As filed with the Securities and Exchange Commission on ~~April~~February 2427, ~~2023~~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~~STATEMENT

~~MODULAR~~UNDER ~~MEDICAL,~~THE ~~INC.~~SECURITIES ACT ~~(Exact~~OF ~~name~~1933 ~~of registrant as specified in its charter)~~

MODULAR MEDICAL INC.

(Exact name of registrant as specified in its charter)

Nevada		3841		87-0620495
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

~~10740~~10470 Thornmint ~~Drive~~Road

San Diego, California 92127

Tel: (858) 800-3500

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

area code, of registrant’s principal executive offices)

James E. Besser

Chief Executive Officer

~~10740~~Modular ~~Thornmint~~Medical ~~Drive~~Inc.

10740 Thornmint Road

San Diego, California 92127

(858) 800-3500

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

~~number, including~~Copies ~~area code, of agent for service)~~to:

With copies to:

Joseph Lucosky	Barry Grossman
Lawrence Metelitsa	Matthew Bernstein
Lucosky Brookman LLP	Ellenoff Grossman & Schole LLP
100 Wood Avenue South	1345 Avenue of the Americas
Woodbridge, NJ 08830	New York, NY 10105
Tel: (732) 395-4400	Tel: (212) 370-1300

~~Joseph~~Approximate ~~Lucosky~~date ~~Lawrence~~of ~~Metelitsa~~commencement ~~Lucosky~~of ~~Brookman~~proposed sale ~~LLP~~to ~~101~~the ~~Wood~~public: ~~Avenue~~As ~~South~~soon ~~Woodbridge,~~as NJpracticable ~~08830~~after ~~(732)~~this ~~395-4400~~registration ~~Stephen~~statement E.is ~~Older~~declared ~~David S~~effective. ~~Wolpa McGuireWoods LLP 1251 Avenue of the Americas, 20th Floor New York, NY 10020 (212) 548-2100~~

AsIf ~~soon~~any asof ~~practicable after~~ the ~~effective~~securities ~~date~~being ofregistered on this ~~registration~~Form ~~statement~~are ~~(Approximate~~to ~~date~~be ofoffered ~~commencement~~on ofa ~~proposed~~delayed ~~sale~~or continuous basis pursuant to Rule 415 under the ~~public)~~Securities Act of 1933 check the following box: ☒

If ~~any~~ ofthis ~~the~~Form ~~securities~~is ~~being~~filed ~~registered~~to onregister ~~this~~additional securities ~~Form~~for ~~are~~an offering pursuant to beRule ~~offered~~462(b) onunder athe ~~delayed~~Securities orAct, ~~continuous~~please ~~basis~~check ~~pursuant~~the tofollowing ~~Rule~~box ~~415~~and ~~under~~list the Securities Act registration statement number of ~~1933,~~the ~~check~~earlier effective registration statement for the ~~following~~same ~~box~~offering. ☒☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) 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(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~~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. ☐

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

The information in this preliminary prospectus is not complete and may be changed. We 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~~these ~~does~~securities itand ~~seek~~we are not soliciting an offer to ~~buy~~ buy these securities in any state or jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED FEBRUARY 27, ~~2023~~ 2026

PRELIMINARY PROSPECTUS

~~Units~~ MODULAR MEDICAL, INC.

~~Each~~Up ~~Unit~~to ~~Consisting~~23,571,007 of ~~Two~~ Shares of Common ~~Stock~~ Stock and Accompanying

~~One~~Common ~~Warrant~~Warrants to Purchase ~~One~~up ~~Share~~to 23,571,007 Shares of Common Stock

We are offering units (each a “unit” and collectively, the “units”) of Modular Medical, Inc. (the “Company,” “Modular Medical,” “we,” “our” or “us”) with each unit consisting of two shares of our common stock, par value $0.001 per share, which we refer to as the “common stock,” and one warrant (a “warrant”) to purchase one share of our common stock. The public offering price is $ per unit. The units have no stand-alone rights and will not be certificated or issued as stand-alone securities. We do not intend to apply for listing of the warrants on any national securities exchange. The shares of our common stock and the warrants comprising the units will be issued separately. The warrants included in the units are exercisable immediately, will expire five years from the date of issuance and have an exercise price of $ per share ( % of the price per unit sold in this offering.) This offering also includes the shares of common stock issuable from time to time upon exercise of the warrants. The warrants will be issued in book-entry form pursuant to a warrant agency agreement between us and Colonial Stock Transfer Company, Inc. as warrant agent.

~~Our~~Up ~~common~~to ~~stock is listed on the Nasdaq Capital Market~~23, ~~or Nasdaq~~571, ~~under~~007 ~~the symbol “MODD.” On April 21, 2023, the last reported sale price~~ of ~~our~~Pre-Funded ~~common~~Warrants ~~stock was $1.90 per share. The public offering price per unit will be determined at the time of pricing and may be at a discount~~ to ~~the current market price. The recent market~~ ~~price~~Purchase ~~used~~Shares ~~throughout this prospectus may not be indicative~~ of ~~the~~Common ~~final~~Stock ~~offering price. There is no established trading market for the warrants,~~ and ~~we do not expect a market to develop.~~Accompanying

	Effective Price Per Share and Accompanying Warrant	Total
Public offering price(1)	$	$
Underwriting discounts and commissions(2)	$	$
Proceeds to us (before expenses)	$	$

Common Warrants to Purchase up to 23,571,007 Shares of Common Stock

~~(1) Based on a price of $ per unit, with each unit consisting of two (2) shares of common stock~~ and ~~one warrant to purchase one share of common stock.~~

~~(2)~~Up ~~The~~to ~~underwriter~~47,142,014 ~~will~~Shares ~~receive~~of ~~compensation~~Common inStock ~~addition~~Issuable Upon toExercise of the ~~underwriting~~Pre-Funded ~~discount.~~Warrants ~~See~~and ~~“Underwriting”~~Common ~~beginning on page 70.~~Warrants

~~(3)~~We ~~The~~are ~~amount~~offering on a best-efforts basis up to $12,000,000 of shares ~~offering~~of ~~proceeds~~our common stock, or up to us23,571,007 ~~presented~~shares inof ~~this~~common ~~table~~stock, ~~does~~par ~~not~~value ~~give~~$0.001, ~~effect~~or “common stock”, and accompanying warrants to ~~any~~purchase ~~exercise~~up to 23,571,007 shares of common stock, or the: ~~(i)~~“common ~~over-allotment~~warrants”, ~~Option~~pursuant weto this ~~have~~prospectus. ~~granted~~The assumed combined public offering price for each share of our common stock, together with a common warrant to purchase one share of common stock, is $0.5091, which represents the ~~underwriter~~last reported sale price of our common stock as ~~described~~reported ~~below~~on the Nasdaq Capital Market on February 19, 2026. Each common warrant will have an exercise price of $ per share, will be exercisable immediately upon issuance and ~~(ii)~~will expire on the ~~Underwriter’s~~fifth ~~Warrants~~anniversary ~~(as~~of ~~defined~~the ~~herein)~~date ~~being~~of issuance. The shares of our common stock and the common warrants are immediately separable and will be issued separately, but will be purchased together in this offering. This prospectus also relates to the ~~underwriter~~offering asof ~~described~~the ~~below~~shares of common stock issuable upon exercise of the common warrants.

~~Investing~~We are also offering pre-funded warrants to purchase up to an aggregate of 23,571,007 shares of common stock, or the “pre-funded warrants” (together with the common warrants, the “warrants”), in lieu of shares of common stock to those purchasers whose purchase of shares of common stock in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our ~~securities~~outstanding ~~involves~~shares of common stock following the consummation of this offering. A holder of pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if the holder, together with its affiliates and certain related parties, would beneficially own in excess of 4.99% (or, at the election of the holder, 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise. Each pre-funded warrant is exercisable for one share of our common stock. Each pre-funded warrant is being issued together with the same common warrant described above being issued with each share of common stock. For each pre-funded warrant that we sell, the number of shares of common stock that we are selling will be decreased on a ~~high~~one-for-one basis. The assumed combined public ~~degree~~offering price of ~~risk~~each pre-funded warrant, together with the accompanying common warrant, is $0.5081, ~~See~~which ~~“Risk~~represents ~~Factors~~the last reported sale price of our common stock as reported on the Nasdaq Capital Market on February 19, 2026 minus $0.001, which will be the per share exercise price of each pre-funded warrant. The pre-funded warrants are immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The pre-funded warrants and the common warrants are immediately separable and will be issued separately, but will be purchased together in this offering. In this prospectus, we refer to the common warrants and pre-funded warrants together as the “warrants.” ~~beginning~~This onprospectus ~~page~~also 10relates to the offering of common stock issuable upon exercise of such warrants. We collectively refer to the shares of common stock and warrants offered hereby and the shares of common stock underlying the warrants as the “securities.”

~~Neither~~We have engaged Maxim Group LLC (the ~~Securities~~“placement agent” ~~and~~or ~~Exchange~~“Maxim”) ~~Commission~~to act as our exclusive placement agent in connection with this offering. The placement agent has ~~nor~~agreed ~~any~~to ~~state~~use its reasonable best efforts to arrange for the sale of the securities ~~commission~~offered ~~has~~by ~~approved~~this prospectus. The placement agent is not purchasing or ~~disapproved~~selling any of ~~these~~the securities orwe ~~passed~~are ~~upon~~offering and the ~~adequacy~~placement agent is not required to arrange the purchase or ~~accuracy~~sale of any specific number of securities or dollar amount. We have agreed to pay the placement agent the fees set forth in the table below, which assumes that we sell all of the securities offered by this prospectus. ~~Any~~ ~~representation~~There is no arrangement for funds to be received in escrow, trust or similar arrangement. There is no minimum offering requirement as a condition of closing of this offering. We may sell fewer than all of the ~~contrary~~securities offered hereby, which may significantly reduce the amount of proceeds received by us. Because there is no escrow account and no minimum number of securities or amount of proceeds, investors could be in a ~~criminal~~position ~~offense~~where they have invested in us, but we have not raised sufficient proceeds in this offering to adequately fund the intended uses of the proceeds as described in this prospectus. See “Risk Factors” for more information regarding risks related to this offering. We will bear all costs associated with the offering. See “Plan of Distribution” for more information regarding these arrangements.

~~The~~There ~~underwriter~~is ~~expects~~no established public trading market for the warrants, and we do not expect a market to ~~deliver~~develop. We do not intend to apply for listing of the ~~units~~warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the warrants will be limited. Our common stock is listed on the Nasdaq Capital Market under the symbol “MODD.” We have assumed a public offering price of $0.5091 per share of common stock together with a common warrant to purchase one share of common stock, which represents the last reported sale price of our common stock as reported on the Nasdaq Capital Market on February 19, 2026. The final public offering price will be determined through negotiation between us, the placement agent and investors in the offering and may be at a discount to the current market price. Therefore, the recent market price used throughout this prospectus may not be indicative of the final public offering price. The price of our common stock on orthe ~~about~~ Nasdaq Capital Market during recent periods will only be one of many factors in determining the final public offering price. Other factors to be considered in determining the final public offering price include our history, our prospects, ~~2023~~the industry in which we operate, our past and present operating results, the previous experience of our executive officers and directors, the general condition of the securities markets at the time of this offering and discussions between the placement agent and prospective investors.

~~Sole~~We ~~Book-Running~~are ~~Manager~~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 comply with reduced public company reporting requirements in future filings. See “Prospectus Summary⸺Implications of Being a Smaller Reporting Company.”

~~Newbridge~~Investing ~~Securities~~in our securities involves a high ~~Corporation~~degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks that we have described beginning on page 11 of this prospectus under the caption “Risk Factors”, under similar headings in any amendment or supplement to this prospectus and in the documents incorporated by reference into this prospectus.

The date of this prospectus is , 2023

Per Share and
Accompanying
Common
Warrant

Per
Pre-Funded
Warrant and
Accompanying
Common
Warrant

Total

Public offering price

Placement agent fees⁽¹⁾

Proceeds to us, before expenses⁽²⁾

(1)	We have agreed to provide the placement agent a cash placement commission up to 7.0% of the public offering price. We have also agreed to reimburse the placement agent for certain expenses in the amount of up to $100,000. See “Plan of Distribution” on page 51 for additional information regarding placement agent compensation.

(2)	The above summary of offering proceeds does not give effect to any proceeds from the exercise of the warrants being issued in this offering.

Neither the Securities and Exchange Commission (“SEC”) 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 placement agent expects to deliver the securities against payment in New York, New York on or about February 27, 2026, subject to the satisfaction of customary closing conditions.

Sole Placement Agent

Maxim Group LLC

The date of this prospectus is , 2026.

TABLE OF CONTENTS

	PAGE
ABOUT THIS PROSPECTUS	ii
PROSPECTUS SUMMARY	1
THE OFFERING	69
SUMMARY FINANCIAL DATA	7
RISK FACTORS	11
RISK FACTORS	10
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS	34
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS	26
USE OF PROCEEDS	35
USE OF PROCEEDS	27
DIVIDEND POLICY	35
DIVIDEND POLICY	28
CAPITALIZATION	36
CAPITALIZATION	29
DILUTION	38
DILUTION	30
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT	40
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	31
DESCRIPTION OF CAPITAL STOCK	41
BUSINESS	35
DESCRIPTION OF OUTSTANDING WARRANTS	45
MANAGEMENT	56
DESCRIPTION OF THE SECURITIES WE ARE OFFERING	48
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS	67
PLAN OF DISTRIBUTION	51
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT	68
LEGAL MATTERS	55
DESCRIPTION OF SECURITIES WE ARE OFFERING	70
EXPERTS	55
UNDERWRITING	71
WHERE YOU CAN FIND MORE INFORMATION	55
LEGAL MATTERS	74
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE	56
EXPERTS	74
WHERE YOU CAN FIND MORE INFORMATION	74
INDEX TO FINANCIAL STATEMENTS	F-1
PART II INFORMATION NOT REQUIRED IN PROSPECTUS	II-1

We have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses we have prepared. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the units offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date.

For investors outside the United States: We have not, and the underwriter has not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the units and the distribution of this prospectus outside of the United States.

Market and Other Industry Data

Unless otherwise indicated, market data and certain industry forecasts used throughout this prospectus were obtained from various sources, including from internal surveys, market research, consultant surveys, publicly available information and industry publications and surveys. While we believe these sources to be reliable, the accuracy and completeness of such information is not guaranteed. We have not independently verified any of the data from third-party sources nor have we ascertained the underlying economic assumptions relied upon therein. Similarly, internal surveys, industry forecasts and market research, which we believe to be reliable based upon our management’s knowledge of the industry, have not been independently verified. The future performance of the industry and markets in which we operate and intend to operate is necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the sections titled “Risk Factors” and “Special Note Regarding Forward-looking Statements” and elsewhere in this prospectus. These and other factors could cause results to differ materially from those expressed in these publications and reports.

All brand names or trademarks appearing in this prospectus are the property of their respective holders. Use or display by us of other parties’ trademarks, trade dress, or products in this prospectus is not intended to, and does not, imply a relationship with, or endorsements or sponsorship of, us by the trademark or trade dress owners.

ABOUT THIS PROSPECTUS

The registration statement we filed with the Securities and Exchange Commission, or the SEC, includes exhibits that provide more detail of the matters discussed in this prospectus. You should read this prospectus and the related exhibits filed with the SEC and the documents incorporated by reference herein before making your investment decision. You should rely only on the information provided in this prospectus or any amendment thereto.

We have not, and the placement agent has not, authorized anyone to provide any information or to make any representations other than those contained in this prospectus or incorporated by reference herein or in any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the securities offered hereby, and only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus or incorporated by reference herein or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of our securities. Our business, financial condition, results of operations and prospects may have changed since that date.

The information provided or incorporated by reference in this prospectus contains statistical data and estimates, including those relating to market size and competitive position of the markets in which we participate, that we obtained from our own internal estimates and research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Industry publications, studies and surveys generally state that they have been obtained from sources believed to be reliable. While we believe our internal company research is reliable and the definitions of our market and industry are appropriate, neither this research nor these definitions have been verified by any independent source.

For investors outside the United States: we have not, and the placement agent has not, done anything that would permit this offering or 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 and the distribution of this prospectus outside the United States.

This prospectus contains or incorporated by reference 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 or will be filed or have been 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 in this prospectus under the heading “Where You Can Find More Information.”

Unless the context otherwise requires, references to “Modular,” “we,” “our,” “us” or the “Company” in this prospectus mean Modular Medical, Inc. and its consolidated subsidiary.

PROSPECTUS SUMMARY

~~This~~ The following summary highlights ~~selected~~ information contained elsewhere in this prospectus and does not contain all of the information that you should consider ~~before~~in making your investment decision. Before investing in our securities, you should carefully read this entire prospectus, including our consolidated financial statements and the ~~information~~related ~~set~~notes ~~forth~~and other documents incorporated by reference herein, as well as the information under the caption “Risk Factors” herein and ~~“Management’s~~under ~~Discussion~~similar ~~and~~headings ~~Analysis~~in ofthe ~~Financial Condition~~other ~~and~~documents ~~Results~~that ofare ~~Operations”~~incorporated ~~sections~~by ofreference into this prospectus ~~and~~including documents ~~our~~that ~~consolidated~~are ~~financial~~filed ~~statements~~after ~~and~~ the ~~accompanying notes~~date ~~included~~hereof. Some of the statements in this prospectus constitute forward-looking statements that involve risks and uncertainties. ~~Except~~See as“Cautionary ~~otherwise~~Note ~~indicated~~Regarding ~~herein~~Forward-Looking orStatements.” asOur ~~the~~actual ~~context~~results ~~otherwise~~could ~~requires,~~differ materially ~~references~~from those anticipated in ~~this~~such ~~prospectus to~~forward-looking ~~“Modular~~statements ~~Medical,”~~as ~~the~~a ~~“Company,”~~result ~~“we,”~~of ~~“us~~certain factors,” ~~and~~including ~~“our”~~those ~~refer~~discussed toin ~~Modular~~the ~~Medical,~~“Risk ~~Inc.~~Factors” and ~~its~~other ~~wholly-owned~~sections ~~subsidiary,~~included ~~Quasuras,~~in ~~Inc~~or incorporated by reference herein.

Overview

~~Modular~~We ~~Medical~~are is a ~~development~~pre-~~stage,~~revenue medical device company focused on the design, development, and commercialization of an innovative insulin ~~pump~~pumps using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two- part patch pump, ~~our~~we ~~MODD1~~seek ~~product candidate, or “MODD1,” the Company seeks~~ to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care that presently -available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training, and day-to-day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass market. The product ~~candidate~~ seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for our initial product, our MODD1, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States. In August 2025, we announced the first human use of our MODD1 pump delivering insulin to a human patient. In addition, in August 2025, we announced our next-generation patch pump, branded as Pivot. We submitted a 510(k) premarket notification to the FDA for our Pivot product on November 13, 2025, when the United States government shutdown ended. We intend to initiate our commercial launch with the Pivot product, after the required regulatory approval from the FDA is received, which is expected by March 31, 2026 or shortly thereafter. We are actively working to i) obtain regulatory clearance and prepare to commence commercialization of our Pivot product, ii) obtain regulatory clearance to market and sell our Pivot product in foreign jurisdictions, iii) improve the manufacturability and usability of our Pivot product and iv) develop new pump products.

~~Differentiation~~Historically, we have financed our operations principally through private placements and public offerings of our common stock and warrants and sales of convertible promissory notes. Based on our current operating plan, substantial doubt about our ability to continue as a going concern for a period of at least one year from the date that the financial statements included in Item 1 of this Report are issued exists. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities, to support our future operations. If we are unable to secure additional capital, we will be required to curtail our research and development initiatives and take additional measures to reduce costs. We have provided additional disclosure in Note 1 to the consolidated financial statements in Item 1 of this Report and under Liquidity below.

We ~~believe~~do ~~that~~not ~~there~~currently ~~are~~have arevenues ~~number~~to ~~of shortcomings~~generate ~~and~~cash ~~issues~~flows ~~with~~to ~~currently~~cover ~~available~~operating ~~insulin~~expenses. ~~pumps~~Since ~~that~~our ~~prevent~~inception, awe ~~substantial~~have ~~number~~incurred ofoperating ~~people~~losses ~~who~~and ~~require~~negative ~~insulin~~cash onflows ain ~~daily~~each ~~basis~~year ~~from~~due ~~choosing~~to anoperating ~~insulin~~expenses ~~pump~~and capital expenditures incurred to ~~treat~~conduct ~~their~~our ~~diabetes~~operations. We ~~believe~~incurred ~~that~~net bylosses ~~tailoring~~of ~~our~~approximately ~~insulin~~$21.9 ~~pump~~million for tothe ~~address~~nine ~~such~~months ~~factors~~ended December 31, we2025 ~~can~~and ~~expand~~ approximately $18.8 million for the ~~scope~~year ended March 31, 2025, and ~~adoption~~we ~~rate~~had ofan ~~insulin~~accumulated deficit ~~pump~~of ~~usage~~approximately $106.6 Wemillion ~~believe~~as ~~that~~of toDecember ~~achieve~~31, ~~broader~~2025. ~~market~~These ~~acceptance,~~and anprior ~~insulin~~year ~~pump~~losses ~~must~~have ~~improve~~resulted in significant negative cash ~~the~~flows ~~clinical~~and ~~experience~~have necessitated that we raise substantial amounts of ~~the~~additional ~~user,~~capital beduring ~~easier~~this toperiod. ~~learn~~This ~~and~~raises ~~use,~~significant ~~less~~doubt about ~~time-consuming~~our ability to ~~operate~~continue as a going concern, ~~more~~which ~~intuitive~~was toalso ~~both~~expressed ~~patients~~by ~~and~~our independent registered public accounting firm in its ~~physicians,~~report ~~and~~on ~~meet~~our ~~the~~consolidated ~~standards~~financial statements for ~~coverage~~the byyear ~~insurance~~ended ~~providers~~March so31, ~~that~~2025. ~~co-payments~~Our ~~required~~ability ~~from~~to ~~patients~~continue ~~are~~as ~~affordable~~a ~~and~~going concern depends ~~the~~on ~~hurdles~~our ability to ~~insurance~~raise ~~coverage~~additional ~~are~~capital, ~~significantly~~through ~~reduced~~the sale of equity or debt securities to support our future operations.

Among the more prominent issues are:

● Complexity: Many existing pumps are highly complex and require significant technical expertise to use effectively. We believe such pumps were designed for “super users,” who have high levels of motivation, technical competence and premium insurance coverage. The complexity of pumps proves daunting to less technically inclined users.

● Cumbersome: We believe that a majority of existing pumps are bulky and difficult to manage, in many cases requiring a pouch to hold the pump and up to 48 inches of tubing. The tubing and the cartridge, which holds the insulin, must be replaced every few days. This requires users to carry spare parts and other equipment adding to the difficulty of using the pump. In comparison, our product only requires a cartridge change every few days.

● Cost: Costs associated with insulin pump therapy are high and can be prohibitive, especially for those on fixed or limited incomes. These costs vary by pump, but multi-thousand-dollar upfront payments, often with substantial co-payments in addition to co-payments on consumables, can easily place current pumps out of reach for patients. This can lead to limited or restricted reimbursement/coverage and high hurdles for the patients, whom could benefit the most, to gain access.

Our team has substantial knowledge of the diabetes industry and experience in developing, obtaining regulatory authorization for, and bringing insulin pumps to market. Based on this experience, we believe that our innovative insulin pump, using a new, low cost and proprietary method of pumping insulin, can address most or all of these shortcomings. It provides a state-of-the-art insulin pump capable of both basal (steady flow) and bolus (mealtime dosing) insulin disbursement. It also has been designed considering a natural migration path to multi-chamber/multi-liquid pumps, potentially offering an exciting array of new therapies to patients with diabetes and other conditions in the future.Products

~~Our~~Instead of building ~~goal~~complex, isbespoke, and difficult to ~~become~~manufacture and maintain pumping and control systems, we began with the ~~leader~~technology and the user in mind. ~~expanding~~Using ~~access~~proprietary tomethods of insulin ~~pump~~measurement, ~~technology~~we were able to aeschew ~~wider~~complex ~~portion~~mechanisms ofand ~~diabetes~~instead ~~sufferers~~built ~~and~~our ~~provide~~pump ~~not~~products, ~~just~~using ~~care~~only ~~for~~parts ~~the~~from ~~super~~high ~~users~~volume consumer electronics manufacturing lines, ~~but~~breaking ~~“diabetes~~the ~~care~~cost ~~for~~vs functionality curve that has existed in the ~~rest~~insulin pump space and representing the first truly modern insulin pump design. We consider this to be a new kind of usproduct for a new kind of patient.”

~~The~~We ~~MODD1~~have ismoved our production line for our Pivot product to our manufacturing partner, Phillips Medisize, a ~~high~~Molex company, a large tier-~~precision~~one ~~product~~medical ~~that~~device wemanufacturer, ~~believe~~which ~~represents~~will ~~the~~manage ~~best~~and ~~choice~~operate our production to produce products for ~~new~~human ~~pump~~use. ~~patients~~We ~~because~~believe itthat isPhillips ~~easy~~Medisize will be able to ~~afford,~~rapidly scale ~~easy~~our production to ~~learn,~~higher ~~easy~~volumes at lower cost. We continue to ~~use,~~devote substantial time and ~~has~~resources, aincluding ~~revolutionary~~exhibiting at major ~~design~~diabetes ~~and~~conferences, ~~technology~~to ~~that~~better ~~enable~~understand ~~precision~~the ~~with~~needs ~~low-cost~~and ~~manufacture~~preferences of Almost Pumpers and ~~high~~the ~~reproducibility~~specific patient/provider/payor requirements to motivate change from MDI therapy. By making the bolus delivery at meals simple, we believe we will drive improved health outcomes.

~~Diabetes Classifications~~Our ~~and~~Pivot ~~Therapies~~product has several distinguishing features:

~~Diabetes~~1. The ispump ~~typically~~has ~~classified~~a simple button to press to deliver insulin as ~~either~~the ~~type~~patient 1,requires orit. ~~“T1D,”~~The electronic pump uses a simple motor for rotating ora ~~type~~cam 2to motivate the insulin into the patient along with low power Bluetooth and near-field communication (NFC) chips to optionally allow the patient to communicate with a smart phone, tablet, or ~~“T2D”:~~other mobile computing device.

●2. The ~~T1D~~pump issnaps antogether ~~auto~~with a three-~~immune~~day ~~condition~~disposable ~~characterized~~cartridge, bywhich the ~~body’s~~patient ~~nearly~~fills ~~complete~~with ~~inability~~insulin tofor ~~produce insulin~~delivery. It isincludes ~~frequently~~a ~~diagnosed~~simple coin ~~during childhood or adolescence~~cell, ~~but~~which ~~can~~allows ~~also~~it ~~onset~~to inrun ~~adulthood.~~through ~~Individuals~~the ~~with~~80-hour ~~T1D~~life ~~require~~of ~~daily~~the ~~insulin therapy to survive~~cartridge.

● T2D represents over 90% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly utilize insulin or produce sufficient insulin. Initially, many people with T2D attempt to manage their condition with improvements in diet and exercise and/or the use of oral medications and/or injection of glucagon-like peptide-1 (GLP-1) drugs. However, as their diabetes advances, patients often progress to requiring insulin therapies such as once-daily long-acting insulin and ultimately to intensified mealtime rapid-acting insulin therapy. This represents an important portion of the diabetes market in the United States with an estimated 1.6 million T2D intensively treated (multiple daily injections) with insulin.

Glucose, the primary source of energy for cells, must be maintained at certain levels in the blood in order to permit optimal cell function and health. In people with diabetes, blood glucose levels are not well controlled and frequently become very high, a condition known as hyperglycemia, and very low, a condition called hypoglycemia. Hyperglycemia can lead to serious long-term complications, including blindness, kidney disease, nervous system disorders, occlusive vascular diseases, lower-limb amputation, stroke, cardiovascular disease, and death. Hypoglycemia can lead to confusion or loss of consciousness, often requiring a visit to the emergency room or, in certain cases, result in seizures, coma, and/or death.

All people with T1D, which is our primary market, require daily insulin. According to the Seagrove 2021 Diabetes Blue Book, approximately 18% of people with T2D in the United States, or approximately 4.7 million people, also require insulin. These 4.7 million people comprise 3.1 million who require multiple daily injections (“MDI”) and the remainder, 1.6 million, who require basal delivery only to manage their diabetes. In this prospectus, we refer to people with T1D and people with T2D who require mealtime insulin as “insulin-requiring people with diabetes.”

~~Currently, there are two primary therapies available~~3. ~~for~~The ~~insulin-requiring~~infusion ~~people~~set ~~with~~is ~~diabetes:~~built ~~multiple daily insulin injections directly~~ into the ~~body~~adhesive ~~through~~pad ~~syringes~~that ~~or insulin pens (a type of syringe) or~~ the ~~use of an insulin~~ pump toattaches ~~deliver mealtime insulin boluses (single doses)~~ to ~~help~~and ~~with glucose absorption after carbohydrate consumption along with a continuous subcutaneous insulin infusion, or “CSII therapy,” into~~ the ~~body.~~needle ~~Generally, CSII~~can ~~therapy~~be issafely ~~considered~~removed toand ~~provide~~discarded ~~a number of advantages over MDI therapy, primarily an improvement in glycemic control, as measured~~ by ~~certain~~the ~~diabetes management tests such as hemoglobin A1c (HbA1c) measure and more recently Time in Range (TIR) where a continuous glucose~~user ~~measuring~~after ~~device~~application. isDespite ~~used to calculate~~ this ~~test.~~true ~~Among~~patch ~~other~~form ~~clinical benefits~~factor, athe ~~study conducted by Tandem Diabetes Care, Inc. in 2021 demonstrated that insulin~~ pump ~~use~~is ~~can~~removable ~~decrease~~by ~~glucose variability, reduce~~ the ~~number~~user ofduring ~~hypoglycemia events, and reduce~~ the ~~fear~~three days of ~~hypoglycemia~~ wear.

~~Notwithstanding~~The ~~these~~system ~~advantages,~~will ~~the difficulty~~deliver ina ~~use~~small ~~resulting~~continuous ~~from~~rate called ~~the~~a ~~complexity~~basal ~~and~~that ~~cumbersome~~will ~~design~~provide ofapproximately ~~available~~50% ~~insulin~~of ~~pumps,~~the ~~optimized~~total ~~for~~daily ~~the~~dose ~~well-motivated~~required, ~~educated~~ and ~~well-insured,~~the asuser ~~well~~will asuse ~~high and often prohibitive costs for both~~ the ~~patient~~on-pump ~~and~~button ~~insurance~~to ~~provider has resulted not~~administer ~~only~~boluses, intypically ~~dissatisfaction~~before ~~among~~and ~~many~~after ~~existing~~meals. ~~pump~~The ~~users~~objective ~~(fewer~~is ~~than~~to ~~half~~make ~~purchase a replacement pump after~~ the ~~warranty~~product ~~expires~~simple ~~per~~to ~~a Seagrove~~acquire ~~Partners~~and ~~estimate~~take ~~in 2020)~~home, ~~but~~simple ~~also~~to ~~has~~learn ~~severely~~and most ~~limited~~importantly, ~~the~~simple ~~adoption~~to ~~rate~~use ofand ~~insulin~~live ~~pumps~~with, byto aexpand ~~large segment of~~ the ~~MDI diabetes~~pump ~~population~~market, ~~whom~~drive weadoption ~~refer~~and, toultimately, inimprove ~~this~~clinical ~~prospectus as “Almost Pumpers~~outcomes.”

WeRecent define Almost Pumpers as individuals who treat their diabetes with MDI. These individuals are aware of pumps, may have been on pumps and understand the potential benefits, however, for a variety of reasons, they choose to continue giving themselves shots. In 2018, we undertook one-on-one interviews with over 200 of these individuals to understand their past experiences on or considering pumps, existing pump shortcomings, the cost and insurance hurtles challenges, complexity to learn and time and complexity to operate that drives them to remain on MDI. With this detailed understanding, we brought a series of prototype models to them to react to, so we could refine the design and include features that would motivate them to be able to use this technology to better care for their diabetes. To date, the MODD1 pump has been well received by these individuals and our clinical advisors.Developments

ItSeptember is2025 ~~estimated~~Warrant ~~that~~Inducement ~~33% of Americans with T1D~~Offering use insulin pump therapy. Clinicians were surveyed on potential pump users and identified that 28% of Americans with T1D, including 44% of those who currently utilize MDI, can be classified as i) having an interest in pump adoption and ii) meeting the American Diabetes Association guidelines for required glucose control. These individuals often do not want to closely manage their glucose levels and incur the considerable time and effort involved with the existing offerings - they are the Almost Pumpers. We have developed what we believe to be the most technologically advanced delivery system to overcome their objections and perform with the motivation level they can provide.

~~Our~~In ~~initial~~September ~~focus~~2025, ~~for~~we ~~our~~entered ~~insulin~~into ~~pump~~inducement offer isletter agreements (the “Inducement Letters”) with certain holders (the “Holders”) of warrants issued in ~~Almost~~May ~~Pumper~~2023 ~~segment~~(the ~~population~~“2023 ~~located~~Warrants”) and in March 2025 (the ~~United~~“March ~~States~~2025 Warrants” and, collectively with the 2023 Warrants, the “Existing Warrants”) to purchase up to an aggregate of 6,504,731 shares of our common stock. WePursuant ~~will~~to ~~then~~the ~~focus~~Inducement Letters, onthe aHolders ~~European~~agreed ~~introduction~~to exercise for cash i) 2023 Warrants to purchase 1,901,700 ~~and~~shares weof ~~believe~~common ~~our~~stock ~~cost~~with an original exercise ~~position~~price of $1.22 per share and ~~reuse~~ii) March 2025 Warrants to purchase 4,603,031 shares with an original exercise price of ~~part~~$1.12 per share at a reduced exercise price of ~~the~~$0.68 ~~product,~~per ~~which~~share ~~eliminates~~in ~~waste~~consideration for our agreement to issue in a private placement new common stock purchase warrants to purchase an aggregate of 3,252,366 ~~will~~shares (the “September 2025 Warrants”). The September 2025 Warrants have ~~significant~~an exercise ~~environmental~~price of 0.84 per share, were exercisable upon issuance and ~~financial~~expire ~~appeal~~on the five-year anniversary of the date of issuance.

~~We believe~~As ~~this~~of ~~conversion~~December ~~process~~31, ~~engaging~~2025, ~~people~~we tohad ~~try~~issued 6,495,481 shares of common stock and ~~thereby~~3,247,741 ~~receive~~September ~~the~~2025 ~~benefits~~Warrants. As of ~~our~~December ~~technology~~31, ~~will~~2025, ~~substantially~~9,250 ~~increase adoption~~shares of ~~insulin~~common ~~pumps~~stock ~~among~~(the ~~both~~“Issuable Shares”) ~~those~~and ~~with~~4,625 ~~T1D~~September ~~and~~2025 ~~T2D~~Warrants ~~who~~were ~~remain~~pending ~~reliant~~issuance. ~~upon~~The ~~multiple~~fair ~~daily~~value ~~injections.~~of ~~Diabetes~~the isunissued aIssuable ~~disease~~Shares has been presented ~~that~~separately ~~appears~~as ~~throughout~~issuable shares on the ~~world.~~condensed ~~Therefore~~consolidated balance sheets and statements of stockholders’ equity as of December 31, 2025. we ~~cannot~~accounted ~~segment~~for the ~~market~~issuance byof ~~socioeconomics,~~the: ~~education~~i) orshares ~~level~~of its common stock and ii) the September 2025 Warrants as a single equity transaction for gross proceeds of ~~care~~approximately $4.4 Wemillion, ~~intend~~which ~~to create~~proceeds anhad ~~insulin~~been ~~pump~~received ~~that~~in ~~appeals~~full toas ~~all~~of ~~Almost~~September ~~Pumpers~~30, 2025.

In relation to the above warrant inducement offering, we engaged Newbridge as the servicing agent and paid it a fee of $400,000 and expense reimbursement of $50,000.

December 2025 Public Offering

On December 10, 2025, we entered into an underwriting agreement with Newbridge Securities Corporation (“Newbridge”), relating to a firm commitment underwritten offering (the “December 2025 Offering”) of (i) 12,173,000 shares of our common stock and (ii) accompanying warrants exercisable to purchase up to 6,086,500 shares of common stock (the “December 2025 Warrants”). The net proceeds from the December 2025 Offering were approximately $4.8 million, after deducting underwriting discounts and commissions and offering expenses. Pursuant to the underwriting agreement, we paid the underwriter a cash fee equal to 7% of the gross proceeds received from the December 2025 Offering and to reimburse the underwriter for its expenses incurred in connection with the December 2025 Offering in an amount up to $85,000.

Each two shares of common stock were sold together with one accompanying December 2025 Warrant at a combined price of $0.77, yielding an effective price of $0.38 per share and $0.01 per warrant. The December 2025 Warrants have an exercise price of $0.45 per share, were exercisable immediately upon issuance, and will expire five years following the date of issuance. The December 2025 Warrants were issued pursuant to a warrant agency agreement entered into by and between us and Colonial Stock Transfer Company, Inc., as warrant agent.

~~Risk~~The ~~Factor~~December ~~Summary~~2025 Offering closed on December 11, 2025. The December 2025 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333- 287313) previously filed with the SEC on May 15, 2025 and declared effective by the SEC on May 22, 2025, and a preliminary prospectus supplement relating to the December 2025 Offering dated December 9, 2025 and a final prospectus supplement relating to the Offering dated December 10, 2025. Pursuant to the underwriting agreement, we granted to Newbridge a 30-day option to purchase (i) up to an additional 1,825,950 shares of common stock, representing 15% of the shares sold in the December 2025 Offering, and/or (ii) additional December 2025 Warrants to purchase up to 912,975 shares of common stock, representing 15% of the December 2025 Warrants sold in the December 2025 Offering, solely for the purpose of covering over-allotments of such securities, if any. Newbridge exercised this option, and, on December 22, 2025, 1,825,950 additional shares and 912,975 additional warrants were issued for net proceeds of $653,781. The fair values of the warrants at the dates of issuance totaled $1,781,699 and are accounted for as liabilities.

~~Our~~We ~~business~~also isagreed ~~subject~~to issue to ~~many~~Newbridge ~~significant~~on the closing ~~risks,~~date asand ~~more~~each ~~fully~~over-allotment ~~described~~option inclosing ~~the~~date, ~~section~~a ~~titled~~warrant (the “~~Risk~~December ~~Factors”~~2025 ~~immediately~~Underwriter ~~following~~Warrant”) ~~this~~for ~~prospectus~~the ~~summary.~~purchase of ~~You~~a ~~should~~number ~~read~~of shares of common stock equal to an aggregate of 7% of the shares sold on the closing date (equal to 852,110 shares) and ~~carefully~~7% of ~~consider~~the ~~these~~Option ~~summary~~Shares ~~risks~~sold on the over-allotment option closing date (equal to 127,816 ~~together~~shares). ~~with~~The December 2025 Underwriter Warrant has substantially the ~~risks~~same ~~set~~terms ~~forth~~as ~~under~~the December 2025 Warrants, except that the ~~section~~December ~~titled~~2025 ~~“Risk~~Underwriter Warrant has an exercise price ~~Factors”~~of $0.462 per share, are not exercisable for 180 days from the closing date and will include piggyback registration rights that are triggered if there is not an effective registration statement covering all of the ~~other~~shares ~~information~~of incommon ~~this~~stock ~~prospectus,~~issuable ~~including~~upon exercise of the ~~financial~~December 2025 ~~statements~~Underwriter ~~and~~Warrant. Pursuant to the ~~related~~Agreement, ~~notes~~each ~~included~~of our directors and executive officers entered into “lock-up” ~~elsewhere~~agreements inwith ~~this~~the ~~prospectus~~Underwriter that, ~~before~~subject ~~deciding~~to ~~whether~~certain toexceptions, ~~invest~~prohibit, inwithout ~~our~~the prior written consent of the underwriter, the sale, transfer, or other disposition of securities. Ifby ~~any~~us for a period of 60 days from the ~~risks~~date ~~discussed~~of inthe ~~this~~December ~~prospectus~~2025 ~~actually~~Offering. We ~~occur~~have agreed not to, ~~our~~subject ~~business~~to certain exceptions, ~~prospects~~offer, ~~financial~~pledge, ~~condition~~sell, contract to sell, sell any option, right or ~~operating~~warrant ~~results~~to ~~could~~purchase, lend beor ~~materially~~otherwise ~~and~~transfer ~~adversely~~or ~~affected.~~dispose, Indirectly ~~particular~~or indirectly, any shares of our capital stock or any securities convertible into or ~~risks~~exercisable ~~include,~~or ~~but~~exchangeable ~~are~~for ~~not~~shares ~~limited~~of tocapital stock, for a period of 90 days from the ~~following:~~date of the December 2025 Offering. The fair values of the Underwriter Warrants at the dates of issuances totaled $248,294 and are accounted for as liabilities.

