with NorthView Acquisition Corp (“NorthView”), where~~ a ~~subsidiary~~reverse ofcapitalization ~~NorthView~~in ~~will~~accordance ~~merge~~ with ~~the~~US ~~Company,~~GAAP. ~~with~~Legacy ~~the~~Profusa ~~Company~~was deemed ~~surviving~~ the ~~Merger~~accounting aspredecessor ~~a wholly owned subsidiary~~ of ~~NorthView. Pursuant to~~ the ~~Merger~~combined ~~Agreement~~business, and ~~assuming~~the aCompany ~~favorable~~(“New ~~vote~~Profusa”) ofas ~~NorthView’s~~the ~~stockholders,~~parent ~~Merger~~company ~~Sub,~~of athe ~~newly formed subsidiary~~combined ~~of NorthView~~business, ~~will~~is ~~be merged with and into Profusa. Upon consummation of~~ the ~~Business~~successor ~~Combination~~SEC registrant, ~~the~~meaning ~~separate~~that ~~corporate~~our ~~existence~~financial ~~of Merger~~statements ~~Sub~~for ~~shall~~previous ~~cease;~~periods ~~Profusa~~ will ~~survive~~be ~~and~~disclosed ~~become~~in athe ~~wholly~~registrant’s future ~~owned~~periodic ~~subsidiary~~reports offiled ~~NorthView,~~with ~~which~~the ~~will be renamed New Profusa, Inc~~SEC. The ~~aggregate~~Business ~~consideration~~Combination towill behave ~~received~~a bysignificant ~~the~~impact ~~Profusa stockholders is based~~ on aour ~~pre-transaction~~future ~~equity~~capital ~~value~~structure ofand operating ~~$155~~results,~~000,000.~~ ~~The exchange~~and ~~ratio~~de-risking ~~will~~our beproduct ~~equal to (a) $155~~development,~~000,000,~~ ~~divided~~manufacturing byand ~~an assumed value of NorthView Common Stock of $10~~commercialization.~~00 per share.~~

~~On February 11, 2025,~~As ~~the~~a ~~parties~~result toof the Merger, ~~Agreement entered into Amendment No. 4 to~~ the ~~Merger~~Company ~~Agreement~~has ~~(the~~become ~~“Amendment”) pursuant to which~~ the ~~parties~~successor ~~agreed~~ to ~~revise~~an ~~the~~SEC-registered ~~Company~~and ~~Reference~~Nasdaq- ~~Value~~listed ~~(as~~company, ~~defined~~which inwill ~~the~~require ~~Merger~~us ~~Agreement)~~ to hire ~~adjust~~additional ~~for~~personnel ~~financing~~and ~~proceeds~~implement ~~received by~~procedures ~~Profusa~~and ~~prior~~processes to ~~the~~address ~~Business~~public ~~Combination,~~company ~~along~~regulatory ~~with~~requirements ~~debt conversions~~ and ~~incentive~~customary ~~shares to be issued~~practices. ~~Additionally, the Amendment~~ ~~(i) revised~~We ~~the~~expect ~~definition of “Milestone Event III” such that the parties extended the period for Profusa~~ to ~~consummate the~~incur ~~APAC~~additional ~~Joint~~annual ~~Venture~~expenses (as ~~defined~~a inpublic ~~the~~company ~~Merger Agreement) and receive the related funding from December 31~~for, ~~2024~~among ~~until~~other ~~December 31~~things, ~~2025,~~ directors’ and ~~(ii) revised~~officers’ ~~the definition of “Milestone Event IV” to change the earnout revenue target from $99,702,000~~liability ~~for~~insurance, ~~the~~director ~~fiscal year ended December 31~~fees, ~~2025~~and toadditional aninternal ~~earnout~~and ~~revenue~~external ~~target of $11~~accounting,~~864,000~~ ~~for~~legal ~~the~~and ~~fiscal~~administrative ~~year ended December 31, 2026~~resources.

On April 2, 2025, the parties to the Merger Agreement entered into an Amendment No. 5 to the Merger Agreement (“Amendment No. 5”) pursuant to which Section 9.01 of the Merger Agreement is hereby amended such that the reference to “March 22, 2025” shall be replaced with “June 22, 2025”. The closing date was then further amended to July 11, 2025.

Subsequent to these financials statements, on July 11, 2025, the Business Combination was successfully completed and was accounted for as a reverse capitalization in accordance with GAAP. Profusa was deemed the accounting predecessor of the combined business, and New Profusa, Inc. (“New Profusa”) as the parent company of the combined business, is the successor SEC registrant, meaning that our financial statements for previous periods will be disclosed in the registrant’s future periodic reports filed with the SEC. The Business Combination will have a significant impact on our future capital structure and operating results, de-risking our product development, manufacturing and commercialization. The most significant changes in New Profusa’s future reported financial positions are expected to be an estimated increase in cash (as compared to our balance sheets at June 30, 2025 and at December 31, 2024) of approximately $9.0 million in proceeds from the PIPE Investment. This $9.0 million is offset by various deferred offering costs and $2.0 million closing fees related to the underwriters marketing fee for the NorthView IPO, which became payable upon a successful consummation of the Business Combination. See “Unaudited Pro Forma Condensed Combined Financial Information.”

In June 2023, the Company entered into a short-term loan agreement with a related party under which it may borrow up to $1.6 million, of which $1.0 million was borrowed on June 26, 2023, $0.3 million was borrowed on July 20, 2023, $0.3 million was borrowed on August 15, 2023 (the “Tasly Convertible debt”). An additional amount of less than $0.02 million was drawn on February 6, 2024. The loans bear interest at a rate of 12% per annum and originally matured on December 31, 2023. The original maturity date was extended to March 31, 2024, subject to the parties’ decision to extend thereafter. The Company is currently in default, as this loan will be repaid subsequent to the SPAC transaction. The Company is currently incurring a default interest rate of 24% per annum, and has classified the entire amount outstanding under the Tasly Convertible Debt as current under the convertible debt payable line item on the Condensed Consolidated Balance Sheet.

As a result of the Merger, the Company has become the successor to an SEC-registered and NASDAQ- listed company, which will require us to hire additional personnel and implement procedures and processes to address public company regulatory requirements and customary practices. We expect to incur additional annual expenses as a public company for, among other things, directors’ and officers’ liability insurance, director fees, and additional internal and external accounting, legal and administrative resources.

Recent Developments

As of the date of this prospectus, the Company has purchased $1.0 million of Bitcoin as part of the Company’s ongoing treasury strategy, representing 8.53 Bitcoins.