●Compliance Wewith ~~might~~Nasdaq ~~not~~Continued beListing ~~able to continue as a going concern;~~Requirements

●On WeJune ~~are~~30, 2025, we received a ~~developmental-stage,~~letter ~~medical-device~~from ~~company~~the Listing ~~and~~Qualifications ~~have~~Staff aof ~~history~~the Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the closing bid price of ~~significant~~our ~~operating~~common ~~losses;~~stock for the 30 consecutive business days ending on June 27, 2025, we ~~expect~~no tolonger ~~continue~~met the requirement to ~~incur~~maintain ~~operating~~a ~~losses~~minimum bid ~~for~~price ~~the~~of ~~foreseeable~~$1 ~~future~~per share, ~~and~~as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we ~~may~~were ~~never~~provided ~~achieve~~a period of 180 calendar days, or ~~maintain~~until ~~profitability;~~December 29, 2025, in which to regain compliance.

●On WeDecember ~~will~~23, ~~need~~2025, ~~substantial~~we submitted a request to Nasdaq for an additional ~~funding~~180-day period (the “Second Compliance Period”) to ~~complete~~provide ~~subsequent~~additional ~~phases~~time for us to demonstrate compliance with the minimum bid price requirement. In such request, we communicated that we intend to regain compliance during the Second Compliance Period by effecting a reverse stock split. On December 30, 2025, we received written notification from the Listing Qualifications Department of Nasdaq, granting our ~~insulin~~request ~~pump~~for ~~product~~a ~~candidate~~180-day ~~and~~extension to ~~operate~~regain compliance with the minimum bid price requirement. We now have until June 29, 2026 to meet the requirement. If at any time prior to June 29, 2026, the bid price of our common stock closes at $1 per share or more for a minimum of 10 consecutive business days, ~~and~~we ~~such~~will ~~funding~~regain ~~may~~compliance with the minimum bid price requirement. In the event we do not regain compliance with the minimum bid price requirement during the additional 180-day extension, Nasdaq will provide written notification to us that our Common Stock will be ~~available~~delisted. orAt that time, we may appeal the relevant delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if itwe isdo ~~available~~appeal the delisting determination by Nasdaq to the hearings panel, isthat ~~likely~~such appeal would be successful. On January 23, 2026, at our annual meeting of shareholders, our shareholders authorized our board of directors to ~~substantially~~effect ~~dilute~~a reverse split, as necessary, to regain compliance. We will continue to monitor the closing bid price of our ~~existing~~common ~~stockholders;~~stock and evaluate available options to regain compliance with the minimum bid price requirement. Nasdaq’s extension notice has no immediate effect on the listing or trading of our common stock, which continues to trade on the Nasdaq Capital Market under the ticker symbol, “MODD.”

●Amendment Weto ~~have~~Amended ~~a limited operating history~~ and ~~historical~~Restated ~~financial~~Articles ~~information~~of ~~upon~~Incorporation, ~~which you may evaluate our performance;~~as Amended

●On ~~The~~January ~~amount~~23, of2026, ~~financing~~following weour ~~require~~fiscal ~~will~~2026 annual ~~depend~~meeting ~~on a number~~ of ~~factors~~shareholders, ~~many~~we offiled ~~which~~an ~~are~~amendment ~~beyond~~of our ~~control.~~Amended ~~Our~~and ~~results~~Restated Articles of ~~operations~~Incorporation, ~~financial~~as ~~condition~~amended, ~~and stock price are likely~~ to beincrease the ~~adversely~~number ~~affected~~of if our ~~funding~~authorized ~~requirements~~shares ~~increase~~of orcommon ~~are~~stock ~~otherwise~~from ~~greater~~100,000,000 ~~than~~shares weto ~~expect;~~250,000,000 shares.

●Credit ~~We are subject to extensive regulation by the FDA, which could restrict the sales and marketing of our insulin pump product candidate and could cause us to incur significant costs;~~Facility

●On ~~Even~~February if23, 2026, we ~~are~~issued ~~able~~a tosecured ~~obtain~~promissory note ~~all~~(the ~~regulatory~~“Note”) ~~approvals~~to ~~and~~James ~~have~~E. ~~completed~~Besser ~~all~~(“the ~~other~~Lender”), ~~steps~~our ~~needed~~chief toexecutive beofficer, ~~taken~~that toprovides ~~commercialize~~us ~~our~~with ~~insulin~~a ~~pump~~$350,000 revolving ifcredit wefacility orwith ~~any~~all ~~contract~~amounts ~~manufacturers~~being wedrawn ~~select~~down ~~fails~~thereunder being due and payable, subject to ~~comply~~acceleration ~~with~~in the ~~FDA’s~~event ~~quality~~of a ~~system~~default, ~~regulations~~on March 25, 2026 (the ~~manufacturing~~“Maturity ~~and~~Date”). ~~distribution~~Interest at the rate of ~~our~~12% ~~product~~is ~~candidate~~payable ~~could~~on beeach ~~interrupted,~~draw ~~and~~down ~~our~~without ~~product~~regard to ~~sales~~the draw down date or the date when interest is paid. Any amounts owed pursuant to the Note will be secured by all assets and ~~operating~~intellectual property ~~results~~of ~~could~~the ~~suffer;~~Company.

●The Weprincipal ~~will~~amount ~~need~~of the Note and interest due thereon is payable to ~~outsource~~the Lender no later than the earlier of: (i) the Maturity Date and ~~rely~~(ii) the date on ~~third~~which ~~parties~~we ~~for~~have ~~various~~received ~~aspects~~proceeds in ~~relating~~excess of $2,000,000 from a transaction or series of related transactions occurring prior to the ~~development,~~Maturity ~~manufacture~~Date, ~~sales~~which ~~and~~such ~~marketing~~transactions constitute equity financings or other issuances of our ~~insulin~~equity ~~pump~~securities. asProvided ~~well~~that no Event of Default (as such term is defined in the ~~connection~~Note) ~~with~~has ~~assisting~~occurred, uson inany date prior to the ~~preparation~~Maturity ~~and~~Date, ~~filing~~upon ofno ~~our~~less ~~FDA~~than ~~submission,~~three ~~and~~days ~~our~~written ~~future~~notice ~~success~~by us specifying the draw amount, the Lender will advance the draw amount us. No draw amount can be ~~dependent~~in onan amount less than $50,000 or exceed an amount equal to $350,000 minus the ~~timeliness~~aggregate ~~and~~principal ~~effectiveness~~amount outstanding under the Note at the time of such draw request. If an Event of Default occurs and is continuing, the ~~efforts~~Lender may declare all of ~~these~~the ~~third~~Note, ~~parties;~~including any interest and other amounts due, to be due and payable immediately.

●As ~~Our~~of ~~future~~the ~~cash~~date ~~requirements~~of ~~may~~this ~~differ~~prospectus, ~~significantly~~we ~~from~~have ~~our~~borrowed $200,000 ~~current~~under ~~estimates;~~the Note.

● We may not receive the necessary regulatory clearance or approvals for our insulin pump, and failure to timely obtain necessary clearances and/or approvals could harm our then operations, including our ability to commercialize our product candidate;

● Obtaining marketing authorization in the United States will not obviate the need to obtain marketing authorization in other jurisdictions We must obtain approval from foreign regulatory authorities before we can market and sell any of our product candidates in countries outside the United States. We will incur additional costs in seeking such approvals, may experience delays in obtaining such approvals and cannot be certain that such approvals will be granted;

● Although our product candidate does not presently require clinical trials to apply to the FDA for clearance, and even if a clinical trial is conducted, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product candidate;

● We expect to rely on third-party manufacturers and will be dependent on their quality and effectiveness;

● We may not be able to successfully scale-up manufacturing of our product candidate in sufficient quality and quantity, which would delay or prevent us from developing our product candidate and commercializing our product candidate;

● Our competitors may develop products that are more effective, safer and less expensive than ours;

●Summary ~~Sales~~ of aRisk ~~significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common stock;~~Factors

●Our Webusiness ~~have~~and ~~limited~~this ~~internal~~offering ~~research~~are subject to numerous risks and ~~development~~uncertainties, ~~personnel~~that could materially adversely affect our business, ~~making~~financial uscondition, ~~dependent~~results onof ~~consulting~~operation ~~relationships;~~and stock price. You should read this summary together with the more detailed description of each risk factor contained below:

● ~~Technological~~We ~~breakthroughs~~might innot ~~diabetes~~be ~~monitoring,~~able ~~treatment~~to orcontinue ~~prevention~~as ~~could~~a ~~render~~going ~~our insulin pump obsolete;~~concern.

● We ~~may~~are ~~not~~a bepre-revenue ~~able~~medical todevice ~~identify,~~company ~~negotiate~~ and ~~maintain~~have ~~the~~a ~~strategic~~history ~~alliances~~of ~~necessary~~significant tooperating ~~develop~~losses; ~~and~~we ~~commercialize~~expect ~~our~~to ~~products~~continue ~~and~~to ~~technologies~~incur operating losses, and we ~~will~~may benever ~~dependent~~achieve onor ~~our~~maintain ~~corporate partners if we do;~~profitability.

● ~~Intellectual~~We ~~property~~will ~~rights~~need dosubstantial additional funding to complete subsequent phases of the development of our insulin pump products and to operate our business and such funding may not ~~necessarily~~be ~~address~~available ~~all~~or, ~~potential~~if ~~threats~~it is available, such financing is likely to substantially dilute our ~~competitive~~existing ~~advantage;~~stockholders.

● We ~~may~~have bea ~~subject~~limited tooperating ~~potential~~history ~~product~~and ~~liability~~historical ~~and~~financial ~~other~~information ~~claims~~upon ~~that~~which ~~could~~you ~~materially~~may ~~impact~~evaluate our ~~business and financial condition;~~performance.

● IfThe weamount ~~are~~of ~~sued~~financing ~~for~~we ~~infringing~~require will depend on ~~third-party~~a ~~intellectual~~number ~~property~~of ~~rights~~factors, itmany ~~will~~of bewhich ~~costly~~are ~~and~~beyond ~~time-consuming~~our control. Our results of operations, ~~and~~financial ancondition ~~unfavorable~~and ~~outcome~~stock ~~would~~price ~~have~~are alikely ~~significant~~to ~~adverse~~be ~~effect~~adversely onaffected if our ~~business;~~funding requirements increase or are otherwise greater than we expect.

● IfOur wefuture ~~are~~cash ~~unable~~requirements tomay ~~protect~~differ ~~the~~significantly ~~confidentiality~~from of our ~~proprietary~~current ~~information, the value of our technology and products could be adversely affected;~~estimates.

● ~~Healthcare~~Purchasers ~~reform~~of ~~laws~~common ~~could~~stock ~~adversely~~in ~~affect~~this ~~our~~offering ~~product~~will ~~candidate~~experience immediate and ~~financial~~substantial ~~condition;~~dilution in the net tangible book value of their investment. You may experience further dilution upon the exercise of outstanding stock options and warrants, or the conversion or exchange of other securities.

● WeA ~~may~~substantial ~~bring~~number ~~infringement~~of ~~claims~~shares orof ~~other~~common ~~legal~~stock ~~proceedings~~may ~~against~~be ~~third~~sold ~~parties,~~in ~~causing~~the usmarket tofollowing ~~spend~~this ~~substantial~~offering, ~~resources~~which onmay ~~litigation~~depress ~~and~~the ~~exposing~~market ~~our~~price ~~own~~for ~~intellectual~~our ~~property~~common ~~portfolio to challenge;~~stock.

● ~~Assuming~~There ~~our~~may ~~insulin~~be ~~pump~~future ~~receives~~sales ~~FDA~~of ~~clearance~~our orcommon ~~approval~~stock, ~~our~~which ~~insulin~~could ~~pump~~adversely ~~will~~affect ~~still~~the bemarket ~~subject~~price toof ~~recalls,~~our ~~which~~common ~~would~~stock ~~harm~~and ~~our~~dilute ~~reputation,~~a ~~business~~stockholder’s ~~operations~~ownership ~~and~~of ~~financial~~common ~~results;~~stock.

● ~~Because~~We ~~our~~have ~~current~~broad ~~insulin~~discretion ~~pump~~to isdetermine ~~still~~how into use the ~~pre~~funds ~~clearance~~raised ~~stage~~in ~~with~~this ~~the FDA~~offering, ~~it does not have reimbursement~~ and ismay ~~not~~use ~~approved~~them ~~for insurance coverage. If~~ in ~~the~~ways ~~future~~that wemay ~~are~~not ~~cleared~~enhance ~~for and are otherwise able to commercialize~~ our ~~insulin~~operating ~~pump,~~results ~~but are unable to obtain adequate reimbursement~~ or ~~insurance~~the ~~coverage~~price ~~for~~of ~~such~~our ~~product~~common ~~candidate from third-party payors, we will be unable to generate significant revenue;~~stock.

● IfThere weis ~~fail~~no topublic ~~establish~~market ~~and~~for maintain an effective system of internal controls, we may not be able to report our financial results accurately or prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation and adversely affect the ~~trading~~warrants ~~price~~being ofoffered ~~our~~in ~~common~~this ~~stock;~~offering.

● ~~Our~~Holders ~~board~~ of ~~directors~~warrants ispurchased ~~able~~in tothis ~~adopt~~offering ~~recapitalizations~~will ~~through~~have ~~forward~~no orrights ~~reverse~~as ~~splits~~a ofcommon ~~our~~stockholder ~~outstanding~~until ~~shares~~such ofholder exercises its warrants and acquires our common stock, ~~without~~except ~~stockholder~~as ~~approval;~~set forth in such warrants.

● WeThe warrants are aspeculative ~~“smaller~~in ~~reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors;~~nature.

● AsPotential wevolatility ~~have~~of ~~broad discretion in how we use~~ the ~~proceeds~~price ~~from~~of ~~this~~our ~~offering,~~common westock ~~may~~could ~~use~~negatively ~~the~~affect ~~proceeds~~your ~~in ways with which you disagree;~~investment.

● ~~Holders~~Provisions of our ~~warrants~~articles ~~will~~of ~~have~~incorporation noand ~~rights~~bylaws asmight delay or prevent a ~~common~~change-of-control ~~stockholder~~transaction ~~until~~and ~~they~~depress ~~acquire~~the ~~our~~market ~~common~~price of our stock;.

● ~~Provisions~~If ofwe are unable to satisfy the ~~warrants~~continued ~~offered~~listing byrequirements ~~this~~of ~~prospectus~~Nasdaq, our common stock could ~~discourage~~be andelisted ~~acquisition~~and the price and liquidity of usour bycommon astock ~~third~~may ~~party;~~be adversely affected.

● The warrants offered by this prospectus are speculative in nature and may not have any value;

● There is no public market for the warrants being offered in this offering;

● You will experience immediate and substantial dilution in the net tangible book value per share of the common stock you purchase; and

● You may experience future dilution as a result of future equity offerings and other issuances of our common stock or other securities. In addition, this offering and future equity offerings and other issuances of our common stock or other securities may adversely affect the price of our common stock.

Corporate Information

Our principal executive offices are located at 10740 Thornmint Drive, San Diego, CA 92127 and our telephone number is (858) 800-3500. We maintain a website at www.modular-medical.com. Information contained on, or accessible through, our website does not constitute a part of this prospectus or our other filings with the SEC, and you should not consider any information contained on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our securities.

~~THE OFFERING~~● We may not be able to utilize a significant portion of our net operating losses and tax credits.

Securities offered by us:		units, each consisting of two shares of common stock and one warrant to purchase one share of our common stock. The units will not be certificated or issued in stand-alone form. The shares of our common stock and the warrants comprising the units will be issued separately, but will be purchased together in this offering.
Description of warrants included in units:		Warrants to purchase shares of common stock. Warrants may only be exercisable for a whole number of shares of common stock and, because the warrants will only be sold in units with two shares of common stock, no fractional shares or warrants to purchase fractional shares will be issued in this offering. The exercise price of the warrants is $ per share ( % of the public offering price per unit). Each warrant will be exercisable immediately upon issuance and will expire five years after the initial issuance date. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the warrants. For more information regarding the warrants, you should carefully read the section titled “Description of Our Securities - Warrants” in this prospectus.
Common stock outstanding prior to this offering(1):		10,949,389 shares of common stock outstanding as of April 24, 2023.
Common stock to be outstanding after this offering(1):		shares, or shares, if the over-allotment option granted to the underwriter is exercised in full.
Use of proceeds:		We estimate that the net proceeds from this offering will be approximately $ , after deducting underwriting discounts and commissions and the estimated offering expenses payable by us. We intend to use the net proceeds of this offering for general corporate purposes, including working capital, to fund our operations through the approval of our product by the FDA, develop our initial sales and marketing infrastructure, to fund additional research and development activities, to develop our initial manufacturing and production capabilities and make related capital expenditures. See “Use of Proceeds” for additional information.
Over-allotment option		We have granted a 30-day option to the underwriter, exercisable one or more times in whole or in part, to purchase up to an additional shares of common stock at a price per share of $ and/or additional warrants to purchase up to additional shares of common stock at a price of $0.01 per warrant, to cover over-allotments, if any.
Risk factors:		Investing in our securities involves substantial risk. You should read the “Risk Factors” section beginning on page 10 and other information included in this prospectus for a discussion of factors to consider carefully before deciding to invest in our securities.
Lock-ups		We and our directors and officers and holders of more than 5.0% of the Company’s outstanding shares of common stock have agreed with the underwriter not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any of our common stock or securities convertible into common stock for a period of three months after the date of this prospectus. See “Underwriting” section.
Nasdaq Capital Market Symbol		MODD

●

Technological breakthroughs in diabetes monitoring, treatment or prevention could render our insulin pump products obsolete.

~~The~~● ~~number~~Any offailure ~~shares~~to ofattract ~~our common stock outstanding before~~ and ~~after~~retain ~~this~~skilled ~~offering~~directors, isexecutives, ~~based~~employees onand ~~10,949,389~~consultants ~~shares~~could ofimpair our ~~common~~product ~~stock~~development ~~outstanding as of April 24, 2023~~ and ~~excludes:~~commercialization activities.

● ~~shares~~We have and will need to outsource and rely on third parties for various aspects relating to the development, manufacture, sales and marketing of our ~~common~~insulin ~~stock~~pump ~~issuable~~products, ~~upon~~as well as in connection with assisting us in the ~~exercise~~preparation and filing of ~~the~~our ~~warrants~~regulatory tosubmissions, and our future success will be ~~issued~~dependent ason ~~part~~the timeliness and effectiveness of the ~~units;~~efforts of these third parties.

● ~~shares~~We ofmay ~~common~~not ~~stock~~be ~~issuable~~able ~~upon~~to ~~exercise~~identify, bynegotiate and maintain the ~~underwriter~~strategic ofalliances ~~the~~necessary ~~Underwriter’s~~to ~~Warrants;~~develop and commercialize our products and technologies, and we will be dependent on our corporate partners if we do.

● ~~767,796~~We ~~shares~~may ofnot receive the necessary regulatory clearance or approvals for our ~~common~~insulin ~~stock~~pump ~~issuable~~products, ~~upon~~and ~~the~~failure ~~exercise~~to oftimely ~~warrants~~obtain ~~with~~necessary anclearances ~~exercise~~and/or ~~price~~approvals ofcould ~~$6.00~~harm ~~per~~our ~~share;~~then operations, including our ability to commercialize our products.

● ~~5,449,478~~Obtaining ~~shares~~marketing ofauthorization ~~our~~in ~~common~~the ~~stock~~United ~~issuable~~States ~~upon~~will not obviate the ~~exercise~~need ofto ~~warrants~~obtain ~~with~~marketing anauthorization ~~exercise~~in ~~price~~other jurisdictions. We must obtain approval from foreign regulatory authorities before we can market and sell any of $6our product candidates in countries outside the United States.60 ~~per~~We ~~share;~~will incur additional costs in seeking such approvals, may experience delays in obtaining such approvals and cannot be certain that such approvals will be granted.

● ~~1,348,314~~Our ~~shares~~competitors ofmay ~~our~~develop ~~common~~products ~~stock~~that ~~issuable~~are ~~upon~~more ~~exercise~~effective, ofsafer ~~pre-funded~~and ~~warrants~~less ~~with~~expensive anthan ~~exercise price of $0~~ours.~~01 per share;~~

● ~~2,647,700~~We ~~shares~~expect ofto ~~our~~rely ~~common~~on ~~stock~~third-party ~~issuable~~manufacturers ~~upon~~and ~~exercise~~will ofbe ~~outstanding~~dependent ~~stock~~on ~~options~~their ~~with~~quality aand ~~weighted average exercise price of approximately $4~~effectiveness.~~94 per share; and~~

● ~~1,996,055~~We ~~shares~~may not be able to successfully scale-up manufacturing of our ~~common~~products ~~stock~~in ~~reserved~~sufficient ~~for~~quality ~~issuance~~and ~~pursuant~~quantity, towhich ~~future~~would ~~awards~~delay ~~under~~or ~~our~~prevent ~~Amended~~us ~~and~~from ~~Restated~~developing ~~2017~~and ~~Equity~~commercializing ~~Incentive~~our ~~Plan,~~products orand ~~the~~product ~~2017 Plan~~candidates.

●

We are dependent upon third-party suppliers to manufacture our products, and this makes us vulnerable to supply shortages and price increases; we may not be able to obtain an adequate supply of components on a timely basis or at all.

●

We may be subject to potential product liability and other claims that could materially impact our business and financial condition.

●

Legislative, regulatory, or medical cost reimbursement changes may adversely impact our business.

●

We are subject to extensive regulation by the FDA, which could restrict the sales and marketing of our insulin pump products and could cause us to incur significant costs.

●

Although our insulin pump products do not presently require clinical trials to apply to the FDA for clearance, and even if a clinical trial is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product candidates.

●

Our success depends substantially upon our ability to obtain and maintain intellectual property protection relating to our insulin pump products and research technologies.

~~SUMMARY FINANCIAL~~● ~~DATA~~If we are sued for infringing on third-party intellectual property rights, it will be costly and time-consuming, and an unfavorable outcome would have a significant adverse effect on our business.

~~The following~~● ~~tables~~If ~~summarize~~we ~~our~~are ~~financial~~unable ~~data~~to ~~for~~protect the ~~periods~~confidentiality ~~presented and should be read together with the sections~~ of ~~this prospectus titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and~~ our ~~financial~~proprietary ~~statements and related notes thereto appearing elsewhere in this prospectus. The following summary statements of operations data for the nine months ended December 31~~information, ~~2022 and 2021 have been derived from our unaudited consolidated financial statements and footnotes included elsewhere in this prospectus and~~ the ~~summary~~value ~~statements~~ of ~~operations data for the years ended March 31, 2022 and 2021 have been derived from~~ our ~~audited~~technology ~~consolidated financial statements~~ and ~~footnotes~~products ~~included~~could ~~elsewhere~~be ~~in this~~adversely ~~prospectus~~affected. The summary balance sheet information as of December 31 and March 31, 2022 has been derived from our unaudited condensed consolidated financial statements and footnotes included elsewhere in this prospectus. Our historical results are not necessarily indicative of our future results or of the results we expect in the future and results of interim periods are not necessarily indicative of results for the entire year.

	Twelve Months Ended March 31,
	2022			2021
Operating expenses
Research and development	$	7,729,240		$	4,083,303
General and administrative		7,197,162			3,253,412
Total operating expenses		14,926,402			7,336,715
Loss from operations		(14,926,402	)		(7,336,715	)
Other income		368,920			130
Interest expense		(2,752,229	)		(39,791	)
Loss on debt extinguishment		(1,321,450	)		—
Loss before income taxes		(18,631,161	)		(7,376,376	)
Provision for income taxes		1,600			1,600
Net loss	$	(18,632,761	)	$	(7,377,976	)
Net loss per share
Basic and diluted	$	(2.74	)	$	(1.20	)
Shares used in computing net loss per share
Basic and diluted		6,807,710			6,211,562

●

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

●

Healthcare reform and drug-pricing reform laws could adversely affect our products and financial condition.

●

Even if we are able to obtain all regulatory approvals and have completed all other steps needed to be taken to commercialize our insulin pump products, if we or any contract manufacturers we select fail to comply with the FDA’s quality system regulations, the manufacturing and distribution of our products could be interrupted, and our product sales and operating results could suffer.

●

We may become involved in disputes with our present or future contract partners over intellectual property ownership or other matters, which would have a significant effect on our business.

●

Our insulin pump products will be subject to recalls, which would harm our reputation, business operations and financial results.

●

Our current insulin pump product does not yet have reimbursement and is not approved for insurance coverage. If in the future we are otherwise able to commercialize our insulin pump, but are unable to obtain adequate reimbursement or insurance coverage for such product from third-party payors, we will be unable to generate significant revenue.

Risks Related to Our Securities

●

We are subject to oversight by the SEC and other regulatory agencies. Investigations by those agencies could divert management’s focus and could have a material adverse effect on our reputation and financial condition.

●

We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.

●

We do not expect any cash dividends to be paid on our shares of common stock for the foreseeable future.

●

If the beneficial ownership of our common stock continues to be concentrated, it may prevent our stockholders from influencing significant corporate decisions.

●

Future sales of our securities could adversely affect the market price of our common stock and our future capital-raising activities could involve the issuance of equity securities, which would dilute your investment and could result in a decline in the trading price of our common stock.

●

Our articles of incorporation allow for our board of directors to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.

●

If we fail to establish and maintain an effective system of internal controls, we may not be able to report our financial results accurately or prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation and adversely affect the trading price of our common stock.

●

Sustained inflation could have a material adverse effect on our business, financial condition, results of operations and liquidity.

●

Our board of directors is able to adopt recapitalizations through forward or reverse splits of our outstanding shares of common stock without stockholder approval.

	Three Months Ended December 31,						Nine Months Ended December 31,
	2022			2021			2022			2021
Operating expenses
Research and development	$	2,196,546		$	1,849,399		$	6,804,069		$	5,742,911
General and administrative		1,161,351			1,981,665			3,502,029			5,156,152
Total operating expenses		3,357,897			3,831,064			10,306,098			10,899,063
Loss from operations		(3,357,897	)		(3,831,064	)		(10,306,098	)		(10,899,063	)
Other income (expense)		(587	)		4			16			368,876
Interest expense		—			(1,010,247	)		—			(2,204,917	)
Loss on debt extinguishment		—			—			—			(1,321,450	)
Loss before income taxes		(3,358,484	)		(4,841,307	)		(10,306,082	)		(14,056,554	)
Provision for income taxes		—			—			1,600			1,600
Net loss	$	(3,358,484	)	$	(4,841,307	)	$	(10,307,682	)	$	(14,058,154	)
Net loss per share
Basic and diluted	$	(0.31	)	$	(0.76	)	$	(0.95	)	$	(2.22	)
Shares used in computing net loss per share
Basic and diluted		10,925,862			6,354,145			10,863,082			6,331,982

Corporate History and Information

We were incorporated in Nevada in October 1998 under the name Bear Lake Recreation, Inc. We had no material business operations until approximately 2017, when we acquired all of the issued and outstanding shares of Quasuras, Inc., a Delaware corporation (“Quasuras”), and changed our name from Bear Lake Recreation, Inc. to Modular Medical, Inc.

We are a pre-revenue, medical device company focused on the design, development and commercialization of innovative insulin delivery systems using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of innovative two-part patch pumps, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care requiring considerable motivation that presently available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration (“FDA”) for its initial product, the MODD1, and, in September 2024, the Company received FDA clearance to market and sell its MODD1 pump in the United States. We are seeking FDA approval for an updated version of the MODD1 product, called the Pivot, which is a tubeless version of the product that integrates the set into a true tubeless patch. We intend to go to market with our Pivot product, after the required regulatory approval from the FDA is received.

Our principal corporate offices are located at 10470 Thornmint Road, San Diego, California 92127. Our telephone number is (858) 800-3500. The address of our website is www.modularmedical.com. The information provided on or accessible through our website (or any other website referred to in the registration statement, of which this prospectus forms a part) is not part of the registration statement, of which this prospectus forms a part.

Implications of Being a Smaller Reporting Company

We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of our voting and non-voting common stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Reports on Form 10-K and have reduced disclosure obligations regarding executive compensation, and, as long as we are a smaller reporting company with less than $100 million in annual revenue, we are not required to obtain an attestation report on internal control over financial reporting from our independent registered public accounting firm.

	December 31, 2022 (Unaudited)			March 31, 2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	7,690,957		$	9,076,372
Prepaid expenses and other		180,164			313,422
Security deposit		100,000			—
TOTAL CURRENT ASSETS		7,971,121			9,389,794
Property and equipment, net		716,409			235,959
Right of use asset, net		51,312			120,693
Security deposit		—			100,000
TOTAL NON-CURRENT ASSETS		767,721			456,652
TOTAL ASSETS	$	8,738,842		$	9,846,446
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable	$	382,080		$	299,951
Accrued expenses		255,545			524,891
Short-term lease liability		77,672			144,857
TOTAL CURRENT LIABILITIES		715,297			969,699
Long-term lease liability		—			39,957
TOTAL LIABILITIES		715,297			1,009,656
Commitments and Contingencies (Note 8)
STOCKHOLDERS’ EQUITY
Preferred Stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding		—			—
Common Stock, $0.001 par value, 50,000,000 shares authorized; 10,932,098 and 10,461,898 shares issued and outstanding as of December 31, 2022 and March 31, 2022, respectively		10,932			10,462
Additional paid-in capital		52,900,066			43,406,099
Accumulated deficit		(44,887,453	)		(34,579,771	)
TOTAL STOCKHOLDERS’ EQUITY		8,023,545			8,836,790
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	8,738,842		$	9,846,446

THE OFFERING

The following summary contains basic information about this offering. The summary is not intended to be complete. You should read the full text and more specific details contained elsewhere or incorporated by reference in this prospectus.

Securities to be offered	Up to 23,571,007 shares of common stock and common warrants to purchase up to 23,571,007 shares of common stock.

Description of common warrants	We are also offering common warrants to purchase up to 23,571,007 shares of common stock. The exercise price of each common warrant will be $ per share. Each common warrant will be immediately exercisable upon issuance for a five-year period after the date of issuance. This prospectus also relates to the offering of the common stock issuable upon exercise of such common warrants. See “Description of the Securities We are Offering” in this prospectus. You should also read the form of common warrant, which is filed as an exhibit to the registration statement that includes this prospectus.

Pre-funded warrants	We are offering to certain purchasers whose purchase of shares of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of such purchaser, 9.99%) of our outstanding shares of common stock immediately following the closing of this offering, the opportunity to purchase, if such purchasers so choose, pre-funded warrants, in lieu of shares of common stock that would otherwise result in any such purchaser’s beneficial ownership, together with its affiliates and certain related parties, exceeding 4.99% (or, at the election of such purchaser, 9.99%) of our outstanding shares of common stock immediately following the consummation of this offering. The purchase price of each pre-funded warrant and accompanying common warrant is equal to the price at which each share of common stock and accompanying common warrant is being sold to the public in this offering, minus $0.001, and the exercise price of each pre-funded warrant is $0.001 per share. The pre-funded warrants are exercisable immediately and may be exercised at any time until all of the pre-funded warrants are exercised in full. For each pre-funded warrant we sell, the number of shares of common stock we are offering will be decreased on a one-for-one basis. This offering also relates to the shares of common stock issuable upon exercise of the pre-funded warrants sold in this offering. See “Description of the Securities We are Offering” on page 48 of this prospectus. You should also read the form of pre-funded warrant, which is filed as an exhibit to the registration statement that includes this prospectus.

Common stock to be outstanding after this offering	101,274,554 shares, assuming no sale of pre-funded warrants, which, if sold, would reduce the number of shares of common stock that we are offering on a one-for-one basis, and no exercise of common warrants.

Use of proceeds	We estimate that the net proceeds of this offering, after deducting the placement agent fees and estimated offering expenses, will be approximately $10.9 million if all of the securities offered hereby are sold in this offering. However, this is a reasonable best efforts offering with no minimum number of securities or amount of proceeds as a condition to closing, and we may not sell all or any of the securities offered pursuant to this prospectus; and, as a result, we may receive significantly less in net proceeds in this offering. For example, if we sell only 25%, 50% or 75% of the maximum amount offered, our net proceeds would be approximately $2.6 million, $5.6 million, or $8.4 million, respectively. We intend to use the net proceeds of this offering for repayment of any amount drawn under the promissory note issued on February 23, 2026 and general corporate purposes, including working capital, to fund our operations through the approval of our Pivot product by the FDA, commence initial commercialization of our Pivot product, to fund additional research and development activities, to further develop our manufacturing and production capabilities and make related capital expenditures. See the section titled “Use of Proceeds” in this prospectus for additional information.

Lock-up restrictions	We and each of our directors and officers are subject to certain lock-up restrictions as identified in the section titled “Plan of Distribution.”

Risk factors	You should read the section entitled “Risk Factors” beginning on page 11 of this prospectus and the other information included and incorporated by reference in this prospectus for a discussion of factors to consider carefully before deciding to invest in our securities.

Nasdaq Capital
Market symbol

Our shares of common stock are traded on The Nasdaq Capital Market under the symbol “MODD.” There is no established public trading market for the warrants, and we do not expect a market to develop. We do not intend to apply for listing of the warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the warrants will be limited.

The number of shares of our common stock to be outstanding after this offering is based on 77,703,547 shares of common stock outstanding as of February 19, 2026, assumes no exercise of any common warrants offered hereby and no sale of any pre-funded warrants offered hereby, and excludes as of such date:

●

9,250 shares of common stock issuable attributable to a warrant inducement offering effected in September 2025;

●

7,378,842 shares of common stock issuable upon the exercise of outstanding stock options, which options have a weighted average exercise price of $2.34 per share;

●

41,668 shares of common stock issuable upon the vesting of restricted stock units;

	●	5,916,993 shares of common stock available for future issuance under the Company’s Amended and Restated Equity Incentive Plan, as amended (the “2017 Equity Incentive Plan”);

	●	6,086,500 shares of common stock issuable upon the exercise of warrants dated December 11, 2025 at $0.45 per share;

	●	912,975 shares of common stock issuable upon the exercise of warrants dated December 22, 2025 at $0.45 per share;

	●	852,110 shares of common stock issuable upon the exercise of warrants dated December 11, 2025 at $0.462 per share;

	●	127,816 shares of common stock issuable upon the exercise of warrants dated December 22, 2025 at $0.462 per share;

	●	3,247,741 shares of common stock issuable upon the exercise of warrants dated September 25, 2025 at $0.84 per share;

●

874,672 shares of common stock issuable upon the exercise of warrants dated March 25, 2025 at $1.40 per share;

●

1,905,042 shares of common stock issuable upon the exercise of warrants dated March 25, 2025 at $1.12 per share;

●

381,540 shares of common stock issuable upon the exercise of warrants dated November 21, 2024 at $1.875 per share;

●

484,006 shares of common stock issuable upon the exercise of warrants dated May 15, 2023 at $1.32 per share;

●

1,671,733 shares of common stock issuable upon the exercise of warrants dated May 15, 2023 at $1.22 per share;

●

1,438,202 shares of common stock issuable upon the exercise of warrants dated May 5, 2022 at $6.60 per share;

●

4,011,276 shares of common stock issuable upon the exercise of warrants dated February 9, 2022 at $6.60 per share; and

●

767,796 shares of common stock issuable upon the exercise of warrants dated May 11, 2021 at $6.00 per share.

Additionally, unless otherwise stated, all information in this prospectus reflects all currency in United States dollars.

RISK FACTORS

Investing in our securities is highly speculative and involves a ~~high~~significant degree of risk. ~~Before~~You ~~you~~should ~~invest~~carefully inconsider the ~~units,~~following risks and uncertainties as well as the ~~warrants~~risks and uncertainties described in the ~~common~~section ~~stock,~~entitled ~~you~~“Risk ~~should~~Factors” ~~carefully~~contained ~~consider~~in our Annual Report on Form 10-K for the ~~following~~fiscal ~~risks~~year ended March 31, 2025 (the “2025 Form 10-K”), as well as ~~general~~in ~~economic~~our ~~and~~subsequent ~~business~~Quarterly ~~risks,~~ and ~~all~~Annual ofReports filed with the SEC, ~~other~~which ~~information~~filings ~~contained~~are incorporated in this ~~registration~~prospectus ~~statement.~~by ~~Any of~~reference ~~the~~in ~~following~~their ~~risks~~entirety. These risk factors could ~~harm~~materially and adversely affect our business, ~~operating~~ results ~~and~~of operations or financial condition. ~~and~~Our ~~cause~~business ~~the~~faces ~~trading~~significant ~~price~~risks ofand ~~our~~the ~~common~~risks ~~stock~~described below toor ~~decline,~~incorporated ~~which~~by ~~would~~reference ~~cause~~herein ~~you~~may tonot ~~lose~~be ~~all~~the oronly ~~part~~risks ofwe ~~your investment~~face. ~~When~~Additional ~~determining~~risks ~~whether~~not presently known to ~~invest~~us or that we currently believe are immaterial may materially affect our business, ~~you~~results ~~should~~of ~~also~~operations, ~~refer~~or ~~to the~~financial ~~other~~condition. ~~information~~If ~~contained~~any inof ~~this~~these ~~prospectus~~risks occur, the ~~including~~trading price of our ~~financial~~common ~~statements~~stock could decline and ~~the~~you ~~related~~may ~~notes~~lose ~~thereto~~all or part of your investment.

Risks Related Toto Our ~~Operations~~Business

We might not be able to continue as a going concern.

Our ~~unaudited~~ condensed consolidated financial ~~statements~~ statements as of December 31, ~~2022~~2025 have been prepared under the assumption that we will continue as a going concern ~~for~~twelve ~~the~~months ~~next~~from ~~twelve~~the date ~~months~~of issuance of this Report. At December 31, ~~2022~~2025, we had cash and cash equivalents of $72.79 million and an accumulated deficit of $44106.9 6 million. ~~Without~~In December 2025, we closed a public offering for net proceeds of approximately $4.8 million, and, during the three months ended December 31, 2025, we generated net proceeds of ~~this~~approximately ~~offering~~$1.2 million from sales under our at-the-market sales program. Even with these proceeds, we do not believe that our cash, and cash equivalents ~~and~~will ~~investments would~~ be sufficient to fund our operations for the next 1230 ~~months~~days, and we ~~would~~ need to raise additional capital. As a result of our expected operating losses and cash burn for the foreseeable future and recurring losses from operations, if we are unable to raise sufficient capital through ~~this offering or~~ additional debt or equity arrangements, there will be uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt as to our ability to continue as a going concern. If we cannot continue as a viable entity, our stockholders would likely lose most or all of their investment in us. If we are unable to generate sustainable operating profit and sufficient cash flows, then our future success will depend on our ability to raise capital. We intend to seek additional financing and evaluate financing alternatives in order to meet our cash requirements for the foreseeable future. We cannot be certain that raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current stockholders may experience dilution. If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current product development programs, cut operating costs, forego future development and other opportunities or even terminate our operations.

IfOur weforecast ~~are~~of ~~unable~~the toperiod ~~generate~~of ~~sustainable~~time ~~operating profit~~through ~~and sufficient cash flows, then~~ which our ~~future~~financial ~~success~~resources will ~~depend~~be onadequate ~~our ability~~ to ~~raise~~support ~~capital.~~our Inoperating ~~addition~~requirements tois ~~this~~a ~~offering, we~~forward-looking ~~are~~statement ~~seeking~~and ~~additional~~involves ~~financing~~risks and uncertainties, ~~evaluating~~and ~~financing~~actual ~~alternatives~~results incould ~~order~~vary toas ~~meet~~a ~~our~~result ~~cash~~of ~~requirements~~a ~~for~~number ~~the~~of ~~next~~factors, 12including ~~months. We~~the ~~cannot~~factors bediscussed ~~certain~~elsewhere ~~that~~in ~~raising~~this ~~additional~~“Risk Factors” ~~capital,~~section ~~whether~~and ~~through~~in ~~this~~Part ~~offering~~I, ~~selling~~Item ~~additional~~1A ~~debt or equity securities or obtaining a line~~ of ~~credit~~our orAnnual ~~other~~Report ~~loan,~~on ~~will~~Form be10-K ~~available~~for tothe usyear ~~or,~~ended ifMarch ~~available~~31, ~~will be on terms acceptable to us~~2025. IfWe wehave ~~issue additional~~based ~~securities~~this toestimate ~~raise~~on ~~funds,~~a ~~these~~number ~~securities~~of ~~may~~assumptions ~~have~~that ~~rights,~~may ~~preferences,~~prove ~~or privileges senior~~ to ~~those~~be ofwrong ~~our~~and ~~common~~changing ~~stock,~~circumstances ~~and~~beyond our ~~current~~ ~~stockholders~~control may ~~experience~~cause ~~dilution.~~us ~~If we are unable~~ to ~~obtain~~consume capital ~~funds~~more ~~when~~rapidly ~~needed~~than orwe oncurrently ~~acceptable~~anticipate. ~~terms,~~Our weinability ~~may be required~~ to ~~curtail~~obtain ~~our~~additional ~~current~~funding ~~product~~when ~~development~~we ~~programs,~~need ~~cut~~it ~~operating~~could ~~costs,~~seriously ~~forego~~harm ~~future development and other opportunities or even terminate~~ our ~~operations~~ business.

We are a developmental stage medical device company and have a history of significant operating losses; we expect to continue to incur operating losses, and we may never achieve or maintain profitability.11

As We are a ~~development~~pre-~~stage~~revenue ~~enterprise,~~medical wedevice docompany and ~~not currently~~ have ~~revenues~~a tohistory ~~generate~~of ~~cash~~significant ~~flows to cover~~ operating ~~expenses.~~losses; ~~Since our inception,~~ we ~~have~~expect ~~incurred~~to ~~operating~~continue ~~losses in each year due~~ to ~~costs~~incur ~~incurred~~operating ~~in connection with research and development activities and general and administrative expenses associated with our operations. For the nine months ended December 31~~losses, ~~2022~~ and ~~year ended March 31, 2022,~~ we ~~incurred net losses of approximately $10.3 million and $18.6 million, respectively. As a result, we need to raise additional capital in the future, which~~ may ornever ~~may~~achieve ~~not be available to us at all~~ or ~~only on unfavorable terms~~maintain profitability.

We ~~expect~~do tonot ~~incur~~currently ~~losses~~have ~~for~~revenues ~~the~~to ~~foreseeable~~generate ~~future~~cash asflows weto ~~continue~~cover ~~the~~operating ~~development~~expenses. ~~of,~~Since ~~and~~our ~~seek~~inception, ~~regulatory~~we ~~clearance~~have ~~and~~incurred ~~approvals~~operating ~~for,~~losses ~~our~~in ~~insulin~~each ~~pump.~~year Asdue ~~our~~to ~~MODD1~~costs ~~insulin~~incurred ~~pump~~in isconnection ~~currently~~with ~~our~~research ~~only~~and ~~product,~~development ifactivities itand ~~fails~~general ~~to gain regulatory approval~~ and ~~market~~administrative ~~acceptance,~~expenses weassociated ~~will~~with ~~not~~our beoperations. ~~able~~For tothe ~~generate~~nine months ~~any~~ended ~~revenue~~December 31, or ~~explore~~2025 ~~other~~and ~~opportunities~~year toended ~~enhance~~March ~~stockholder~~31, ~~value~~2025, ~~such~~we asincurred ~~through~~net alosses ~~sale.~~of Ifapproximately we$21.9 ~~fail~~million ~~to generate revenue~~ and ~~eventually~~$18.8 ~~become profitable~~million, respectively. orAs ifa result, we ~~are~~will ~~unable~~need to ~~fund~~raise ~~our~~additional ~~continuing~~capital ~~losses~~in the future, ~~our~~which ~~stockholders~~may ~~could~~or ~~lose~~may ~~all~~not orbe aavailable ~~substantial~~to ~~part~~us ofat ~~their~~all ~~investment~~or only on unfavorable terms.

We ~~will~~expect ~~need~~to ~~substantial~~incur ~~additional~~losses ~~funding to~~for ~~complete~~the ~~subsequent~~foreseeable future ~~phases~~as ofwe continue the development of, and seek regulatory clearance and approvals for, our insulin pump products. Our Pivot insulin pump is currently our only product, ~~candidate~~which ~~and~~we expect to ~~operate~~commercialize ~~our~~in ~~business~~2026, and, ~~such~~if ~~funding~~it ~~may not~~fails to gain market acceptance, we will not be ~~available~~able orto generate any revenue, ifor itexplore isother ~~available~~opportunities to enhance stockholder value, such ~~financing~~as isthrough ~~likely~~a sale. If we fail to ~~substantially~~generate revenue ~~dilute~~and eventually become profitable, or if we are unable to fund our ~~existing~~continuing losses, our stockholders could lose all or a substantial part of their investment.

~~The~~We ~~discovery,~~will ~~development,~~need ~~and~~substantial ~~commercialization~~additional funding ofto ~~new~~complete ~~medical~~subsequent ~~devices,~~phases ~~such~~of ~~as our insulin pump, entails significant costs. While we believe that we have generally completed~~ the ~~engineering and~~development ~~mechanical aspects~~ of our insulin pump ~~and~~products ~~cartridge along with production-level assembly equipment, we still must refine~~ and ~~finalize our insulin pump~~ to, ~~among~~operate ~~other~~our ~~things,~~business ~~meet the general needs~~ and ~~preferences~~such offunding ~~the~~may ~~Almost~~not ~~Pumper marketplace and the guidelines of~~be ~~third-party~~available ~~payors.~~or, Toif ~~enable~~it usis toavailable, ~~accomplish~~such ~~these~~financing ~~and~~is ~~other~~likely ~~related items and continue~~ to ~~operate~~substantially dilute our ~~business,~~existing westockholders. ~~will need to raise substantial additional capital and/or enter into strategic partnerships or joint ventures to enable us to:~~

●The ~~fund~~discovery, ~~clinical~~development, ~~studies~~and commercialization of new medical devices, such as our insulin pump, entails significant costs. We have completed the engineering and ~~seek~~mechanical ~~regulatory~~development of ~~approvals;~~our insulin pump and cartridge, and obtained FDA clearance for our initial MODD1 product. In addition, we have also implemented a production-level manufacturing process, including purchasing required equipment for low-level manufacturing. We have developed a follow-on product, our Pivot pump, to, among other things, meet the general needs and preferences of the Almost Pumper marketplace and the guidelines of third-party payors. We intend to commercialize our Pivot product if and when FDA approval is received. To enable us to accomplish these and other related items and continue to operate our business, we will need to raise substantial additional capital and/or enter into strategic partnerships or joint ventures to enable us to:

● ~~build~~seek orEuropean ~~access~~regulatory ~~manufacturing~~approvals ~~and~~with ~~commercialization~~appropriate ~~capabilities~~clinical studies;

● ~~develop,~~expand ~~test,~~ and, ifcontinue ~~approved,~~to ~~market~~improve our ~~product~~manufacturing ~~candidate~~and commercialization capabilities;

●

develop, test, and, if approved, market our future product candidates;

●

acquire or license additional internal systems and other infrastructure; and

● hire and support additional management, ~~engineering~~administrative, sales and ~~scientific~~marketing, and technical personnel.

10Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never achieve, we expect to finance our cash needs primarily through public or private equity offerings, debt financings or through the establishment of possible strategic alliances. We may in the future seek additional capital from public or private offerings of our capital stock or borrow additional amounts under new credit lines or from other sources. If we issue equity or debt securities to raise additional funds, our existing stockholders may experience dilution, we may incur significant financing costs, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders. In addition, if we raise additional funds through collaborations, licensing, joint ventures, strategic alliances, partnership arrangements or other similar arrangements, it may be necessary to relinquish valuable rights to our pump products or our potential future products or proprietary technologies or grant licenses on terms that are not favorable to us.

Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never achieve, we expect to finance our cash needs primarily through public or private equity offerings, debt financings or through the establishment of possible strategic alliances. This offering is being conducted to obtain such funding, although there can be no guarantee that we will successfully raise all the funding we require in this offering. Depending on the amount of funding we receive in this offering, as well as other factors, we may in the future seek additional capital from public or private offerings of our capital stock or borrow additional amounts under new credit lines or from other sources. If we issue equity or debt securities to raise additional funds, our existing stockholders may experience dilution, we may incur significant financing costs, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders. In addition, if we raise additional funds through collaborations, licensing, joint ventures, strategic alliances, partnership arrangements or other similar arrangements, it may be necessary to relinquish valuable rights to the MODD1 pump or our potential future products or proprietary technologies or grant licenses on terms that are not favorable to us.12

We cannot be certain that additional funding will be available on acceptable terms, or at all. If we are not able to secure additional equity funding when needed, we may have to delay, reduce the scope of, or eliminate one or more of our post-market clinical studies, development programs or future commercialization initiatives. In addition, any additional equity funding that we do obtain will dilute the ownership held by our existing equity holders. The amount of this dilution may be substantially increased if the trading price of our common stock is lower at the time of any financing. Regardless, the economic dilution to stockholders will be significant if our stock price does not increase significantly, or if the effective ~~price~~ price of any sale is below the price paid by a particular stockholder. Any debt financing that we obtain in the future could involve ~~substantial~~ substantial restrictions on activities and creditors could seek a pledge of some or all of our assets. We have not identified potential sources for such financing that we will require, and we do not have commitments from any third parties to provide any future debt financing. If we fail to obtain funding as needed, we may be forced to cease or scale back operations, and our business, prospects, results of operations, financial condition and stock price would be adversely affected.

We have a limited operating history and historical financial information upon which you may evaluate our performance.

You should consider, among other factors, our prospects for success in light of the risks and uncertainties encountered by companies that, like us, are in their early stages of development. We may not successfully address these risks and uncertainties or successfully complete our studies and/or implement our existing and new products. If we fail to do so, it could materially harm our business and impair the value of our common stock. Unanticipated problems, expenses and delays are frequently encountered in establishing a new business, conducting research, and developing new products. These include, but are not limited to, inadequate funding, failure to obtain regulatory approval, unforeseen research issues, lack of consumer, physician or third-party payor acceptance, competition, sluggish product development, and inadequate sales and marketing. The failure by us to meet any of these conditions would have a materially adverse effect upon us and may force us to reduce or curtail operations. No assurance can be given that we can or will ever operate profitably.

The amount of financing we require will depend on a number of factors, many of which are beyond our control. Our results of operations, financial condition and stock price are likely to be adversely affected if our funding requirements increase or are otherwise greater than we expect.

Our future funding requirements will depend on many factors, including, but not limited to:

● the testing costs for our insulin pump product ~~candidate~~candidates and other development activities conducted by us directly, and our ability to successfully conclude the studies and activities and achieve favorable results;

●

our ability to attract future strategic partners to pay for or share costs related to our product development efforts;

● the costs and timing of seeking and obtaining regulatory clearance and approvals for our product ~~candidate~~candidates;

●

the costs of filing, prosecuting, maintaining and enforcing any patents and other intellectual property rights that we may have and defending against potential claims of infringement;

●

decisions to hire additional scientific, engineering or administrative personnel or consultants;

●

our ability to manage administrative and other costs of our operations; and

●

the presence or absence of adverse developments in our research program.

If any of these factors cause our funding needs to be greater than expected, our operations, financial condition, ability to continue operations and stock price may be adversely affected.

1113

Our future cash requirements may differ significantly from our current estimates.

Our cash requirements may differ significantly from our estimates from time to time, depending on a number of factors, including:

● the costs and results of our clinical studies regarding our insulin pump product ~~candidate~~candidates;

●

the time and costs involved in obtaining regulatory clearance and approvals;

●

whether we are able to obtain funding under future licensing agreements, strategic partnerships, or other collaborative relationships, if any;

●

the costs of compliance with laws, regulations, or judicial decisions applicable to us; and

●

the costs of general and administrative infrastructure required to manage our business and protect corporate assets and stockholder interests.

If we fail to raise additional funds on a timely basis, ~~even after the completion of this offering,~~ we will need to scale back our business plans, which would adversely affect our business, prospects, results of operations, financial condition, and stock price, and we may even be forced to discontinue our operations and liquidate our assets.

~~Technological breakthroughs~~We inmay ~~diabetes~~not ~~monitoring,~~be ~~treatment~~able orto ~~prevention~~utilize ~~could~~a ~~render~~significant portion of our ~~insulin~~net operating ~~pump~~losses ~~obsolete~~and tax credits.

~~The~~As ~~diabetes~~of ~~treatment~~March ~~market~~31, is2025, ~~subject~~our tofederal ~~rapid~~net operating ~~technological~~loss ~~change~~carryforwards ~~and~~totaled ~~product~~$45.6 ~~innovation~~million, of which $0.7 ~~Our~~million ~~insulin~~will ~~pump~~expire isin ~~based~~2037 onand ~~our~~2038 ~~proprietary~~and ~~technology,~~$44.9 ~~but~~million awill ~~number~~not ofexpire. ~~companies,~~We ~~medical~~have ~~researchers~~federal ~~and~~R&D ~~existing~~tax ~~pharmaceutical~~credit ~~companies~~carryforwards ~~are~~of ~~pursuing~~$2.6 ~~new~~million ~~delivery~~which ~~devices,~~will ~~delivery~~expire ~~technologies,~~in ~~sensing~~various ~~technologies,~~years ~~procedures, drugs~~between ~~and~~2038 ~~other~~through ~~therapeutics~~2045. ~~for~~U.S. ~~the~~federal ~~monitoring,~~net operating ~~treatment~~losses ~~and/or~~arising ~~prevention~~in oftax ~~insulin-dependent~~years ~~diabetes.~~beginning ~~Any~~after ~~technological~~December ~~breakthroughs in~~31, ~~diabetes~~2017 ~~monitoring,~~can ~~treatment~~be orcarried ~~prevention~~forward ~~could~~indefinitely, ~~render~~but ~~our~~for ~~insulin~~taxable ~~pump~~years ~~obsolete~~beginning after December 31, ~~which~~2020, ~~since~~the ~~our~~deductibility ~~insulin~~of ~~pump~~such isU.S. ~~our~~federal ~~only~~NOLs ~~product candidate,~~is ~~would~~limited ~~have~~to a80% ~~material~~of ~~adverse~~current ~~effect~~year ontaxable ~~our~~income. ~~business~~Additionally, we ~~prospectus,~~have ~~results~~state ofnet ~~operations~~operating ~~and~~loss ~~financial~~carryforwards ~~condition~~of ~~and~~$68.0 ~~could result~~million which will expire in ~~stockholders~~various ~~losing~~years ~~their~~between ~~entire~~2038 ~~investment~~through 2045.

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses and other tax attributes to offset future taxable income or income tax. In general, an “ownership change” occurs if there is a greater than 50 percentage point change (by value) in a corporation’s equity ownership by certain stockholders over a rolling three year period. We may have experienced ownership changes in the past and may experience ownership changes in the future as a result of subsequent shifts in our stock ownership (many of which are outside our control). If it is determined that we have in the past experienced an ownership change, or if we undergo one or more ownership changes as a result of future transactions in our stock then we may not be able to utilize a material portion of our net operating losses prior to their expiration, even if we were to achieve profitability. To the extent we are not able to offset future taxable income with our net operating losses, our net income and cash flows may be adversely affected.

Technological breakthroughs in diabetes monitoring, treatment or prevention could render our insulin pump products obsolete.

The diabetes treatment market is subject to rapid technological change and product innovation. Our insulin pump products are based on our proprietary technology, but a number of companies, medical researchers and existing pharmaceutical companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs and other therapeutics for the monitoring, treatment and/or prevention of insulin-dependent diabetes. Any technological breakthroughs in diabetes monitoring, treatment or prevention could render our products obsolete, which would have a material adverse effect on our business, prospects, results of operations and financial condition and could result in stockholders losing their entire investment.

Any failure to attract and retain skilled directors, executives, employees and consultants could impair our product development and commercialization activities.

Our business depends on the skills, performance, and dedication of our directors, executive officers and key engineering, scientific and technical advisors. Many of our current engineering or scientific advisors are independent contractors and are either self-employed or employed by other organizations. As a result, they may have conflicts of interest or other commitments, such as consulting or advisory contracts with other organizations, which may affect their ability to provide services to us in a timely manner. We will need to recruit additional directors, executive management employees, and advisers, particularly engineering, scientific and technical personnel, which will require additional financial resources. In addition, there is currently intense competition for skilled directors, executives and employees with relevant engineering, scientific and technical expertise, and this competition is likely to continue. If we are unable to attract and retain persons with sufficient engineering, scientific, technical and managerial experience, we may be forced to limit or delay our product development activities or may experience difficulties in successfully conducting our business, which would adversely affect our business, prospects, results of operations and financial condition.

Our operations are substantially dependent upon key personnel.

Our performance is substantially dependent on the continued services and performance of our senior management and certain other key personnel. ~~The~~In ~~loss~~particular, ofwe ~~services~~are ofdependent ~~any~~on the performance and continued engagement of Paul DiPerna, our ~~executive~~chairman, president and principal financial officer. Although we believe we ~~officers~~will orbe ~~other~~able ~~key~~to ~~employees~~engage ~~could~~qualified ~~have~~personnel afor ~~material~~such ~~adverse~~purposes, ~~effect~~an oninability to do so could materially adversely affect our ~~business~~ability to market, ~~financial~~sell, ~~condition~~ and ~~results~~enhance ofour ~~operations~~products. ~~In addition~~While Mr. DiPerna is currently devoting his full-time working efforts to us, ~~any~~other ~~future~~employees and ~~expansion~~consultants ofmay ~~our~~only ~~business~~be ~~will~~available ~~depend~~to us on ~~our~~a ~~ability~~part-time tobasis. ~~identify,~~The ~~attract,~~loss ~~hire~~of services of one or more of our executive officers, ~~train~~especially Mr. DiPerna, ~~retain~~or other key employees or our inability to hire and ~~motivate~~retain other ~~highly~~ ~~skilled~~qualified ~~managerial~~employees, ~~marketing,~~including ~~customer~~but ~~service~~not limited to research and ~~manufacturing~~development, ~~personnel~~sales, manufacturing, and ~~our~~administrative ~~inability~~support tostaff, ~~do so~~ could have a material adverse effect on our business, ~~financial condition and~~ prospects, results of operations and financial condition.

We ~~are~~have ~~dependent~~and will need to outsource and rely on third parties for various aspects relating to the ~~performance~~development, manufacture, sales and marketing of our insulin pump products, ~~continued~~as ~~engagement~~well as in connection with assisting us in the preparation and filing of our ~~Chairman~~regulatory submissions, ~~President~~and our future success will be dependent on the timeliness and ~~Principal~~effectiveness ~~Financial~~of ~~Officer~~the efforts of these third parties.

We are dependent on ~~the~~third ~~performance~~parties ~~and~~for ~~continued~~important ~~engagement~~aspects of ~~Paul DiPerna,~~ our ~~Chairman,~~business ~~President and Principal Financial Officer~~strategy. ~~Although~~We wedo ~~believe~~not wehave ~~will~~the berequired ~~able~~financial toresources ~~engage~~and ~~qualified~~ personnel ~~for~~to ~~such~~carry ~~purposes,~~out anindependently ~~inability~~all toaspects of dothe sodevelopment ~~could~~of ~~materially~~our ~~adversely~~products, ~~affect~~and ~~our~~have ~~ability~~limited resources to ~~market~~manufacture, ~~sell,~~market and ~~enhance~~sell our ~~products. While~~current Mrproduct candidate. ~~DiPerna~~As isa ~~currently~~result, we ~~devoting~~contract ~~his~~with ~~full-time~~and ~~working~~rely ~~efforts~~on tothird usparties for important functions, ~~other~~including ~~employees~~in ~~and~~connection ~~consultants~~with ~~may~~certain ~~only~~aspects beof ~~available~~the todevelopment and usfinalization onof aour ~~part-time~~products, ~~basis.~~the ~~The~~preparation ~~loss~~and filing of ~~one~~our orregulatory ~~more~~submissions and manufacturing and commercialization of our pump ~~key~~products. ~~employees,~~We ~~especially~~have ~~Mr.~~in ~~DiPerna,~~the orpast ~~our~~and ~~inability~~will continue to ~~hire~~enter ~~and~~into ~~retain~~multiple ~~other~~agreements with third parties for such services. If problems ~~qualified~~develop ~~employees~~in our relationships with third parties, ~~including~~or ~~but~~if ~~not~~such ~~limited~~parties fail to ~~research~~perform ~~and~~as ~~development~~expected, ~~sales,~~it ~~manufacturing,~~could ~~and~~lead ~~administrative~~to ~~support~~delays ~~staff,~~or ~~could~~lack of progress ~~have~~in aobtaining ~~material~~regulatory ~~adverse~~clearance, ~~effect~~significant oncost increases, changes in our ~~business~~strategies, ~~prospects,~~and ~~results~~even failure of ~~operations~~our ~~and~~product ~~financial condition~~initiatives.

We have limited internal research and development personnel, making us dependent on consulting relationships.

We consider research and development to be an important part of the process of designing, developing, obtaining regulatory required approvals and the eventual commercialization of our insulin pump. We continue to incur increased research and development expenditures, which are primarily attributable to effort and expenses incurred in designing and developing our innovative insulin pump. We expect to continue to incur substantial costs related to research and development.

We will need to outsource and rely on third parties for various aspects relating to the development, manufacture, sales and marketing of our insulin pump as well as in connection with assisting us in the preparation and filing of our FDA submission, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.

We are dependent on consultants for important aspects of our product development strategy. We do not have the required financial resources and personnel to carry out independently the development of our product candidate, and do not have the capability or resources to manufacture, market or sell our current product candidate. As a result, we contract with and rely on third parties for important functions, including in connection with the development and finalization of our insulin pump, the preparation and filing of our FDA submission and eventual manufacturing and commercialization of our product candidate. We have recently entered into several agreements with third parties for such services. If problems develop in our relationships with third parties, or if such parties fail to perform as expected, it could lead to delays or lack of progress in obtaining FDA clearance, significant cost increases, changes in our strategies, and even failure of our product initiatives.

We may not be able to identify, negotiate and maintain the strategic alliances necessary to develop and commercialize our products and technologies, and we will be dependent on our corporate partners if we do.

We may seek to enter into a strategic alliance with a diabetes-related service providing company for the further development and approval of our insulin pump product candidate. At this time, we have not entered into any such strategic alliance. Strategic alliances, if entered into, could potentially provide us with additional funds, expertise, access, and other resources in exchange for exclusive or non-exclusive licenses or other rights to the product that we are currently developing or a product we may explore in the future. We cannot give any assurance that we will be able to enter into strategic relationships with a diabetes-related service providing company or others in the near future or at all. In addition, we cannot assure you that any agreements that we do reach will allow us to achieve our goals or that such grants will be on terms that prove to be economically beneficial to us. When we do enter into strategic or contractual relationships, we become dependent on the successful performance of our partners or counter-parties. If they fail to perform as expected, such failure could adversely affect our financial condition, lead to increases in our capital needs, or hinder or delay our development efforts. See “Our Business -Employees” below.

We may not receive the necessary regulatory clearance or approvals for our insulin pump, and failure to timely obtain necessary clearances and/or approvals could harm our then operations, including our ability to commercialize our product candidate.15

~~Before~~We wemay ~~can~~not ~~market a new medical device, such as our insulin pump, we must first~~ receive ~~clearance under Section 510(k) of~~ the ~~Federal~~necessary ~~Food, Drug, and Cosmetic Act, or the “FDCA.”~~regulatory ~~In the 510(k)~~ clearance ~~process,~~or ~~before~~approvals afor ~~device~~our ~~may~~insulin bepump ~~marketed~~products, ~~the~~and ~~FDA~~failure ~~must determine that such proposed device is “substantially equivalent”~~ to atimely ~~legally-marketed~~obtain ~~“predicate”~~necessary ~~device,~~clearances which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre-amendments device), a device that was originally on the U.S. market pursuant to a premarket approval (PMA) and ~~later down-classified,~~ /or aapprovals ~~510(k)-exempt~~could ~~device.~~harm ~~To be “substantially~~our ~~equivalent,”~~then ~~the proposed device must have the same intended use as the predicate device~~operations, ~~and~~including ~~either~~our ~~have~~ability ~~the~~to ~~same~~commercialize ~~technological characteristics~~our ~~as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device~~products.

~~Certain~~Before ~~future~~we ~~modifications~~can ~~made~~market toa ~~our~~new ~~product candidate~~medical device, ~~which~~such as our insulin pump, we ~~currently~~must ~~expect~~first toreceive beclearance ~~cleared~~under ~~through~~Section 510(k) of the Federal Food, ~~may~~Drug, ~~require~~and aCosmetic ~~new~~Act, ~~510(k)~~or ~~clearance~~the “FDCA.” In ~~The~~the 510(k) clearance process, ~~can be~~before ~~expensive,~~a ~~lengthy~~device ~~and~~may ~~uncertain.~~be ~~The~~marketed, the FDA’s ~~510(k)~~must ~~clearance~~determine ~~process~~that ~~usually~~such ~~takes~~proposed ~~from~~device ~~three~~is “substantially equivalent” to 12a ~~months~~legally-marketed “predicate” device, ~~but~~which ~~can~~includes ~~last~~a ~~longer. Despite~~device ~~the~~that ~~time,~~has ~~effort~~been ~~and~~previously ~~cost~~cleared through the 510(k) process, a device ~~may~~that ~~not~~was belegally ~~approved~~marketed orprior ~~cleared~~to byMay ~~the~~28, ~~FDA.~~1976 ~~Any~~(preamendments ~~delay~~device), ora ~~failure~~device tothat ~~obtain~~was ~~necessary~~originally ~~regulatory~~on ~~authorizations~~the ~~could~~U.S. ~~harm~~market ~~our~~pursuant ~~business, including our ability~~ to ~~commercialize~~a ~~our~~premarket ~~product~~approval ~~candidate~~(PMA) and ~~our~~later ~~stockholders~~down ~~could~~classified, ~~lose their~~or ~~entire~~a ~~investment~~510(k)-exempt device. ~~Furthermore~~To be “substantially equivalent,” ~~even~~the ifproposed wedevice ~~are~~must ~~granted~~have the ~~required~~same ~~regulatory~~intended ~~authorizations~~use as the predicate device, ~~such~~and ~~authorizations~~either ~~may~~have bethe ~~subject~~same technological tocharacteristics ~~significant~~as ~~limitations~~the onpredicate ~~the~~device ~~indicated~~or ~~uses~~have ~~for~~different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. In September 2024, ~~which~~we ~~may~~received ~~limit~~FDA ~~the~~clearance to market ~~for~~and sell our initial pump product, ~~candidate~~our MODD1, in the United States.

IfOur Pivot product, which will be our second product after our MODD1 product, is the ~~FDA~~product ~~requires~~that uswe intend to gocommercialize ~~through~~in ~~a lengthier~~2026, ~~more~~if ~~rigorous~~and ~~examination~~when FDA approval is obtained. We submitted a 510(k) clearance for our Pivot product. ~~candidate~~The 510(k) clearance process can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process usually takes less than we12 ~~had~~months, ~~expected~~but it can last longer. Despite the time, ~~product~~effort ~~introductions~~and cost, a device may not be approved or ~~modifications~~cleared ~~could~~by bethe ~~delayed~~FDA. Any delay or ~~canceled,~~failure ~~which~~to obtain necessary regulatory authorizations could ~~adversely~~harm ~~affect~~our business, including our ability to commercialize our future product candidates and our stockholders could lose their entire investment. Furthermore, even if we are granted the required regulatory authorizations, such authorizations may be subject to ~~grow~~significant limitations on the indicated uses for the device, which may limit the market for our ~~business~~future product candidates.

13If the FDA requires us to go through a lengthier, more rigorous examination for our future product candidates than we had expected, product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business.

The FDA can delay, limit or deny clearance or approval for our ~~insulin~~product ~~pump~~candidates ~~medical device~~ for many reasons, including, for example:

● our inability to demonstrate to the satisfaction of the FDA that ~~our~~a product candidate is substantially equivalent to the proposed predicate device;

●

the disagreement of the FDA with the design or implementation of our performance testing protocols or the interpretation of data from our performance testing;

●

the data from performance testing may be insufficient to support a determination of substantial equivalence or that our device meets required special controls or applicable performance standards;

●

our inability to demonstrate that the benefits of our pump outweigh the risks;

● the manufacturing process or facilities we intend to use may not meet applicable requirements; for example, we experienced issues maintaining insulin stability on an initial version of our ~~pump~~MODD1 product ~~candidate~~, and we attributed this issue to the materials used in the initial production ~~of our product~~process; we ~~believe we have~~ made the necessary changes to our materials and process to address this issue ~~and~~to ~~will~~obtain beFDA ~~completing~~clearance for the ~~required~~MODD1 ~~testing prior to our FDA submission~~product; and

●

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

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 product ~~candidate~~candidates or impact our ability to modify our future product candidate after clearance on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain clearance for our proposed future pump products, increase the costs of compliance or restrict our ability to maintain our current approval.

As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of data supporting the safety and performance of the product candidates during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

Obtaining marketing authorization in the United States will not obviate the need to obtain marketing authorization in other jurisdictions We must obtain approval from foreign regulatory authorities before we can market and sell any of our product candidates in countries outside the United States. We will incur additional costs in seeking such approvals, may experience delays in obtaining such approvals and cannot be certain that such approvals will be granted.

The development, manufacture, and marketing of our product candidates outside the United States is subject to government regulation. In most foreign countries, we must complete rigorous pre-clinical testing and extensive human clinical trials that demonstrate the safety and efficacy of a product in order to apply for regulatory approval to market the product. If foreign regulatory authorities grant regulatory approval of a product, the approval may be limited to specific indications or limited with respect to its distribution. Expanded or additional indications for approved devices may not be approved, which could limit our potential revenues. Foreign regulatory authorities may refuse to grant any approval. Consequently, even if we believe that ~~pre-clinical~~preclinical and clinical data are sufficient to support regulatory approval for our products, foreign regulatory authorities may not ultimately grant approval for commercial sale in any jurisdiction. If our product candidates are not approved in such jurisdictions, our ability to generate revenues will be limited and our business will be adversely affected.

Our competitors may develop products that are more effective, safer and less expensive than ours.

Existing insulin pumps are expensive, with the more popular models ~~having~~receiving ~~purchase~~reimbursement ~~prices~~ exceeding $4,000 ~~for~~under ~~individuals~~durable medical equipment or pharmacy benefit coverage from individuals without health insurance and often ~~require~~requiring significant patient copays. Others have daily use costs that exceed the reimbursement rates of many health insurance plans, forcing some users to spend thousands of dollars a year in copays. We believe this makes insurers hesitant to pay for any pumps and places pumps out of reach for many patients who cannot afford such out of pocket expenses.

We are engaged in the diabetes treatment sector of the healthcare marketplace, which is intensely competitive. There are current products that are quite effective at addressing the effects of diabetes, and we expect that new developments by other companies and academic institutions in the areas of diabetes treatment will continue. If approved for marketing by the FDA, depending on the approved clinical indication, our product will be competing with existing and future products related to treatments for diabetes.

Our competitors may:

●

develop product candidates and market products that increase the levels of safety or efficacy that our product candidates will need to show in order to obtain regulatory approval;

●

develop product candidates and market products that are less expensive or more effective than ours;

●

commercialize competing products before we can launch any products we are working to develop;

●

hold or obtain proprietary rights that could prevent us from commercializing our products; or

● introduce therapies or market medical products that render our ~~potential~~current product and future product candidates obsolete.

We expect to compete against large medical device companies, such as Medtronic, Inc., Tandem Diabetes Care, Inc. and Insulet Corporation and smaller companies that are collaborating with larger medical device companies, new companies, academic institutions, government agencies and other public and private research organizations. These competitors, in nearly all cases, produce similar products relative to the treatment of diabetes and have substantially greater financial resources than we do. Our competitors also have significantly greater experience in:17

We expect to compete against large medical device companies, such as Medtronic, Inc., Tandem Diabetes Care, Inc. and Insulet Corporation, smaller companies that are collaborating with larger medical device companies, new companies, academic institutions, government agencies and other public and private research organizations. These competitors, in nearly all cases, produce similar products relative to the treatment of diabetes and have substantially greater financial resources than we do. Some of our competitors also have significantly greater experience in:

●

developing medical device and other product candidates;

●

undertaking testing and clinical studies;

●

building relationships with key customers and opinion-leading physicians;

●

obtaining and maintaining FDA and other regulatory approvals;

●

formulating and manufacturing medical devices;

●

launching, marketing and selling medical devices;

●

providing management oversight for all of the above-listed operational functions; and

● obtaining insurance coverage and reimbursement for ~~our~~their ~~product~~competitive products.

If we fail to achieve acceptance over other existing or newly developed products, we may be unable to obtain regulatory approval or successfully commercialize our ~~MODD1~~future insulin pump product ~~candidate or any future products~~candidates. If our competitors’ market medical devices that are less expensive, safer or more effective than our insulin pump, or that gain or maintain greater market acceptance, we may not be able to compete effectively, which would adversely affect our business, prospects, results of operations and financial condition. See “Business - Competition.”

We expect to rely on third-party manufacturers and will be dependent on their quality and effectiveness.

Our insulin pump requires precise, high-quality manufacturing. The failure to achieve and maintain high manufacturing standards, including failure to detect or control anticipated or unanticipated manufacturing errors or the frequent occurrence of such errors, could result in patient injury or death, discontinuance or delay of ongoing or planned clinical studies, delays or failures in product testing or delivery, cost overruns, product recalls or withdrawals and other problems that could seriously hurt our business. Contract medical device manufacturers often encounter difficulties involving production yields, quality control and quality assurance and shortages of qualified personnel. These manufacturers are subject to stringent regulatory requirements, including the FDA’s current good-manufacturing-practices regulations. If our contract manufacturers fail to maintain ongoing compliance at any time, the production of our product could be interrupted, resulting in delays or discontinuance of our clinical studies, additional costs and loss of potential revenues.

15We may not be able to successfully scale-up manufacturing of our products in sufficient quality and quantity, which would delay or prevent us from commercializing our products.

WeIn order to conduct larger-scale or late-stage clinical studies and for commercialization of our insulin pump products, if 510(k) clearance is granted for any product, we will need to manufacture it in larger quantities. We may not be able to successfully increase the manufacturing capacity for our MODD 1 product or future product candidates in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up ~~manufacturing~~activities. If we are unable to successfully scale up the manufacture of our product candidate in sufficient quality and quantity, ~~which~~the ~~would delay~~development orand ~~prevent~~testing usof ~~from developing~~ our product ~~candidate~~candidates and ~~commercializing~~regulatory ~~our~~approval ~~product~~or ~~candidate~~commercial launch may be delayed, which could significantly harm our business.

In order to conduct larger-scale or late-stage clinical studies and for commercialization of our insulin pump, if 510(k) clearance is granted, we will need to manufacture it in larger quantities. We may not be able to successfully increase the manufacturing capacity for our product candidate in a timely or cost-effective manner, or at all. In addition, quality issues may arise during scale-up activities. If we are unable to successfully scale up the manufacture of our product candidate in sufficient quality and quantity, the development and testing of our product candidate and regulatory approval or commercial launch may be delayed, which could significantly harm our business.

We are dependent upon third-party suppliers to manufacture our product, and this makes us vulnerable to supply shortages and price increases; we may not be able to obtain an adequate supply of components on a timely basis or at all.

The ~~future~~ manufacture of our product will require ~~the~~ the timely delivery of sufficient amounts of components from multiple suppliers in various countries. We ~~intend~~have tobeen ~~work~~working closely with our suppliers to ensure continuity of supply, but we cannot guarantee these efforts will be successful. Due to the supply chain issues experienced by the semiconductor industry, at times, we have experienced delays obtaining integrated circuits from certain suppliers. We may need to enter into “take or pay” contracts with suppliers. We have also seen price increases for various components. We do not have supply agreements with any of our suppliers, and we make purchases based on individual purchase orders. An interruption, delay, or or inability to obtain components from our third-party suppliers at acceptable prices in a timely manner, could hinder our ability to ~~manufacture~~ manufacture our products and have a material adverse effect on our business, prospects, financial condition and results of operations.

We may be subject to potential product liability and other claims that could materially impact our business and financial condition.

The ~~development~~marketing and sale of our insulin pump ~~exposes~~ exposes us to the risk of significant damages from product liability and other claims, and the use of our product ~~candidate~~ in clinical studies may result in adverse effects from liability claims. We cannot predict all the possible harms or adverse effects that may result. We ~~intend~~have ~~to obtain~~ obtained product liability insurance to provide some protection from potential claims. Nonetheless, we may not have sufficient resources to pay for any liabilities resulting from a personal injury or other claim, even if it is partially covered by insurance. In addition to the possibility of direct claims, we may be required to indemnify third parties against damages and other liabilities arising out of our development, commercialization and other business activities, which would increase our liability exposure. If third parties that ~~have~~ have agreed to indemnify us fail to do so, we may be held responsible for those damages and other liabilities as well.

Legislative, regulatory, or medical cost reimbursement changes may adversely impact our business.

New laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to the health care system in the U.S. and in other jurisdictions may change the nature of and regulatory requirements relating to innovations in medical devices, testing and regulatory approvals, limit or eliminate payments for medical procedures and treatments, or subject the pricing of medical devices to government control. In addition, third-party payors in the U.S. are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement of new products. Consequently, significant uncertainty exists as to the reimbursement status of newly approved health care products. Significant changes in the health care system in the U.S. or elsewhere, including changes resulting from adverse trends in third-party reimbursement programs, could have a material adverse effect on our projected future operating results and our ability to raise capital, commercialize products, and remain in business.

We are subject to extensive regulation by the ~~U.S. Food and Drug Administration~~FDA, which could restrict the sales and marketing of our insulin pump products and could cause us to incur significant costs.

Our insulin pump isproducts are subject to extensive regulation by the FDA. These regulations relate to manufacturing, labeling, sale, promotion, distribution and shipping. Before a new medical device, or a new intended use of a legally marketed device, can be marketed in the United States, it must be cleared or approved by the FDA through the applicable premarket review process (510(k), PMA, or de novo classification), unless an exemption applies. While If we ~~receive~~have received 510(k) clearance for our initial insulin pump product, the MODD1, which we do not intend to commercialize, we may be required to obtain new 510(k) clearances for significant post-market modifications to the pump. For example, our Pivot product, which is the product that we will commercialize, requires 510(k) clearance, and we made a submission to the FDA and are responding to FDA comments on our submission. Each premarket submission and review process can be expensive and lengthy, and entail significant ~~user~~ user fees, unless exempt.

Medical devices may be marketed only for the indications for which they are approved or cleared. Further, 510(k) ~~clearances~~clearance can be revoked if safety or effectiveness problems develop once the device is on the market.

The current regulatory requirements to which we are subject may change in the future in a way that adversely affects us. If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement action by the FDA, which may include any of the following sanctions:

●

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

●

customer notification, or orders for repair, replacement or refunds;

●

voluntary or mandatory recall or seizure of our current or future products;

●

administrative detention by the FDA of medical devices believed to be adulterated or misbranded;

●

imposing operating restrictions, suspension or shutdown of production;

● refusing our requests for 510(k) clearance, PMA or de -novo classification of any new products, new intended uses or modifications to our insulin pump;

●

rescinding 510(k) clearance that has already been granted; and

●

criminal prosecution.

The occurrence of any of these events would have a material adverse effect on our business, financial condition and results of operations and could result in stockholders losing their entire investment.

Although our insulin pump product candidate does not presently require clinical trials to apply to the FDA for clearance and even if a clinical trial is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product candidate.19

~~Clinical trials~~Although ~~are~~our ~~almost~~insulin ~~always~~pump ~~required~~products todo ~~support a PMA application and may also be required to support 510(k) submissions although at this~~not ~~time~~presently ~~ours does not~~ require a PMA. If the device presents a “significant risk” to human health as defined by the FDA, the FDA requires the study sponsor to submit an investigational device exemption (“IDE”) application and obtain IDE approval prior to commencing human clinical trials. ~~The~~to ~~IDE~~apply ~~must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe~~ to ~~test~~ the ~~device in humans and that the testing protocol is scientifically sound. An IDE will automatically become effective 30 days after receipt by the~~ FDA, unless the FDA denies the application or notifies the sponsor that the investigation is on hold and may not begin until the sponsor provides supplemental information about the investigation that satisfies the agency’s concerns. The FDA may also notify the sponsor that the study is approved as proposed. If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the study, the FDA may permit a clinical trial to proceed under a conditional approval. Furthermore, the agency may withdraw approval of an IDE under certain circumstances. Clinical trials for a significant risk device may begin once an IDE is approved by the FDA and the appropriate Institutional Review Board (“IRB”) at each clinical trial site. If the product is deemed a “non-significant risk” deviceclearance, IDE approval from the FDA would not be required, but the clinical trial would need to meet other requirements including IRB approval. Our clinical trials must be conducted in accordance with FDA regulations and ~~federal~~even ~~and~~if ~~state regulations concerning human subject protection, including informed consent and healthcare privacy. A clinical trial may be suspended by the FDA or at~~ a ~~specific site by the relevant IRB at any time for various reasons, including a determination that the risks to the trial participants outweigh the benefits of participation in the~~ clinical trial. ~~Even if a clinical trial~~ is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product candidates.