Inflation, Monetary Response, and Economic Impacts

The world economy is experiencing stubbornly high inflation, a challenge not faced for decades. Following the global financial crisis, with inflationary pressures muted, interest rates were extremely low for years and investors became accustomed to low volatility. The resulting easing of financial conditions supported economic growth, but it also contributed to a buildup of financial vulnerabilities. With inflation at multi-decade highs, monetary authorities in advanced economies are accelerating the pace of policy normalization. Policymakers have continued to tighten policy against a backdrop of rising inflation and currency pressures, albeit with notable differences across regions. Global financial conditions have tightened notably this year, leading to capital outflows. Amid heightened economic and geopolitical uncertainties, investors have aggressively pulled back from risk-taking and adjusted their investment preferences generally. Key gauges of systemic risk, such as higher dollar funding costs and counterparty credit spreads, have risen. There is a risk of a disorderly tightening of financial conditions that may be amplified by vulnerabilities built over the years.

In addition, our business, growth, financial condition or results of operations could be materially adversely affected by instability or changes in a country’s or region’s economic conditions; inflation; changes in laws or regulations or in the interpretation of existing laws or regulations, whether caused by a change in government or otherwise; increased difficulty of conducting business in a country or region due to actual or potential political or military conflict; or action by the U.S. or foreign governments that may restrict our ability to transact business in a foreign country or with certain foreign individuals or entities. A possible slowdown in global trade caused by increasing tariffs or other restrictions could decrease consumer or corporate confidence and reduce consumer, government and corporate spending in countries inside or outside the U.S., which could adversely affect our operations. Climate-related events, including extreme weather events and natural disasters and their effect on critical infrastructure in the U.S. or internationally, could have similar adverse effects on our operations, users, or third-party suppliers.

~~PIPE~~Nasdaq ~~Transaction~~Continued Listing

~~Initial~~On ~~Note~~September 11, 2025, we received written notice from Nasdaq stating that we were not in compliance with certain continued listing requirements of the Nasdaq Global Market, including the Minimum Bid Price Requirement and the MVLS Requirement. Nasdaq provided us an initial compliance period of 180 calendar days, or until March 10, 2026, to regain compliance with each of the Minimum Bid Price Requirement and the MVLS Requirement.

On ~~February 11~~October 27, 2025, ~~NorthView~~ ~~executed a Securities Purchase Agreement (~~the ~~“PIPE~~Company ~~Subscription~~received ~~Agreement”)~~a ~~with~~letter ~~Ascent~~from ~~Partners~~the ~~Fund~~Staff ~~LLC (“Ascent”,~~notifying ~~and together with any additional investors who become parties to~~ the ~~PIPE~~Company ~~Subscription Agreement~~that, for the ~~“PIPE~~previous ~~Investors”).~~30 ~~Pursuant to~~consecutive ~~the~~business ~~PIPE Subscription Agreement~~days, the ~~PIPE~~Company’s ~~Investors~~market ~~are~~value ~~expected,~~of ~~subject~~publicly toheld ~~the~~shares ~~conditions~~was ~~relating~~below ~~to such purchase set forth in~~ the $15,000,000 ~~PIPE~~threshold ~~Subscription~~required ~~Agreement,~~for tocontinued ~~purchase~~listing ~~from~~on ~~NorthView~~the ~~senior~~Nasdaq ~~secured~~Global ~~convertible~~Market ~~notes~~under inthe anMarket ~~aggregate~~Value ~~principal~~Requirement. ~~amount~~The ofStaff ~~up to~~provided ~~$22,222,222 (~~the ~~“PIPE~~Company ~~Convertible~~with ~~Notes”) for a~~ an ~~aggregate~~initial ~~purchase~~period ~~price~~ of up180 tocalendar ~~$20~~days,~~000,000,~~ ~~reflecting~~or auntil ~~10%~~April ~~original issue~~27, ~~discount~~2026, to regain compliance with the ~~face~~Market ~~amount~~Value ~~(“OID”)~~Requirement.

At the closing of our Business Combination and pursuant to the PIPE Subscription Agreement, we issued a PIPE Convertible Note in the principal amount of $10,000,000 (the “Initial Note”) for a purchase price of $9,000,000, reflecting a 10% OID. The Initial Note matures on January 11, 2027, which is 18-months from Closing on July 11, 2025 (the “Maturity Date”) and is convertible at any time at the PIPE Investor’s option at a conversion price equal to the lower of $10 or 95% of the lowest daily volume-weighted average price per share (“VWAP”) of our Common Stock in the 10 trading days prior to the original issue date of the Initial Note and shall be adjusted, without limitation, based on down-round and most-favored nation (MFN) price and terms protections (the “Conversion Price”).

The Initial Note includes a “Minimum Interest Amount” equal to 10% of the principal amount, which represents a full year of interest payments under the Initial Note; provided, that such Minimum Interest Amount shall be reduced by the amount of interest accrued on the principal amount of the Initial Note. Interest shall accrue on the aggregate unconverted and then outstanding principal amount of the Initial Note at a rate of 10% per annum, provided that the Minimum Interest Amount shall be fully earned and accrued on the original issue date of the Initial Note. Upon an event of default, the interest rate shall be adjusted and increase to 24% per annum. Payments made in cash under the Initial Note shall be subject to a 5% fee, which shall be in addition to any amounts owed thereunder. The Initial Note provides for certain events of default that are typical for a transaction of this type, including, among other things, any breach of the representations or warranties made by us and our subsidiaries. The Initial Note also provides for a 10% late fee in case of late payments and mandatory prepayments upon Subsequent Offerings (as defined in the Initial Note) and, in the absence of an event of default, may be prepaid upon 10 business days prior notice, subject to certain conversion rights of the PIPE Investors.

The Initial Note may not be converted by the PIPE Investors into shares of our Common Stock if such conversion would result in the investors or their affiliates owning in excess of 4.99% of the number of shares of our Common Stock outstanding immediately after giving effect to the issuance of all shares issuable upon conversion of the Initial Note (the “Beneficial Ownership Limitation”); provided, that the PIPE Investors may increase or decrease the Beneficial Ownership Limitation upon at least 61 days’ prior notice to us so long as such increase does not exceed 9.99% of the number of shares of our Common Stock outstanding immediately after giving effect to the issuance of all shares issuable upon conversion of the Initial Note. On August 1, 2025, pursuant to a Notice and Waiver, the Beneficial Ownership Limitation was increased from 4.99% to 9.99% and we waived the requirement for the 60 days’ advance notice for such increase.

The Company issued the Initial Note pursuant to the exemption from the registration requirements of the Securities Act available under Section 4(a)(2).

The foregoing description of the Initial Note is not complete and is qualified in its entirety by reference to the text of such document, which is filed as Exhibit 10.6 hereto and incorporated herein by reference.