~~Our~~Clinical trials are almost always required to ~~success~~support ~~depends~~a ~~substantially~~PMA ~~upon~~application and may also be required to support 510(k) submissions, although at this time our ~~ability~~products do not require a PMA. If the device presents a “significant risk” to human health as defined by the FDA, the FDA requires the study sponsor to submit an investigational device exemption, or IDE, application and obtain IDE approval prior to commencing human clinical trials. The IDE must be supported by appropriate data, such as animal and ~~maintain~~laboratory ~~intellectual~~testing ~~property~~results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. An IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA denies the application or notifies the sponsor that the investigation is on hold and may not begin until the sponsor provides supplemental information about the investigation that satisfies the agency’s concerns. The FDA may also notify the sponsor that the study is approved as proposed. If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the study, the FDA may permit a clinical trial to proceed under conditional approval. Furthermore, the agency may withdraw approval of an IDE under certain circumstances. Clinical trials for a significant risk device may begin once an IDE is approved by the FDA and the appropriate Institutional Review Board, or IRB, at each clinical trial site. If the product is deemed a “non-significant risk” device, IDE approval from the FDA would not be required, but the clinical trial would need to meet other requirements including IRB approval. Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, ~~relating~~including informed consent and healthcare privacy. A clinical trial may be suspended by the FDA or at a specific site by the relevant IRB at any time for various reasons, including a determination that the risks to the trial participants outweigh the benefits of participation in the clinical trial. Even if a clinical trial is completed, the results of our ~~product~~clinical ~~candidate~~testing may not demonstrate the safety and ~~research~~efficacy ~~technologies~~of the device or may be equivocal or otherwise not be sufficient for us to obtain approval of our product.

WeOur ~~have~~success ~~applied~~depends tosubstantially ~~the U.S. Patent and Trademark~~upon ~~Office (the USPTO) and various foreign patent agencies for patents on~~ our ~~proprietary~~ability ~~fluid movement technology and our insulin delivery methodology. To date, the USPTO has granted three patents~~ to ~~us,~~obtain and wemaintain ~~have~~intellectual ~~additional~~property ~~applications~~protection ~~pending~~relating and in various stages of review by the USPTO and foreign patent agencies. There can be no assurance that we will be issued additional patents by the USPTO or foreign patent agencies and that any of our patents will prevent other companies from competing with us. We will continue to ~~attempt to patent~~ our ~~innovations,~~insulin aspump ~~appropriate,~~products toand ~~help~~research ~~ensure a sustainable competitive advantage~~technologies.

17We have applied to the U.S. Patent and Trademark Office, or the USPTO, and various foreign patent agencies for patents on our proprietary fluid movement technology and our insulin delivery methodology. To date, the USPTO has granted six patents to us, and we have been awarded four patents by foreign jurisdictions. We have additional applications pending and in various stages of review by the USPTO and foreign patent agencies. There can be no assurance that we will be issued additional patents by the USPTO or foreign patent agencies and that any of our patents will prevent other companies from competing with us. We will continue to attempt to patent our innovations, as appropriate, to help ensure a sustainable competitive advantage.

Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering health care product inventions, our ability to enforce our existing patents and to obtain and enforce patents that may issue from any pending or future patent applications is uncertain and involves complex legal, scientific and factual questions. To date, no consistent policy has emerged regarding the breadth of claims allowed in medical device patents. Thus, we cannot be sure that any patents will issue from any pending or future patent applications owned by or licensed to us. Even if patents do issue, we cannot be sure that the claims of these patents will be held valid or enforceable by a court of law, will provide us with any significant protection against competing products, or will afford us a commercial advantage over competitive products. If, at some point in the future, one or more products resulting from our product candidates is approved for sale by the FDA and we do not have adequate intellectual property protection for those products, competitors could duplicate them for approval and sale in the United States without repeating the extensive testing required of us to obtain FDA approval.

If we are sued for infringing on third-party intellectual property rights, it will be costly and time-consuming, and an unfavorable outcome would have a significant adverse effect on our business.

Our ability to commercialize our ~~product~~pump ~~candidate~~ products depends on our ability to use, manufacture and sell our product ~~candidate~~current and future product candidates without infringing the patents or other proprietary rights of third parties. Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the diabetes medical device area. There may be existing patents, unknown to us, on which our activities with our insulin pump ~~candidate~~products could infringe.

If a third party claims that our actions infringe on its patents or other proprietary rights, we could face a number of issues that could materially harm our competitive position, including, but not limited to:

●

infringement and other intellectual property claims that, even if meritless, can be costly and time-consuming, delay the regulatory approval process and divert management’s attention from our core business operations;

● Anan order that we pay substantial damages for infringement, including consequential damages for lost of profits or market share, if a court determines that our products or technologies infringe on a third party’s patent or other proprietary rights;

●

a court prohibiting us from selling or licensing our products or technologies unless the holder licenses the patent or other proprietary rights to us, which it is not required to do; and

●

even if a license is available from a holder, we may have to pay substantial royalties or grant cross-licenses to our patents or other proprietary rights.

If any of these events occur, it could significantly harm our operations and financial condition and negatively affect our stock price.

If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected.

In addition to patented technology and technology for which patent protection is being sought, we rely on our unpatented technology, trade secrets and know-how. We generally seek to protect ~~this~~ this information by confidentiality, non-disclosure and assignment of invention agreements with our officers, employees, contractors and other service providers and with parties with which we do business. These agreements may be breached, which breach may result in the misappropriation of such information, and we may not have adequate remedies for any such breach. We cannot be certain that the steps we have taken will prevent unauthorized use or reverse engineering of our technology.

Moreover, our trade secrets may be disclosed to or otherwise become known or be independently developed by competitors. To the extent that our officers, employees, contractors, other service providers, or other third parties with whom we do business use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. If, for any of the above reasons, our intellectual property is disclosed or misappropriated, it would harm our ability to protect our rights and have a material adverse effect on our business, financial condition, and results of operations.

1821

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

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 gain and maintain a competitive advantage. The following examples are illustrative:

●

others may be able to make devices that are similar to our insulin pump but that are not covered by the claims of the patents that we own;

●

we or any collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own;

●

we might not have been the first to file patent applications covering certain of our inventions;

●

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

●

it is possible that our pending patent applications will not lead to issued patents;

●

issued patents that we own may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;

●

our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as 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; and

●

we may not develop additional proprietary technologies that are patentable.

Healthcare reform and drug-pricing reform laws could adversely affect our ~~product~~products ~~candidate~~ and financial condition.

In the United States, there have been, and continue to be, a number of legislative initiatives to contain healthcare costs. In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (ACA), was enacted in the United States, which made a number of substantial changes in the way healthcare is financed by both governmental and private insurers. Among other ways in which it may ~~affect~~ affect our business, the ACA implemented payment system reforms, including a national pilot program on payment bundling to encourage hospitals, physicians, and other providers to improve the coordination, quality, and efficiency of certain healthcare services through bundled payment models and expanded the eligibility criteria for Medicaid programs. Since its enactment, there have been judicial, executive, and Congressional challenges to certain aspects of the ACA. It is unclear how the ACA and its implementation, as well as efforts to repeal or replace, or invalidate, the ACA, or portions thereof, will affect our insulin pump or our business. Additional legislative changes, regulatory changes, and judicial challenges related to the ACA remain possible. It is possible that the ACA, as currently enacted or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future, could have an adverse effect on our industry generally and on our ability to commercialize our insulin pump products and achieve profitability. We have assumed in all of our financial projections that there is not an increase in the reimbursement for our ~~product~~products through the pharmacy or durable medical equipment routes.

~~President Biden intends, as his predecessor did, to take action against drug prices which are considered “high.”~~ Drug pricing continues to be a subject of debate at the executive and legislative levels of U.S. government. The American Rescue Plan Act of 2021 ~~includes~~eliminated ~~a provision that will eliminate~~ the statutory ~~cap~~ cap on rebates that drug manufacturers pay to Medicaid beginning in January 1, 2024. With the elimination of the rebate cap, manufacturers ~~may~~ may be required to compensate states in an amount greater than what the state Medicaid programs pay for the drug. Additionally, the ~~Inflation~~ Inflation Reduction Act of 2022 contains substantial drug pricing reforms, including the establishment of a drug price negotiation program within the U.S. Department of Health and Human Services that would require manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain drugs payable under Medicare Parts B and D to penalize price increases that outpace inflation, and requires manufacturers to provide discounts on Part D drugs. Substantial penalties can be assessed for noncompliance with the drug pricing provisions in the Inflation Reduction Act of 2022. The Inflation Reduction Act of 2022 could have the effect of reducing the prices we can charge and reimbursement we receive for our products, if approved, thereby reducing our profitability, and could have a material adverse effect on our financial condition, results of operations and growth prospects. The effect of Inflation Reduction Act of 2022 on our business and the pharmaceutical industry in general is not yet known.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. We expect that additional federal, state and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures.

19These and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any current product or future product candidate. Any reduction in reimbursement from Medicare or other government healthcare programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products. Legislative and regulatory proposals have been made to expand post approval requirements and restrict sales and promotional activities for drugs. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of any current or future product candidates, if any, may be. In addition, increased Congressional scrutiny of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

~~These~~Even ~~and~~if ~~other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that~~ we ~~receive for~~are ~~any~~able ~~current~~to ~~product~~obtain orall ~~future product candidate. Any reduction in reimbursement from Medicare or other government healthcare programs~~regulatory ~~may~~approvals ~~result~~and inhave acompleted ~~similar~~all ~~reduction in payments from private payors. The implementation of cost containment measures or~~ other ~~healthcare reforms~~steps ~~may~~needed ~~prevent~~to usbe ~~from~~taken ~~being~~to ~~able~~commercialize toour ~~generate~~insulin ~~revenue~~pump, ~~attain~~if ~~profitability~~we or ~~commercialize~~any ~~our~~contract ~~products. Legislative and regulatory~~manufacturers ~~proposals~~we ~~have~~select ~~been~~fail ~~made~~ to ~~expand~~comply ~~post-approval~~with ~~requirements and restrict sales and promotional activities for drugs. We cannot be sure whether additional legislative changes will be enacted, or whether~~ the FDA’s ~~regulations,~~quality ~~guidance~~system ~~or interpretations will be changed~~regulations, ~~or what~~ the ~~impact~~manufacturing ofand ~~such~~distribution ~~changes on the marketing approvals~~ of ~~any~~our ~~current~~products orcould ~~future product candidates, if any, may~~ be~~. In addition, increased~~ ~~Congressional scrutiny of the FDA’s approval process may significantly delay or prevent marketing approval~~interrupted, asand ~~well~~our assales ~~subject us to more stringent product labeling~~ and ~~post-marketing~~operating ~~testing~~results ~~and~~could ~~other requirements~~suffer.

~~Even if~~We wehave ~~are~~established ~~able~~initial, tolow-volume ~~obtain~~manufacturing capability ~~all~~in ~~regulatory~~our ~~approvals~~facility and ~~have~~with ~~completed~~a ~~all~~tier ~~other~~one ~~steps~~medical ~~needed~~device tocontract bemanufacturer. ~~taken~~We toand ~~commercialize~~the contract manufacturer of our insulin pump products will be required to comply with the FDA’s quality system regulations, ifwhich weimpose a complex regulatory framework that covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of medical devices. The FDA enforces its quality system regulations through periodic unannounced inspections. We cannot assure you that, in the future, any manufacturing facilities owned by us or any contract ~~manufacturers~~manufacturer wewill ~~select~~pass ~~fails~~any toquality ~~comply~~system inspection. ~~with~~In the ~~FDA~~event that our or any contract manufacturer’s facilities fails a quality system ~~regulations~~inspection, the manufacturing ~~and~~or distribution of our ~~product~~products ~~candidate~~ could be interrupted, and our ~~product~~operations ~~sales~~disrupted. Failure to take adequate and ~~operating~~timely ~~results~~corrective action in response to an adverse quality system inspection could ~~suffer~~force a suspension or shutdown of any packaging and labeling operations or then manufacturing operations of any contract manufacturers, or a recall of our insulin pump products. If any of these events were to occur, we at such time would not be able to provide our customers with the quantity of insulin pumps that they require on a timely basis, our reputation could be harmed and we could lose any customers we then have, any or all of which could have a material adverse effect on our business, financial condition and results of operations.

A material step in the process of the commercialization of our product candidate will involve selecting a manufacturer or manufacturers for our pump. We and any future contract manufacturers of our insulin pump will be required to comply with the FDA’s quality system regulations, which impose a complex regulatory framework that covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of medical devices. The FDA enforces its quality system regulations through periodic unannounced inspections. We cannot assure you that, in the future, any manufacturing facilities owned by us or any contract manufacturer will pass any quality system inspection. In the event that our or any contract manufacturer’s facilities fails a quality system inspection, the manufacturing or distribution of our product candidate could be interrupted and our operations disrupted. Failure to take adequate and timely corrective action in response to an adverse quality system inspection could force a suspension or shutdown of any packaging and labeling operations or then manufacturing operations of any contract manufacturers, or a recall of our insulin pump. If any of these events were to occur, we at such time would not be able to provide our customers with the quantity of insulin pumps that they require on a timely basis, our reputation could be harmed and we could lose any customers we then have, any or all of which could have a material adverse effect on our business, financial condition and results of operations.

We may bring infringement claims or other legal proceedings against third parties, causing us to spend substantial resources on litigation and exposing our own intellectual property portfolio to challenge.

We may come to believe that third parties are infringing on our patents or other proprietary rights. To prevent infringement or unauthorized use, we may need to file infringement and/or misappropriation suits, which are very expensive and time-consuming, could result in meritorious counterclaims against us and would distract management’s attention. Also, in an infringement or misappropriation proceeding, a court may decide that one or more of our patents is invalid, unenforceable, or both, in which case third parties may be able to use our technology without paying license fees or royalties. Even if the validity of our patents is upheld, a court may refuse to stop the other party from using the technology at issue on the grounds that the other party’s activities are not covered by our patents. See “Business - Patents,” below.

2023

We may become involved in disputes with our present or future contract partners over intellectual property ownership or other matters, which would have a significant effect on our business.

Inventions discovered in the course of performance of contracts with third parties or contractors may become jointly owned by such third -party contractors and us, in some cases, and the exclusive property of one of us, in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention or whether it is jointly owned, and disputes could arise regarding ownership or use of those inventions or jointly developed improvements thereto. Other disputes may also arise relating to the performance or alleged breach of our agreements with third parties. Any disputes could be costly and time-consuming, and an unfavorable outcome could have a significant adverse effect on our business.

~~Assuming our~~Our insulin pump ~~receives~~products ~~FDA~~may ~~clearance or approval, our insulin pump will still~~ be subject to recalls, which would harm our reputation, business operations and financial results.

~~Even assuming~~The ~~we obtain~~ FDA ~~approval or clearance with regard to our insulin pump, the FDA~~ has the authority to require the recall of our pump products, if we commence manufacturing of our insulin ~~pump~~pumps, and we, or any contract manufacturers we retain, fail to comply with relevant regulations pertaining to manufacturing practices, labeling, advertising or promotional activities, or if new information is obtained concerning the safety or efficacy of the device. A government-mandated recall could occur if the FDA finds that there is a reasonable probability that our device would cause serious, adverse health consequences or death. A voluntary recall by us could occur as a result of manufacturing defects, labeling deficiencies, packaging defects or other failures to comply with applicable regulations. Any recall would divert management’s attention and financial resources and harm our reputation with customers. A recall involving our insulin pump products would be particularly harmful to our business, financial condition and results of operations because itthese are is currently our only ~~product candidate~~products.

Our current insulin pump product does not yet have reimbursement and is not approved for insurance coverage. If in the future we are otherwise able to commercialize our insulin pump products, but are unable to obtain adequate reimbursement or insurance coverage for such product from third-party payors, we will be unable to generate significant revenue.

Our Pivot insulin pump is not yet eligible for reimbursement and is not approved for insurance coverage. The future availability of insurance coverage and reimbursement for newly approved medical devices is highly uncertain. In the United States, patients using insulin pumps are generally reimbursed for all or part of the product cost by Medicare or other third-party payors. Any future commercial success of our insulin pump products will be substantially dependent on whether third-party coverage and reimbursement is available for future customers. Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new medical devices, and, as a result, they may not cover or provide adequate reimbursement for our insulin pump, assuming we are able to fully develop and obtain all regulatory approval to market it in the United States. In addition, in certain countries, no uniform policy of coverage and reimbursement for medical device products and services exists among third- party payors. Therefore, coverage and reimbursement for medical device products and services can differ significantly from payor to payor. In addition, payors continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained or maintained, if obtained. Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a product must be approved for reimbursement before it can be approved for sale in that country. Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. Accordingly, unless government and other third-party payors provide coverage and reimbursement for our insulin pump products, patients may not use it, which would cause investors to lose their entire investment.

Risks Related to Our Securities

Any disruption and/or instability in economic conditions and capital markets could adversely affect our ability to access the capital markets, and thus adversely affect our business and liquidity.

Negative economic conditions and instability or uncertainty in the financial markets could have a negative impact on our ability to access the capital markets, and thus have a negative impact on our then operations and liquidity. We face certain risks in the event of a sustained deterioration of financial market liquidity, as well as in the event of sustained deterioration in the liquidity, or failure, of our banking, cash management and custodial financial institutions. A general shortage of liquidity and credit combined with the substantial losses in worldwide equity markets could lead to an extended worldwide recession in the future. If such occurred, we would face significant challenges if conditions in the capital markets did not improve. Our ability to access the capital markets under such circumstances could be severely restricted at a time when we need to access such markets, which could have a negative impact on our business plans. Even if we are able to raise capital under such circumstances, it may not be at a price or on terms that are favorable to us. We cannot predict the occurrence of future disruptions or how long such negative conditions might continue.

~~Because~~International ~~our~~trade ~~current~~policies, ~~insulin pump is still~~including inprotectionist ~~the~~trade ~~pre clearance stage with the FDA~~policies, itsuch ~~does~~as ~~not~~tariffs ~~have reimbursement~~ and issanctions, ~~not~~could ~~approved~~adversely ~~for~~affect ~~insurance coverage. If in the future we are cleared for and are otherwise able to commercialize~~ our ~~insulin pump~~business, ~~but~~results ~~are~~of ~~unable~~operations toand ~~obtain adequate reimbursement or insurance~~financial ~~coverage for such product candidate from third-party payors, we will be unable to generate significant revenue~~condition.

~~Because~~Due ~~our~~to ~~current insulin pump is still in~~ the ~~pre~~interconnectedness ~~clearance by the FDA stage, it does not have reimbursement and is not approved for insurance coverage. The future availability~~ of ~~insurance coverage and reimbursement for newly approved medical devices is highly uncertain. In~~ the ~~United~~global ~~States~~economy, ~~patients using~~ ~~insulin~~policy ~~pumps~~changes ~~are~~in ~~generally~~one ~~reimbursed~~area ~~for all or part~~ of the ~~product~~world ~~cost~~can byhave ~~Medicare~~an orimmediate ~~other~~and ~~third-party~~material ~~payors.~~adverse ~~Any~~impact ~~future commercial success of our insulin pump will be substantially dependent~~ on ~~whether~~markets ~~third-party~~around coverage and reimbursement is available for future customers. Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new medical devices, and, as a result, they may not cover or provide adequate reimbursement for our insulin pump, assuming we are able to fully develop and obtain all regulatory approval to market it in the United Statesworld. InChanges ~~addition,~~ in ~~certain countries, no uniform policy of coverage and reimbursement for medical device products and~~international ~~services~~trade ~~exists among third-party payors. Therefore~~policies, ~~coverage~~including: ~~and~~(i) ~~reimbursement~~changes ~~for medical device products and services can differ significantly from payor~~ to ~~payor.~~existing Intrade ~~addition,~~agreements; ~~payors~~(ii) ~~continually~~greater ~~review~~restrictions ~~new~~on ~~technologies~~free ~~for~~trade ~~possible~~generally; ~~coverage~~ and ~~can,~~(iii) ~~without notice, deny coverage~~significant ~~for~~increases ~~these~~in ~~new~~customs ~~products~~duties and ~~procedures.~~tariffs Ason agoods ~~result,~~imported ~~the~~into ~~coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for~~ the ~~use~~United ofStates ~~our products to each payor separately, with no assurance that coverage~~ and ~~adequate~~reciprocal ~~reimbursement~~actions ~~will be obtained, or maintained if obtained. Reimbursement systems in international markets vary significantly~~ by ~~country~~other ~~and by region within some~~ countries, ~~and~~could ~~reimbursement approvals must be obtained on a country-by-country basis.~~adversely Inaffect ~~many~~our ~~international markets~~business, aresults ~~product~~of ~~must~~operations be approved for reimbursement before it can be approved for sale in that country. Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and ~~procedures.~~financial Accordingly, unless government and other third-party payors provide coverage and reimbursement for our insulin pump, patients may not use it, which would cause investors to lose their entire investmentcondition.

21Current or future tariffs or other restrictive trade measures may raise the costs of raw materials, components or finished goods, which may adversely impact both our product offerings and our operational expenses. Such cost increases may reduce our margins and require us to increase prices, which could harm our competitive position, reduce customer demand and damage customer relationships.

Trade disputes, trade restrictions, tariffs and other political tensions between the U.S. and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability, and economic recessions or downturns, which may also negatively impact customer demand for our products or services, delay purchases or renewals, limit expansion opportunities with customers, limit our access to capital, or otherwise negatively impact our business and operations. Ongoing tariff, trade restrictions and macroeconomic uncertainty has and may continue to contribute to volatility in the price of our common stock.

Ongoing uncertainty regarding trade policies may also complicate our short- and long-term strategic planning, and that of our partners and customers, including decisions regarding hiring, product strategy, capital investment, supply chain design and geographic expansion.

While we continue to monitor trade developments, the ultimate impact of these risks remains uncertain and any prolonged economic downturn, escalation in trade tensions, or deterioration in international perception of U.S.-based companies could materially and adversely affect our supply chain, as well as our business, results of operations and financial condition. In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described in this Report.

Third parties might attempt to gain unauthorized access to our network or seek to compromise our products.

Our business is dependent on the security and efficacy of our networks and computer and data management systems, and we rely on our internal computer networks for many of the systems we use to operate our business generally. From time to time, we may face attempts by others to gain unauthorized access through the Internet or otherwise or to introduce malicious software to our information technology systems. We or our products may be a target of computer hackers, organizations or malicious attackers who attempt to:

●

gain access to our network;

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steal proprietary information related to our business, products and employees; or

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interrupt our systems.

From time to time, we may encounter attempts at gaining unauthorized access to our network, and we periodically run security checks. While we seek to detect and investigate unauthorized attempts and attacks against our network and products of which we become aware, and to prevent their recurrence where practicable through changes to our internal processes and tools and/or changes to our products, we remain potentially vulnerable to additional known or unknown threats. In addition to intentional security breaches, the integrity and confidentiality of Company and customer data and our intellectual property may be compromised as a result of human error, product defects, or technological failures. Different geographic markets may have different regulations regarding data protection, raising potential compliance risks. Further, retaliatory acts by foreign governments or terrorist organizations in response to policies of the United States government could include cyber-attacks that could disrupt the economy more generally or that could also impact our operations directly or indirectly. Any failure or perceived failure by us or our service providers to prevent information security breaches or other incidents or system disruptions, or any compromise of security that results in or is perceived or reported to result in unauthorized access to, or loss, theft, alteration, release or transfer of, our information, or any personal information, confidential information, or other data could result in loss or theft of proprietary or sensitive data and intellectual property, could harm our reputation and competitive position and could expose us to legal claims, regulatory investigations and proceedings, and fines, penalties, and other liability. Any such actual or perceived security breach, incident or system disruption could also divert the efforts of our personnel, and could require us to incur significant costs and operational consequences in connection with investigating, remediating, eliminating and putting in place additional tools, devices, policies, and other measures designed to prevent actual or perceived security breaches and other incidents and system disruptions, and in, for example, rebuilding internal systems, reduced inventory value, providing modifications to our products and services, defending against claims and litigation, responding to regulatory inquiries or actions, paying damages, or taking other remedial steps with respect to third parties. Moreover, we could be required or otherwise find it appropriate to expend significant capital and other resources to respond to, notify third parties of, and otherwise address the incident or breach and its root cause, and to notify individuals, regulatory authorities and others of security breaches involving certain types of data.

Further, we cannot assure that any limitations of liability provisions in our current or future contracts that may be applicable would be enforceable or adequate or would otherwise protect us from any liabilities or damages with respect to any particular claim relating to a security breach or other security-related matter. We also cannot be sure that any insurance coverage will continue to be available on acceptable terms or will be available in sufficient amounts to cover claims related to a security breach or incident, or that the insurer will not deny coverage as to any future claim. The successful assertion of claims against us that exceed available insurance coverage, or the occurrence of changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, could have a material adverse effect on our business, including our financial condition, operating results, and reputation.

We are subject to the regulation and oversight of the SEC and state regulatory agencies, in addition to the FDA. As a result, we may face legal or administrative proceedings by these agencies. We are unable to predict the effect of any investigations on our business, financial condition or reputation. In addition, publicity surrounding any investigation, even if ultimately resolved in our favor, could have a material adverse effect on our business.

If we are unable to satisfy the continued listing requirements of Nasdaq, our common stock could be delisted and the price and liquidity of our common stock may be adversely affected.

Our common stock may lose value and could be delisted from Nasdaq due to several factors or a combination of such factors. While our common stock is currently listed on Nasdaq, we can give no assurance that we will be able to satisfy the continued listing requirements of Nasdaq in the future, including but not limited to the corporate governance requirements and the minimum closing bid price requirement or the minimum equity requirement.

On June 30, 2025, we received a letter from Nasdaq’s Listing Qualifications Staff indicating that, based upon the closing bid price of our common stock for the 30 consecutive business days ending on June 27, 2025, we no longer met the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided a period of 180 calendar days, or until December 29, 2025, in which to regain compliance. In order to regain compliance with the minimum bid price requirement, the closing bid price of our common stock must be at least $1 per share for a minimum of ten consecutive business days during this 180-day period. In the event we did not regain compliance within this 180-day period, we were eligible to seek an additional compliance period of 180 calendar days provided we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and if we provided written notice to Nasdaq of our intent to cure the deficiency during this second compliance period by effecting a reverse stock split, if necessary. On December 30, 2025, we received written notification from the Listing Qualifications Department of Nasdaq, granting our request for a 180-day extension to regain compliance with the Bid Price Rule. We now have until June 29, 2026 to meet the requirement. If at any time prior to June 29, 2026, the bid price of our common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, we will regain compliance with the minimum bid price requirement. If we do not regain compliance with the minimum bid price requirement during the additional 180-day extension, Nasdaq will provide. written notification that our common stock will be delisted. At that time, we may appeal the relevant delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if we do appeal the delisting determination by Nasdaq to the hearings panel, that such appeal would be successful. We will continue to monitor the closing bid price of our common stock and evaluate its available options to regain compliance with the minimum bid price requirement.

If we were to be delisted, we would expect our common stock to be traded in the over-the-counter market which could adversely affect the liquidity of our common stock. Additionally, we could face significant material adverse consequences, including:

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a limited availability of market quotations for our common stock;

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

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reduced liquidity for our stockholders;

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potential loss of confidence by customers, collaboration partners and employees; and

●

loss of institutional investor interest.

In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement, or prevent future non-compliance with Nasdaq’s listing requirements.

We are a “smaller reporting company,” and are subject to lesser disclosure obligations in our SEC filings compared to other issuers. Specifically, “smaller reporting companies” are able to provide simplified executive compensation disclosures in their filings, are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting and have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. Decreased disclosures in our SEC filings due to our status as a “smaller reporting company” may make it harder for investors to analyze our operating results and financial prospects.

We do not expect any cash dividends to be paid on our shares of common stock for the foreseeable future.

We have never declared or paid a cash dividend and we do not anticipate declaring or paying dividends on our common stock for the foreseeable future. We expect to use future financing proceeds and earnings, if any, to fund operating expenses. Consequently, stockholders’ only opportunity to achieve a return on their investment is if the price of our stock appreciates and they sell their shares at a profit. We cannot assure stockholders of a positive return on their investment when they sell their shares or that stockholders will not lose the entire amount of their investment.

If the beneficial ownership of our common stock continues to be ~~highly~~ concentrated, it may prevent our stockholders from influencing significant corporate decisions.

As of ~~March~~February 2419, ~~2023~~2026, our executive officers, directors and certain persons, who may be deemed affiliates, beneficially ~~own~~owned approximately 5012.5% of our issued and outstanding common stock. Specifically, James Besser, our chief executive officer, isand Morgan Frank, a member of our board of directors, are the ~~beneficial~~principals of ~~owner~~Manchester Explorer, L.P., our largest stockholder. As of February 19, 2026, in the aggregate, Messrs. Besser and Frank were the beneficial owners of approximately 296.4% of our outstanding ~~capital~~common stock. As a result, such persons may exercise substantial influence over the outcome of corporate actions requiring stockholder approval including, without limitation, the election of directors, certain mergers, consolidations and sales of all or substantially all of our assets or any other significant corporate transactions. Such persons may also vote against a change of control, even if such a change of control would benefit our other stockholders. Thus, investors in our common stock cannot reasonably expect to have any influence over the election of our directors or other matters submitted to a vote of our stockholders. Instead, our existing significant stockholders may exert a substantial influence on the election of our directors and any actions requiring or otherwise put to a stockholder vote, potentially in a manner that you do not support. The concentrated amount of control over our affairs held by a relatively few ~~number of~~ significant investors could serve to reduce the attractiveness or liquidity of our common stock, and thereby depress its trading price. Additionally, conflicts of interest may arise between these executive officers, directors and other affiliates, on the one hand, and us and our other stockholders, on the other hand. In resolving these conflicts of interests, these investors may favor their own interests and the interests of their affiliates, over the interests of our other stockholders, which could cause a material adverse effect on our business, prospects, financial condition and results of operations.

We may sell securities in the public or private equity markets at prices per share below the current market price of our common stock, even if we do not have an immediate need for additional capital at that time. Sales of substantial amounts of shares of our common stock, or the perception that such sales could occur, could adversely affect the prevailing market price of our shares and our ability to raise capital. We may issue additional shares of common stock in future financing transactions or as incentive compensation for our executive management and other key personnel, consultants and advisors. Issuing any equity securities would be dilutive to the equity interests represented by our then-outstanding shares of common stock. Moreover, sales of substantial amounts of shares in the public market, or the perception that such sales could occur, may adversely affect the prevailing market price of our common stock and make it more difficult for us to raise additional capital. Such resulting significant downward pressure on the price of our common stock could also encourage short sales by third parties. Such an event could place further downward pressure on the price of our common stock.

Furthermore, we and our directors and officers and holders of more than 5% of the Company’s outstanding shares of common stock have agreed with the underwriter not to offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any of our common stock or securities convertible into common stock for a period of three months after the date of this prospectus. The underwriter may, in its discretion, release the restrictions on any such shares at any time without notice. See “Underwriting.” We cannot predict the effect that future sales of our common stock would have on the market price of our common stock.

Our board of directors has the authority to fix and determine the relative rights and preferences of preferred stock. Currently, our board of directors has the authority to designate and issue up to 5,000,000 shares of our preferred stock without further stockholder approval. In the future, our board of directors could authorize the issuance of one or more series of preferred stock that would grant to holders, among other rights, the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and the right to the redemption of our preferred shares acquired by such persons, together with a premium, prior to the redemption of our common stock. In addition, our board of directors could authorize the issuance of a series of preferred stock that has greater voting power than our common stock or that is convertible into our common stock, which could decrease the relative voting power of our common stock or result in dilution to our existing stockholders.

Effective internal controls are necessary for us to provide reliable financial reports and prevent fraud. If we cannot provide reliable financial reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control environment existed, and our business and reputation with investors may be harmed. Our management has concluded that our internal controls over financial reporting are ineffective and has identified a material weakness in our internal controls over financial statement reporting. While management is working to remediate the material weakness, there is no assurance that such changes, when economically feasible and sustainable, will remediate the identified material weakness or that the controls will prevent or detect future material weaknesses. If we are unable to maintain effective internal controls, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a public company, including the requirements of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act). In addition, we may be unable to accurately report our financial results in future periods, or report them within the timeframes required by the requirements of the SEC or the Sarbanes-Oxley Act. Failure to comply with the Sarbanes-Oxley Act, when and as applicable, could also potentially subject us to sanctions or investigations by the SEC or other regulatory authorities. Any failure to maintain or implement required new or improved controls, or any difficulties we encounter in their implementation, could result in identification of additional material weaknesses or significant deficiencies, cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements.

23Furthermore, Section 404 of the Sarbanes-Oxley Act and related regulations require our management to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year. Based on its evaluation, our management concluded that our internal controls over financial reporting were effective as of March 31, 2025. We cannot provide assurance that, in the future, a material weakness or significant deficiency will not exist or otherwise be discovered. If that were to happen, it could harm our operating results and cause stockholders to lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on the trading price of our securities.

~~Furthermore,~~Sustained ~~Section~~inflation ~~404~~could ofhave ~~the~~a ~~Sarbanes-Oxley Act and related regulations~~material ~~require~~adverse ~~our~~effect ~~management~~on ~~to evaluate the effectiveness of~~ our ~~internal control over financial reporting as of the end of each fiscal year. Based on its evaluation~~business, ~~our management concluded that our internal controls over~~ financial ~~reporting were effective as of March 31~~condition, ~~2022. We cannot provide assurance that, in the future, a material weakness or significant deficiency will not exist or otherwise be discovered. If that were to happen, it could harm our operating~~ results ~~and cause stockholders to lose confidence in our reported financial information. Any such loss~~ of ~~confidence~~operations ~~would~~and ~~have a negative effect on the trading price of our securities~~liquidity.

Inflation rates in the United States have remained elevated and may continue to rise. Inflation over the last several months has led us to experience higher costs, including, among others, labor and transportation. Some of our suppliers have raised their prices and may continue to raise prices, and, assuming we achieve FDA clearance and commence commercialization of our product, in the future, we may not be able to make corresponding price increases to obtain adequate gross margins and achieve profitability. If inflation rates continue to rise or remain elevated for a sustained period of time, they could have a material adverse effect on our business, financial condition, results of operations and liquidity.

Our board of directors is able to adopt recapitalizations through forward or reverse splits of our outstanding shares of common stock without stockholder approval.

Pursuant to our amended and restated articles of incorporation, our board of directors has the power, without obtaining stockholder approval, to effectuate recapitalizations of us through forward or reverse splits of our outstanding common stock. As a result of such provision, our board of directors can implement recapitalizations of us by effectuating a forward or reverse stock split of our outstanding common stock, which would increase or decrease each of our stockholder’s number of shares owned, and our stockholders will have no right to approve or disapprove any such action even if such actions have a material adverse effect on them.

Risks Related to This Offering

After this offering, we will need to raise additional capital in the future to execute our business plan.

We expect the net proceeds to us from this offering will approximate $ million. Upon closing of this offering, we expect to have cash and cash equivalents of approximately $ million. After the closing of this offering, we believe we will have adequate funds to operate our business for the at least the next . During that timeframe, we intend to complete our 510(K) submission and obtain approval from the FDA, commence our initial commercialization efforts and complete our manufacturing capability. We will require additional funding to fully commercialize our pump product and bring it to market on a large scale.

We cannot be certain that additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current stockholders may experience dilution. If we are unable to obtain funds when needed or on acceptable terms, we may be required to curtail our current product development programs, cut operating costs, forego future development and other opportunities or even terminate our operations.

As we have broad discretion in how we use the proceeds from this offering, we may use the proceeds in ways with which you disagree.

We have not allocated the net proceeds from this offering for any specific purpose, except as generally set forth under “Use of Proceeds.” As set forth therein, our management will have significant flexibility in applying the net proceeds of this offering. You will be relying on the judgment of our management with regard to the use of these net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used in ways you would agree with or ways which are likely to increase the value of your investment. Because of the number and variability of factors that will determine our use of our net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. It is possible that the net proceeds will be invested in a way that does not yield a favorable, or any, return for our company or your investment. The failure of our management to use such funds effectively could have a material adverse effect on our business, financial condition, operating results and cash flow.

Holders of our warrants will have no rights as a common stockholder until they acquire our common stock.

The warrants included in the units in this offering do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of our common stock at a fixed price for a limited period of time. Specifically, commencing on the date of issuance, holders of the warrants may exercise their right to acquire the common stock and pay the exercise price per share, prior to five years from the date of issuance, after which date any unexercised warrants will expire and have no further value. Until holders of the warrants acquire common stock upon exercise of the warrants, the holders will have no rights with respect to the common stock issuable upon exercise of the warrants. Upon exercise of the warrants, the holder will be entitled to exercise the rights of a stockholder as to the security exercised only as to matters for which the record date occurs after the exercise. There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the warrants, and consequently, whether it will ever be profitable for holders of the warrants to exercise the warrants.

Provisions of the warrants offered by this prospectus could discourage an acquisition of us by a third party.

In addition to the discussion of the provisions of our governing organizational documents, certain provisions of the warrants offered by this prospectus could make it more difficult or expensive for a third party to acquire us. The warrants prohibit us from engaging in certain transactions constituting “fundamental transactions” unless, among other things, the surviving entity assumes our obligations under the warrants. These and other provisions of the warrants offered by this prospectus could prevent or deter a third party from acquiring us even where the acquisition could be beneficial to you.

The warrants offered by this prospectus are speculative in nature and may not have any value.

The warrants offered by this prospectus will be exercisable for five years from the date of issuance. There can be no assurance that the market price of our common stock will ever exceed the exercise price of the warrants. In the event that our common stock price does not exceed the exercise price of the warrants during the term of the warrants, the warrants may not have any value.

There is no public market for the warrants being offered in this offering.

There is no public trading market for the warrants offered by this prospectus, and we do not expect a market to develop. In addition, we do not intend to apply to list the warrants on a national securities exchange. Without an active market, the liquidity of the warrants will be limited.

You will experience immediate and substantial dilution in the net tangible book value per share of the common stock you purchase.

As of December 31, 2022, our net tangible book value (deficit) was approximately $8.0 million, or approximately $0.73 per share. Since the effective price per share of our common stock being offered in this offering is substantially higher than the net tangible book value per share of our common stock, you will suffer substantial dilution with respect to the net tangible book value of the common stock you purchase in this offering. Based on the assumed public offering price of $ per share of common stock being sold in this offering, and our net tangible book value per share as of December 31, 2022, if you purchase shares of common stock in this offering, you will suffer immediate and substantial dilution of $ per share with respect to the net tangible book value of the common stock (assuming no exercise of the underwriter’s option to purchase additional shares). See the section titled “Dilution” below for a more detailed discussion of the dilution you will incur if you purchase common stock in this offering.

You may experience future dilution as a result of future equity offerings and other issuances of our common stock or other securities. In addition, this offering and future equity offerings and other issuances of our common stock or other securities may adversely affect the price of our common stock.

In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock (such as warrants, convertible debt or preferred stock) at prices that may not be the same as the price per share in this offering. We may not be able to sell shares of common stock or other securities in any other offering at a price per share that is equal to or greater than the price per share paid by investors in this offering, and investors purchasing shares of common stock or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our common stock or securities convertible into common stock in future transactions may be higher or lower than the price per share in this offering. In addition, the sale of shares of common stock in this offering and any future sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could adversely affect the price of our common stock. We cannot predict the effect, if any, that market sales of those shares of common stock or the availability of those shares of common stock for sale will have on the market price of our common stock.

SPECIAL 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, which we refer to as the “Securities Act,” and Section 21E of the Securities Exchange Act of 1934, as amended, which we refer to as the “Exchange Act,” that relate to future events or to our future operations or financial performance. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement.

Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “forecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “targets,” “likely,” “will,” “would,” “could,” “should,” “continue,” “scheduled” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus, we caution you that these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. Actual results, level of activity, performance, experience or achievements may differ materially from those expressed or implied by any forward-looking statement as a result of various important factors, including risks and uncertainties relating, to:

● our strategies, prospects, plans, expectations, forecasts or objectives;

● our ability to achieve a marketable product (i.e., our insulin pump) and the costs and timing thereof;

● acceptance of our product candidate by our target market and our ability to compete in such market;

● our ability to raise additional financing when needed and the terms and timing thereof;

● our ability to expand, protect and maintain our intellectual property rights;

● our future operations, financial position, revenues, costs, expenses, uses of cash, capital requirements, our need for additional financing or the period for which our existing cash resources will be sufficient to meet our operating requirements;

● our analysis of the target market for our insulin pump;

● our ability to obtain all regulatory approvals and clearances relating to our insulin pump including those of the FDA;

● regulatory developments in the United States and other countries;

● the timing and costs of our obtaining all regulatory approvals and clearances identified immediately above;

● our compliance with all applicable laws, rules and regulations, including those of the SEC and the FDA;

● our ability to compete in the diabetes marketplace with larger and more substantial medical device companies;

● general economic, business, political and social conditions;

● our reliance on and our ability to retain (and if necessary, timely recruit and replace) our officers, directors and key employees and their ability to timely and competently perform at levels expected of them;

● our ability to generate significant revenues and achieve profitability;

● our ability to manage the growth of our business;

● our commercialization, marketing and manufacturing capabilities and strategies;

● our ability to expand, protect and maintain our intellectual property position;

● the success of competing third-party products;

● our ability to fully remediate our identified internal control material weaknesses;

● our ability to meet the initial or continuing listing requirement of the Nasdaq Capital Market;

● our ability to comply with regulatory requirements relating to our business, and the costs of compliance with those requirements, including those on data privacy and security;

● the specific risk factors discussed under the heading “Risk Factors” set forth in this prospectus; and

● various other matters, many of which are beyond our control.

USE OF PROCEEDS

We estimate that our net proceeds from this offering will be approximately $ , based on an assumed public offering price of $ per unit, which is the last reported sale price of our common stock on the Nasdaq Capital Market on , 2023, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

As of December 31, 2022, we had cash and cash equivalents of approximately $7.7 million. We currently expect to use the net proceeds from this offering, together with the $7.7 million of cash and cash equivalents, primarily for the following purposes:

● Approximately $ for research and development for new products and improvements to our initial pump product candidate including, but not limited to, hiring of key personnel, and costs for continued research activities;

● Approximately $ for the initial development of our sales, marketing and administrative capabilities and organization, including but not limited to adding additional staff, public relations and advertising;

● Approximately $ for the continued development of our manufacturing and production capability, including capital expenditures; and

● The remainder for working capital, other capital expenditures and general corporate purposes.

We believe that our existing cash and cash equivalents, along with the net proceeds from this offering, together with interest on cash balances, will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months. The amount and timing of our actual expenditures and actual use of the net proceeds of the offering will depend upon numerous factors, including the timing of our submission to the FDA for 510(k) clearance of our product candidate, which is necessary to commence commercialization, the timing and results of our product launch, including all commercialization activities, the progress of our continuing product research and development activities, our ability to establish our outsourced manufacturing operations, and our ability to add the required staff to execute our business plan, any collaborations that we may enter into with third parties, and any unforeseen delays or cash needs.

Our expected use of the net proceeds from this offering represents our current intentions based upon our present plans and business conditions. As a result, our management will have broad discretion in the application of the net proceeds, and investors will be relying on our judgment regarding the application of the net proceeds of this offering. In addition, we might decide to postpone or not pursue these certain of these activities if the net proceeds from this offering and the other sources of cash are less than, or do not last as long as, expected. We have no current understandings, agreements or commitments for any material acquisitions or licenses of any products, businesses or technologies.

Pending their use, we plan to invest the net proceeds from this offering in high-quality, short-term interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

DIVIDEND POLICY

We have never declared or paid any cash dividend on our capital stock. We do not anticipate paying any cash dividends in the foreseeable future and we intend to retain all of our earnings, if any, to finance our growth and operations and to fund the expansion of our business. Payment of any dividends will be made in the discretion of our board of directors, after its taking into account various factors, including our financial condition, operating results, current and anticipated cash needs and plans for expansion. Any dividends that may be declared or paid on our common stock, must also be paid in the same consideration or manner, as the case may be, on our shares of preferred stock, if any.

CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of December 31, 2022.

● an actual basis; and

● on a pro-forma basis to give effect to the issuance and sale of the units by us in this offering at the assumed public offering price of $ per unit, after deducting underwriting discussions and commissions and estimated offering expenses payable by us for net proceeds of $, which assumes that the over-allotment option is not exercised.

The as adjusted information below is illustrative only and our capitalization following the closing 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 information together with our financial statements and the related notes thereto included elsewhere in this prospectus and the information set forth under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus.

	As of December 31, 2022
	Unaudited
	Actual			Pro Forma(1)
Cash and cash equivalents	$	7,690,957		$
Stockholders’ equity:
Preferred stock, par value $0.001; 5,000,000 shares authorized and undesignated, actual, pro forma; no shares issued and outstanding, actual or pro forma		—
Common Stock, $0.001 par value, 50,000,000 shares authorized; 10,932,098 shares issued and outstanding, actual; shares issued and outstanding, pro forma		10,932
Additional paid-in capital		52,900,066
Accumulated deficit		(44,887,453	)
Total stockholders’ equity	$	8,023,545		$
Total capitalization	$	8,738,842		$

(1) If the underwriter’s option to purchase up to an additional shares of our common stock and warrants to purchase an additional shares of our common stock, or any combination thereof, is exercised in full and assuming no exercise of the warrants, (i) we would receive approximately $ in additional net proceeds, based on the assumed initial public offering price per unit of $ , which is the last reported sale price of our common stock on the Nasdaq Capital Market on , 2023, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us; and (ii) cash and cash equivalents, total stockholders’ equity and total capitalization would each also increase by approximately $ .

Each $1.00 increase (decrease) in the assumed public offering price of $ per unit would increase (decrease) the as adjusted amount of cash and cash equivalents, additional paid-in capital, total stockholders’ equity (deficit) and total capitalization by approximately $ , assuming that the number of units offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of units we are offering. Each increase (decrease) of 100,000 units in the number of units we are offering would increase (decrease) the as adjusted amount of cash and cash equivalents, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $ , assuming that the assumed public offering price remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. The as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

The number of shares of our common stock to be outstanding after this offering is based on 10,932,098 shares of our common stock outstanding as of December 31, 2022, and excludes:

● shares of our common stock issuable upon the exercise of the warrants to be issued as part of the units;

● shares of common stock issuable upon exercise by the underwriter of the Underwriter’s Warrants;

● 2,174,198 shares of our common stock issuable upon exercise of outstanding stock options with a weighted average exercise price of approximately $5.69 per share;

● 767,796 shares of our common stock issuable upon the exercise of warrants with an exercise price of $6.00 per share;

● 5,449,478 shares of our common stock issuable upon the exercise of warrants with an exercise price of $6.60 per share;

● 1,348,314 shares of our common stock issuable upon exercise of pre-funded warrants with an exercise price of $0.01 per share; and

● 445,559 shares of our common stock reserved for issuance pursuant to future awards under our Amended 2017 Equity Incentive Plan, or the 2017 Plan.

~~DILUTION~~Risks Related to this Offering and Ownership of Our Common Stock

~~Each unit,~~This ~~with~~is ana ~~assumed~~reasonable ~~public~~best-efforts offering ~~price of $~~ , ~~per~~with ~~unit,~~no ~~which~~minimum isamount ~~the last reported sale price~~ of ~~our~~securities ~~common stock~~required onto ~~The~~be ~~Nasdaq~~sold, ~~Capital~~and ~~Market~~we ~~on ,~~may ~~2023,~~sell ~~consists~~fewer ofthan ~~two~~all ~~shares~~ of ~~common~~the ~~stock~~securities ~~and~~offered ~~one warrant to purchase one share of common stock~~hereby.

IfThe ~~you~~placement ~~invest~~agent inhas ~~our~~agreed ~~units,~~to ~~your~~use ~~interest~~its ~~will~~reasonable bebest ~~diluted~~efforts ~~immediately~~to solicit offers to purchase the ~~extent~~securities in this offering. The placement agent has no obligation to buy any of the ~~difference~~securities from ~~between~~us ~~the~~or ~~offering~~to ~~price~~arrange ~~per~~for ~~share~~the purchase or sale of ~~our~~any ~~common~~specific ~~stock~~number ~~that~~or isdollar ~~part~~amount of the ~~unit~~securities. There is no required minimum number of securities that must be sold as a condition to completion of this offering, and there can be no assurance that the asoffering contemplated ~~adjusted~~hereby will ultimately be consummated. Assuming that we receive net ~~tangible~~proceeds ~~book~~of ~~value~~approximately ~~per~~$10.9 ~~share~~million from this offering (assuming an offering with gross proceeds of ~~our~~$12.0 ~~common~~million), ~~stock~~we ~~immediately~~believe ~~after~~that ~~giving~~the ~~effect~~net toproceeds from this offering, together with our existing cash and cash equivalents, will meet our capital needs for at least the next four months under our current business plan.

AsEven ofif ~~December~~we ~~31,~~sell ~~2022~~securities offered hereby, ~~our~~because there ~~historical~~is ~~net~~no ~~tangible book~~minimum ~~value~~offering amount required as a condition to closing of this offering, ~~which~~the ~~represents~~actual ~~our~~offering ~~total~~amount ~~tangible~~is ~~assets~~not presently determinable and may be substantially less ~~total~~than ~~liabilities,~~the ~~was~~maximum ~~$8.0~~amount ~~million,~~set orforth ~~$0.73~~on ~~per~~the ~~share~~cover page of ~~common~~this ~~stock~~prospectus. ~~Historical~~We may sell fewer ~~net~~than ~~tangible~~all ~~book~~of ~~value~~the ~~per~~securities ~~share~~offered ~~represents~~hereby, ~~the~~which ~~amount~~may ofsignificantly ~~our~~reduce ~~total~~the ~~tangible~~amount ~~assets~~of ~~reduced~~proceeds received by ~~total~~us. ~~liabilities~~Thus, ~~divided~~we bymay ~~10,932,098,~~not raise the ~~number~~amount of ~~shares~~capital ofwe ~~common~~believe ~~stock~~is ~~outstanding~~required onfor ~~December~~our 31operations in the short-term and may need to raise additional funds, ~~2022~~which may not be available or available on terms acceptable to us.

~~After~~ Because ~~giving~~there ~~effect~~is tono ~~the~~minimum ~~sale~~required offor the ~~units, at the assumed~~ offering ~~price~~to ~~of $ per unit~~close, ~~which~~investors isin ~~the~~this ~~last reported sale price of our common stock on The Nasdaq Capital Market on , 2023, after deducting estimated underwriting discounts and commissions and estimated~~ offering ~~expenses~~will ~~payable~~not byreceive ~~us,~~a ~~but~~refund ~~assuming~~in ~~no exercise of~~ the ~~warrants~~event ~~offered~~that ~~hereby~~we ordo ~~the~~not ~~Underwriter’s~~sell ~~Warrant,~~an ~~our net tangible book value as of December 31, 2022 would have been $ or $ per share of common stock. This~~ amount ~~represents an immediate increase in net tangible book value~~ of ~~$ per~~securities ~~share~~sufficient to ~~our~~pursue ~~existing~~the ~~stockholders.~~business ~~Investors~~goals ~~purchasing~~outlined ~~our common stock~~ in this ~~offering will have paid $ more than the as adjusted net tangible book value per share of common stock after this offering~~prospectus.

~~The~~We have not specified a minimum offering amount ~~following~~in ~~table~~connection ~~illustrates~~with this ~~dilution~~offering. onBecause there is no minimum offering amount, investors could be in a ~~per~~position ~~share~~where ~~basis:~~they have invested in our company, but we are unable to fulfill our objectives due to a lack of interest in this offering. Further, because there is no minimum investment amount, any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. Investor funds will not be returned under any circumstances whether during or after the offering.

Assumed offering price per share			$
Historical net tangible book value per share as of December 31, 2022		8,023,545
Increase in net tangible book value per share attributable to new investors	$
Net tangible book value per share after the offering
Dilution per share to new investors			$

Purchasers of common stock in this offering will experience dilution in the net tangible book value of their investment. You may experience dilution upon the exercise of outstanding stock options and warrants, or the conversion or exchange of other securities.

The ~~dilution~~public ~~information~~offering ~~discussed~~price ~~above~~per isshare ~~illustrative~~of common ~~only~~stock and ~~may~~accompanying ~~change~~common ~~based~~warrants in this offering is lower than the net tangible book value per share of our common stock before giving effect to this offering. Based on an assumed combined public offering price of $0.5091 per share of common stock and accompanying common warrant, if you purchase common stock in this offering, you will incur immediate dilution of approximately $0.34 per share, representing the ~~actual~~difference ~~initial~~between our net tangible book value per share as of December 31, 2025 and the public offering price per share of common stock and accompanying common warrant. However, if outstanding options or warrants are exercised, other ~~terms~~securities are converted or exchanged for shares of common stock, you could experience dilution. For a further description of the dilution that you will experience immediately after this offering, see the section in this prospectus entitled “Dilution.”

Each $1.00 increase (decrease) in the assumed public offering price of $ per unit would increase (decrease) our net tangible book value after this offering by approximately $ per share, and increase (decrease) the dilution per share to new investors by approximately $ per share, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us full.

The number of shares of our common stock to be outstanding after this offering is based on 10,932,098 shares of our common stock outstanding as of December 31, 2022, and excludes:

● shares of our common stock issuable upon the exercise of the warrants to be issued as part of the units;

● shares of common stock issuable upon exercise by the underwriter of the Representative’s Warrants;

● 2,174,198 shares of our common stock issuable upon exercise of outstanding stock options with a weighted average exercise price of approximately $5.69 per share;

● 767,796 shares of our common stock issuable upon the exercise of warrants with an exercise price of $6.00 per share;

● 5,449,478 shares of our common stock issuable upon the exercise of warrants with an exercise price of $6.60 per share;

● 1,348,314 shares of our common stock issuable upon exercise of pre-funded warrants with an exercise price of $0.01 per share; and

● 445,559 shares of our common stock reserved for issuance pursuant to future awards under the 2017 Plan.

If the shares described above that are reserved for issuance to the holders of our options and under our 2017 Plan are issued, or we otherwise issue additional shares of common stock in the future, there could be further dilution to investors participating in this offering. In addition, we anticipate needing to raise additional capital before generating positive cash flows and we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

If the underwriters exercises their option to purchase additional shares of our common stock and/or warrants in full, the pro forma as adjusted net tangible book value after this offering would be $ per share, the increase in pro forma net tangible book value would be $ per share and the dilution to new investors would be $ per share, in each case assuming an public offering price of $ per unit, which is the last reported sale price of our common stock on the Nasdaq Capital Market on , 2023.

~~MANAGEMENT’S~~A substantial number of shares of common ~~DISCUSSION~~stock ~~AND~~may ~~ANALYSIS~~be OFsold ~~FINANCIAL~~in ~~CONDITION~~the ~~AND~~market ~~RESULTS~~following OFthis ~~OPERATIONS~~offering, which may depress the market price for our common stock.

~~Management’s~~Sales of a substantial number of shares of our ~~Discussion~~common ~~and~~stock ~~Analysis~~in the public market following this offering could cause the market price of ~~Financial~~our ~~Condition~~common stock to decline. A substantial majority of the outstanding shares of our common stock are, and ~~Results~~the shares of ~~Operations~~common stock sold in this offering upon issuance will be, freely tradable without restriction or further registration under the Securities Act.

~~You~~Upon ~~should~~completion ~~read~~of ~~the~~this ~~following~~offering, ~~discussion~~based ~~and analysis~~on ~~in conjunction with~~ our ~~unaudited condensed consolidated financial statements and the notes to those financial statements for~~ ~~the~~shares ~~three~~of ~~and~~common ~~nine~~stock ~~months~~outstanding ~~ended~~as ~~December~~of February 3119, ~~2022~~2026 and ~~December~~the ~~31,~~assumed ~~2021~~combined ~~and~~offering ~~our~~price ~~audited~~of ~~consolidated~~$0.5091 ~~financial~~per ~~statements~~share and ~~notes to~~accompanying ~~those~~common ~~financial~~warrant, ~~statements~~we ~~for~~will ~~the~~have approximately ~~years~~101.3 ~~ended~~million shares ~~March~~of ~~31,~~common ~~2022~~stock ~~and March 31~~outstanding, ~~2021,~~the inmajority ~~each~~of ~~case,~~which ~~included~~may ~~elsewhere in this prospectus.~~be ~~This~~resold ~~discussion~~into ~~contains~~the ~~forward-looking~~public ~~statements~~market ~~based~~immediately ~~upon~~without ~~current~~restriction, ~~expectations~~unless ~~that~~owned ~~involve~~or ~~risks~~purchased ~~and~~by ~~uncertainties.~~our ~~See~~ “~~Special Note Regarding Forward-Looking Statements.~~affiliates” ~~Our~~as ~~actual~~that ~~results~~term is ~~may~~defined ~~differ materially from those contained~~ in orRule ~~implied~~144 byunder ~~any~~the ~~forward-looking statements.~~Securities Act.

~~Company~~As of February 19, 2026, we had outstanding ~~Overview~~warrants exercisable for up to 22.8 million shares with exercise prices ranging from $0.45 to $6.60 per share. The shares of our common stock underlying the warrants to be issued in this offering will, upon issuance, be freely tradeable without restriction or further registration under the Securities Act.

~~We are~~There amay ~~development-stage~~be ~~medical~~future ~~device~~sales ~~company focused on the design, development and commercialization~~ of ~~an innovative insulin pump using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two-part patch pump,~~ our ~~MODD1 product, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care~~common ~~that presently-available insulin pumps provide. By simplifying and streamlining the user experience from introduction~~stock, ~~prescription, reimbursement,~~which ~~training~~could ~~and~~adversely ~~day-to-day~~affect ~~use, we seek to expand~~ the ~~wearable insulin delivery device~~ market ~~beyond~~price ~~the~~of ~~highly~~our ~~motivated “super~~common ~~users”~~stock and ~~expand~~dilute ~~the~~a ~~category~~stockholder’s ~~into~~ownership ~~the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms~~ of ~~device~~common ~~adoption, type 2 diabetes markets~~stock.

~~Historically,~~The sale of our common stock resulting from (a) weexercise ~~have~~of ~~financed~~any options or vesting of restricted stock units granted to executive officers and other employees under our ~~operations~~equity ~~principally~~compensation plan ~~through~~and ~~private~~(b) ~~placements~~of any warrants, and ~~public~~other ~~offerings~~issuances of our common stock ~~and~~could ~~sales~~have an adverse effect on the market price of ~~convertible~~the shares ~~promissory~~of ~~notes~~our common stock. ~~Based~~Other onthan ~~our~~the ~~current~~restrictions ~~operating~~set ~~plan~~forth in the section titled “Plan of Distribution,” we ~~believe~~are wenot restricted ~~have~~from ~~adequate~~issuing ~~cash~~additional ~~for~~shares atof ~~least~~common ~~the~~stock, ~~next~~including 12any ~~months.~~securities ~~Our~~that ~~long-term~~are convertible into or exchangeable for, or ~~ability~~that represent the right to ~~continue~~receive asshares aof ~~going~~common ~~concern~~stock, ~~depends~~provided onthat ~~our~~we ~~ability~~are subject to ~~raise~~the ~~additional~~requirements ~~capital,~~of ~~through~~the Nasdaq Capital Market (which generally requires stockholder approval for any transactions which would result in the ~~sale~~issuance of ~~equity~~more orthan ~~debt~~20% ~~securities,~~of our then outstanding toshares ~~support~~of common stock or voting rights representing over 20% of our ~~future~~then ~~operations~~outstanding shares of stock). IfSales weof ~~are~~a ~~unable~~substantial tonumber of ~~secure~~shares ~~additional~~of ~~capital,~~our wecommon ~~will~~stock bein ~~required~~the topublic ~~curtail~~market ~~our~~or ~~research~~the ~~and~~perception ~~development~~that such sales might occur could materially adversely affect the ~~initiatives~~market ~~and~~price ~~take~~of ~~additional~~the ~~measures~~shares toof ~~reduce~~our ~~costs~~common stock. WeBecause ~~have~~our ~~provided~~decision ~~additional~~to ~~disclosure~~issue securities in ~~Note~~any 1future tooffering will depend on market conditions and other factors beyond our control, we cannot predict or estimate the ~~consolidated~~amount, ~~financial~~timing or nature of our future offerings. ~~statements~~Accordingly, inour ~~Item~~stockholders 1bear the risk that our future offerings will reduce the market price of ~~this~~our ~~Registration~~common ~~Statement~~stock and ~~under Liquidity~~dilute ~~and~~their stock ~~Capital~~holdings ~~Resources below~~in us.

~~Recent~~We ~~Economic~~have ~~Disruptions~~broad discretion to determine how to use the funds raised in this offering, and may use them in ways that may not enhance our operating results or the price of our common stock.

~~The~~Our ~~global~~management ~~outbreak of~~will have broad discretion over the ~~coronavirus~~use ~~disease~~of ~~2019~~net ~~(COVID-19)~~proceeds ~~was~~from ~~declared~~this aoffering, ~~pandemic~~and bywe could spend the ~~World~~net ~~Health~~proceeds ~~Organization~~from ~~and~~this aoffering ~~national~~in ~~emergency~~ways byour ~~the~~stockholders may not agree ~~U.S.~~with ~~government~~or inthat ~~March~~do ~~2020.~~not ~~This~~yield ~~negatively~~a ~~affected~~favorable ~~the~~return, Uif at all.S. ~~and~~We ~~global~~currently ~~economy,~~expect ~~disrupted~~to ~~global~~use ~~supply~~the ~~chains,~~net ~~significantly restricted~~proceeds ~~travel~~from ~~and~~this ~~transportation,~~offering ~~resulted~~for ingeneral ~~mandated~~corporate purposes, ~~closures~~including ~~and~~working ~~orders~~capital, to ~~“shelter-in-~~fund ~~place”~~our ~~and~~operations ~~created significant~~through ~~disruption~~the approval of ~~the~~our ~~financial~~Pivot ~~markets~~product ~~during~~by ~~2020~~the FDA, ~~2021~~to ~~and~~commence ~~into~~initial commercialization ~~2022.~~of ~~While~~our ~~the~~Pivot ~~national~~product, ~~emergency~~to isfund ~~set~~additional toresearch ~~expire~~and ~~in May~~development ~~2023~~activities, and ~~most~~to ~~closures~~further develop our manufacturing and ~~“shelter-in-place”~~production ~~orders~~capabilities ~~have~~and ~~ended,~~make ~~there~~related ~~can~~capital beexpenditures. noHowever, ~~assurance~~our ~~that~~use ~~the~~of ~~COVID-19 pandemic~~these ~~will~~net ~~not~~proceeds ~~impact~~may ondiffer substantially from our ~~operational~~current ~~and~~plans. ~~financial~~If ~~performance~~we indo ~~the~~not ~~future,~~invest asor apply the ~~duration~~net ~~and~~proceeds ~~spread~~ of ~~the~~this ~~pandemic~~offering ~~and related~~in ~~actions~~ways ~~taken~~that byimprove ~~U.S.~~our ~~and~~operating ~~foreign~~results, ~~government~~we ~~agencies~~may fail to ~~prevent~~achieve ~~disease~~expected ~~spread~~financial ~~are uncertain~~results, ~~out~~which ofcould cause our ~~control,~~stock ~~and cannot~~price beto ~~predicted~~decline.

The Russian invasion of Ukraine in February 2022 has led to further economic disruptions. Mounting inflationary costs pressures and recessionary fears have negatively impacted the global economy. During the third quarter of 2022, the U.S. Federal Reserve continued to aggressively address elevated inflation by increasing interest rates. The U.S. Federal reserve increased interest rates by 75 basis points in each of its meetings held in July, September and November 2022, 50 basis points in its meeting held in December 2022, and 25 basis points in its meeting held in each of February 2023 and March 2023, as inflation remains elevated. We were able to raise additional capital through equity offerings in February 2022 and May 2022, however, we will need to raise additional capital to commercialize our pump product candidate and support our operations in the future. We may be unable to access the capital markets, and additional capital may only be available to us on terms that could be significantly detrimental to our existing stockholders and to our business.

For additional information on risks that could impact our future results, please refer to “Risk Factors” on page 10.

~~Critical~~There is no public market for the warrants ~~Accounting~~being ~~Policies~~offered ~~and~~in ~~Estimates~~this offering.

~~The discussion~~There ~~and~~is ~~analysis~~no ofestablished ~~our~~public ~~financial~~trading ~~condition~~market for ~~and~~the ~~results~~warrants ofbeing ~~operations~~offered ~~are~~in ~~based~~this ~~upon our condensed consolidated financial statements~~offering, ~~which~~ ~~have~~and ~~been~~we ~~prepared~~do innot ~~accordance~~expect ~~with~~a ~~U.S.~~market ~~GAAP. The preparation of these condensed consolidated financial statements requires us~~ to ~~make~~develop. ~~certain~~In ~~estimates and judgments that affect the reported amounts of assets~~addition, ~~liabilities,~~we ~~and~~do ~~expenses.~~not Onintend anto ~~ongoing~~apply ~~basis,~~to welist ~~make~~the ~~these~~warrants ~~estimates based~~ on ~~our~~any ~~historical~~national ~~experience~~securities ~~and~~exchange onor ~~assumptions~~other ~~that~~nationally werecognized ~~consider~~trading ~~reasonable~~system, ~~under~~including the ~~circumstances.~~Nasdaq ~~Actual results~~Capital ~~may differ from these estimates and reported results could differ under different assumptions or conditions~~Market. ~~Our significant~~ ~~accounting~~Without ~~policies~~an ~~and~~active ~~estimates~~market, ~~are~~the ~~disclosed~~liquidity ~~in Note 1~~ of the ~~Notes~~warrants towill ~~Consolidated~~be ~~Financial Statements for the year ended March 31, 2022~~limited. ~~As of December 31, 2022, there have been no material changes to our significant accounting policies and estimates.~~

~~Results~~ Holders of ~~Operations~~ warrants purchased in this offering will have no rights as a common stockholder until such holder exercises its warrants and acquires our common stock, except as set forth in such warrants.

~~Nine~~Until holders of warrants acquire shares of our ~~Months~~common ~~Ended~~stock ~~December~~upon 31exercise thereof, ~~2022~~such ~~and~~holders ~~December~~will 31have no rights with respect to the shares of our common stock underlying the warrants. Upon exercise of the warrants, ~~2021~~the holders will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

~~Research and~~The ~~Development~~warrants are speculative in nature.

	December 31,				Change
	2022		2021		Fiscal 2022 to Fiscal 2023
Research and development – Three months ended	$	2,196,546	$	1,849,399	$	347,147	18.8	%
Research and development – Nine months ended	$	6,804,069	$	5,742,911	$	1,061,158	18.5	%

The warrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price for a limited period of time. Specifically, holders of the common warrants may exercise their right to acquire the common stock and pay an exercise price of $___ per share, subject to certain adjustments, commencing immediately until expiration on the fifth anniversary of the date of issuance, after which period any unexercised common warrants will expire and have no further value. Moreover, following this offering, the market value of the warrants, if any, is uncertain and there can be no assurance that the market value of the warrants will equal or exceed their imputed offering price. The warrants will not be listed or quoted for trading on any market or exchange. There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the warrants, and consequently, it may not ever be profitable for holders of the warrants to exercise the warrants.

~~Our research~~Certain ~~and~~provisions ~~development~~of ~~expenses~~the ~~include~~pre-funded ~~personnel, consulting, product prototyping~~ warrants and ~~other~~common ~~costs~~warrants ~~associated~~could ~~with~~discourage ~~the~~an ~~development and~~acquisition ~~initial production~~ of ~~our~~us ~~insulin~~by ~~pump~~a ~~product.~~third ~~We expense research and development costs as they are incurred~~party.

~~Research and~~Certain ~~development,~~provisions orof ~~R&D, expenses increased for~~ the ~~three~~warrants ~~and~~could ~~nine~~make it ~~months~~more ~~ended~~difficult ~~December~~or ~~31,~~expensive ~~2022~~for ~~compared~~a ~~with~~third ~~the~~party ~~same period of fiscal 2021, primarily due~~ to ~~increased~~acquire ~~engineering~~us. ~~and~~The ~~operations~~warrants ~~personnel~~prohibit ~~costs,~~us ~~prototype~~from ~~and~~engaging ~~production~~in ~~component~~certain ~~and~~transactions ~~material costs~~constituting ~~and~~“fundamental ~~higher~~transactions” ~~stock-based~~unless, ~~compensation~~among ~~expenses.~~other ~~The~~things, ~~increases~~the insurviving ~~R&D~~entity ~~expenses~~assumes ~~were~~our ~~partially~~obligations ~~offset~~under bythe awarrants. ~~decrease in consulting costs~~Further, asthe wecommon ~~reduced~~warrants ~~our~~provide ~~utilization of consultants~~that, asin ~~we increased our employee headcount and~~ the ~~consultants~~event ~~completed development~~ of ~~aspects of~~certain ~~our~~transactions ~~pump~~constituting ~~design~~“fundamental ~~and features. Our full-time R&D employee headcount increased to 32 at December 31~~transactions,” ~~2022~~with ~~from 18 at December 31,~~some ~~2021.~~exception, ~~R&D~~holders ~~expenses included stock-based compensation expenses~~ of ~~$356,752~~such ~~and~~warrants ~~$204,962~~will ~~for~~have the ~~three months ended December 31~~right, ~~2022 and~~at ~~2021,~~their ~~respectively~~option, ~~and~~to ~~$1,034,674~~require ~~and~~us ~~$459,989~~to ~~for~~repurchase ~~the~~such ~~nine~~common ~~months~~warrants ~~ended~~at ~~December~~a ~~31,~~price described ~~2022~~in ~~and~~such ~~2021, respectively~~warrants. WeThese ~~expect research~~ and ~~development~~other ~~expenses~~provisions toof ~~remain comparable for~~ the ~~remainder~~warrants ofcould ~~fiscal~~prevent ~~2023,~~or asdeter wea ~~continue~~third toparty ~~advance~~from ~~the~~acquiring ~~development~~us ofeven ~~our pump~~where ~~product~~the ~~and~~acquisition ~~develop~~could ~~our~~be ~~manufacturing~~beneficial ~~process~~to you.

~~General~~Potential volatility of the price of our ~~and~~common ~~Administrative~~stock could negatively affect your investment.

	December 31,				Change
	2022		2021		Fiscal 2022 to Fiscal 2023
General and administrative – Three months ended	$	1,161,351	$	1,981,665	$	(820,314	)	(41.4	)%
General and administrative – Nine months ended	$	3,502,029	$	5,156,152	$	(1,654,123	)	(32.1	)%

We cannot assure you that there will continue to be an active trading market for our common stock. Historically, the stock market, as well as our common stock, has experienced significant price and volume fluctuations. Market prices of securities of technology companies can be highly volatile and frequently reach levels that bear no relationship to the operating performance of such companies. These market prices generally are not sustainable and are subject to wide variations. If our common stock trades to unsustainably high levels, it is likely that the market price of our common stock will thereafter experience a material decline. As a result of fluctuations in the price of our common stock, you may be unable to sell your shares at or above the price you paid for them. In addition, as we seek additional financing, including through the sale of equity or convertible securities, such sales could cause our stock price to decline and result in dilution to existing stockholders.

General and administrative expenses consist primarily of personnel and related overhead costs for finance, human resources, legal, marketing and general management.

General and administrative, or G&A, expenses decreased for the three months ended December 31, 2022 compared with the same period of 2021, primarily as a result of decreased stock-based compensation, personnel and benefit costs and legal fees, which in fiscal 2022 related to our public offering and listing on the Nasdaq that was completed in February 2022. These decreases were partially offset by increased consulting and professional services fees.

~~G&A expenses~~In ~~decreased~~addition, ~~for~~ the ~~nine~~stock ~~months~~markets ~~ended~~in ~~December 31~~general, ~~2022~~and the ~~compared~~markets ~~with~~for ~~the~~medical ~~same~~device ~~period~~stocks ofin ~~2021~~particular, ~~primarily~~have asexperienced asignificant ~~result~~volatility ofthat ~~decreased stock-based~~has ~~compensation,~~often ~~personnel~~been ~~and~~unrelated ~~benefit~~to ~~costs,~~the ~~consulting~~financial condition ~~and~~or ~~legal~~results ~~fees~~of ~~and~~operations ~~marketing~~of ~~costs~~particular companies. These ~~decreases~~broad ~~were~~market ~~partially offset~~fluctuations bymay ~~increased~~adversely ~~accounting~~affect ~~fees,~~the ~~travel~~trading ~~costs~~price of our common stock and, ~~office-related~~consequently, ~~expenses.~~adversely ~~Our~~affect ~~full-time~~the ~~G&A~~price ~~employee~~at ~~headcount~~which ~~increased~~you ~~to 3~~could atsell ~~December~~the ~~31,~~shares ~~2022~~that ~~from~~you 2purchase atin ~~December~~this 31offering. In the past, ~~2021.~~following ~~G&A~~periods ~~expenses~~of ~~included~~volatility ~~stock-based~~in ~~compensation~~the ~~expenses~~market ofor ~~$282,753~~significant ~~and~~price $1declines,~~016,774 for~~ ~~the~~securities ~~three~~class-action ~~months~~litigation ~~ended~~has ~~December~~often been ~~31,~~instituted ~~2022~~against ~~and~~companies. ~~2021~~Such litigation, ~~respectively~~if ~~and~~instituted $1against us,~~085,839~~ ~~and~~could ~~$2,280,098~~result ~~for~~in ~~the~~substantial ~~nine~~costs ~~months~~and ~~ended~~diversion ~~December~~of management’s ~~31,~~attention ~~2022~~ and ~~2021~~resources, ~~respectively.~~which Wecould ~~expect~~materially ~~G&A~~and ~~expenses~~adversely toaffect ~~remain~~our ~~flat~~business, ~~for~~financial ~~the~~condition, ~~remainder~~results of ~~fiscal~~operations ~~2023~~and growth prospects.

~~Years~~Provisions of our certificate of incorporation ~~Ended~~and ~~March~~bylaws ~~31,~~might ~~2022~~delay or prevent a change-of-control transaction and ~~March~~depress ~~31,~~the ~~2021~~market price of our stock.

~~Research~~Various provisions of our certificate of incorporation, as amended, and ~~Development~~bylaws might have the effect of making it more difficult for a third party to acquire, or discouraging a third party from attempting to acquire, control of our company. These provisions could limit the price that certain investors might be willing to pay in the future for shares of our common stock. Certain of these provisions eliminate cumulative voting in the election of directors, limit the right of stockholders to call special meetings and establish specific procedures for director nominations by stockholders and the submission of other proposals for consideration at stockholder meetings.

	Years ended March 31,				Year-over-Year Change
	2022		2021		2022 to 2021
Research and development	$	7,729,240	$	4,083,303	$	3,645,937	89.3	%

Under our certificate of incorporation, our board of directors may issue up to a maximum of 5,000,000 shares of preferred stock without stockholder approval on such terms as the board might determine. The rights of the holders of common stock will be subject to, and might be adversely affected by, the rights of the holders of any preferred stock that might be issued in the future.

~~Our~~Purchasers who ~~research~~purchase ~~and~~our ~~development~~securities ~~expenses~~in ~~include~~this ~~personnel,~~offering ~~materials~~pursuant ~~and~~to ~~supplies~~a ~~and~~securities ~~other~~purchase ~~costs~~agreement ~~associated~~may ~~with~~have ~~the~~rights ~~development~~not ofavailable ~~our~~to ~~insulin~~purchasers that ~~pump~~purchase ~~product~~without ~~candidate.~~the Webenefit ~~expense~~of ~~research~~a ~~and~~securities ~~development~~purchase ~~costs as they are incurred~~agreement.

~~Research~~In addition to rights and ~~development,~~remedies oravailable ~~R&D,~~to ~~expenses~~all ~~increased~~purchasers in ~~fiscal~~this ~~2022~~offering ~~compared~~under ~~with~~federal ~~fiscal~~securities ~~2021 primarily due to increased consulting costs, engineering~~ and ~~operations~~state ~~personnel~~law, ~~stock~~the ~~compensation~~purchasers ~~expense~~that ~~and~~enter ~~materials~~into ~~and~~a ~~supplies~~securities purchase ~~expenditures.~~agreement ~~Our~~will ~~R&D~~also ~~employee~~be ~~headcount increased~~able to 23bring atclaims ~~March~~of ~~31,~~breach ~~2022,~~of ~~from~~contract 17against atus. ~~March~~The ~~31,~~ability ~~2021. R&D~~to ~~expenses~~pursue ~~included~~a ~~stock-based~~claim ~~compensation~~for ~~expenses~~breach of ~~$758,938~~contract ~~and~~provides ~~$390,045~~those ~~for~~investors ~~fiscal~~with ~~2022~~the ~~and~~means ~~fiscal~~to ~~2021,~~enforce ~~respectively. We~~the ~~expect~~covenants ~~R&D~~uniquely ~~expenses~~available to ~~continue~~them tounder ~~increase~~the insecurities ~~fiscal~~purchase ~~2023,~~agreement asincluding, webut ~~complete~~not ~~the~~limited ~~development~~to: of(i) ~~our~~timely ~~pump~~delivery ~~product~~of ~~candidate,~~securities; ~~engage~~and ~~third~~(ii) ~~parties~~indemnification tofor ~~test~~breach ~~our~~of ~~product and develop a low-volume manufacturing process~~contract.

General and Administrative

	Years ended March 31,				Year-over-Year Change
	2022		2021		2022 to 2021
General and administrative	$	7,197,162	$	3,253,412	$	3,943,750	121.2	%

General and administrative expenses consist primarily of personnel and related overhead costs for marketing, finance, human resources and general management.

General and administrative expenses, or G&A, increased in fiscal 2022 compared with fiscal 2021 primarily as a result of increased personnel and consulting costs, stock-based compensation expenses and professional services fees, primarily related to our financing activities, including our public offering that was completed in February 2022. G&A expenses included stock-based compensation expenses of $3,272,964 and $837,533 for fiscal 2022 and fiscal 2021, respectively. We expect G&A expenses to continue to increase in fiscal 2023, as we will increase headcount as we expand our organization to support our anticipated growth and prepare for the expected commencement of the commercialization of our product in late fiscal 2023.

Interest Expense

	Years ended March 31,				Year-over-Year Change
	2022		2021		2022 to 2021
Interest expense	$	2,752,229	$	39,791	$	2,712,438	6,816.7	%

Interest expense consisted of interest expense incurred from our convertible promissory notes, including amortization of debt issuance costs, and our promissory (bridge) note. We retired our outstanding debt in February 2022. See Notes 5 and 6 to the consolidated financial statements included in this Registration Statement for additional disclosure.

~~Liquidity and~~CAUTIONARY ~~Capital~~NOTE ~~Resources~~ REGARDING FORWARD-LOOKING STATEMENTS

~~December~~Some 31of the statements in this prospectus constitute forward-looking statements. These statements involve known and unknown risks, ~~2022~~uncertainties, and other factors that may cause our or our industry’s 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. These factors include, among others, those discussed under “Risk Factors” above, and under a similar heading in any other annual, periodic or current report incorporated by reference into this prospectus or that we may file with the SEC in the future.

AsIn asome ~~development-stage enterprise~~cases, weyou docan ~~not~~identify ~~currently have revenues to generate cash flows to cover operating expenses. Since our inception, we have incurred~~forward-looking ~~operating~~statements ~~losses~~by ~~and~~terminology ~~negative~~such ~~cash~~as ~~flows in each year due to costs incurred in connection with R&D activities and G&A expenses associated with our operations. For the nine months ended December 31~~“may,” ~~2022~~“will,” ~~we incurred a net loss of approximately $10.3 million. For the years ended March 31~~“should,” ~~2022 and 2021~~“expects,” ~~we incurred net losses of approximately $18.6 million and $7.4 million~~“intends, ~~respectively. At December~~” 31“plans,” ~~2022~~“anticipates,” we“believes,” ~~had~~“estimates,” ~~a cash balance of approximately $7.7 million and an accumulated deficit of approximately $44.9 million. When considered with our current operating plan~~“predicts,” ~~these conditions raise substantial doubt about our ability to continue as a going concern for a period~~“potential,” of at least one year from the date that of issuance of the consolidated financial statements included in in this prospectus. Our consolidated financial statements do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to “continue” ~~as a going concern. Our ability to continue as a going concern depends on our ability to raise additional capital through the sale of equity~~ or ~~debt~~similar ~~securities to support our future operations, and we are currently seeking such additional financing~~terms. ~~In May 2022, we completed a registered direct offering of securities for net proceeds of approximately $7.4 million.~~

~~Our operating~~Although ~~needs~~we ~~include~~believe that the ~~planned~~expectations ~~costs~~reflected in tothe ~~operate~~forward-looking ~~our~~statements ~~business~~are reasonable, ~~including~~we ~~amounts~~cannot ~~required~~guarantee tofuture ~~fund~~results, ~~research~~levels ~~and~~of ~~development activities~~activity, ~~including~~ ~~clinical studies~~performance, ~~working~~or ~~capital and capital expenditures~~achievements. Our ~~During~~actual ~~the~~results ~~nine~~could ~~months~~differ ~~ended~~materially ~~December~~from ~~31,~~those weexpressed ~~made~~or ~~capital~~implied ~~expenditures of~~by ~~approximately~~these ~~$574,000,~~forward-looking statements as ~~we have begun procuring equipment to develop~~ a ~~low-volume~~result ~~manufacturing~~of ~~production line to build our pump~~various ~~product~~factors, toincluding ~~demonstrate~~the ~~and~~risk ~~develop~~factors ~~our~~under ~~manufacturing~~the ~~process.~~section Wetitled ~~expect~~“Risk toFactors,” ~~incur~~and ~~increased~~under ~~capital~~a ~~expenditures~~similar ~~for~~heading ~~the~~in ~~remainder~~any ofother ~~fiscal 2023. At December 31~~annual, ~~2022,~~periodic weor ~~had~~current ~~outstanding,~~report ~~non-cancelable~~incorporated ~~purchase~~by ~~orders~~reference ~~for~~into ~~production~~this ~~equipment~~prospectus ~~totaling~~or ~~$735,000,~~that ~~and~~ we ~~expect~~may tofile ~~receive~~with ~~and~~the ~~pay~~SEC ~~for~~in ~~this equipment over~~ the ~~following six months. Our~~ future, ~~capital requirements~~ and a ~~the~~variety ~~adequacy~~ of ~~our available~~other ~~funds will depend on many~~ factors, including, without limitation, ~~our~~statements ~~ability~~about ~~to successfully commercialize~~ our ~~product,~~future ~~competing technological~~business operations and ~~market developments~~results, ~~and~~ the ~~need~~market ~~to enter into collaborations with other companies or acquire other companies or technologies~~for ~~to enhance or complement~~ our ~~product offerings. If we are unable to secure additional capital timely~~technology, ~~we will be required to curtail~~ our ~~research~~strategy and ~~development initiatives and take additional measures to reduce costs in order to conserve our cash~~competition.

~~For the nine months ended December 31~~Moreover, ~~2022,~~neither we ~~used~~nor ~~$8,184,696~~any inother ~~operating~~person ~~activities, which primarily resulted from our net loss of $10,307,682,~~assumes asresponsibility ~~adjusted~~ for ~~stock-based~~the ~~compensation~~accuracy ~~expenses of $2,120,513, $150,412 for issuances of shares of common stock in exchange for services~~ and ~~depreciation~~completeness ~~and amortization expenses~~ of ~~$92,616,~~these ~~and increased by net changes in operating lease assets and liabilities of $37,761 and operating assets and liabilities $202,794 and other immaterial adjustments~~statements. ~~For~~We ~~the~~undertake ~~nine~~no ~~months~~obligation ~~ended~~to ~~December~~update ~~31,~~or ~~2021,~~revise weany ~~used $7,128,787 in operating activities, which primarily resulted from our net loss~~ of ~~$14,058,154, increased for a non-cash gain on~~ the ~~PPP~~forward-looking ~~Note extinguishment of $368~~statements,~~780~~ ~~and~~whether ~~net changes in operating lease assets and liabilities of $34,422,~~ as ~~adjusted for changes to operating assets and liabilities of $1,197,988,~~ a ~~loss~~result ~~on debt extinguishment~~ of $1new information,~~321,450~~ ~~stock-based~~future ~~compensation~~events ~~expenses~~or ~~of $2~~otherwise,~~740,086,~~ ~~$388,021 for~~except ~~issuances~~as ofrequired ~~shares~~by oflaw. ~~common~~In ~~stock~~light ~~in exchange for services, $149,994 for issuable shares~~ of ~~common~~these ~~stock in exchange for services~~risks, ~~depreciation~~ uncertainties and ~~amortization expenses of $80~~assumptions,~~268~~ ~~and~~the ~~interest~~forward-looking ~~expense~~events ofdiscussed ~~$1,454,762~~in ~~for~~this ~~amortization~~prospectus ofmay ~~debt~~not ~~discount~~occur.

For the nine months ended December 31, 2022 and 2021, cash used in investing activities of $573,066 and $22,779, respectively, was for the purchase of property and equipment.

Cash provided by financing activities of $7,372,347 for the nine months ended December 31, 2022 was attributable to net proceeds from the issuance of common stock upon completion of an equity offering, net of underwriting fees and issuance costs. Cash provided by financing activities of $5,887,199 for the nine months ended December 31, 2021 was primarily attributable to $4,137,199 of net proceeds from the issuance of our convertible promissory notes, $250,000 from the sale of shares of common stock to officers of the Company and $1,500,000 from the issuance of a promissory bride note.

Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements are detailed in Note 1 in the Notes to the Condensed Consolidated Financial Statements for the three and nine months ended December 31, 2022, included in this prospectus.

~~BUSINESS~~USE OF PROCEEDS

~~Overview~~We estimate that the net proceeds to us from this offering will be approximately $10.9 million, assuming the sale of the maximum number of securities offered hereby, based upon a public offering price of $0.5091 per share and accompanying common warrant, after deducting estimated placement agent fees and estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the warrants issued pursuant to this offering. In addition, if all of the common warrants offered pursuant to this prospectus are exercised in full for cash, we will receive approximately an additional $12 million in cash. We cannot predict when or if these common warrants will be exercised. It is possible that these common warrants may expire and may never be exercised.

~~Modular Medical~~We isintend ato ~~development-stage,~~use ~~medical~~the ~~device company~~net ~~focused~~proceeds onof ~~the~~this offering ~~design,~~for ~~development,~~repayment ~~and commercialization~~ of anany ~~innovative~~amounts ~~insulin~~drawn ~~pump~~under ~~using~~the ~~modernized~~promissory ~~technology~~note issued to ~~increase~~ ~~pump~~our ~~adoption~~Chief inExecutive ~~the~~Officer ~~diabetes~~on ~~marketplace.~~February ~~Through~~23, ~~the~~2026 ~~creation~~and general ofcorporate apurposes, ~~novel~~including ~~two-part~~working ~~patch pump~~capital, ~~the~~to ~~Company~~fund ~~seeks~~our ~~to fundamentally~~operations ~~alter~~through the ~~trade-offs~~approval ~~between~~of ~~cost~~our ~~and~~Pivot ~~complexity~~product ~~and~~by ~~access~~the FDA, to ~~the~~commence ~~higher~~initial ~~standards~~commercialization of ~~care~~our ~~that~~Pivot ~~presently~~product, ~~available insulin~~to ~~pumps~~fund ~~provide.~~additional Byresearch ~~simplifying~~ and ~~streamlining~~development ~~the~~activities, ~~user~~to ~~experience~~further develop ~~from~~our ~~introduction,~~manufacturing ~~prescription,~~and ~~reimbursement,~~production ~~training~~ capabilities and ~~day-~~to~~-day~~ ~~use,~~make werelated ~~seek~~capital toexpenditures. ~~expand~~We ~~the~~may ~~wearable~~also ~~insulin~~use ~~delivery~~a ~~device~~portion ~~market~~of ~~beyond~~ the ~~highly~~net proceeds ~~motivated~~from ~~“super users”~~this ~~and~~offering ~~expand~~to ~~the~~acquire ~~category~~or ~~into~~invest ~~the~~in ~~mass~~complementary ~~market.~~businesses, ~~The~~technologies, ~~product~~products ~~candidate~~or ~~seeks~~assets. toAlthough ~~serve~~we currently ~~both~~have ~~the~~no ~~type~~agreements, 1commitments ~~and~~or ~~the~~obligations ~~rapidly growing~~to do so, ~~especially~~we evaluate such opportunities and engage in ~~terms~~related ofdiscussions with ~~device~~third ~~adoption,~~parties ~~type~~from 2time ~~diabetes~~to ~~markets~~time.

~~Differentiation~~However, this is a reasonable best efforts offering with no minimum number of securities or amount of proceeds as a condition to closing, and we may not sell all or any of the securities offered pursuant to this prospectus; and, as a result, we may receive significantly less in net proceeds in this offering. For example, if we sell only 25%, 50% or 75% of the maximum amount offered, our net proceeds would be approximately $2.6 million, $5.6 million, or $8.4 million, respectively.

~~We believe~~Our ~~that~~expected ~~there~~use ~~are a number~~ of ~~shortcomings~~the ~~and~~net ~~issues~~proceeds ~~with~~from ~~currently~~this offering ~~available~~represents ~~insulin~~our ~~pumps~~intentions ~~that~~based ~~prevent~~upon aour ~~substantial~~current ~~number~~plans ~~of people~~and ~~who~~business ~~require~~conditions. ~~insulin~~As onof athe ~~daily~~date ~~basis~~of ~~from~~this ~~choosing~~prospectus, anwe ~~insulin~~cannot predict ~~pump~~with tocertainty ~~treat~~all ~~their~~of ~~diabetes.~~the Weparticular ~~believe,~~uses ~~that~~for bythe ~~tailoring~~net ~~our insulin~~proceeds ~~pump~~ to ~~address~~be ~~such~~received ~~factors,~~upon ~~we can expand~~ the ~~scope~~completion ~~and~~of ~~adoption~~this ~~rate~~offering ofor ~~insulin~~the ~~pump~~amounts that ~~usage.~~we Wewill ~~believe~~actually ~~that~~spend toon ~~achieve~~the ~~broader market~~uses ~~acceptance,~~set anforth ~~insulin~~above. ~~pump~~The ~~must~~amounts beand ~~easier~~timing toof ~~learn~~our toactual ~~use,~~expenditures bemay ~~less~~vary ~~time-~~significantly ~~consuming~~depending on tonumerous ~~operate~~factors, ~~more~~including ~~intuitive~~the toprogress ~~both~~of ~~patients and~~our ~~physicians,~~development efforts and ~~meet~~any ~~the~~unforeseen ~~standards~~cash ~~for~~needs. ~~coverage~~As bya ~~insurance~~result, ~~providers~~our somanagement ~~that~~will retain ~~co-payments~~broad ~~required~~discretion ~~from~~over ~~patients~~the ~~are~~allocation ~~affordable and~~of the ~~hurdles~~net toproceeds ~~insurance~~from ~~coverage~~this ~~are significantly reduced~~offering.

~~Among~~Pending the uses described above, we plan to invest the ~~more~~net ~~prominent~~proceeds ~~issues~~from ~~are:~~this offering in short-term, interest-bearing obligations, investment-grade instruments or other securities.

●Each ~~Complexity:~~$0.10 ~~Many~~increase ~~existing~~or ~~pumps~~decrease ~~are~~in ~~highly~~the ~~complex~~assumed public offering price of $0.5091 per share and ~~require~~accompanying ~~significant~~common ~~technical~~warrant, ~~expertise~~the last reported sale price of our common stock on the Nasdaq Capital Market on February 19, 2026, would increase or decrease the net proceeds to ~~use~~us ~~effectively~~from this offering by approximately $ 2.2 million, Weassuming ~~believe~~the ~~such~~number ~~pumps~~of ~~were~~shares ~~designed~~of ~~for~~common ~~“super~~stock ~~users~~offered by us,” ~~who~~as ~~have~~set ~~high~~forth ~~levels~~on the cover of ~~motivation~~this prospectus, remains the same and ~~technical~~after ~~competence~~deducting placement agent fees and estimated offering expenses payable by us. ~~The~~We ~~complexity~~may also increase or decrease the number of ~~pumps~~shares ~~may~~of becommon ~~daunting~~stock that we are offering. An increase or decrease of four million shares of common stock offered by us would increase or decrease the net proceeds to ~~less~~us ~~technically~~from ~~inclined~~this offering by approximately $1.9 million, ~~less~~assuming ~~motivated~~the ~~users~~sale of all shares of common stock offered hereby, at an assumed public offering price of $0.5091 per share and accompanying common warrant, the last reported sale price of our common stock on the Nasdaq Capital Market on February 19, 2026, after deducting placement agent fees and estimated offering expenses payable by us.

●DIVIDEND Cumbersome: We believe that a majority of existing pumps are bulky and difficult to manage, requiring a means of carrying the pump around and up to 48 inches of tubing to the injection site to connect the catheter to a pump. The tubing and the cartridge, which holds the insulin, must be replaced every few days. This requires users to carry spare parts and other equipment adding to the difficulty of using the pump. In comparison, our product only requires a cartridge change every few days.POLICY

●To ~~Cost:~~date, ~~Costs~~we ~~associated~~have ~~with~~paid ~~insulin~~no ~~pump~~cash ~~therapy~~dividends ~~can be high and prohibitive, especially for those~~ on ~~fixed~~our shares orof ~~limited~~common ~~incomes.~~stock ~~These costs vary by pump~~ and ~~insurance~~we ~~coverage,~~do ~~but~~not ~~multi-thousand-dollar~~expect ~~upfront payments, often with substantial co-payments in addition~~ to ~~possible~~pay ~~additional~~cash ~~co-payments~~dividends on ~~consumables,~~our ~~can~~common ~~easily~~stock ~~place~~in ~~current~~the ~~pumps~~foreseeable ~~out of reach for patients~~future. ~~This~~We ~~leads~~intend to ~~limited~~retain future orearnings, ~~absent~~if ~~reimbursement/coverage~~any, ~~and~~to ~~potentially~~provide ~~high~~funds ~~financial hurdles~~ for ~~patients~~operations toof ~~gain~~our ~~access~~business. ●Therefore, ~~Outdated~~any ~~style:~~potential ~~Consumer~~return ~~electronics~~investors ~~devices~~may have ~~evolved~~ in ~~both~~our ~~form~~common stock ~~and function. Diabetes pumps have not experienced similar progress. We believe that consumers~~ will be ~~more~~in ~~receptive of products designed with~~ the ~~user~~form ~~experience~~of inappreciation, ~~mind~~if ~~and that many have low tolerance for complex~~any, ~~difficult~~in ~~procedures~~the ~~for~~market ~~use~~value ~~and maintenance~~ of ~~products.~~their ●shares ~~Pump~~of ~~mechanism~~common ~~limitations: Traditional pumps generally utilize a syringe and plunger mechanism to deliver insulin~~stock. We ~~believe~~are ~~this~~not ~~design~~subject ~~limits~~to ~~the~~any ~~ability~~legal restrictions torespecting ~~reduce~~ the ~~size~~payment of ~~the pump~~dividends, ~~and~~except ~~also~~that ~~potentially~~we ~~exposes~~may ~~the~~not ~~user~~pay todividends ~~the~~if ~~unintended delivery of~~ the ~~full~~payment ~~volume~~would ofrender ~~insulin~~us ~~within the pump, which can cause hypoglycemia or death~~insolvent. WeAny future ~~believe~~determination ~~that~~as to the ~~fear~~payment of ~~adverse~~cash ~~health~~dividends ~~events~~on ~~due~~our tocommon ~~technical~~stock ~~malfunctions~~will ~~related~~be toat ~~traditional pump mechanism limitations deters~~ the ~~adoption~~discretion of ~~insulin~~our ~~pump~~board ~~therapy~~of directors.

Our team has substantial knowledge of the diabetes industry and experience in developing, obtaining marketing authorization for, and bringing insulin pumps to market. Based on this experience, we believe that our innovative insulin pump, using a new and proprietary method of pumping insulin, can address most or all of these shortcomings. It provides a state-of-the-art insulin pump capable of both basal (steady flow) and bolus (mealtime dosing) insulin disbursement. It also has been designed considering a natural migration path to multi-chamber/multi-liquid pumps, potentially offering an exciting array of new therapies to patients with diabetes and other conditions.

Our goal is to become the leader in expanding access to insulin pump technology to a wider portion of diabetes sufferers and provide not just care for the super users, but “diabetes care for the rest of us.” While our initial target market is people with Type 1 diabetes, we believe there is a substantial opportunity to penetrate the type 2 marketplace, whether through our initial MODD1 pump or further simplification of our pump to address the type 2 marketplace.CAPITALIZATION

The ~~MODD1~~ isfollowing atable ~~high-precision~~sets ~~pump~~forth ~~that~~our ~~we believe represents the best choice for new pump patients because it is easy to afford, easy to~~capitalization ~~learn,~~as ~~easy~~of toDecember ~~use~~31, ~~and has a revolutionary design and technology that enable precision with low-cost manufacture and high reproducibility.~~2025:

~~Key features~~● ~~include:~~on an actual basis;

● ~~Two~~on ~~parts~~a pro-forma ~~one~~basis ~~reusable,~~to ~~one~~give ~~disposable~~effect -to ~~snap~~give ~~together~~effect to ~~form~~the issuance and sale of the ~~working~~securities ~~system;~~by us in this offering at the assumed public offering price of $0.5091 per share and accompanying common warrant, assuming the sale of the maximum number of securities offered hereby after deducting estimated placement agent fees and estimated offering expenses payable by us for net proceeds of $10.9 million.

●You ~~One~~should ~~button~~read ~~interface,~~this ~~easy~~table totogether ~~learn~~with the information contained under the heading “Management’s Discussion and ~~use;~~Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes incorporated by reference herein.

● 90-day reusable, 3-day disposable;

	December 31, 2025
	(unaudited; in thousands, except per-share amounts)
	Actual			Pro Forma
Current assets
Cash and cash equivalents	$	2,937		$	13,866
Total liabilities		4,378			4,378
Stockholders’ equity
Preferred stock, $0.01 par value; 5,000 shares authorized; none issued and outstanding, actual and pro forma		—			—
Common stock, $0.001 par value; 100,000 shares and 250,000 authorized actual and pro forma⁽¹⁾; 77,703 shares and 101,275 shares issued and outstanding, actual and pro forma		78			101
Additional paid-in capital		112,402			123,308
Common stock issuable		6			6
Accumulated deficit		(106,605	)		(106,605	)
Total stockholders’ equity	$	5,881		$	16,810

●(1) ~~Disposable~~The ~~portion~~pro ~~removable~~forma atinformation ~~any~~gives ~~time~~effect to the increase in the number of our authorized shares of common stock from an100,000,000 ~~adhesive-backed~~to ~~retainer~~250,000,000, which ~~remains~~was ineffective ~~place;~~January 23, 2026.

● No external controller required, no charging, no battery replacement; and

● Slim profile, lighter weight.

A proprietary survey of American healthcare payors representing 50 million covered lives (approximately 1/3 of U.S. covered lives) performed for us by industry leading survey firm ISA in 2019 has demonstrated that payors are willing to grant equivalent or preferential coverage for a product with this feature set at launch in exchange for discounts of approximately 20%.

Diabetes Classifications and Therapies

Diabetes is typically classified as either type 1 or type 2:

● T1D is an auto-immune condition characterized by the body’s nearly complete inability to produce insulin. It is frequently diagnosed during childhood or adolescence, although it can sometimes have onset in adulthood. Individuals with T1D require daily insulin therapy to survive.

● T2D represents over 90% of all individuals diagnosed with diabetes and is characterized by the body’s inability to either properly utilize insulin or produce sufficient insulin. Initially, many people with T2D attempt to manage their condition with improvements in diet and exercise and/or the use of oral medications and/or injection of glucagon-like peptide-1 (GLP-1) drugs. However, as their diabetes advances, patients often progress to requiring insulin therapies such as once-daily long-acting insulin and ultimately to intensified mealtime rapid-acting insulin therapy. This represents an important portion of the diabetes market with an estimated 1.6 million T2D intensively treated with insulin currently in the United States.

All people with T1D, which is our primary market, require daily insulin. According to the Seagrove 2021 Diabetes Blue Book, approximately 18% of people with T2D in the United States, or 4.7 million people, require insulin (basal alone represent 3.1 million and basal plus mealtime represent 1.6 million) to manage their diabetes. In this prospectus, we refer to people with T1D and people with T2D who require mealtime insulin as “insulin-requiring people with diabetes.”

~~Currently,~~Each ~~there~~$0.10 increase ~~are~~(decrease) ~~two~~in ~~primary~~the ~~therapies~~assumed ~~available~~public ~~for~~offering ~~insulin-requiring~~price ~~people~~of ~~with~~$0.5091 per ~~diabetes:~~share ~~multiple~~would ~~daily~~increase ~~insulin~~(decrease) ~~injections~~the ~~directly~~pro ~~into~~forma ~~the~~amount ~~body~~of ~~through~~cash ~~syringes~~and orcash equivalents, additional ~~insulin~~paid-in ~~pens~~capital, ~~referred~~total tostockholders’ asequity ~~Multiple~~and ~~Daily~~total ~~Injection,~~capitalization orby ~~MDI~~approximately ~~therapy~~$ 2.2 million, orassuming that the ~~use~~ number of anshares ~~insulin~~offered ~~pump~~by tous, ~~deliver~~as ~~mealtime~~set ~~insulin boluses~~forth toon ~~help~~the ~~with~~cover ~~glucose~~page ~~absorption~~of ~~after~~this ~~carbohydrate~~prospectus, ~~consumption~~remains ~~and~~the asame ~~continuous~~and ~~subcutaneous~~after ~~insulin~~deducting ~~infusion,~~the orestimated ~~CSII~~placement ~~therapy,~~agent ~~into~~fees ~~the~~and ~~body.~~estimated ~~Generally,~~offering ~~CSII~~expenses ~~therapy~~payable isby ~~considered~~us. toWe ~~provide~~may aalso increase or decrease the number of ~~advantages~~units ~~over~~we ~~MDI~~are ~~therapy,~~offering. ~~primarily~~Each anincrease ~~improvement~~(decrease) inof ~~glycemic~~four ~~control,~~million shares asin ~~measured~~the bynumber ~~certain~~of ~~diabetes~~shares ~~management~~we ~~tests~~are ~~such~~offering aswould ~~hemoglobin~~increase ~~A1c~~ (~~HbA1c~~decrease) ~~measure~~the ~~and~~pro ~~more recently~~forma ~~Time~~amount inof ~~Range~~cash and ~~(TIR)~~cash ~~where~~equivalents, aadditional ~~continuous~~paid-in ~~glucose~~capital, ~~measuring~~total ~~device~~stockholders’ isequity ~~used~~and tototal ~~calculate~~capitalization ~~this~~by ~~test~~approximately $1.9 ~~Among~~million , assuming ~~other~~that ~~medical benefits,~~the aassumed ~~study~~public ~~conducted~~offering byprice ~~Tandem~~remains ~~Diabetes~~the ~~Care~~same, ~~Inc.~~and inafter ~~2021~~deducting ~~demonstrated~~the ~~that~~estimated ~~insulin~~placement ~~pump~~agent ~~use~~fees ~~can~~and ~~decrease glucose~~estimated ~~variability,~~offering ~~reduce~~expenses ~~the~~payable ~~number~~by ofus. ~~hypoglycemic~~The ~~events,~~pro ~~decrease~~forma ~~the~~information ~~daily~~discussed ~~doses~~above ofis ~~insulin~~illustrative only and ~~reduce~~will be adjusted based on the ~~fear~~actual public offering price and other terms of ~~hypoglycemia~~this offering determined at pricing.

~~Notwithstanding~~The ~~these~~table ~~advantages, we believe the difficulty in use resulting from the complexity~~ and ~~cumbersome~~discussion ~~design~~above ofare ~~available~~based ~~insulin~~on pumps as well as high and often prohibitive costs for both the patient and insurance provider has resulted not only in dissatisfaction among many existing pump users (fewer than half purchase a new pump after the warranty expires77, ~~as noted in a Seagrove Partners 2021 study)~~703, ~~but also has severely limited the adoption~~547 ~~rate~~shares of ~~insulin~~common ~~pumps~~stock byoutstanding aas ~~large segment~~ of ~~the~~December ~~MDI~~31, ~~diabetes population~~2025, ~~whom~~and weexcludes, ~~refer to in this prospectus~~ as ~~“Almost~~of ~~Pumpers.”~~such date:

~~We define~~● ~~Almost~~9,250 ~~Pumpers~~shares ~~as insulin-requiring people with diabetes who are aware~~ of ~~pumps~~common ~~and~~stock ~~their~~issuable ~~potential~~attributable ~~benefits but because of past experiences, pump shortcomings, cost, complexity, and time and learning required~~ to ~~adopt~~a ~~and~~warrant ~~utilize~~inducement ~~currently~~offering ~~available~~effected ~~insulin~~in ~~pumps, continue~~September ~~to receive their daily insulin through MDI therapy.~~2025;

~~Our initial~~● ~~focus~~7,340,122 ~~for~~shares ~~our~~of ~~insulin~~common ~~pump~~stock isissuable upon the ~~almost~~exercise ~~pumper~~of ~~segment~~outstanding ~~population~~stock ~~located~~options, inwhich ~~the~~options ~~United~~have ~~States~~a weighted average exercise price of $2.38 per share;

~~Our~~● ~~research~~41,668 ~~along~~shares ~~with marketplace data provided by Seagrove Partners in 2023, estimates that 33%~~ of ~~Americans~~common ~~with~~stock ~~T1D~~issuable ~~have~~upon ~~an insulin pump and 28% of Americans with T1D (44% of those who currently utilize MDI) can be classified as having an interest in pump adoption and meeting~~ the ~~American~~vesting ~~Diabetes Association guidelines~~ of ~~glucose~~restricted ~~control~~stock if their objections to the currently available suite of products can be overcome. They do not want to closely manage their glucose levels and incur the associated time and effort involved. They are the Almost Pumpers. We have developed what we believe to be the most technologically advanced delivery system overcome the objections and provided motivation for this market. We believe that there are four addressable hurdles to adoption:units;

● ~~Usability:~~2,955,714 ~~the~~shares ~~device~~of ~~needs~~common tostock beavailable ~~easy~~for tofuture ~~learn~~issuance under the Amended and toRestated ~~operate~~2017 Equity Incentive Plan, as amended (the “2017 Equity Incentive Plan”); ● 6,086,500 shares of common stock issuable upon the exercise of warrants dated December 11, 2025 at $0.45 per share; ● 912,975 shares of common stock issuable upon the exercise of warrants dated December 22, 2025 at $0.45 per share; ● 852,110 shares of common stock issuable upon the exercise of warrants dated December 11, 2025 at $0.462 per share; ● 127,816 shares of common stock issuable upon the exercise of warrants dated December 22, 2025 at $0.462 per share; ● 3,247,741 shares of common stock issuable upon the exercise of warrants dated September 25, 2025 at $0.84 per share; ● 874,672 shares of common stock issuable upon the exercise of warrants dated March 25, 2025 at $1.40 per share;

● ~~Affordability:~~1,905,042 weshares ~~will~~of ~~focus~~common onstock ~~overcoming~~issuable ~~copay~~upon ~~and~~the ~~insurance~~exercise ~~hurdles~~of ~~rather~~warrants ~~than~~dated ~~leaving~~March ~~the~~25, ~~“insurance~~2025 ~~journey”~~at to$1.12 ~~the~~per ~~clinician and patient~~share;

● ~~Accessibility~~381,540 ~~and~~shares ~~Education:~~of wecommon ~~will~~stock ~~seek~~issuable toupon ~~engage~~the ~~patients~~exercise toof ~~sample~~warrants ~~this~~dated ~~new~~November ~~technology~~21, by2024 ~~supplying~~at ~~clinicians~~$1.875 ~~with~~per ~~free samples and simple training to allow people to see first-hand the typical barriers to adoption that have been overcome~~share; ~~and~~

● ~~Service~~484,006 ~~and~~shares ~~Support:~~of ~~where~~common westock ~~will~~issuable ~~answer~~upon ~~their~~the ~~questions~~exercise ~~and~~of ~~concerns~~warrants ~~during~~dated ~~this~~May ~~diabetes~~15, ~~experience~~2023 at $1.32 per share;

~~We believe~~● ~~this conversion process~~1,671,733 ~~engaging~~shares ~~people to try and thereby receive the benefits~~ of ~~our~~common ~~technology~~stock ~~will~~issuable ~~substantially increase adoption of insulin pumps among both those with T1D and T2D who remain reliant~~ upon ~~multiple daily injections. Diabetes is a disease that appears throughout~~ the ~~world.~~exercise ~~Therefore,~~of wewarrants ~~cannot~~dated ~~segment~~May ~~the market by socioeconomics~~15, ~~education~~2023 orat ~~level of care~~$1.22 Weper ~~intend to create an insulin pump that appeals to all Almost Pumpers.~~share;

●

1,438,202 shares of common stock issuable upon the exercise of warrants dated May 5, 2022 at $6.60 per share;

●

4,011,276 shares of common stock issuable upon the exercise of warrants dated February 9, 2022 at $6.60 per share; and

●

767,796 shares of common stock issuable upon the exercise of warrants dated May 11, 2021 at $6.00 per share.

~~Market~~DILUTION

~~The~~If ~~International~~you ~~Diabetes~~invest ~~Federation~~in ~~estimated that,~~our common stock in ~~2019~~this offering, your ~~approximately~~ownership ~~460~~interest ~~million~~will ~~people~~be ~~were~~diluted ~~living~~to ~~with~~the ~~diabetes~~extent ~~worldwide,~~of the difference between the public offering price per share of our common stock and byaccompanying ~~2045,~~common warrants in this ~~number~~offering ~~will~~and ~~increase~~the topro ~~approximately~~forma pro forma net tangible book value per share of our common stock after ~~700~~the ~~million~~closing ~~people~~of this offering.

AnOur ~~estimated~~historical 34net ~~million~~tangible ~~people~~book invalue ~~the~~as ~~United~~of ~~States~~December ~~live with diabetes. Within this group~~31, ~~T1D~~2025 ~~accounts~~was ~~for approximately 1~~$5.89 million, ~~people~~or ~~with~~$0.08 ~~the~~per ~~remainder~~share, ~~being~~based ~~T2D.~~on ~~All~~77,703,547 ~~people~~shares ~~with T1D~~of ~~require~~common ~~daily~~stock ~~insulin.~~outstanding ~~However,~~as of ~~the~~December ~~approximately~~31, 322025.2 ~~million~~Our ~~people~~historical net ~~with~~tangible ~~T2D,~~book ~~about~~value ~~1.6~~represents ~~million~~our oftotal ~~them~~tangible ~~require~~assets ~~multiple~~fewer ~~daily injections~~total ofliabilities. ~~insulin~~Historical tonet ~~manage~~tangible ~~their~~book ~~diabetes.~~value ~~This~~per ~~represents~~share ais our ~~large~~historical ~~and~~net ~~growing~~tangible ~~market~~book ~~with~~value divided by the ~~effects~~number of ~~diabetes~~shares ~~accounting for roughly 25%~~ of ~~all~~our ~~healthcare~~common ~~dollars~~stock ~~spent~~outstanding ~~annually~~as inof ~~the~~December ~~United~~31, ~~States~~2025.

~~According~~After giving further effect to the ~~National~~sale ~~Diabetes~~of 23,571,007 shares of ~~HCP~~our ~~Survey~~common stock and common warrants to purchase 23,571,007 shares of our common stock in this offering at an assumed public ~~conducted~~offering price of $0.5091 per share (which was the last reported sale price of our common stock on the Nasdaq Capital Market on February 19, 2026) and accompanying common warrant, assuming no sale of any pre-funded warrants, and after deducting estimated placement agent fees and estimated offering expenses payable by ~~Seagrove~~us, ~~Partners~~our as pro forma pro forma net tangible book value as of December 31, ~~LLC~~2025 inwould ~~2021~~have been $16.8 million, ~~approximately~~or ~~25%~~$0.17 per share. This represents an immediate increase in pro forma pro forma net tangible book value of $0.09 per share to our existing stockholders and an immediate dilution of $0.34 per share to investors purchasing our common stock and common warrants in this offering at the 1assumed combined public offering price.6 ~~million~~The ~~highly~~information ~~insulin~~above ~~intensive~~is ~~T2D~~illustrative ~~have~~only ~~considered~~and ~~going~~will “change based on actual ~~pump~~pricing and other terms of this offering determined at pricing.” The final public offering price will be determined through negotiation between us and the placement agent in the offering and may be at a discount to the current market price. Therefore, the assumed offering price used throughout this prospectus may not be indicative of the final public offering price.

~~Insulin~~The ~~pumps~~following ~~have~~table ~~been~~illustrates ~~shown~~this todilution ~~provide~~on a higher level of care for insulin dependent people with diabetes and result in better glycemic control, fewer comorbidities, fewer trips to the emergency room, and higher overall quality of life. They also result in lower overall costs to the healthcare system, reducing typical expense per ~~patient~~share ~~year from $27,195 to $16,992.~~basis:

Despite these benefits, only 1 in 3 (33%) of the 1.8 million Americans with T1D and very few of the 1.6 million T2D intensively treated with insulin currently use an insulin pump, for a total of approximately 670,000 current users, with only a slow increase of insulin pump use. The remaining 68% of T1D’s and virtually all of the T2D’s rely on multiple daily injections (MDI) for glucose control. Decades of advances in technology advances have left these non-pumpers at a significant disadvantage from a control perspective versus their “pumping” counterparts.

Assumed combined public offering price per share of common stock and accompanying common warrant			$	0.5091
Historical net tangible book value per share as of December 31, 2025	$	0.08
Decrease in net tangible book value per share as of December 31, 2025 attributable to investors purchasing shares in this offering	$	0.09
Pro forma net tangible book value per share as of December 31, 2025 after giving effect to this offering			$	0.17
Dilution per share to investors participating in this offering			$	0.3391

WeEach ~~have~~$0.10 ~~identified~~increase aor ~~large~~decrease ~~segment~~in the assumed public offering price of $0.5091 per share and accompanying common warrant, the ~~market~~last reported sale price of our common stock on ~~that~~the weNasdaq ~~refer~~Capital toMarket ason February ~~“Almost~~19, ~~Pumpers.”~~2026, ~~Almost~~would ~~Pumpers~~increase ~~are~~or ~~those~~decrease ~~insulin-requiring~~our ~~people~~pro ~~with~~forma ~~diabetes~~net ~~(T1D~~tangible ~~and~~book ~~T2D)~~value ~~who~~per ~~feel~~share after ~~that~~this ~~they~~offering by $0.02 per share. Each $0.10 increase or decrease in the assumed public offering price would ~~adopt~~have no impact on the dilution ~~pump~~per ifshare itto ~~were~~new ~~less~~investors, ~~expensive~~assuming that the number of shares of common stock offered by us, ~~less~~as ~~time~~set ~~consuming~~forth on the cover page of this prospectus, ~~less~~remains ~~technically~~the ~~intimidating~~same, and ifafter ~~there~~deducting ~~was~~estimated noplacement ~~separate~~agent fees and estimated offering expenses payable by us. ~~controller~~An increase of four million shares of common stock offered by us would decrease the pro forma net tangible book value after this offering by $0.01 Weper ~~believe~~share ~~that~~and ~~they~~decrease ~~represent~~the ~~approximately~~dilution ~~32%~~per share to new investors by $0.01, and a decrease of shares of common stock offered by us would decrease the ~~T1D~~pro ~~market~~forma ~~correlating~~net tangible book value by $0.01 per share and decrease the dilution per share to anew investors by $10.901, ~~billion~~assuming ~~growth~~that ~~opportunity~~the assumed public offering price remains the same, and after deducting estimated placement agent fees.

Insulin pumps on the market today require a substantial amount of time to manage the therapy, have high out-of-pocket costs that place these technologies out of reach for a large part of the population, and are feature-heavy with complex systems that we believe have hampered adoption and intimidated many users. The most commonly used insulin pumps today require extensive training and hours of daily management. The average pump user must go through 42 steps of setup and refill process every 72 hours to “stay on track.” Our product only requires nine steps for setup and refill every 72 hours.

The current reluctance to adopt the insulin pump has had serious consequences on the healthcare system. In the United States, people living with T1D have struggled to attain glycemic targets. A 2019 analysis of the large T1D Exchange clinical registry found that only 21% of U.S. adults with T1D achieved the ADA A1c goal (<7.0%). Further, according to a study published in JAMA Internal Medicine, researchers found no significant improvements in diabetes care between 2005 and 2016, with persistent gaps in care related to socioeconomic status.