Amendment No. 1 to the Securities Purchase Agreement and Initial Note

On August 25, 2025, the Company entered into Amendment No. 1 (the “SPA Amendment”) to the PIPE Subscription Agreement. Pursuant to the SPA Amendment, Section 2.1 of the PIPE Subscription Agreement was amended and restated to provide for four tranches of Notes: (i) an initial closing for Notes in an aggregate principal amount of $10,000,000 (the “First Tranche”), which already occurred in July 11, 2025; (ii) a second closing for Notes in an aggregate principal amount of $2,222,222 (the “Second Tranche”) for a purchase price of $2,000,000, subject to the satisfaction of certain conditions including the filing of a registration statement on Form S-1 covering all conversion shares and no Nasdaq listing deficiency; (iii) a third closing for Notes in an aggregate principal amount of $5,555,556 (the “Third Tranche”) for a purchase price of $5,000,000, subject to the satisfaction of certain conditions including the full conversion or repayment of the First Tranche, effectiveness of a registration statement, no Nasdaq listing deficiency, and receipt of stockholder approval; and (iv) a fourth closing for Notes in an aggregate principal amount of $4,444,444 (the “Fourth Tranche”) for a purchase price of $4,000,000, subject to the satisfaction of certain conditions including the full repayment of the First and Second Tranches, at least fifty percent (50%) repayment or conversion of the Third Tranche, effectiveness of a registration statement, and no Nasdaq listing deficiency. The Amendment supersedes and replaces all prior provisions relating to “Additional Closings” and “Additional Notes,” and all references to such terms in the PIPE Subscription Agreement and related documents are to be construed in accordance with the new tranche structure.

Concurrently, on August 25, 2025, the Company entered into Amendment No. 1 (the “Note Amendment”) to the Initial Note. The Note Amendment modifies the terms of the Initial Note, specifically amending Section 4(b) to revise the conversion price provisions on any conversion date to be the lower of (i) the Conversion Price on such date and (ii) ninety-five percent (95%) of the lowest daily volume weighted average price (“VWAP”) for the Company’s common stock during the ten consecutive trading days immediately preceding the applicable conversion date (the “Alternate Conversion Price”), provided that in no event shall the conversion price be less than the Floor Price of twenty percent (20%) of the closing sale price of the common stock on the principal trading market on the trading day immediately preceding the Note Amendment’s effective date, which was August 22, 2025.

The foregoing description of SPA Amendment, Note Amendment, and the Form of Amended Senior Secured Convertible Promissory Note, is a summary only and does not purport to be complete and is qualified in its entirety by reference to the full text of the SPA Amendment, Note Amendment, and Form of Amended Senior Secured Convertible Promissory Note, copies of which are filed herewith as Exhibits 10.21, 10.22, and 10.23 and are incorporated herein by reference.

PIPE Lock-Up Agreement

On July 11, 2025, the PIPE Investors entered into a lock-up agreement (the “PIPE Lock-Up Agreement”), pursuant to which they agreed to, subject to certain customary exceptions, not offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of any shares of our Common Stock or securities convertible, exchangeable or exercisable into shares of our Common Stock beneficially owned, held or acquired by them. The period for such restrictions shall apply from the Closing Date until the termination of the PIPE Lock-Up Agreement in accordance with its terms.

PIPE Registration Rights Agreement

On July 11, 2025, we and the PIPE Investors entered into a registration rights agreement (the “PIPE Registration Rights Agreement”), which provides customary demand and piggyback registration rights.

The PIPE Registration Rights Agreement provided that we will, as soon as practicable, but in any event within 20 calendar days after the Closing Date (the “Filing Date”), use our reasonable best efforts to file with the SEC a registration statement registering the resale of certain Common Stock issuable to the PIPE Investors upon conversion of the PIPE Convertible Notes. We will use our reasonable efforts to have the registration statement declared effective within 45 days (but in any event no later than the 60th calendar day) after the filing thereof.

On August 1, 2025, we entered into Amendment No. 1 to the PIPE Registration Rights Agreement, whereby we amended the Filing Date to September 14, 2025.

Security Agreement

On July 11, 2025, we and old Profusa (collectively, the “Profusa Parties”) entered into a Security Agreement with Ascent, as collateral agent (the “Security Agreement”), pursuant to which the Profusa Parties granted a security interest in substantially all of their respective assets to Ascent, to secure their respective obligations under the PIPE Convertible Notes.

Guaranty

On July 11, 2025, the Profusa Parties and their respective subsidiaries, successors and permitted assigns entered into a guaranty (the “Guaranty”), pursuant to which each such party guaranteed the other parties’ obligations under the PIPE Convertible Notes.

The Committed Equity Facility

On July 28, 2025, we entered into the Purchase Agreement and the ELOC Registration Rights Agreement with Ascent. Upon the terms and subject to the satisfaction of the conditions contained in the Purchase Agreement, from and after the Effective Date, we will have the right, in our sole discretion, to sell to Ascent up to $100,000,000 of shares of our Common Stock, subject to certain limitations set forth in the Purchase Agreement, from time to time after the date of this prospectus and during the term of the Purchase Agreement. Sales of Common Stock by us to Ascent under the Purchase Agreement, and the timing of any such sales, are solely at our option, and we are under no obligation to sell any securities to Ascent under the Purchase Agreement. See the section titled “The Committed Equity Facility” in this prospectus for more information. As of August 27, 2025, approximately $0.9 million in shares of our Common Stock was sold pursuant to the Purchase Agreement.

Principles of Accounting and Consolidation

The accompanying condensed consolidated financial statements have been prepared in conformity with ~~accounting principles generally accepted in the United States of America (“~~U.S. GAAP”) and pursuant to applicable rules and regulations of the ~~Securities~~SEC and ~~Exchange Commission (“SEC”) and~~ include all adjustments necessary for the fair presentation of the Company’s financial position as of ~~June~~ September 30, 2025, and ~~June 30~~ December 31, 2024 and the results of operations and cash flows for the three and ~~six~~nine month periods then ended. The accompanying ~~condensed~~ condensed consolidated financial statements include the accounts of Profusa Inc. and its wholly owned subsidiary, Profusa Asia Pacific Pte. Ltd (“APAC”). All intercompany balances and transactions have been eliminated in consolidation.

9684

Components of Results of Operations

Government Grant Revenue

Government grant revenue consists of amounts we earn under grants from two government agencies: NIH and DARPA. These grants are provided either in the form of expense reimbursement (expense reimbursement grants) or on a fixed fee basis (fixed fee grants). Under the expense reimbursement grants the government agencies reimburse us for a portion of our expenses (allowable expenses) that have been incurred in a given period on the basis of reports that we provide to these agencies. Fixed fee grants are awarded for specific research and development programs undertaken by us. Under these grants we receive milestone payments from the government agencies upon our submission and approval by the government of agreed upon deliverables, consisting primarily of the documented results of the specific research and development programs.

Research and Development Expenses

Research and development expenses consist primarily of personnel expenses, including salaries, benefits, and stock-based compensation, costs of consulting, supplies, depreciation and amortization and allocations of facility- related expenses. We expect our research and development expenses to increase as we increase staffing to support product development, continue our clinical trials, build prototypes, and continue to explore and develop next generation technologies.

General and Administrative Expenses

General and administrative expenses consist of personnel expenses, including salaries, benefits, and stock-based compensation, related to executive management, finance, legal, human resource functions, and business development, contractor and professional services fees, audit and compliance expenses, insurance costs and general corporate expenses, including allocated facility-related expenses and information technology costs.

Loss on Change in the Fair Value of Tasly Convertible Debt

We elected to apply fair value option to account for the convertible loans issued between June 2023 and March 2024 (the “Tasly Convertible Debt”), under which none of the embedded conversion or redemption features were bifurcated and separately accounted for. Rather, the Tasly Convertible Debt in its entirety was recorded at fair value at inception and is subject to remeasurement to fair value at each balance sheet date, with the change in fair value reflected in the statements of operations and comprehensive loss.

Fair Value of Financial Instruments

The Company’s financial instruments consist of other receivables, accounts payable, warrant liabilities, earnout, promissory notes, convertible promissory notes and senior notes. The Company states accounts payable at their carrying value, which approximates fair value due to the short time to the expected receipt or payment. The promissory notes are stated at amortized cost, which approximates their fair value, because the Company believes their terms approximate those that would be available to it on a similar loan from an unrelated party.

Earnout Arrangements

In connection with the Business Combination, the Company entered into earnout arrangements that provide for the issuance of additional shares of the Company’s Common Stock (or cash payments, if applicable) to certain pre-Business Combination holders upon the achievement of specified post-closing share-price or operational milestones.

The Company evaluates earnout arrangements in a de-SPAC transaction in accordance with ASC 805, Business Combinations, and the classification guidance under ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging. Earnouts that are contingent on future market-based or performance-based conditions and each milestone is legally detachable and separate. Milestones I, II, and IV are equity classified contingent consideration which were fair-valued as of the Close Date at $1.7 million and will not be subsequently remeasured. Milestone III was determined to be liability-classified contingent consideration with no value associated due to a lack of probability. This was continue to be revalued through the Milestone III conclusion date which is December 31, 2025 with changes in fair value recognized in earnings.

The earnouts that meet the criteria for equity classification—generally those settled in a fixed number of shares and not requiring cash settlement—are recorded within additional paid-in capital at the acquisition-date fair value and are not subsequently remeasured.

Warrants

The Company reviews the terms of warrants to purchase its Common Stock to determine whether warrants should be classified as liabilities or stockholders’ deficit in its condensed consolidated balance sheets. In order for a warrant to be classified in stockholders’ deficit, the warrant must be (i) indexed to the Company’s equity and (ii) meet the conditions for equity classification.

If a warrant does not meet the conditions for stockholders’ deficit classification, it is carried on the condensed consolidated balance sheets as a warrant liability measured at fair value, with subsequent changes in the fair value of the warrant recorded in other non-operating losses (gains) in the condensed consolidated statements of operations. If a warrant meets both conditions for equity classification, the warrant is initially recorded, at its relative fair value on the date of issuance, in stockholders’ deficit in the condensed consolidated balance sheets, and the amount initially recorded is not subsequently remeasured at fair value.

Gain on PPP Loan Forgiveness

On April 16, 2020 and May 25, 2021, we borrowed $1.2 million (the “PPP Loan 1”) and $1.3 million (the “PPP Loan 2”), respectively, as a Paycheck Protection Program loan (together the “PPP Loans”). The Paycheck Protection Program, established as part of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, provides for loans to qualifying businesses and is administered by the U.S. Small Business Administration (the “SBA”). The annual interest rate of the PPP Loans is 1%. The PPP Loans are eligible for forgiveness, provided the borrower has met the respective forgiveness requirements, has timely submitted an application for forgiveness and the forgiveness has been granted by the SBA. PPP Loan 1 has been approved for loan forgiveness, and management intends to apply for PPP Loan 2 forgiveness in 2025. PPP Loan 2 is currently in default due to non-payment, and is classified as a current liability on the balance sheet.

Interest Expense

Interest expense consists primarily of the interest on our convertible notes, senior notes, Tasly ~~convertible~~Convertible ~~debt~~Debt, promissory notes, and PPP Loans.

9786

Other Income

Other income consists primarily of income earned from sale of equipment and a short-term sublease of a portion of our facilities.

Results of Operations

Comparison of the Three ~~months~~ ~~ended~~Months ~~June~~ Ended September 30, 2025 to the Three ~~months~~ ~~ended~~Months ~~June~~ Ended September 30, 2024

The following table sets forth our unaudited condensed consolidated statements of operations and comprehensive loss for the interim periods indicated (in thousands):

	Three Months Ended June 30,						Change
	For the three months ended September 30,
	2025			2024			Change $			Change %
Revenue	$	—		$	25		$	(25	)		(100	)%
Government grant revenue		-			75			(75	)		-100	%
Operating expenses:		-			-			-			0	%
Research and development	$	~~393~~722		$	~~432~~411		$	~~(39~~311	)		(976	)%
General and administrative		~~610~~20,987			~~569~~767			4120,220			72636	%
Total operating expenses		121,~~003~~709			1,~~001~~178			220,531			01743	%
Loss from operations		(121,~~003~~709	)		(~~976~~1,103	)		(2720,606	)		31868	%
Other income (expense)
Other income (expenses)
Loss on change in the fair value of related party Tasly convertible debt		(57	)		(15	)		(42	)		280	%
Gain (loss) on change in the fair value of related party convertible debt		258			(320	)		578			181	%
Interest expense		(1,289	)		(1,081	)		(208	)		19	%
Gain on change in fair value of warrant liabilities		884			-			884			100	%
Other income (expense)		1			1			—			0
Loss on change in fair value of digital assets		(28	)		-			(28	)		100	%
Total other expense, net		(1,345	)		(1,095	)		(250	)		23	%
Interest expense (including related parties amounts of $629 and $575 for the three months ended September 30, 2025 and September 30, 2024, and $1,962 and $1,774 for the nine months ended September 30, 2025 and September 30, 2024, respectively)		(169	)		(1,073	)		904			-84	%
Net loss	$	(2,348	)	$	(2,071	)	$	(277	)		13	%
Financing costs		(1,443	)		-			(1,443	)		100	%
Other income		15			(1	)		16			-1600	%
Total other expense, net		(483	)		(1,394	)		911			-65	%
Net loss and comprehensive loss		(22,192	)		(2,497	)		(19,695	)		789	%

Revenue ~~— Grant~~ – Grant revenue was recognized in 2024, while no grant revenue was recognized in 2025, ~~while~~as the Company focused on ~~the~~ closing on the ~~Merger transaction~~Business Combination.

Research and Development — – Research and development expenses ~~remained~~increased ~~constant and decreased~~ by $39311 thousand or 976% during the three months ended ~~June~~ September 30, 2025 due to aan ~~reduction~~increase in ~~research~~personnel ~~studies~~and regulatory fees.