~~Another~~The ~~transition~~foregoing indiscussion ~~the~~and ~~care~~tables ofabove ~~diabetes is~~are ~~the~~based ~~measuring~~on ~~of glucose from finger-stick tests to continuous glucose monitoring~~77, ~~or “CGM”~~703,547 ~~sensors,~~shares ~~which are wearable devices. These sensors are placed under the skin and give a reading every five minutes~~ of ~~the~~common ~~user’s~~stock ~~glucose~~outstanding ~~level.~~as ~~While Dexcom has been a market leader in this field, the introduction and rapid adoption~~ of ~~the~~December ~~Freestyle Libre by Abbott Labs has made CGM easier and more affordable~~31, ~~expanded the product category~~2025, and ~~doubled the market size. The Freestyle Libre product is a more affordable~~excludes, ~~easier~~as ~~to use and smaller version~~ of the popular Dexcom, Inc. (Dexcom) CGM product. Now for the first time, there is an easy, less painful, i.e., no more finger sticks, way for patients to have the data they need to understand more about their glucose levels and their insulin requirements. Access to such data has motivated patients to ask their diabetes clinician how they can achieve better glycemic control and made them more comfortable with using technology and wearables to treat their diabetes. Pumps offer a clear pathway to better control and better overall care. We believe that the insulin pump market is ready for a similar transition as that experienced in the CGM space. MODD1 pump represents a new and better offering to assist and induce a wide variety of patients to make the transition and bridge the void to superior control by becoming a “pumper.”date:

We● ~~believe the present pump marketplace is approximately a $1.~~9 ~~billion market~~,250 ~~comprising~~shares ~~33%~~ of ~~T1D~~common ~~pumpers~~stock ~~and~~issuable aattributable ~~small~~to ~~group~~a ofwarrant ~~T2D~~inducement ~~pumpers.~~offering ~~Seagrove~~effected ~~Partners estimates~~ in ~~its~~September 2021 report that 28% of T1D patients and 25% of T2D patients would adopt technology that was easier to use, access and pay for. We believe the total addressable market approximates $3 billion, assuming revenue of $4,128 per patient, per year. We expect to spend approximately 15% of our total revenue on discounts and free samples to encourage adoption of our pump product.2025;

~~We are~~● ~~dedicated~~7,340,122 toshares ~~helping~~of ~~all~~common ~~people~~stock ~~with~~issuable ~~diabetes~~upon ~~gain access to high quality care. We aim to help people with diabetes - especially Almost Pumpers and~~ the ~~historically~~exercise ~~underserved~~of ~~communities~~outstanding -stock ~~gain~~options, ~~access~~which tooptions ~~insulin~~have ~~pump~~a ~~technology~~weighted byaverage ~~making~~exercise itprice ~~affordable~~of ~~and~~$2.38 ~~easy to~~per ~~use.~~share;

~~Diabetes Care~~● is41,668 atshares anof ~~Inflection~~common ~~Point~~stock issuable upon the vesting of restricted stock units;

~~We believe~~● ~~that~~2,955,714, shares of common stock available for future issuance under the ~~insulin~~Company’s ~~pump~~Amended ~~market~~and ~~stands~~Restated at2017 aEquity ~~crossroads~~Incentive Plan, as aamended ~~confluence~~(the “2017 Equity Incentive Plan”); ● 6,086,500 shares of ~~events~~common ~~makes~~stock issuable upon the ~~timing~~exercise ~~for~~of awarrants ~~new~~dated ~~product~~December ~~introduction ideal~~11, 2025 at $0.45 per share; ● 912,975 shares of common stock issuable upon the exercise of warrants dated December 22, 2025 at $0.45 per share; ● 852,110 shares of common stock issuable upon the exercise of warrants dated December 11, 2025 at $0.462 per share; ● 127,816 shares of common stock issuable upon the exercise of warrants dated December 22, 2025 at $0.462 per share; ● 3,247,741 shares of common stock issuable upon the exercise of warrants dated September 25, 2025 at $0.84 per share; ● 874,672 shares of common stock issuable upon the exercise of warrants dated March 25, 2025 at $1.40 per share;

~~2020 was~~● a1,905,042 ~~very~~shares ~~difficult year in diabetes. Between COVID-19 and a loss~~ of ~~glycemic~~common ~~control~~stock ~~during~~issuable ~~quarantines~~upon ~~and isolation, deaths from diabetes rose by 17% in 2020 versus~~ the ~~prior~~exercise ~~year.~~of ~~This~~warrants ~~was~~dated ~~sharpest~~March ~~among the young who saw deaths rise 29% in the~~ 25~~-44~~, ~~year~~2025 ~~old~~at ~~demographic~~$1. ~~This~~12 ~~has~~per ~~created a pain point and a desire to find new and better solutions and has raised awareness among patients, caregivers, payors, and policy makers.~~share;

~~COVID-19 also~~● ~~encouraged~~381,540 ~~(and~~shares ~~required) trial and adoption~~ of ~~telehealth~~common ~~models~~stock ~~and~~issuable aupon ~~great~~the ~~many~~exercise ~~people have found them to their liking with a high proportion~~ of ~~patients~~warrants ~~and~~dated ofNovember ~~health~~21, ~~care~~2024 ~~providers~~at ~~(HCPs) that want to continue to use these technologies~~$1.875 Weper expect much of this shift and newfound comfort with distance care models to persist and believes that this can provide a patient acquisition and engagement model for insulin pumps and diabetes care, especially for pumps optimized for free trial and easy learning.share;

~~At the~~● ~~same time~~484,006 ~~reimbursement~~shares ~~for~~of ~~patch~~common ~~pumps~~stock ~~has~~issuable ~~been~~upon ~~increasingly~~the ~~moving~~exercise toof awarrants ~~pharmacy~~dated ~~benefits~~May ~~manager (PBM) model~~15, ~~which~~2023 ~~simplifies reimbursement~~at ~~which will further aid in a “frictionless launch~~$1.”32 ~~This~~per ~~represents a fundamental shift in the insulin pump market, making onboarding rapid and simplifying a previously complex and time-consuming “insurance journey.”~~share;

We● ~~believe~~1,671,733 ~~these~~shares ~~CGM users are increasingly interested in adopting technology and wearables to manage their diabetes. We believe they are a natural market for a new type~~ of ~~pump~~common ifstock itissuable ~~can~~upon ~~meet their needs and address their objections and that~~ the ~~conjunction~~exercise of ~~the~~warrants ~~above~~dated ~~trends~~May ~~represents~~15, a2023 ~~unique~~at ~~opportunity~~$1.22 inper ~~the insulin pump market’s history.~~share;

~~Diabetes technology~~● ~~companies understand that we are at a turning point with new markets (T2D~~1,438,202 ~~T1D~~shares ~~that~~of ~~are~~common ~~currently~~stock ~~not~~issuable ~~using~~upon ~~technologies). This~~the ~~can~~exercise beof ~~seen~~warrants ~~with~~dated ~~increased~~May ~~discussion around this topic during recent national diabetes conferences~~5, as2022 ~~well~~at ~~as but also an increase in marketing promotion. For example, Dexcom purchased a~~ $56.560 ~~million~~per ~~30-second spot during the 2021 Super Bowl.~~share;

~~All~~● ~~these~~4,011,276 ~~recent~~shares ~~changes support the high proportion~~ of ~~T1D~~common ~~and~~stock ~~T2D~~issuable ~~intensively~~upon ~~treated~~the ~~with~~exercise ~~insulin~~of ~~that~~warrants ~~are~~dated ~~considered~~February ~~as Almost Pumpers~~9, a2022 ~~number~~at ~~that~~$6.60 ~~may~~per ~~grow~~share; ~~in the next years~~ and ~~that may be more reachable with adequate marketing strategies.~~

●

767,796 shares of common stock issuable upon the exercise of warrants dated May 11, 2021 at $6.00 per share.

To the extent that any outstanding warrants or options are exercised, new options or other equity awards are issued under our equity incentive plans, or we issue additional shares in the future, there will be further dilution to new investors participating in this offering. In addition, we may choose to raise additional capital due to market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or equity-based securities, the issuance of these securities could result in further dilution to our stockholders.

~~Our Insulin~~SECURITY ~~Pump~~OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

~~Instead of~~The ~~building~~following ~~complex,~~table ~~bespoke,~~sets ~~and~~forth ~~difficult~~certain ~~to manufacture and maintain pumping and control systems, we began with the technology and~~information ~~the~~as ~~user in mind. Using proprietary and patented methods~~ of ~~insulin measurement~~ February 19, we2026 ~~were~~concerning ~~able to eschew complex mechanisms and instead built a product candidate using only parts from high volume consumer electronics manufacturing lines, breaking~~ the ~~cost~~ownership ~~vs functionality curve that has existed in the insulin pump space and representing the first truly modern insulin pump design. This is a new kind~~ of ~~product for~~our acommon ~~new~~stock ~~kind of patient.~~by:

~~The~~● ~~production~~each ~~models~~stockholder ofknown ~~our~~by ~~low-cost~~us ~~insulin pump are now undergoing the testing required~~ to ~~submit~~be to the ~~FDA~~beneficial ~~for~~owner ~~510k~~of ~~clearance~~more tothan ~~market~~5% ~~them~~of in the ~~United~~outstanding ~~States.~~shares Weof ~~continue to~~our ~~devote,~~common ~~substantial~~stock ~~time~~(currently ~~and~~our ~~resources~~only toclass ~~better understand the needs and preferences~~ of ~~Almost~~voting ~~Pumpers and the specific patent/provider/payor requirements to motivate change from MDI.~~securities);

~~MODD1 has~~● ~~several~~each ~~distinguishing~~of ~~features:~~our directors;

1● -each ~~The~~of ~~pump has a simple button to press to deliver insulin as~~ the ~~patient~~named ~~requires~~executive ~~it.~~officers; ~~The electronic pump uses a simple motor~~ and rotating cam to motivate the insulin into the patient along with a low power Bluetooth and near-field communication (NFC) chips to optionally allow the patient to communicate with their smart phone, tablet, or other mobile computing platform. Our mobile device application will be included in our 510k submission and will be a part of our introductory product.

~~2 -~~● ~~The~~all ~~pump~~directors ~~snaps~~and ~~together~~executive ~~with~~officers aas ~~three-day disposable cartridge that is patient filled with insulin for delivery. It includes the power source and~~ a ~~simple coin cell that allows it to run through the 80-hour life of the cartridge~~group.

3Beneficial ownership is determined in accordance with Rule 13d-3 ~~There~~of isthe anExchange ~~infusion~~Act ~~set~~and ~~(not~~includes ~~shown)~~all shares over which the beneficial owner exercises voting or investment power. Shares that are issuable upon the exercise of options, warrants and other rights to acquire common stock that are presently exercisable or exercisable ~~contains~~within 60 days of February 19, 2026, are reflected in a ~~soft~~separate 6column mmin ~~cannula~~the ~~and~~table anbelow. ~~introducer~~These ~~for~~shares ~~insertion~~are taken into account in the ~~skin~~calculation of the total number of shares beneficially owned by a particular holder and ~~removal~~the total number of shares outstanding for the ~~needle~~purpose ~~used~~of tocalculating ~~transfer~~percentage ~~insulin~~ownership of the particular holder. We have relied on information supplied by our officers, directors and certain stockholders and on information contained in filings with the SEC. Except as otherwise indicated, and subject to community property laws where applicable, we believe, based on information provided by these persons, that the ~~body~~persons named in the table have sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them. The percentage of beneficial ownership is based on 77,703,547 shares of common stock outstanding as of February 19, 2026.

~~4 -~~Unless ~~MODD1~~otherwise ~~comes~~stated, ~~with a variety of methods for~~ the ~~patient~~business ~~to wear the pump. Options include: a base plate with adhesive (shown) for attaching~~address toof ~~the~~each ~~body~~of ~~that~~our ~~has~~directors ~~features~~and ~~for~~named ~~holding~~executive ~~the~~officers ~~pump~~listed toin the ~~patient;~~table ~~overwraps~~is to10740 ~~hold~~Thornmint ~~the~~Road, ~~product~~San ~~candidate~~Diego, toCalifornia ~~the patient; and a velcro strap with a base plate suitable for wrapping around the arm or leg of the patient~~92127.

The system will deliver a small continuous rate called a basal that will provide approximately 50% of the total daily dose required and the user will use the on-pump button to administer boluses, typically before and after meals.

Name and Principal Position	Number of Shares Beneficially Owned (Excluding Outstanding Equity Awards and Warrants)			Number of Shares Issuable on Exercise of Outstanding Equity Awards and Warrants⁽¹⁾		Percent of Class
JEB Partners, L.P.		330,473	(2)		-		*
Manchester Explorer, LP		3,805,575	(3)		913,927		6.00
Manchester Management Company, LLC		4,136,048	(4)		913,927		6.42
Solas Capital Management, LLC		4,291,327	(5)		512,837		6.14

Directors and Officers:
James Besser		422,000	(6)		275,761		*
Paul DiPerna		2,553,586	(7)		946,864		4.45
Kevin Schmid		-			420,271		*
Duane DeSisto		233,222			20,833		*
Steven Felsher		253,927			150,584		*
Morgan C. Frank		206,226	(8)		243,083		*
Jeffrey Goldberg		-			22,500		*
Philip Sheibley		97,513			69,167		*
Carmen Volkart		21,460			188,058		*
Ellen O’Connor Vos		18,519			235,188		*
All current directors and executive officers as a group (10 persons)		3,806,453			2,572,310		7.61

~~The objective~~* isRepresents toholdings ~~make~~of ~~the~~less ~~product~~than ~~candidate~~one ~~simple to acquire and take home, simple to learn and most importantly, simple to use to expand the pump market, drive adoption and ultimately better clinical outcomes~~percent.

Technological Advantages

The adoption of new ultra-high volume technologies will result in far easier manufacturing scale up as parts sourcing and assembly processes are far easier. The MODD1 was designed from the beginning for mass manufacturing processes and “lights out” or near lights out production assembly lines whereby a minimal number of workers will be required in our production facility. This advantage is compounded by the high availability and already optimized cost reduction in its components. This has resulted in a cost of goods, estimated on the competitors’ announced margins and sales, 50% lower than our closest patch pump competitor.

The adoption of modern, miniaturized technologies has led to numerous other advantages as well. Our MODD1 pump is smaller in overall volume than Insulet’s popular Omnipod product and has a lower profile to the skin. Despite this, it holds a full 3mL (300 units) of insulin in line with full sized pumps such as Tandem and Medtronic, 50% more than the 2mL reservoir in the Omnipod. We believe that this volume advantage over other patch pumps will be significant as 24% of type 1 and over 50% of the rapidly growing type 2 market require more than 2mL of insulin every three days (the expected wear time of patch pumps).

~~In addition,~~(1) ~~our~~Represents ~~new~~the ~~and~~number ~~patented~~of ~~pumping~~shares ~~modality~~subject ~~will~~to ~~provide~~outstanding ~~what~~options, werestricted ~~believe~~stock isunits ~~the most even (~~and ~~thus~~warrants ~~closest~~ to ~~the~~acquire ~~function~~shares of ~~a healthy~~our ~~pancreas)~~common ~~delivery~~stock ofthat ~~basal insulin in the industry. Basal rate can be delivered almost continuously while other pumps~~ are ~~delivering micro-boluses~~exercisable ~~every~~within 560 ~~minutes~~days ~~for~~of ~~the~~February ~~Omnipod~~19, ~~Tandem and Medtronic pumps~~2026. ~~We plan to demonstrate the impact of our system on glycemic control in a future clinical study.~~

~~The~~(2) ~~technology~~Consists ~~allows~~of ~~the~~330,473 ~~patient~~shares todirectly ~~simply add~~held ~~insulin~~by ~~and~~JEB ~~operate~~Partners, L.P., ~~The~~of ~~battery~~which: is(a) ~~included~~252,525 shares were purchased in ~~each~~a ~~cartridge~~private ~~and~~placement in 2017 (the ~~device~~“2017 isPlacement”); ~~operated~~(b) ~~without~~53,333 shares were purchased in a ~~controller.~~private ~~Nothing~~placement ~~needs charging.~~in ~~MODD1~~2018 ~~has~~(the ~~been~~“2018 ~~made~~Placement”) ~~push~~and ~~button~~(c) ~~simple~~11,614 toshares ~~appeal~~were topurchased in a ~~wider~~private ~~audience~~placement ofin ~~users~~2020 (the “2020 Placement”) and (d) 13,000 shares were purchased in the open market.

~~This new~~(3) ~~technology~~Consists ~~has~~of ~~also~~3,805,575 ~~made~~shares ~~the~~directly ~~MODD1~~held ~~lighter~~by ~~than~~Manchester ~~existing~~Explorer, ~~offerings~~L.P. ~~Compared~~of towhich (a) 1,515,152 shares were purchased in the ~~Insulet~~2017 ~~Omnipod~~Placement, ~~MODD1~~(b) ~~weighs~~157,037 20shares ~~grams~~were ~~(vs.~~purchased ~~26 grams~~in the 2018 Placement, (c) ~~empty~~11,614 ~~and~~were 23purchased ~~grams~~in the 2020 Placement, (~~vs.~~d) 28300,000 ~~grams~~shares were purchased in a public offering in February 2022, (e) ~~fully~~234,274 ~~filled~~shares were acquired upon the conversion of a convertible note in February 2022, (~~despite~~f) ~~carrying~~900,000 ~~50%~~shares ~~more~~were ~~insulin~~purchased in our February 2024 public offering, (g) 166,666 shares purchased in a ~~reduction~~public ofoffering ~~23%~~in November 2024 and ~~18%~~(h) 520,832 ~~respectively. Also~~shares purchased in a private placement in March 2025 (the “2025 Placement”); (iii) 330,473 ~~unlike~~shares ~~existing~~held ~~patch~~by ~~pumps~~JEB Partners, L.P. of which (a) 252,526 shares were purchased in the ~~MODD1~~2017 ~~can~~Placement, be(b) ~~removed~~53,333 ~~from~~shares were purchased in the ~~needle~~2018 Placement and ~~taken~~(c) ~~off~~11,614 ~~and~~shares ~~replaced~~were ~~later~~purchased ifin the ~~user~~2020 ~~desires~~Placement; and (iv) 206,226 shares held by Mr. ~~This avoids~~Frank, ~~loss~~which shares were received upon our acquisition of ~~insulin~~Quasuras in aexchange ~~pump~~for ~~due~~Mr. toFrank’s ~~accidental~~shares ~~dislodging~~of Quasuras. Mr. Besser, as the managing member, and Mr. Frank, as the portfolio manager and consultant of Manchester Management Company, LLC, (“MMC”) the ~~soft~~general ~~canula~~partner of Manchester Explorer, anL.P. ~~issue~~and ~~that~~JEB ~~users~~Partners, L. P., have ~~expressed~~shared ~~considerable~~voting ~~dissatisfaction with~~and ondispositive ~~other~~power ~~patch~~over ~~pumps~~shares held by Manchester Explorer, L.P. and JEB Partners, L.P. The address for Manchester Explorer, L.P is 2 Calle Candina, No. 1701, San Juan, Puerto Rico 00907.

~~Our~~(4) ~~approach~~Consists ~~to the care~~ of ~~diabetes~~3,805,575 ~~can~~shares bedirectly ~~further enhanced~~held by ~~leveraging~~Manchester ~~the~~Explorer, ~~MODD1~~L.P. ~~single-pumping chamber technology~~ and ~~reusable~~330,473 ~~pump~~shares ~~approach~~held toby ~~apply~~JEB toPartners, ~~dual~~L.P. ~~(or more) chamber pumping solutions~~Mr. WeBesser, ~~believe~~as ~~that~~the ~~such~~managing ~~multi-chamber~~member, ~~pumps~~and ~~will~~Mr. beFrank, ~~integral~~as to the ~~realization~~portfolio ofmanager ~~high~~and ~~time-in-range~~consultant ~~artificial pancreas solutions that require no human intervention because~~ of ~~the~~MMC ~~application~~and ~~of,~~JEB ~~for instance~~Partners, ~~drugs~~L. ~~to raise glucose levels coupled with drugs to lower glucose~~P., ~~They~~have ~~will~~shared bevoting ~~the next step forward from the cumbersome~~ and ~~awkward~~dispositive ~~solutions~~power ~~today~~over ~~that~~shares ~~require~~held ~~the~~by ~~user~~Manchester ~~to announce meals~~Explorer, ~~count~~ L.P. and ~~input~~JEB ~~carbohydrates~~Partners, ~~and~~L.P. ~~adjust~~The ~~delivery~~address for ~~exercise and sleep to prevent overdosing of insulin. Instead~~MMC, ifJEB ~~a user overdosed insulin~~Partners, ~~the~~ ~~user would simply pump in a drug to release sugar stores to raise it up~~L.P., ~~We believe that a pre-filled peel~~ and ~~stick~~Manchester ~~patch pump with the ability to function in a fully autonomous closed loop system with a CGM device~~Explorer, ~~which~~L.P is ~~measuring~~2 ~~and~~Calle ~~transmitting glucose-level information~~Candina, ~~represents the next generation of diabetes care~~No. We1701, ~~believe~~San ~~that~~Juan, wePuerto ~~have~~Rico ~~demonstrated our technology and are securing intellectual property protection on our approach~~00907.

We(5) ~~believe~~Based ~~this~~on ~~technology,~~information ~~especially~~reported inby ~~dual chamber~~Solas Capital Management, ~~will~~LLC ~~open~~(“Solas”) upon ~~numerous~~a ~~applications~~Schedule ~~outside~~13G offiled ~~diabetes~~with ~~where~~the ~~medication~~SEC ~~compliance~~on ofNovember ~~complex~~14, ~~therapy~~2025. ~~regimes~~Solas is ~~difficult~~a registered investment adviser and serves as the investment manager to two private funds (the “Funds”) and as sub-adviser to another private fund (the “Other Fund”), which hold securities for the benefit of their investors. ~~Example applications~~Solas ~~would~~and ~~include~~Mr. ~~weight~~Frederick ~~loss~~Tucker Golden, ~~fertility~~as portfolio manager of Solas, with the power to exercise investment and ~~simplifying~~voting discretion, may be deemed to be the ~~delivery~~beneficial owner of ~~complex~~all ~~multi~~shares of common stock held by the Funds and by the Other Fund. Pursuant to Rule 13d-~~drug~~4 ~~cocktails~~under the Exchange, ~~especially~~each ~~those~~of ~~with diverse~~the Funds expressly disclaims beneficial ownership over any of the securities reported as held by Solas. The address for Solas and ~~challenging~~Mr. ~~dosing~~Golden ~~schedules~~is 1063 Post Road, Darien, CT 06820.

~~Our Solution~~(6) Consists of 422,000 shares directly held by Mr. Besser, of which: (a) 60,277 shares were received in exchange for Mr. Besser’s shares as a result of our acquisition of Quasuras; (b) 29,630 shares were purchased in a private placement in 2018 (the “2018 Placement”) and (c) 34,843 shares were purchased in a private placement in 2020 (the “2020 Placement”), (d) 141,000 shares were purchased in the open market and (e) 156,250 shares were purchased in the 2025 Placement. The address for Mr. Besser is c/o MMC, 2 Calle Candina, No. 1701, San Juan, Puerto Rico 00907.

~~Our~~(7) ~~proposed~~Consists ~~pump~~of is(i) ~~being~~2,000,000 ~~designed~~shares ~~and~~owned ~~developed to~~by ~~address~~ the ~~aforementioned~~Paul ~~shortcomings~~DiPerna ofIrrevocable ~~the~~Trust, ~~existing pump market and to appeal to:~~ (iii) ~~the~~333,334 ~~substantial~~shares ~~group~~owned ofby ~~“Almost-Pumpers” who~~Mr. ~~may~~DiPerna’s beadult ~~interested~~daughters, inKelsie ~~using~~DiPerna anand ~~insulin~~Alaria ~~pump~~DiPerna, ~~but~~over ~~have~~which ~~not~~Mr. ~~done~~DiPerna sohas ~~because~~sole ofvoting ~~the complexity~~power, ~~cost or cumbersome nature of existing products, and~~ (iiiii) ~~people~~207,906 ~~who~~shares ~~are~~owned ~~using~~by ~~one of~~ the ~~currently~~Paul ~~available~~DiPerna ~~insulin~~Trust, ~~pumps~~and ~~but~~(iv) ~~are~~12,346 ~~dissatisfied~~shares ~~with~~owned ~~such~~by ~~products~~Mr. WeDiPerna. ~~believe that,~~Mr. ~~owing~~DiPerna tois ~~our~~the ~~new~~trustee ~~proprietary~~of ~~technology,~~both ~~our proposed insulin pump will be~~ the ~~simplest~~Paul ~~and~~DiPerna ~~least~~Irrevocable ~~expensive~~Trust ~~product on the market~~ and the ~~easiest~~Paul ~~for~~DiPerna ~~providers to prescribe~~Trust.

~~Our~~(8) ~~current~~Includes ~~pump~~206,226 ~~has~~shares ~~been~~directly ~~built~~held toby ~~test~~Mr. ~~what we~~Frank, ~~believe~~of towhich: be(a) ~~our~~60,277 ~~novel~~shares ~~approach~~were toreceived ~~insulin~~in ~~pumps.~~exchange Byfor ~~providing~~Mr. aFrank’s ~~pump~~shares ~~that~~as wea ~~believe~~result ~~will establish industry standards in terms~~ of ~~technology,~~our ~~simplicity~~acquisition ~~to understand, ease~~ of ~~use~~Quasuras and ~~price~~(b) 145,949 weshares ~~believe~~were ~~our~~purchased ~~proposed~~in ~~pump will offer~~ the ~~vast~~open ~~majority~~market. ofThe ~~benefits afforded~~address byfor ~~more~~Mr. ~~expensive~~Frank ~~and~~is ~~complex~~c/o ~~pumps~~MMC, ~~but~~2 ~~remain~~Calle ~~accessible~~Candina, toNo. a1701, ~~substantially~~San ~~greater~~Juan, ~~percentage~~Puerto ofRico ~~diabetes sufferers requiring daily insulin therapy~~00907.

WeDESCRIPTION ~~believe~~OF ~~people~~CAPITAL generally will not use technology that intimidates them. In addition, we believe that physicians are hesitant to prescribe such technology due to the level of training and support required with the present pump product offerings. We believe mass-market products, such as is intended for our proposed pump, must be “user friendly” and affordable. We believe this approach is fundamentally different from that applied to the existing pump market today, where most pumps are continuously adding complex features appealing to super users and leaving the other people with diabetes further behind.STOCK

~~Our current~~Capital goal is to successfully design, develop and obtain all required regulatory approvals for our proposed insulin pump, and, thereafter, commercialize the finished product. Our long-term goal is to become a leading provider of insulin pump therapy by focusing on both consumer and clinical needs.Stock

The following description of our capital stock is summarized from, and qualified in its entirety by reference to, our certificate of incorporation, as amended, including the certificates of designation, as amended, setting forth the terms of our preferred stock. This summary is not intended to give full effect to provisions of statutory or common law. We urge you to review the following documents because they, and not this summary, define the rights of a holder of shares of common stock and preferred stock:

●

the Nevada Revised Statutes, or the “NRS,” as it may be amended from time to time;

●

our articles of incorporation, as it may be amended or restated from time to time; and

●

our bylaws, as they may be amended or restated from time to time.

~~To achieve our above stated immediate and current goals, we intend to pursue the following business strategies:~~General

●As ~~Use~~of the date of ~~innovative~~this ~~proprietary~~prospectus, ~~technology~~our authorized capital stock currently consists of 255,000,000 shares, which are divided into two classes consisting of 250,000,000 shares of common stock, par value $0.001 per share, and 5,000,000 shares of preferred stock, par value $0.001 per share.

~~Based~~As ~~upon the substantial experience~~ of ~~Paul DiPerna~~February 19, ~~our President~~2026, ~~Chief~~there ~~Financial Officer~~were 77, ~~Treasurer and Chairman of our Board of Directors~~703, ~~in engineering design and innovative~~547 ~~technology~~shares ~~in the medical device industry and, in particular, with the invention, market vision and technical development~~ of ~~insulin~~common ~~pumps, we~~stock ~~have generated proprietary technology that has been incorporated into our proposed insulin pump~~outstanding. WeIn ~~believe this technology allowing for a two-part~~addition, ~~yet~~as ~~small~~of ~~enough to wear~~February 19, ~~pump product~~2026, ~~along~~there ~~with~~were simplified mechanics for pumping, will greatly assist us in creating a simpler, user-friendly pump. We believe the proposed design, engineering and technology being incorporated into our proposed pump will make it substantially simpler and more affordable than those currently available. These features, together with the safety and reliability of our proposed pump, are designed to create the next generation of insulin pumps that will feature important and well-differentiated attributes compared to those currently available and make it available to consumers across mostly all socioeconomic groups in the United States and around the world.outstanding:

● ~~Keep~~9,250 ~~costs~~shares ~~low~~of ~~during~~common ~~our~~stock ~~design and development process.~~issuable;

~~To attempt~~● ~~to ensure that we have sufficient funds to design~~7, ~~develop~~378,842 ~~and~~shares ~~obtain~~of ~~all~~common ~~required~~stock ~~regulatory~~issuable ~~approvals~~upon ~~for~~the ~~our~~exercise ~~proposed~~of ~~insulin pump~~outstanding ~~without~~stock ~~having to sacrifice quality and efficiency~~options, wewhich ~~intend~~options tohave ~~maintain~~ a ~~tight~~weighted ~~budget~~average ~~and~~exercise ~~limit~~price ~~expenditures where possible. We believe this will be possible because~~ of ~~the extensive knowledge and experience of Mr~~$2.34 ~~DiPerna,~~per not only in the diabetes industry and more specifically in the insulin pump device market, but also his experience in designing and developing insulin pumps and other medical devices and his ability to manage a small, focused development team. We currently expect that various other expenses, such as product scale up, and sales and marketing costs, will not be incurred until such time as development work is completed and regulatory approvals obtained.share;

● ~~Employ experienced engineers selected~~41,668 ~~supervised,~~shares ~~and~~of ~~led~~common bystock ~~Mr.~~issuable ~~DiPerna,~~upon athe ~~highly~~vesting ~~experienced~~of ~~and~~restricted ~~respected~~stock ~~engineer and executive in the insulin pump industry.~~units;

~~To attempt~~● to5,916,993 ~~ensure~~shares ~~our~~of ~~proposed~~common ~~insulin~~stock ~~pump~~available isfor ~~“state~~future ofissuance under the ~~art,”~~Company’s ~~functional,~~Amended and ~~efficient,~~Restated as2017 ~~well~~Equity Incentive Plan, as toamended ~~conserve~~(the ~~funds, substantially~~“2017 ~~all~~Equity ofIncentive ~~our~~Plan”); ~~employees~~● ~~will~~6,086,500 ~~initially~~shares beof ~~hand-picked~~common ~~engineers~~stock ~~under~~issuable upon the ~~leadership~~exercise of ~~Mr.~~warrants ~~DiPerna.~~dated WeDecember ~~believe~~11, ~~that~~2025 ~~there is~~at a$0.45 ~~strong~~per ~~pool~~share; of● ~~engineers~~912,975 ~~with~~shares ~~significant~~of ~~applicable~~common ~~experience~~stock ~~and~~issuable ~~knowledge~~upon ~~who~~the weexercise ~~will~~of bewarrants ~~able~~dated toDecember ~~initially~~22, ~~employ~~2025 onat a$0.45 ~~contract and/or~~per ~~outsource~~share; ~~basis~~● to852,110 ~~help~~shares usof ~~design~~common ~~and~~stock ~~develop~~issuable ~~our~~upon ~~proposed~~the ~~insulin~~exercise ~~pump.~~of Wewarrants ~~believe~~dated byDecember ~~hiring~~11, ~~such~~2025 ~~persons~~at on$0.462 anper ~~out-source~~share; ~~basis~~● 127, we816 ~~will~~shares ~~save~~of ~~substantial~~common ~~resources~~stock ~~and~~issuable byupon ~~having~~the ~~Mr.~~exercise ~~DiPerna~~of ~~lead~~warrants ~~and~~dated ~~focus~~December ~~the~~22, ~~team~~2025 onat ~~technological~~$0.462 ~~and~~per ~~mechanical~~share; ~~aspects~~● of3,247,741 ~~our~~shares ~~proposed insulin~~of ~~pump,~~common westock ~~believe~~issuable ~~our~~upon ~~team~~the ~~will~~exercise beof ~~well~~warrants ~~guided,~~dated ~~focused,~~September ~~cost efficient~~25, ~~and~~2025 ~~able~~at to$0.84 ~~efficiently~~per ~~design~~share; ~~and~~● ~~develop~~874,672 ~~our~~shares ~~product candidate~~of ~~that~~common westock ~~believe~~issuable ~~can~~upon ~~eventually~~the beexercise aof ~~competitive~~warrants ~~and~~dated ~~popular~~March ~~choice~~25, ~~for~~2025 ~~people~~at ~~with~~$1.40 ~~insulin~~per ~~requiring diabetes.~~share;

~~Commercialization Strategy:~~● ~~Overcoming~~1,905,042 shares of common stock issuable upon the ~~Insurance~~exercise ~~Hurdles~~of warrants dated March 25, 2025 at $1.12 per share;

~~Our goal~~● is381,540 toshares ~~establish~~of ~~MODD1~~common asstock ~~the~~issuable ~~best~~upon ~~option for new pump patients as we expand~~ the ~~market~~exercise ~~into~~of ~~the~~warrants ~~Almost~~dated ~~Pumpers~~November ~~(Type~~21, 12024 ~~and~~at ~~Type 2) and the newly motivated CGM users~~$1.875 Weper ~~seek to grow the market by providing first-line insulin pump therapy that is well suited to meet the needs of both diabetes patients requiring insulin and their clinicians.~~share;

● We484,006 ~~believe~~shares ~~that~~of ~~MODD1~~common isstock ~~approximately~~issuable ~~50%~~upon ~~less~~the ~~expensive~~exercise toof ~~manufacture~~warrants ~~than~~dated ~~Omnipod.~~May ~~This~~15, ~~low~~2023 ~~cost~~at ~~allows us to spend more on patients and sampling~~$1.32 Weper ~~believe that this will save money for payers because we expect to offer the pump with no upfront cost to patients. Expected benefits of MODD1 include:~~share;

o● ~~20%~~1,671,733 ~~discount~~shares vsof ~~Insulet~~common ~~(PODD)~~stock ~~will~~issuable ~~drive~~upon ~~preferred~~the ~~status~~exercise of warrants dated May 15, 2023 at $1.22 per share;

o● ~~Designed~~1,438,202 toshares ~~use~~of ~~Pharmacy~~common ~~Benefit~~stock ~~Manager~~issuable ~~(PBM)~~upon ~~codes~~the asexercise aof ~~disposable~~warrants dated May 5, 2022 at $6.60 per share;

o● No4,011,276 ~~new~~shares ~~code~~of ~~needed~~common tostock beissuable ~~reimbursed~~upon atthe ~~launch~~exercise ~~because~~of ~~MODD1~~warrants ~~will~~dated beFebruary ~~able~~9, to2022 ~~use~~at ~~existing~~$6.60 ~~CMS~~per ~~codes~~share; and

o● ~~Saves~~767,796 ~~provider~~shares anof ~~estimated~~common ~~$1,062/patient/year~~stock vsissuable ~~Omnipod,~~upon asthe weexercise ~~will~~of ~~offer~~warrants ~~providers~~dated ~~discounts~~May ~~from~~11, ~~the~~2021 ~~existing~~at ~~reimbursement~~$6.00 ~~code~~per share.

● The MODD1 will be sampled and given to patients by the doctor or diabetes nurse educator at the time of the patient visit. When a patient is motivated to make change, our starter kit will make it easy for the clinician to initiate the new therapy that same day. We seek to eliminate the currently challenging “insurance journey” and product acquisition timeline and significantly reduce training time for the busy clinician, which we believe are all major hurdles to pump adoption. We intend to add telehealth support to help the patient throughout adoption and use and to facilitate greater collaboration between patients and their physicians.

~~Europe~~Common represents another large potential market for MODD1, as approximately 60 million people in Europe live with diabetes. $161 billion is spent annually on diabetes healthcare costs in the Europe based on data from a Seagrove Partners 2023 study. At present, cost containment is restricting pump uptake across Europe. Current pump usage hovers between 10% and 20% in many markets. Single payor healthcare systems across the Europe traditionally attempt to contain costs in the short term and seek low price technologies with moderate medical benefits. We anticipate MODD1 will offer a rebalance of this risk/reward strategy in that payors will incur only minor incremental short-term costs with the benefit of longer -term cost savings associated with reliable pump use. We intend to employ a partnership strategy across Europe following in-house managed regulatory and pricing activities in the major markets (e.g., UK) and more cost receptive markets (e.g., Nordics). We are targeting European and United Kingdom approval towards mid 2024. Our initial target market for our insulin pump is the Almost Pumper population located in the United States followed quickly by an effort to obtain CE mark approval for distribution throughout Europe.Stock

~~Marketing~~At February 19, 2026, 77,703,547 shares of our common stock were outstanding and held of record by 76 stockholders. The actual number of stockholders is significantly greater than this number of stockholders of record and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees. This number of stockholders of record also does not include stockholders whose shares may be held in trust by other entities.

~~MODD1 tackles~~Each ~~the~~holder ~~most~~of ~~significant~~our ~~barriers~~common tostock ~~pump use-access and affordability-and makes it easier for clinicians, caregivers and individuals to manage diabetes care. Our commercialization plan will drive adoption and~~ is ~~designed~~entitled to ~~expand the market and is intended to do the following~~:

● ~~Maximize~~one ~~adoption~~vote ~~with~~per ashare ~~comprehensive~~on ~~frictionless~~all ~~launch~~matters ~~program.~~submitted ~~We will seek~~ to ~~decrease~~a ~~the~~vote ~~level~~ of ~~reimbursement effort and cost to encourage HCPs to offer our pumps and encourage patient trials. Our product candidate reduces~~ the technical hurdles to widen appeal, new starts and increase adherence. We will encourage MDI patients who want or need more control to make the switch to the pump earlier in their treatment-ideally right at diagnosis.stockholders;

● ~~Leverage~~dividends ~~technology~~as tomay ~~support~~be ~~sales~~declared ~~and~~by ~~new~~our ~~patient~~board ~~acquisition.~~of Wedirectors ~~intend~~out toof ~~set~~funds uplegally ~~tech-enabled~~available ~~sales~~for ~~teams~~that ~~backed~~purpose, ~~with~~subject ~~a full omnichannel program~~ to ~~drive~~the ~~awareness~~rights ~~and~~of ~~trial~~any ~~with~~preferred ~~HCPs~~stock ~~and patients. We will focus on educating providers~~ that ~~our~~may ~~product~~be ~~candidate~~outstanding; ~~is simple to teach~~ and ~~easy to support making it an ideal front line offering.~~

● ~~Facilitate~~his, ~~patient~~her ~~trials.~~or Toits ~~facilitate~~pro ~~patient~~rata ~~trials,~~share wein ~~intend~~any ~~to:~~distribution of our assets after payment or providing for the payment of liabilities and the liquidation preference of any outstanding preferred stock in the event of liquidation.

oHolders ~~Provide~~of acommon ~~free~~stock ~~sample~~have ~~pump,~~no ~~insurance~~cumulative ~~verification~~voting rights, ~~co-pay~~redemption ~~coupons~~rights or preemptive rights to purchase or subscribe for any shares of our common stock or other securities. All of the outstanding shares of common stock are fully paid and ~~telehealth~~nonassessable. ~~support~~The rights, aspreferences ~~may~~and beprivileges ~~allowed~~of ~~under~~holders ~~federal~~of our common stock are subject to, and ~~state~~may ~~law~~be adversely affected by, tothe ~~patients~~rights ~~thereby~~of ~~reducing~~the ~~outlay~~holders of ~~time~~shares of any series of preferred stock that we may designate and ~~money;~~issue in the future.

oPreferred ~~Partner with connected care companies to provide superb support of patients from trial through the first year; and~~Stock

WeOur board of directors has the authority, subject ~~believe~~to ~~that~~any ~~MODD1~~limitations ~~will~~prescribed beby Nevada law, to issue shares of preferred stock in one or more series and to fix and determine the ~~only~~relative rights ~~insulin~~and ~~pump~~preferences ~~that~~of ~~patients~~the ~~can~~shares ~~take~~constituting ~~home~~any ~~immediately~~series ~~from~~to be established, without any further vote or action by the ~~doctor’s~~stockholders. Any ~~office~~shares of our preferred stock so issued may have priority over our common stock with respect to dividend, liquidation and other rights.

●Our ~~Leverage~~board ~~MODD1~~of ~~300-unit~~directors ~~chamber~~may toauthorize ~~increase~~the ~~adoption~~issuance of ~~with~~our ~~Type~~preferred 2stock ~~patients.~~with Wevoting ~~believe~~or ~~MODD1~~conversion ~~has~~rights athat ~~major~~could ~~advantage~~adversely ~~over~~affect ~~existing~~the ~~patch~~voting ~~pumps~~power inor ~~that~~other ~~the~~rights ~~chamber~~of ~~carries~~the ~~enough~~holders ~~insulin~~of our tocommon ~~meet~~stock. Although the ~~high~~issuance ~~doses~~of ~~many~~our ~~Type~~preferred 2stock ~~patients~~could ~~need.~~provide Weus ~~intend~~with toflexibility ~~promote~~in ~~this~~connection ~~advantage~~with possible acquisitions and ~~capture~~other acorporate ~~significant~~purposes, ~~share~~under ofsome circumstances, it could have the ~~existing~~effect ~~Type~~of 2delaying, ~~pump~~deferring ~~users~~or aspreventing ~~well~~a aschange ~~new~~of ~~starts~~control.

● Work with key organizations and policy makers to pave the way for greater access to pumps. We will promote MODD1 technology among the underserved, who are typically low users of health technology. We will identify individuals, patient organizations, professional societies, and policy and DEI organizations that are critically important to the adoption of new technologies in the diabetes space and build relationships with these influential stakeholders.

● Initiate a clinical study program (with key diabetes centers) to provide additional clinical support for MODD1 in special patient types and clinical setting. After obtaining 510(k) clearance, we intend to conduct a soft launch and clinical research program in major markets to pave the way for the full launch in late 2024. We will work with our advisors and key diabetes associations to educate the community about the MODD1. In addition, we will conduct clinical studies to develop competitive claims and market expansion.

● Work with major health plans to establish MODD1 as the first line pump for Type 2 patients. We believe MODD1 will be payor preferred for both Type 1 and Type 2 patients. It was designed to attain preferential reimbursement and avoid the coverage pitfalls many other pumps have experienced.

o Payors want an effective product whereby the users realize the clinical benefit. We intend to launch with a discount program for payors of 20% to drive uptake.

o Designed to use existing PBM codes as a disposable

o No new reimbursement code: Reimbursed at launch

~~Tie-in with the massive movement to telehealth.~~ Indemnification

~~2020 saw~~The ~~personal~~following ~~telehealth~~summary gois ~~from~~qualified ~~beta~~in ~~test~~its ~~to mainstream. Customers and providers have become comfortable with it. There are only 4,000~~entirety ~~patient-facing~~by ~~endocrinologists~~reference into the ~~United~~complete ~~States.~~text ~~The treatment~~ of ~~diabetes~~any ~~will~~statutes bereferred ~~significantly enhanced with telehealth~~ to ~~drive more~~below ~~volume~~ and ~~clinical~~to ~~enhancements~~our ~~through~~certificate ~~their practices. Telemedicine is a force multiplier for a small group~~ of ~~doctors to better serve a large market. MODD1 was designed to be affordable enough for free sampling and trial~~incorporation, ~~and~~as ~~simple enough for self-guided user training. We believe that by combining telehealth support with MODD1~~amended, ~~we will decrease the burden of diabetes care~~ and ~~improve~~our ~~the lives of people with diabetes~~bylaws.