General and Administrative — – General and administrative expenses increased by $4120,220 thousand ~~million~~, or 72636%, to $~~610~~20,987 thousand during the three months ended ~~June~~ September 30, 2025 from $~~569~~767 thousand during the three months ended ~~June~~ September 30, 2024. The increase was driven primarily by the increase in ~~accounting~~transaction costs of $15,219 thousand related to the closing of the Business Combination, an increase related to stock based compensation relating to the non-recourse note settlement of $428 thousand, an increase in insurance and legal fees of $294 thousand, an increase in accounting costs of $457 thousand as a result of increased audit fees, $700 thousand increase in general other expenses such as professional consulting services and ~~accounting~~travel ~~fees~~costs, along with $3,395 thousand increase in personnel costs due to additional headcount and transaction completion bonus accruals.

~~Loss~~ Gain on Change in the Fair Value of ~~the~~Related ~~Tasly~~Party Convertible ~~Loans — Loss~~Debt – Gain on change in the fair value of the ~~Tasly~~related ~~Convertible~~party ~~Loan~~convertible ~~was~~loan ~~less than~~was $~~0.1 million~~258 thousand during the three months ended ~~June~~ September 30, 2025. The ~~loss~~gain during the three months ended ~~June~~ September 30, 2025 was driven by the remeasurement of the Tasly Convertible ~~Loans~~Debt, the Ascent PIPE loan, and the Sponsor Working Capital loan.

Interest Expense — – Interest expense ~~increased~~decreased by $~~0.2 million~~904 thousand to $~~1.3 million~~(169) thousand during the three months ended ~~June~~ September 30, 2025 from $(1~~.1 million~~ ,073) thousand during the three months ended ~~June~~ September 30, 2024. The ~~increase~~decrease was primarily due to ~~interest~~the ~~accrued~~repayment of convertible notes upon conversion of the loans on ~~$3.5 million~~July in11, ~~additional senior~~2025 ~~notes~~when ~~that~~the ~~have~~Company ~~been~~successfully ~~issued~~completed the business combination.

9887

~~Comparison~~Financing Costs of– ~~the~~Increased ~~Six months~~by ~~ended June 30~~$1, ~~2025~~443 thousand in relation to the ~~Six months~~issuance ~~ended~~of ~~June 30,~~shares ~~2024~~on the ELOC agreement.

Other Income (expense) – Other income (expense) increased by an immaterial $16 thousand during the three months ended September 30, 2025 relating to income on our operating account.

Comparison of the Nine Months Ended September 30, 2025 to the Nine Months Ended September 30, 2024

The following table sets forth our unaudited condensed consolidated statements of operations and comprehensive loss for the interim periods indicated (in thousands):

	Six Months Ended June 30,						Change
	Nine Months Ended September 30,						Change
	2025			2024			$			%
Revenue	$	—		$	25100		$	(25100	)		(100	)%
Operating expenses:
Research and development	$	~~827~~1,549		$	~~938~~1,349		$	~~(111~~200	)		~~(12~~0	)%
General and administrative		122,~~600~~587			12,~~402~~169			~~198~~20,418			14941	%
Total operating expenses		224,~~427~~136			23,~~340~~518			8720,618			4586	%
Loss from operations		(224,~~427~~136	)		(23,~~315~~418	)		(~~112~~20,718	)		5606	%
Other income (expense)
Loss on change in the fair value of related party Tasly convertible debt		(118	)		(11	)		(107	)		10
Loss on change in the fair value of related party convertible debt		(52	)		(427	)		375			-88	%
Interest expense		(2,~~519~~496	)		(23,~~161~~138	)		~~(358~~642	)		17-20	%
Other income		—			6			(6	)		(100	)%
Gain on change in fair value of warrant liabilities		884			—			884			100	%
Total other expense, net		(2,637	)		(2,166	)		(471	)		22	%
Loss on change in fair value of digital assets		(28	)		—			(28	)		100	%
Net loss	$	(5,064	)	$	(4,481	)	$	(583	)		13	%
Financing costs		(1,443	)		—			(1,443	)		100	%
Other income		15			5			10			200	%
Total other expense, net		(3,120	)		(3,560	)		440			-12	%
Net loss	$	(27,256	)	$	(6,978	)	$	(20,278	)		291	%

Research and Development — – Research and development expenses ~~decreased~~increased by $~~0.1 million~~200 thousand, or 1215%, to $~~0.8 million~~1,549 thousand during the ~~six~~ nine months ended ~~June~~ September 30, 2025 from $~~0.9 million~~1,349 thousand during the ~~six~~ nine months ended ~~June~~ September 30, 2024. The ~~decrease~~increase was driven primarily by the ~~decrease~~increase in ~~CRO~~regulatory and ~~personnel~~ CRO costs of $~~0.1 million~~300 asthousand, aplus ~~result~~laboratory rent costs of $115 thousand, which is in line with the Company’s ~~completion~~intent ofto ~~several~~focus ~~clinical~~on ~~studies~~research and adevelopment ~~reduction~~to ofcomplete ~~personnel~~device ~~while~~functionality and reach the point of commercialization ~~Company~~in ~~focused~~the onnear ~~closing~~future. This increase is then partially offset by personnel costs decrease of $253 thousand as a result of a reduced headcount on the ~~business~~direct ~~combination~~labor and research team.

General and Administrative — – General and administrative expenses increased by $~~0.2 million~~20,418 thousand, or 14941%, to $~~1.6 million~~22,587 ~~during~~thousand during the ~~six~~ nine months ended ~~June~~ September 30, 2025 from $~~1.4 million~~2,169 thousand during the ~~six~~ nine months ended ~~June~~ September 30, 2024. The increase was driven primarily by the increase in ~~accounting~~ transaction closing costs of $~~0.2 million~~15,219 asplus aaccounting ~~result~~fees increase of ~~increased~~$680 ~~audit~~thousand, an increase related to stock-based compensation relating to the non recourse note settlement of $428 thousand, $766 thousand of professional services, an increase to office rent of $49 thousand, and ~~accounting~~a new increase to insurance and legal fees of $129 thousand.

Loss on Change in the Fair Value of ~~the~~Related ~~Tasly~~Party Convertible ~~Loans —~~ Debt – Loss on change in the fair value of ~~the~~related ~~Tasly~~party ~~Convertible~~convertible debt ~~Loan~~ was $~~0.1 million~~ 52 thousand during the ~~six~~ nine months ended ~~June~~ September 30, 2025. The loss during the ~~six~~ nine months ended ~~June~~ September 30, 2025 was driven by the remeasurement of the Tasly Convertible ~~Loans~~Debt, the Ascent PIPE note, and the Northview Sponsor working capital convertible loan.

Interest Expense — Interest expense increased by $0.4 million, or 17%, to $2.5 million during the six months ended June 30, 2025 from $2.1 million during the six months ended June 30, 2024. The increase was primarily due to the $3.5 million in additional senior notes that have been issued.88

~~Other Income — Other~~Interest ~~income~~Expense – Interest expense decreased by ~~less~~$375 ~~than~~thousand, or -20%, to $~~0.1 million~~(2,496) thousand during the ~~six~~ nine months ended ~~June~~ September 30, 2025 from $(3,138) thousand during the nine months ended September 30, 2024. The increase was primarily due to junior and senior convertible notes being converted and settled on July 11, 2025 which reduced quarterly accrued interest on these notes from the usual 12 weeks, down to 1.5 weeks of accrued interest.

Financing Costs – Increased by $1,443 thousand in relation to the issuance of shares on the ELOC agreement.

Other Income (expense) – Other income increased by an immaterial $10 thousand during the nine months ended September 30, 2025 relating to income on our operating account.

Liquidity and Capital Resources

Sources of Liquidity

We incurred net losses and negative operating cash flows from operations since inception, and we expect to continue to incur losses and negative operating cash flows for the foreseeable future until we successfully commence sustainable commercial operations. To date, we have funded our operations primarily with proceeds from the issuance of convertible preferred stock, junior and senior convertible notes, related party loans payable, ELOC, PPP Loans available to us under the Paycheck Protection Program and promissory notes. From inception through ~~June~~ September 30, 2025, we raised gross proceeds of $98.0 million from the issuances of convertible preferred stock and convertible notes and loans, ~~received~~$11 million from related party loans payable, $3.5 million from ELOC, $2.5 million from PPP Loans and ~~received~~ $0.9 million from issuance of promissory notes. As of ~~June~~ September 30, 2025, we had cash ~~and cash equivalents~~ of $03,009 thousand.~~1 million.~~

99Our junior convertible notes bore interest at 12% per annum and their outstanding principal and accrued but unpaid interest automatically converted into shares of Company Common Stock at $7.00 per share upon consummation of the Business Combination. In addition, upon consummation of the Business Combination, all junior noteholders have a right to receive additional shares upon achievement by the Company of certain share price and sales milestones (the earnout shares).

~~Our~~We commenced ~~junior~~issuance of our senior convertible notes in April 2021 and continued issuing them until the Closing. Our senior convertible ~~bear~~notes bore interest at 12% per annum and, ~~as of June 30, 2025,~~ their ~~then~~ outstanding principal and accrued but unpaid interest automatically converted into ~~common~~ shares of ~~New~~Company ~~Profusa~~Common atStock between $70.50 and $4.00 per share upon consummation of the ~~Merger~~Business ~~transaction~~Combination, based on the fixed conversion price defined in the notes. In addition, upon consummation of the ~~Merger~~Business Combination, all ~~junior~~senior noteholders ~~have~~obtained athe right to receive additional shares upon achievement by ~~New~~the ~~Profusa~~Company of certain share price and sales milestones (the earnout shares). ~~We refer you to Footnote 14, Subsequent Events, 14 for the conversion of these notes as of the closing of the Merger on July 11, 2025.~~

WeOn August ~~commenced~~8, ~~issuance~~2023, ofa ~~our senior~~new ~~convertible~~wholly ~~notes~~owned insubsidiary, ~~April 2021~~Profusa Asia Pacific Pte. Ltd (“APAC”), was created and ~~continued~~incorporated ~~issuing~~by ~~them~~Legacy Profusa tounder ~~date~~the laws of Singapore. ~~Our~~Upon ~~senior~~creation, ~~convertible~~the ~~notes~~new ~~bear~~entity ~~interest~~was atcapitalized ~~12%~~by ~~per~~Legacy Profusa by payment of $1,000 for 1,000 Ordinary ~~annum~~Shares. ~~and~~As ~~their~~a ~~then~~result, ~~outstanding~~at ~~principal~~the ~~and~~time ~~accrued~~of ~~but~~incorporation, ~~unpaid~~the ~~interest~~entity ~~automatically~~became ~~converted~~a ~~into~~wholly ~~common~~owned ~~shares~~subsidiary of ~~New~~Legacy Profusa ~~between $0~~.50 ~~and~~The ~~$4.00~~entity ~~per~~was ~~share~~created with ~~upon~~the ~~consummation~~expectation of jointly conducting the ~~Merger~~business ~~transaction~~of developing, ~~which~~manufacturing ~~occurred~~and oncommercializing ~~July 11,~~the ~~2025,~~Lumee ~~based~~Glucose onand the ~~fixed conversion~~Lumee ~~price~~Oxygen ~~defined~~products, incurrently under development by the ~~agreement~~Company, together with a third party. InNo ~~addition,~~business ~~upon~~or ~~consummation~~activities ofwill ~~the~~have ~~Merger,~~been ~~all~~conducted by ~~senior~~the ~~noteholders~~entity ~~obtained~~from the ~~right~~date toof ~~receive~~formation ~~additional shares~~through ~~upon~~and ~~achievement~~until bythe ~~New~~closing ~~Profusa~~date of ~~certain~~the ~~share~~proposed ~~price~~License Agreement and ~~sales~~Shareholders ~~milestones~~Agreement between (the ~~earnout~~Company ~~shares)~~and Best Life Technology Ltd, an entity wholly owned and controlled by the Tasly.

On August 8, 2023, a new wholly owned subsidiary, Profusa Asia Pacific Pte. Ltd (“APAC”), was created and incorporated by the Company under the laws of Singapore. Upon creation, the new entity was capitalized by the Company by payment of $1,000 for 1,000 Ordinary Shares. As a result, at the time of incorporation, the entity became a wholly owned subsidiary of the Company. The entity was created with the expectation of jointly conducting the business of developing, manufacturing and commercializing the Lumee Glucose and the Lumee Oxygen products, currently under development by the Company, together with a third party. No business or activities will have been conducted by the entity from the date of formation through and until the closing date of the proposed License Agreement and Shareholders Agreement between the Company and Best Life Technology Ltd, an entity wholly owned and controlled by the Tasly Holding Group (“Tasly”). Subsequent to the closing of the Merger between the Company and NorthView, the Company expects to sign and execute a License Agreement and Shareholders Agreement (the “APAC Joint Venture”) setting forth the relative and other terms under which the development and business activities of the entity will be conducted.89

~~The~~In ~~Company~~the isevent inwe ~~the~~either ~~process of~~fail ~~negotiating~~to complete the formation of the ~~joint~~APAC ~~venture~~Joint Venture or fail to repay the amounts under the Tasly Convertible Debt when they become due, the lender will have an option to convert the outstanding balance and accrued but unpaid interest (~~“APAC~~in ~~Joint~~part ~~Venture”~~or in full) into senior unsecured promissory notes on substantially the same terms as the outstanding Senior Notes as of September 30, 2025 (which ~~includes~~terms include conversion into Company Common Stock). Notwithstanding the ~~related~~conversion ~~party~~provisions ~~from~~above, ~~which~~any repayment obligations (in part or in full) of the outstanding principal ~~amounts~~balance and accrued but unpaid interest under the Tasly Convertible Debt ~~was~~may, ~~borrowed.~~at ~~The~~the ~~proceeds~~lender’s option, be made through conversion of ~~the~~part ~~loan~~or ~~are~~all ~~intended~~amounts topayable ~~continue~~into (i) senior unsecured promissory notes on substantially the ~~development~~same ~~and~~terms ~~commercialization~~as the outstanding Senior Notes as of ~~the~~September 30, 2025, $0.50 per share, or (ii) Company’s ~~technology~~Common inStock ~~certain~~at ~~countries~~a ofconversion ~~the~~price ~~Asia~~of ~~Pacific~~$1.92 ~~region~~per share.

~~In the event we either fail~~Our tooutstanding ~~complete~~PPP ~~the~~Loan ~~formation~~ of ~~the~~$1.4 ~~APAC~~million ~~Joint~~bears ~~Venture~~interest orat ~~fail~~1% toper ~~repay~~annum. ~~the~~The ~~amounts~~repayment ~~under~~of the ~~Tasly~~PPP ~~Convertible~~Loan ~~Debt~~was ~~when~~expected ~~they~~to ~~become~~be ~~due, the~~made ~~lender~~in ~~will~~equal ~~have~~monthly payments anof ~~option~~principal ~~to convert the outstanding balance~~ and ~~accrued but unpaid~~ interest ~~(in~~from ~~part~~October or25, in2022 ~~full)~~until ~~into~~May ~~senior~~25, ~~unsecured promissory~~2026; ~~notes~~however, onwe ~~substantially~~are ~~the~~currently ~~same~~in ~~terms as~~ the ~~outstanding~~process ~~Senior Notes as~~ of ~~June 30,~~applying ~~2025 (which terms include conversion~~for ~~into~~forgiveness ~~common~~for ~~stock~~this ~~of New Profusa)~~loan.

~~Notwithstanding~~Our outstanding ~~the~~promissory ~~conversion provisions~~notes ~~above,~~accrue ~~any~~interest ~~repayment~~at ~~obligations~~5% ~~(in~~and ~~part~~12% orper inannum, ~~full)~~most of ~~the~~which ~~outstanding~~do ~~principal~~not ~~balance~~have ~~and~~a ~~accrued~~set ~~but~~maturity ~~unpaid~~date. ~~interest under~~Any ~~the~~promissory ~~Tasly~~notes that ~~Convertible~~did ~~Debt~~have ~~may,~~an atinitial ~~the~~maturity ~~lender’s option~~date, bewhich ~~made~~has ~~through~~passed, ~~conversion~~the ofCompany ~~part~~has orverbally ~~all~~agreed ~~amounts~~to ~~payable~~pay ~~into~~off ~~(i) senior unsecured~~these ~~promissory~~loans ~~notes~~subsequent onto ~~substantially~~ the ~~same~~Closing. The ~~terms~~Company asis ~~the~~currently ~~outstanding~~in ~~Senior~~default; ~~Notes as of June 30~~accordingly, ~~2025~~the ~~(which~~Company ~~terms~~classified ~~include conversion~~the ~~into~~entire ~~common~~outstanding ~~stock~~amount ofas ~~New~~a ~~Profusa),~~current orliability ~~(ii) our~~on ~~common~~the condensed ~~stock~~consolidated atbalance ~~a conversion price of $1~~sheets.~~92 per share.~~

~~Our~~Additional funds ~~outstanding~~may ~~PPP~~be ~~Loan~~necessary ~~of $1.4 million~~to ~~bears~~maintain ~~interest~~current atoperations 1%and ~~per~~will ~~annum.~~be ~~The~~required ~~repayment~~for ofsuccessful product commercialization efforts. Subsequent to the ~~PPP~~period ~~Loan~~ended isSeptember ~~expected~~30, to2025, bemanagement ~~made~~obtained inadditional ~~equal~~funds ~~monthly~~from ~~payments~~the ofELOC, ~~principal~~however, conditions exist that raise substantial ~~and~~doubt ~~interest~~about ~~from~~our ~~October 25,~~ability ~~2022~~to ~~until~~continue ~~May 25,~~as ~~2026;~~a ~~however,~~going weconcern ~~are~~within ~~currently~~one inyear from the ~~process~~date ofhereof ~~applying~~and for ~~forgiveness for~~the ~~this~~nine ~~loan~~months ended September 30, 2025 are issued.

Our outstanding promissory notes accrue interest at 5% and 12% per annum, most of which do not have a set maturity date. Any promissory notes that did have an initial maturity date, which has passed, the Company has verbally agreed to pay off these loans subsequent to the consummation of the business combination. The Company is currently in default; accordingly, the Company classified the entire outstanding amount as a current liability on the condensed consolidated balance sheet.

Additional funds may be necessary to maintain current operations and will be required for successful product commercialization efforts. Subsequent to the period ended June 30, 2025, management obtained additional funds as a result of the Business Combination and PIPE investment, which mitigates the relevant conditions or events that raise substantial doubt about our ability to continue as a going concern within one year from the date the unaudited condensed consolidated financial statements as of and for the six months ended June 30, 2025 are issued.

100

Long-Term Liquidity Requirements

We expect our cash and cash equivalents on hand, and cash that we received from the Business Combination and PIPE Investment, together with proceeds from the ELOC and the cash we expect to generate from future operations, will provide sufficient funding to support initial commercial operations. The cash generated from the ~~business~~ ~~combination~~Business Combination includes an initial net $9 million in PIPE proceeds from the first tranche ofand anet ~~convertible note, along with an expected~~ $2 million ~~additional tranche~~ from the ~~PIPE~~second tranche of a convertible note. toThe becash ~~received~~generated ~~within~~from the ~~nine months~~ELOC ~~ended~~was ~~September 30,~~$3.5 million in ~~2025~~the third quarter. Until we generate sufficient operating cash flow to cover our operating expenses, working capital needs and planned capital expenditures, or if circumstances evolve differently than anticipated, we expect to utilize a combination of equity and debt financing to fund any future capital needs. If we raise funds by issuing equity securities, dilution to stockholders may result. Any equity securities issued may also provide for rights, preferences, or privileges senior to those of holders of ~~common~~Common ~~stock~~Stock. If we raise funds by issuing debt securities, these debt securities may have rights, preferences, and privileges senior to those of common stockholders. The terms of debt securities or borrowings could impose significant restrictions on our operations. The capital markets are currently experiencing, and may continue to experience in the future, periods of upheaval that could impact the availability and cost of equity and debt financing.

Our principal uses of cash in recent periods have been funding our research and development activities, legal and bank transaction fees, and other personnel cost. Near-term capital requirements through ~~June~~ September 30, 2025 leading to and supporting initial commercialization are estimated to total approximately $719.3 4 million and include further research and development to enable us to obtain the required regulatory approvals, manufacturing, commercialization and wide-scale marketing for our Lumee Oxygen and Lumee Glucose devices. Our future capital requirements will depend on many factors, including our revenue growth rate, the timing and the amount of cash received from our customers, the expansion of sales and marketing activities, the timing and extent of spending to support development efforts. In the future, we may enter into arrangements to acquire or invest in complementary businesses, products, and technologies. For any periods after the twelve months subsequent to ~~the~~this filing ~~of these financial statements as of June 30~~, ~~2025,~~ we may be required to seek additional equity or debt financing. In the event that we require additional financing we may not be able to raise such financing on acceptable terms or at all. If we are unable to raise additional capital or generate cash flows necessary to continue our research and development and invest in continued innovation, we may not be able to compete successfully, which would harm our business, results of operations, and financial condition. If adequate funds are not available, we may need to reconsider our production investments, the pace of our production ramp-up, expansion plans or limit our research and development activities, which could have a material adverse impact on our business prospects and results of operations.

Cash Flow Summary

The following table summarizes our cash flows for the periods presented (in thousands):

	Six Months Ended June 30,
	For the nine months ended,
	2025			2024			Change $			Change %
Net cash provided by (used in):
Net cash used in operating activities	$	(11,119	)	$	(1,828	)	$	(9,291	)		508	%
Operating activities	$	(1,126	)	$	(1,008	)
Net cash used in investing activities	$	(1,000	)	$	—		$	(1,000	)		-
Investing activities	$	—		$	—
Net cash provided by financing activities	$	14,937		$	1,826		$	13,111			718	%
Financing activities	$	974		$	904

Operating Activities

Cash used in operating activities for the ~~six~~ nine months ended ~~June~~ September 30, 2025 of $111.1 million was primarily driven by our net loss of $527.1 3 million, adjusted for non-cash charges of $210.7 million and net cash inflows of $15.2 4 million provided by changes in our operating assets and liabilities. Non-cash charges primarily consisted of non-cash interest expense of $2.5 million, ~~and~~ the change in the fair value of related ~~party~~ party convertible loan of $0.2 million, net with $7.6 million in non-cash issuance of shares through the private placement and issuance of shares associated with transaction costs, 1 .0 million in non-cash issuance of ELOC Warrants, stock-based compensation of $0.7 million, and offset by a gain on fair value of warrant liabilities of $0.9 million. The main driver of the cash inflows from the changes in operating assets and liabilities was primarily related to an increase in accounts payable of $13.0 2 million and in accrued liabilities of $02.3 ~~million~~ million and a decrease in prepaid expenses and other current assets of less than $0.1 million.

Cash used in operating activities for the ~~six~~ nine months ended ~~June~~ September 30, 2024 of $1.0 8 million was primarily driven by our net loss of $47.5 0 million, adjusted for non-cash charges of $23.2 6 million and net cash inflows of $1.3 5 million provided by changes in our operating assets and liabilities. Non-cash charges primarily consisted of non-cash interest expense of $23.2 million, partially offset by change in the fair value of related party convertible loan of ~~less than~~ $0.1 3 million. The main driver of the cash inflows from the changes in operating assets and liabilities was primarily related to an increase in accounts payable of $0.5 7 million and in accrued liabilities of $01.8 1 million and a decrease in prepaid expenses and other current assets of $0.1 3 million.

101

Financing Activities

Cash provided by financing activities was $114.0 9 million the ~~six~~ nine months ended ~~June~~ September 30, 2025, which consisted primarily of net proceeds from the issuance of senior notes, ofPIPE ~~$1.4 million~~proceeds, ~~offset~~ELOC byproceeds, ~~payment~~and the close of ~~deferred~~the ~~offering~~business ~~costs~~combination of(as $0discussed above).~~4 million.~~

Cash provided by financing activities was $01.9 8 million for the ~~six~~ nine months ended ~~June~~ September 30, 2024, which consisted primarily of net proceeds from the issuance of senior notes of $12.1 million, offset by payment of deferred offering costs of $0.1 million and repayment of related party promissory notes of $0.1 2 million.

Contractual Obligations

The following table summarizes our contractual obligations as of ~~June~~ September 30, 2025, and the years in which these obligations are due (in thousands):

	Total		2025		~~Thereafter~~2026
Convertible notes	$	19,533	$	19,533	$	—
Tasly Convertible Debt - Related Party	$	2,207	$	2,207	$	—
Tasly convertible loan		2,543		2,543		—
Convertible promissory note - related party		1,920		1,920
Senior notes		27,895		27,895		—
Loans payable - related party		14,359		—		14,359
Promissory notes		940		940		—
Senior notes		154		154		—
PPP loan		1,383		1,383		—
Promissory notes		1,045		1,045		—
Total contractual obligations	$	52,294	$	52,294	$	—
PPP loan		1,386		1,386		—
Total contractual obligations	$	21,071	$	6,712	$	14,359

Critical Accounting Estimates

Management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.

We consider an accounting estimate to be critical if: (1) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (2) changes in the estimate that are reasonably likely to occur from period to period, or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations.

Management has discussed ~~the development~~several ~~and~~significant ~~selection of these critical~~ accounting estimates ~~with~~and believes that the ~~Audit~~fair ~~Committee~~value of ~~our~~the ~~Board~~related ofparty ~~Directors.~~Ascent InPIPE ~~addition, there~~Convertible ~~are~~note ~~other~~is ~~items~~the ~~within~~only ~~our~~accounting ~~financial~~estimate ~~statements~~ that ~~require~~rises ~~estimation,~~to ~~but~~the ~~are~~level ~~not~~of ~~deemed~~a critical asaccounting ~~defined above~~estimate. ~~Changes in estimates used in these and other items could have a material impact on our financial statements.~~

~~Fair~~The related ~~Value~~party convertible loan is carried at fair value based on unobservable market inputs. The fair value of ~~Financial~~financial ~~Instruments~~instrument is determined using various valuation techniques, including the market approach. Where observable market prices are not available, we use models that incorporate assumptions about credit risk, interest rates, and market volatility. These estimates require significant judgment, particularly for instruments classified as Level 3 in the fair value hierarchy. Changes in these assumptions could materially affect the reported fair values and related income or expense. We regularly review and update our valuation to reflect current market conditions and ensure consistency with accounting standards.

The Company’s financial instruments consist of other receivables, accounts payable, promissory notes, convertible promissory notes and senior notes. The Company states accounts payable at their carrying value, which approximates fair value due to the short time to the expected payment. The promissory notes are stated at amortized cost, which approximates their fair value, because the Company believes their terms approximate those that would be available to it on a similar loan from an unrelated party.92

~~102~~Management considered various fair value instruments; however, only the Ascent PIPE convertible note is both classified as a Level 3 fair value instrument and is considered very material, and individually over $5.0 million. The Ascent PIPE convertible loan was valued at $14.4 million as of September 30, 2025, and is a new loan that was issued on the Closing Date. As such, we have one critical accounting estimates to report, and have included our considerations below.

Filing Compare · Profusa, Inc.