Our Amended and Restated Articles of Incorporation and our Amended and Restated Bylaws provide that each person who was or is made a party or is threatened to be made a party to or is otherwise involved (including, without limitation, as a witness) in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or she is or was one of our directors or officers or is or was serving at our request as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, whether the basis of such action, suit or proceeding is alleged action in an official capacity as a director, officer or trustee or in any other capacity while serving as a director, officer or trustee, shall be indemnified and held harmless by us to the fullest extent authorized by the Nevada Revised Statutes, or NRS, against all expense, liability and loss (including attorneys’ fees and amounts paid in settlement) reasonably incurred or suffered by such. NRS 78.7502 permits a corporation to indemnify any director or officer of the corporation against expenses (including attorneys’ fees) and amounts paid in settlement actually and reasonably incurred in connection with any action, suit or proceeding brought by reason of the fact that such person is or was a director or officer of the corporation, if such person (i) is not liable pursuant to NRS78.138 and (ii) acted in good faith and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe the conduct was unlawful. In a derivative action (i.e., one brought by or on behalf of the corporation), indemnification may be provided only for expenses actually and reasonably incurred by any director or officer in connection with the defense or settlement of such an action or the suit if such person (i) is not liable pursuant to NRS 78.138 and (ii) acted in good faith and in a manner which he or she reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification shall be provided if such person shall have been adjudged to be liable to the corporation, unless and only to the extent that the court in which the action or suit was brought or some other court of competent jurisdiction determines that such person is fairly and reasonably entitled to indemnity for such expenses as the court deems proper.

We have entered into agreements with each of our directors that, among other things, indemnify them for certain expenses (including attorneys’ fees), judgments, fines and settlement amounts incurred by them in any action or proceeding, including any action by us or in our right, arising out of the person’s services as a director or officer of ours or any other company or enterprise to which the person provides services at our request.

In the ordinary course of business, we enter into contractual arrangements under which we may agree to indemnify the counter-party from losses relating to a breach of representations and warranties, a failure to perform certain covenants, or claims and losses arising from certain external events as outlined within the contract, which may include, for example, losses arising from litigation or claims relating to past performance. Such indemnification clauses may not be subject to maximum loss clauses. We have also entered into indemnification agreements with our officers and directors. No material amounts related to these indemnifications were reflected in our consolidated financial statements for the fiscal year ended March 31, 2025 or our condensed consolidated financial statements for the nine months ended December 31, 2025.

We have not estimated the maximum potential amount of indemnification liability under these agreements due to the limited history of prior claims and the unique facts and circumstances applicable to each particular agreement. To date, we have not made any payments related to these indemnification agreements.

~~Pre-Launch/Trial~~DESCRIPTION OF OUTSTANDING WARRANTS

~~We intend~~December to2025 initiate a “soft launch” following FDA clearance of the MODD1 device. Our plan is to select a group of clinicians who are well trained, experienced and have the support infrastructure to take on initial patients and monitor them carefully to provide clinical feedback on our performance to further refine our product candidate and support infrastructure prior to full commercial launch. Many of these clinicians will have been those who assisted in the development of the MODD1 offering.Warrants

WeOn December 10, 2025, we entered into an underwriting ~~intend~~agreement towith ~~continue~~Newbridge Securities Corporation (“Newbridge”), relating to ~~modify~~a firm commitment underwritten offering (the “December 2025 Offering”) of (i) 12,173,000 ~~refine~~shares of our common stock and ~~finalize~~(ii) ~~our~~accompanying ~~system~~warrants exercisable to ~~best~~purchase ~~meet:~~up to 6,086,500 shares of common stock (the “December 2025 Warrants”).

oEach ~~The~~two ~~general~~shares ~~needs~~of common stock were sold together with one accompanying December 2025 Warrant at a combined price of $0.77, yielding an effective price of $0.38 per share and ~~preferences~~$0.01 per warrant. The December 2025 Warrants have an exercise price of ~~our~~$0.45 ~~Almost~~per ~~Pumper~~share, ~~target~~were ~~market~~exercisable ~~based~~immediately upon ~~our~~issuance, ~~knowledge~~and ofwill expire five years following the ~~diabetes~~date ~~industry~~of ~~and~~issuance. ~~information~~The ~~available~~December ~~and/or~~2025 ~~obtained~~Warrants bywere usissued ~~from~~pursuant ~~Almost~~to ~~Pumpers~~a warrant agency agreement to be entered into by and ~~their~~between ~~caregivers;~~us and Colonial Stock Transfer Company, Inc., as warrant agent.

oThe December 2025 Offering closed on December 11, 2025. The ~~general~~December ~~guidelines~~2025 ofOffering ~~third~~was made pursuant to an effective registration statement on Form S-~~party~~3 ~~payors~~(Registration Statement No. 333- 287313) previously filed with the SEC on May 15, ~~private~~2025 and ~~public~~declared ~~insurance~~effective ~~companies~~by the SEC on May 22, ~~preferred~~2025, ~~provider~~and ~~organizations~~a preliminary prospectus supplement relating to the December 2025 Offering dated December 9, 2025 and ~~other~~a ~~managed~~final ~~care~~prospectus ~~providers~~supplement ~~with~~relating ~~particular~~to ~~focus~~the onOffering dated December 10, 2025. Pursuant to the ~~guidelines~~underwriting ~~established~~agreement, bywe granted to Newbridge a 30-day option to purchase (i) up to an additional 1,825,950 shares of common stock, representing 15% of the ~~Center~~shares ~~for~~sold ~~Medicare~~in ~~and~~the ~~Medicaid~~December ~~Services~~2025 Offering, and/or ~~“CMS~~(ii) additional December 2025 Warrants to purchase up to 912,”975 ~~which~~shares ~~administrates~~of ~~the~~common ~~United~~stock, ~~States~~representing ~~Medicare~~15% ~~program.~~of Tothe ~~assist~~December us2025 Warrants sold in ~~making~~the December 2025 Offering, solely for the purpose of covering over-allotments of such ~~modifications~~securities, if any. Newbridge exercised this option, and, ~~refinements~~on December 22, we2025, 1,825,950 ~~have~~additional ~~retained~~shares ~~independent~~and ~~consultants~~912,975 toadditional ~~focus~~warrants onwere ~~ensuring~~issued ~~that~~for ~~our~~net ~~product~~proceeds ~~candidate~~of ~~satisfies~~$653,781. ~~the~~The ~~existing~~fair ~~coverage~~values ~~and~~of ~~reimbursement~~the ~~criteria~~warrants at the dates of ~~such~~issuance ~~third-party~~totaled ~~payors~~$1,781,699 and are accounted for as liabilities.

~~Manufacturing~~The net proceeds from the December 2025 Offering were approximately $4.8 million, deducting underwriting discounts and commissions and offering expenses. Pursuant to the underwriting agreement, we paid the underwriter a cash fee equal to 7% of the gross proceeds received from the December 2025 Offering and to reimburse the underwriter for its expenses incurred in connection with the December 2025 Offering in an amount up to $85,000.

~~Our~~We ~~pump~~also ~~product~~agreed ~~comprises~~to ~~the~~issue ~~pump,~~to aNewbridge ~~disposable~~on the closing ~~cartridge~~date ~~that~~and ~~holds~~each ~~the~~over-allotment ~~insulin~~option ~~reservoir~~closing date, if any, a ~~baseplate~~warrant ~~that~~(the ~~affixes~~“December 2025 Underwriter Warrant”) for the ~~pump~~purchase of ~~product~~a number of shares of common stock equal to an aggregate of 7% of the ~~user’s~~shares ~~body~~sold ~~and~~on the ~~infusion~~closing ~~set~~date (equal to 852,110 ~~which~~shares) and ~~includes~~7% aof ~~cannula~~the shares sold on each over-allotment option closing date (equal to ~~infuse~~127,816 shares). The December 2025 Underwriter Warrant has substantially the ~~insulin~~same ~~into~~terms as the ~~body.~~December We2025 ~~intend~~Warrants, toexcept ~~manufacture~~that the ~~pump~~December 2025 Underwriter Warrant have an exercise price equal to $0.462 per share, are not exercisable for 180 days from the ~~cartridge~~Closing Date and will include piggyback registration rights that are triggered if there is not an effective registration statement covering all of the ~~baseplate~~shares of common stock issuable upon exercise of the December 2025 Underwriter Warrant. Pursuant to the Agreement, each of our directors and ~~purchase~~executive officers entered into “lock-up” agreements with the ~~infusion~~Underwriter ~~set~~that, subject to certain exceptions, prohibit, without the prior written consent of the underwriter, the sale, transfer, or other disposition of securities by us for a period of 60 days from ~~third~~the ~~parties~~date of the December 2025 Offering. ~~Prior~~We have agreed not to, ~~shipment~~subject to certain exceptions, offer, pledge, sell, contract to sell, sell any option, right or warrant to purchase, lend or otherwise transfer or dispose, directly or indirectly, any shares of our ~~pump~~capital ~~product~~stock ~~will~~or beany ~~packaged~~securities ~~with~~convertible aninto ~~infusion~~or ~~set~~exercisable or exchangeable for shares of capital stock, for a period of 90 days from the date of the December 2025 Offering. InThe ~~connection~~fair ~~therewith:~~values of the Underwriter Warrants at the dates of issuances totaled $248,294 and are accounted for as liabilities.

●Warrant WeInducement ~~have implemented automation machines in our facility that will be capable of assembling the cartridges at a rate sufficient to supply 15,000 patients (150,000 per month).~~Offering

●In ~~Product~~September ~~packaging~~2025, ~~will~~we ~~initially~~entered beinto inducement ~~performed~~offer ~~manually~~letter byagreements ~~our~~(the ~~personnel~~“Inducement Letters”) with certain holders (the “Holders”) of warrants issued in May 2023 (the “2023 Warrants”) and in March 2025 (the “March 2025 Warrants” and, collectively ~~while~~with the ~~cartridge~~2023 ~~automation~~Warrants, isthe ~~refined~~“Existing Warrants”) to purchase up to an aggregate of 6,504,731 shares of our common stock. WePursuant ~~expect~~to the Inducement Letters, the Holders agreed to exercise for cash i) 2023 Warrants to purchase 1,901,700 shares of common stock with an original exercise price of $1.22 per share and ~~implement~~ii) ~~packaging~~March ~~automation~~2025 ~~equipment~~Warrants asto purchase 4,603,031 shares with an original exercise price of $1.12 per share at a reduced exercise price of $0.68 per share in consideration for our agreement to issue in a private placement new common stock purchase warrants to purchase an aggregate of 3,252,366 shares (the “September ~~second~~2025 ~~phase~~Warrants”). The September 2025 Warrants have an exercise price of ~~automation~~0.84 per share, were exercisable upon issuance and expire on the five-year anniversary of the ~~cartridge~~date of issuance.

● The infusion sets will be purchased from a third-party supplier to cost-effectively introduce our product and focus on our core expertise.

We have commenced working with a tier-one medical product manufacturer to develop the tooling equipment required to produce the components used in our product. As discussed above, we are in the process of implementing the cartridge assembly tooling equipment in our facility. Prior to product launch, we expect to transfer the cartridge automation equipment to this contract manufacturer in early 2024 to verify and validate into our manufacturing process. The medical product manufacturer would perform all manufacturing responsibilities to ensure compliance with FDA regulations. To date, we have entered into a development agreement with this contract manufacturer for these development activities, but we have not yet entered into a contract manufacturing agreement.

FDA Clearance

The FDA requires us to meet all applicable regulations for insulin pumps, a subcategory of infusion pumps, which are generally considered Class II devices by the FDA. The design of the MODD1 pump has been completed, units have been built and testing is underway to verify that the design meets all FDA requirements prior to submission. There are 17 specific tests required to submit for 510(k) clearance. One of the more important tests addresses insulin stability, and we must demonstrate that our MODD1 pump does not damage the insulin molecules during infusion. We have performed preliminary tests on insulin stability to increase the likelihood that we will pass these tests. In an earlier version of our pump product candidate, we experienced issues demonstrating insulin stability. To address those issues, we began working with a medical product manufacturer to develop a full commercial version of our product utilizing alternative component parts. In addition, we must demonstrate: i) biocompatibility, meaning that we don’t use materials that compromise long-term patient safety, ii) occlusion detection, meaning that our device will inform the patient of a lack of insulin delivery and iii) cybersecurity controls to ensure that our product has adequate security protection to ensure it cannot be hacked by a third party. Appropriate design control and standard operating procedures have been implemented to allow us, when testing is completed, to submit for clearance under the premarket notification (or 510(k)) process. To achieve this, we will continue to work closely with our regulatory consultants to complete, finalize and file our submission to the FDA for 510(k) clearance and all other documentation necessary to obtain marketing authorization of our insulin pump.

● We have engaged the FDA in three pre-submission conferences to ensure that we understand and meet the FDA’s requirements, expectations and standards with regard to clearance of our product candidate. At these meetings, our team, including our FDA regulatory consultant, received FDA comments and guidance regarding our proposed submission during the pre-market notification period for 510(k) clearance (including any suggested modifications to the device description, indications for use or summary of supporting data contained in the notification);

● We are currently preparing our premarket notification, which will be part of our FDA submission. The purpose of the premarket notification is to demonstrate that our insulin pump is substantially equivalent to an insulin pump that has: i) previously been cleared and approved for use by the FDA and ii) legally marketed to the public and generally safe and effective for its intended use. We are also preparing other parts of our submission to the FDA, which will include the relevant results of our performance and human factor tests relating to, among other things, user effectiveness, sterility, pump efficiency and shipping compatibility demonstrating the accuracy and usability of our insulin pump, which we believe will satisfy the mandates of the FDCA and any applicable performance standards.

~~Commercialization~~As ~~Steps~~of September 30, 2025, we had issued 5,860,483 shares of common stock and 2,930,242 September 2025 Warrants, and the processing of the exercise of 175,500 2023 Warrants and 468,748 2025 Warrants was pending. As a result, as of September 30, 2025, 644,248 shares of common stock (the “Issuable Shares”) and 322,124 September 2025 Warrants were pending issuance. The fair value of the unissued Issuable Shares was presented separately as issuable shares on the condensed consolidated balance sheets and statements of stockholders’ equity as of September 30, 2025. We accounted for the issuance of the: i) shares of common stock and ii) the September 2025 Warrants as a single equity transaction for gross proceeds of approximately $4.4 million, which proceeds had been received in full as of September 30, 2025.

ToIn ~~commercialize~~relation ~~our~~to ~~product,~~the weabove ~~must~~warrant ~~successfully~~inducement offering, ~~complete~~we engaged Newbridge as the servicing agent, and we paid a ~~number~~fee of ~~material~~$400,000 ~~steps~~and ~~including:~~reimbursed $50,000 of expenses to Newbridge.

●March ~~Continue~~2025 toPlacement ~~refine~~Agent ~~and finalize the production version of our product to ensure it meets FDA requirements for 510(k) clearance;~~Warrants

oOn March 20, 2025, we entered into securities purchase agreements (the ~~general~~“Purchase ~~needs~~Agreements”) with investors (the Investors) for the private placement (the “Private Placement”) of 6,247,656 units (each a Unit), with each Unit consisting of (A) two shares of the Company’s common stock and ~~preferences~~(B) one warrant (a “Warrant”) to purchase one share of ~~our~~common ~~Almost-Pumper~~stock, ~~target~~at ~~market~~an ~~based~~offering ~~upon~~price ~~our~~of ~~knowledge~~$1.92 per Unit. Certain affiliates, officers and directors of ours purchased a total of 374,478 Units in the ~~diabetes~~Private ~~industry~~Placement. The common stock and ~~information~~the ~~available~~Warrants included in the Units and~~/or~~ ~~obtained~~the bycommon usstock ~~from~~underlying ~~Almost~~the ~~Pumpers~~Warrants are collectively referred to herein as the “Securities.” The Private Placement closed on March 26, 2025 with aggregate gross proceeds totaling approximately $12 million, before deducting placement agent fees and ~~their~~other ~~caregivers;~~expenses. Concurrently with the Private Placement, we entered into a subscription agreement with a foreign investor pursuant to which we completed a direct private placement of 260,417 Units for additional aggregate gross proceeds of approximately $0.5 million on the same terms as the Private Placement.

oThe ~~the~~Warrants ~~general~~have ~~guidelines~~an exercise price of ~~third-party~~$1.12 ~~payors,~~per share. ~~private~~Each Warrant is exercisable immediately and ~~public~~will ~~insurance~~expire ~~companies,~~four ~~preferred~~years ~~provider~~from ~~organizations~~the date of issuance. The exercise price and ~~other~~number ~~managed~~of shares ~~care~~of ~~providers~~common ~~with~~stock ~~particular~~issuable ~~focus~~upon onexercise of the ~~guidelines~~warrants ~~established~~is bysubject ~~the~~to ~~Center~~appropriate ~~for~~adjustment ~~Medicare~~in ~~and~~the ~~Medicaid~~event ~~Services~~of stock dividends, stock splits, reorganizations or ~~CMS~~similar ~~which~~events ~~administers~~affecting the ~~United~~common ~~States~~stock ~~Medicare~~and ~~program,~~the orexercise ~~Medicare~~price. ToSubject ~~assist~~to uslimited inexceptions, ~~making~~an ~~such~~Investor may ~~modifications~~not ~~and~~exercise ~~refinements~~any portion of its warrants to the extent that the Investor would beneficially own more than 4.99% (or, weat ~~have~~the ~~retained~~election of ~~independent~~the ~~consultants~~holder prior to ~~focus~~the ondate ~~ensuring~~of ~~that~~issuance, 9.99%) of our ~~product~~outstanding ~~candidate~~common ~~satisfies~~stock after exercise. In the ~~existing~~event ~~coverage~~of ~~and~~certain ~~reimbursement~~fundamental transactions, ~~criteria~~the holder of ~~such~~the ~~third-party~~Warrants ~~payors;~~will have the right to receive the Black Scholes Value (as defined in the Warrants) of its Warrants calculated pursuant to a formula set forth in the Warrants, payable in cash.

●Newbridge ~~Refine~~acted as our ~~manufacturing~~placement ~~process~~agent ~~during~~in connection with the ~~submission~~Private ~~process~~Placement, pursuant to ~~qualify~~that ~~and~~certain ~~test~~engagement ~~our~~letter, ~~product~~dated ~~for~~as ~~transfer~~of toFebruary a10, ~~manufacturer;~~2025, Webetween ~~recently~~us ~~moved~~and Newbridge, pursuant to which we paid Newbridge (i) a ~~larger~~cash ~~facility~~fee equal to 7.25% of the aggregate gross proceeds from the sale of the Securities in the Private Placement and ~~have~~(ii) ~~purchased~~reimbursement ~~production~~for certain of out-~~level~~of-pocket ~~tools~~expenses, including for reasonable expenses and ~~assembly~~legal ~~equipment~~fees of $50,000. In addition, we issued to ~~manufacture~~the ~~our~~Placement ~~disposable~~Agent ~~cartridge~~or ~~and~~its ~~reusable~~designees ~~pump.~~warrants It(the is“Placement ~~our~~Agent ~~intention~~Warrants”) to ~~transfer~~purchase ~~these~~up ~~tools~~ to aan aggregate ~~tier~~of 1874,672 ~~medical~~shares ~~product~~of ~~manufacturer~~common ~~prior~~stock (7.0% of the common stock sold in the Private Placement). The Placement Agent Warrants have substantially the same terms as the Warrants except the Placement Agent Warrants will have an exercise price equal to ~~product~~$1.40 ~~launch;~~per share (125% of the exercise price of the Warrants). The Placement Agent Warrants will be exercisable six months from the date of issuance and expire on the fourth anniversary of the issuance date.

●November ~~Take~~2024 ~~such actions, if any, as may be required by the FDA as a condition to granting approval and providing 510(k) clearance for our insulin pump; and~~Warrants

●In ~~Hire~~November ~~and~~2024 ~~retain~~Public ~~appropriate~~Offering In November ~~sales~~2024, ~~and~~we ~~marketing~~entered ~~personnel~~into an underwriting agreement (the “Agreement”) with Titan Partners Group LLC, a division of American Capital Partners, LLC (“Titan”), relating to ~~develop~~a firm commitment underwritten offering (the “November 2024 Offering”) of 5,450,573 ~~implement~~shares ~~and~~(the ~~launch~~“Shares”) of common stock of the Company, at a ~~promotional~~public ~~campaign~~offering ~~for~~price ~~our~~of ~~insulin~~$1.50 per ~~pump~~share. ~~substantially~~The ~~focused~~November 2024 Offering closed on ~~our~~November ~~target~~25, ~~market~~2024 (the “Closing Date”), resulting in gross proceeds to us of approximately $8.2 million, before deducting underwriting discounts, commissions and offering expenses.

AsPursuant ~~with~~to ~~any~~the ~~medical~~Agreement, ~~device~~as ~~attempting~~partial compensation for its services, we issued to ~~enter and~~Titan ~~successfully~~on ~~compete~~the ~~with~~Closing ~~existing~~Date, ~~products~~warrants in(the “Underwriter Warrants”) to purchase an ~~established~~aggregate ~~and~~of 381,540 ~~competitive~~shares ~~marketplace~~of common stock. The Underwriter Warrants were exercisable, wein ~~will~~whole ~~face~~or ~~significant~~in ~~hurdles~~part, tocommencing ~~accomplish~~on May 21, 2025 and expire ~~the~~on ~~above~~November ~~steps~~25, to2029, ~~commercialization~~at ~~including:~~an exercise price per share of $1.875.

● Obtaining FDA 510(k) clearance to market and sell our insulin pump to the public;

● Obtaining any other FDA-required authorizations with regard to our product candidate, as required by the FDCA;

● Educating endocrinologists, physician’s assistants, nurse practitioners and nurse educators, who typically prescribe pump usage, and certified diabetes educators and dieticians, who provide education and guidance to diabetes patients, as to what we believe to be the superior qualities of our product candidate;

● Demonstrating to select general practitioners, who have historically been skeptical of the heightened support inherent in insulin pumps, our product candidate’s ease of use and convenience;

● Ensuring that our final product does, in fact, meet the needs of Almost-Pumpers;

● Overcoming the historic obstacles and reluctance of Almost-Pumpers to using insulin pumps to treat their diabetes; and

● Ensuring that third party payors agree to cover all or a substantial portion of the purchase price and recurring costs of the use of our insulin pump.

~~Looking Forward~~May 2023 Warrants

~~Going forward~~On May 15, 2023, we ~~expect~~entered tointo ~~continue~~an underwriting agreement (the “Underwriting Agreement”) with Newbridge with respect to ~~evolve~~the issuance and sale in a firm commitment underwritten offering (the ~~MODD1~~“2023 ~~pumps~~Offering”) of units of our securities. Upon the closing of the 2023 Offering, we sold 8,816,900 shares of common stock and ~~their~~warrants ~~capabilities~~to purchase 4,408,450 shares of common stock for aggregate gross proceeds of approximately $9,390,000, before deducting underwriting discounts and ~~functionality~~commissions ~~both~~and inother ~~response~~offering toexpenses. ~~patient~~The ~~needs~~securities were sold as a unit, with each unit consisting of two shares of common stock and one warrant (the “2023 Warrants”) to purchase one share of common stock, at a public offering asprice ~~part~~of $2.13 per unit. The 2023 Warrants were immediately separable and exercisable, have a per share exercise price of ~~our~~$1.22 ~~current~~and ~~platform~~expire five ~~roadmap~~years from the date of issuance.

●Pursuant ~~With~~to ~~our~~the ~~future~~Underwriting ~~MODD1+ product~~Agreement, we ~~intend~~granted the toUnderwriter ~~seek~~a ~~to add phone~~30-~~based~~day ~~control~~option ~~and~~to ~~Alternative~~purchase ~~Controller~~up ~~Enabled (“ACE”) and Automated Insulin Deliver (“AID”) capability~~ to ~~allow~~an ~~integration~~additional ~~with~~1,322,534 ~~popular~~shares ~~continuous~~of ~~glucose~~common ~~monitors.~~stock ~~This~~and ~~will~~an ~~expand~~additional ~~our~~661,267 ~~available~~of ~~market~~the 2023 Warrants to ~~include~~cover ~~many~~over-allotments, ~~existing~~if ~~pumpers~~any. ~~The~~On ~~new~~May ~~model~~25, ~~has~~2023, the ~~same~~Underwriter ~~modular~~exercised ~~design~~this ~~and~~option ~~low-cost~~in ~~components~~full ~~as MODD1~~ and ~~provides~~purchased athe ~~much~~additional securities ~~desired breakthrough~~ for ~~patients~~aggregate -gross ~~two-factor~~proceeds ~~command~~to ~~authentication~~us ~~that~~of ~~allows~~approximately ~~the~~$1,408,000, ~~wearer~~before todeducting ~~use~~underwriting andiscounts ~~application~~and oncommissions ~~his/her~~and other ~~cell~~offering ~~phone as the controller~~expenses.

●The ~~Additionally~~Underwriter was paid a cash fee of 7.0% of the aggregate gross proceeds of the 2023 Offering (including the over-allotment option) and reimbursed certain out-of-pocket expenses of approximately $125,000. ~~adds~~In ~~AID~~addition, ~~control~~pursuant ~~functionality~~to ~~via~~the anUnderwriting Agreement, we initially issued to the Underwriter common stock purchase warrants (the “~~ACE~~UW Warrants”) ~~designation~~for ona total of 709,760 shares. Subsequently, the ~~pump~~UW Warrants were reissued to the Underwriter and its agents for a total of 604,623 shares. The UW warrants were exercisable six months from the respective issuance dates and have a four-year term and a per share exercise price of $1.32.

●May ~~Any~~2022 ~~approved algorithm controller can drive insulin delivery in “auto” mode~~Warrants

●On ~~CGM~~May ~~integration~~2, ~~allows~~2022, we entered into a securities purchase agreement (the ~~controller~~“Purchase Agreement”) with an institutional investor, pursuant to ~~potentially~~which ~~adjust~~we ~~basal~~sold, ~~insulin~~in ~~rate~~a ~~for~~registered ~~meals~~direct offering, which closed on May 5, 2022, an aggregate of 449,438 shares (the “Shares”) of common stock, par value $0.001 per share, at a purchase price per Share of $4.45 and pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of approximately 1,348,000 shares of common stock at a purchase price per Pre-Funded Warrant of $4.44. The Pre-Funded Warrants were exercisable immediately on the date of issuance at an exercise ~~with~~price of $0.01 per share and were exercised in full as of May 2025. In a concurrent private placement under the Purchase Agreement, we issued to the Investor warrants (the “Private Placement Warrants”) to purchase an ~~approved~~aggregate of ~~algorithm~~1,438,202 shares of common stock at an exercise price of $6.60 per share. The Private Placement Warrants were exercisable beginning on the six-month anniversary of the date of issuance (the “Initial Exercise Date”) and will expire on the five-year anniversary of the Initial Exercise Date.

●February ~~With~~2022 ~~our future MODD2 product, we will seek to move to a full-featured, multi-chamber pump optimized for high time in range fully autonomous close loop insulin delivery utilizing the form factor~~ and ~~cost~~2021 advantages of its pumping designs to create an affordable, easy to use drug delivery system to realize the aspiration of true “artificial pancreas” systems. We envision moving to a drug prefill model such that cartridges can be filled with insulin or other drugs and shipped cold chain to patients, further simplifying the use process.Warrants

~~Employees~~From February through April 2021, we sold $2,310,000 of convertible promissory notes (each an Original Note and, collectively, the Original Notes), at par in a private placement transaction effected pursuant to an exemption from the registration requirements under the Securities Act of 1933, as amended. Effective April 30, 2021, pursuant to a revocation and replacement agreement between each holder of an Original Note and us (the Revocation Agreement), the $2,310,000 of Original Notes and accrued interest thereon as of April 30, 2021 were replaced with $2,360,550 aggregate principal amount of Notes and 2021 Warrants (as defined below).

~~As of~~During ~~March~~the 31three months ended June 30, ~~2023~~2021, pursuant to a securities purchase agreement by and between us and each investor (the “SPA”), we ~~had~~sold 38to ~~employees~~investors $4,250,000 ~~all~~aggregate principal amount of ~~whom~~convertible ~~are~~promissory ~~located~~notes in(the “Notes”) and warrants to purchase shares of its common stock (the ~~United~~2021 ~~States~~Warrants). ~~and~~The 37Notes were unsecured obligations of ~~whom~~ours ~~are~~with ~~full-time~~each ~~employees~~Note having a stated maturity date of 12 months from its issue date and accrued interest at a rate of 12% per annum, ~~consisting~~payable on maturity. If we completed an offering of its common stock or other securities in excess of 36$12,000,000 of gross proceeds (a Qualified Capital Raise, as defined in ~~research~~the Notes), ~~and~~each ~~development~~Note ~~and~~holder ~~manufacturing~~would ~~operations~~be ~~and~~required 2to convert its Adjusted Note Amount (as defined below) into the securities of such Qualified Capital Raise. Adjusted Note Amount equals the product of (i) the sum of all outstanding principal plus accrued interest on a Note, multiplied by (ii) 1.25. In connection with the issuance of the Notes, we issued the 2021 Warrants to purchase in ~~general~~the aggregate ~~and~~767,796 ~~administrative~~shares ~~functions~~of its common stock at an initial exercise price of $24. 00 per share.

Upon the closing of a public offering in February 2022, which was a Qualified Capital Raise, in accordance with their terms, the Notes converted into 1,511,276 shares of common stock and the holders of the Notes received an additional 1,511,276 common stock purchase warrants with an exercise price of $6.60 per share. In addition, as a result of the February 2022 equity offering, the exercise price of the 767,796 outstanding 2021 Warrants was reduced to $6.00 per share.

~~Competition~~DESCRIPTION OF THE SECURITIES WE ARE OFFERING

~~Today,~~Common inStock ~~the United States, only three companies are commercializing insulin pumps~~ to ~~T1D~~be ~~patients~~Issued ~~and~~as ~~insulin~~Part ~~treated~~of ~~T2D patients:~~this Offering

●The ~~Medtronic~~material -terms ~~commercializes~~and ~~the~~provisions ~~durable~~of ~~Minimed~~our ~~770G~~common stock and ~~also~~each ~~offers~~other ~~older~~class ~~durable~~of ~~pumps~~our ~~(670G,~~securities ~~630G~~which ~~etc.).~~qualifies Inor ~~2020~~limits our common stock are described above under the sections “Description of Capital Stock—Common Stock,” ~~they~~“Description ~~held~~of ~~approximately~~Capital ~~51%~~Stock—Preferred Stock,” and “Description of ~~the~~Outstanding USWarrants” ~~insulin~~of ~~pump~~this ~~market~~prospectus.

●Warrants ~~Tandem~~to -be ~~commercializes~~Issued ~~the~~as ~~durable~~Part ~~t:slim X2 pump (with or without algorithms - Basal-IQ and Control-IQ). In 2020, they held approximately 28%~~ of ~~the~~this ~~US insulin pump market.~~Offering

●Common ~~Insulet - commercializes the disposable Omnipod patch pump with about 19% of the US market in 2020.~~warrants

~~Older~~The ~~insulin~~common ~~pumps~~warrants ~~are~~will ~~also~~be ~~still~~issued ~~being~~in ~~used~~a form filed byas aan ~~minority~~exhibit to the registration statement of ~~patients~~which ~~previously~~this ~~provided~~prospectus byis ~~Roche~~a orpart. ~~Animas~~You ~~though~~should ~~these~~review ~~pumps~~a ~~are~~copy ~~not~~of ~~commercialized~~the ~~any~~form ~~longer.~~of Tocommon warrant for a ~~lesser~~complete ~~extent, the~~description ~~pumps~~of ~~described~~the ~~below~~terms ~~are~~and ~~also~~conditions ~~used~~applicable into ~~small~~the ~~numbers~~common warrants.

~~Medtronic~~Pursuant ~~pump~~to a warrant agency agreement between us and ~~infusion~~Colonial ~~set~~Stock ~~Tandem~~Transfer ~~pump~~Company, Inc., as warrant agent, the common warrants will be issued in book-entry form and ~~infusion~~shall ~~set~~initially be represented only by one or more global warrants deposited with the warrant agent, as custodian on behalf of The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC. The following is a brief summary of the common warrants and is still subject in all respect to the provisions contained in the form of common warrant.

~~These~~Duration ~~three insulin pump offerings are vying for the attention of the most motivated~~ and ~~well~~Exercise insured in hope of converting them away from their reliance on MDI. The t:slim X2 and Minimed 770G each have a ~$5,000 list price that is covered through Durable Medical Equipment (DME) reimbursement and daily consumables, which comprise cartridge, tubing and set for each three-day period, as well. These products have controllers integrated into the pump, making them cumbersome and bulky, along with long (> 20 inch) tubing between the pump and the cannular site. The Omnipod is the third offering, a patch pump that attaches to your body for 72 hours and uses a separate controller to manage the insulin delivery process. Insurance coverage for Omnipod can be provided via DME but also via Pharmacy Benefit (PB). The Omnipod patch pump is more expensive per day and less accurate than other insulin pumps, according to a Mende 2022 study. Around 33% of people living with T1D are currently using insulin pumps; of these, the vast majority are using one of these three offerings, a statistic that has not changed significantly over the last 5+ years.Price

~~All~~Each ofcommon ~~these~~warrant ~~pump~~will ~~products~~have ~~require~~an ~~extensive~~exercise ~~training~~price toof ~~initiate~~$ per share, ~~two~~will tobe ~~four~~immediately ~~hours~~exercisable ~~per~~upon ~~day~~issuance ~~to use~~ and ~~manage~~will expire on anthe ~~ongoing~~fifth ~~basis~~anniversary of the date of issuance. WeThe ~~believe~~exercise ~~this~~price ~~level~~and number of ~~sophistication~~shares ~~and~~of ~~effort~~common ~~along~~stock issuable upon exercise is subject to appropriate adjustment ~~with~~in the ~~cost~~event ~~and~~of ~~awkwardness~~stock ofdividends, ~~these~~stock ~~products~~splits, ~~contribute~~reorganizations toor similar events affecting our common stock and the ~~limited~~exercise ~~uptake~~price.

~~Although~~The ~~there~~common ~~are~~warrants ~~purely~~will ~~mechanical~~be ~~pumps~~issued ~~available~~separately tofrom ~~patients with a small percentage of T2D patients using~~ the ~~Mannkind~~common ~~V-Go~~stock ~~patch pump, a fixed basal rate~~ and apre-funded ~~button~~warrants toincluded ~~deliver~~in ~~small boluses~~this offering. ~~This~~Each ~~pump~~share isof ~~simple~~our tocommon ~~use~~stock ~~though~~or ~~gives~~pre-funded ~~little~~warrant ~~performance decision to the user (no possibility to change the basal rate, no~~purchased ~~possibility~~in tothis ~~stop~~offering ~~bolus~~will ~~doses,~~include ~~small~~one ~~reservoir,~~common ~~pump~~warrant ~~that needs~~ to bepurchase ~~changed~~one ~~every~~share ~~day,~~of ~~etc.).~~our ~~The~~common ~~last available patch pump is provided by Cequr, called Simplicity, a bolus only delivery option without basal delivery that is yet to be commercially available~~stock.

In the future, Medtronic intends to launch a new version of their insulin pump, the Minimed 780G, already available in some European countries with an advanced algorithm, but no obvious change in hardware. Tandem is currently developing a patch pump called Mobi, coupled with an algorithm with potential launch expected in 2024. The Mobi is expected to have a small 2mL reservoir and would be controlled by a separate unit, similar to the current Omnipod product. Insulet has also launched the Omnipod 5, a similar patch pump to their offering today, that includes an AID algorithm.Exercisability

The common warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below in “⸺Certain Adjustments”). A holder may not exercise any portion of the common warrant to the extent that the holder would beneficially own more than 4.99% (or, at the election of the purchaser prior to the date of issuance, 9.99%) of the outstanding common stock after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s common warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the common warrants.

Certain Adjustments

The exercise price and the number of shares issuable upon exercise of the common warrants is subject to appropriate adjustment in the event of stock splits, stock dividends, recapitalizations, reorganizations, schemes, arrangements or similar events affecting our common stock. The common warrant holders must pay the exercise price in cash or wire transfer of immediately available funds upon exercise of the common warrants, unless such holders are utilizing the cashless exercise provision of the common warrants, which is only available in certain circumstances such as if the underlying shares are not registered with the SEC pursuant to an effective registration statement. We intend to use commercially reasonable best efforts to have the registration statement of which this prospectus forms a part, effective when the common warrants are exercised.

~~Approximately~~Fundamental 79% of the people who rely upon MDI choose to not administer a shot outside of their house, which creates a poorly controlled group. MODD1 is designed to focus upon a segment of these people and mobilize them via a simple, easy to use, affordable product.Transactions

~~Intellectual~~In ~~Property~~the event we consummate a merger or consolidation with or into another person or other reorganization event in which our common stock is converted or exchanged for securities, cash or other property, or we sell, lease, license, assign, transfer, convey or otherwise dispose of all or substantially all of our assets or we or another person acquire 50% or more of our outstanding shares of common stock, then following such event, the holders of the common warrants will be entitled to receive upon exercise of the common warrants the same kind and amount of securities, cash or property which the holders would have received had they exercised the common warrants immediately prior to such fundamental transaction. Any successor to us or surviving entity shall assume the obligations under the common warrants.

Our success depends in part on our ability to obtain patents and trademarks, maintain trade secret and know-how protection, enforce our proprietary rights against infringers, and operate without infringing on the proprietary rights of third parties. Because of the length of time and expense associated with developing new products and bringing them through the regulatory approval process, the health care industry places considerable emphasis on obtaining patent protection and maintaining trade secret protection for new technologies, products, processes, know-how, and methods.Transferability

AsSubject ofto ~~March~~applicable ~~31,~~laws ~~2023,~~and wethe ~~held three U.S. utility~~restriction ~~and~~on notransfer ~~foreign~~set ~~patents,~~forth ~~and we also held 22 pending applications~~ in the ~~United~~common ~~States and abroad. The patents and patent applications cover various aspects of our technology~~warrant, ~~including~~the ~~our~~common ~~proprietary~~warrant ~~fluid~~may ~~movement~~be ~~technology~~transferred ~~and~~at ~~associated~~the ~~features~~option of ~~our insulin delivery methodology. There can be no assurance that~~ the ~~pending~~holder ~~patent~~upon ~~applications~~surrender ~~will~~of ~~result in~~ the ~~issuance of patents, that patents issued~~common warrant to ~~or licensed by~~ us ~~will~~together ~~not~~with bethe ~~challenged~~appropriate orinstruments ~~circumvented~~of ~~by competitors, or that these patents will be found to be valid or sufficiently broad to protect our technology or provide us with a competitive advantage~~transfer.

~~Government Regulation~~Exchange Listing

~~Our operations~~There ~~are~~is ~~subject~~no toestablished ~~comprehensive~~trading ~~federal,~~market ~~state,~~for ~~and local laws and regulations in~~ the common ~~jurisdictions~~warrants. inIn ~~which~~addition, we ~~or our research and development partners~~ do ~~business.~~not ~~The~~intend ~~laws and regulations governing our business and interpretations of those laws and regulations and are subject~~ to ~~frequent~~apply ~~change.~~for ~~Our~~the ~~ability~~listing ~~to operate profitably will depend in part upon our ability, and that~~ of ~~our~~the ~~research and~~common ~~development~~warrants ~~partners~~on ~~and~~any ~~affiliates,~~national tosecurities ~~operate in compliance with applicable laws and regulations~~exchange. ~~The laws and regulations relating~~Without toan ~~medical~~active ~~products~~trading ~~and healthcare services that apply to our business and that of our partners and affiliates continue to evolve~~market, ~~and we must, therefore, devote significant resources to monitoring developments in legislation, enforcement, and regulation in such areas. As~~ the ~~applicable~~liquidity ~~laws and regulations change, we are likely to make conforming modifications in our business processes from time to time. We cannot provide assurance that a review~~ of ~~our business by courts or regulatory authorities will not result in determinations that could adversely affect our operations or that~~ the ~~regulatory~~common ~~environment~~warrants will ~~not~~be ~~change in a way that restricts our operations~~limited.

Right as a Stockholder

Except as otherwise provided in the common warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the common warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their common warrants.

Waivers and Adjustments

Subject to certain exceptions, any terms of the common warrants may be amended or waived with our written consent and the written consent of the holder.

Pre-Funded warrants

The pre-funded warrants will be issued in a form filed as an exhibit to the registration statement of which this prospectus is a part. You should review a copy of the form of pre-funded warrant for a complete description of the terms and conditions applicable to the pre-funded warrants.

The pre-funded warrants will be issued in certificated forms. The following is a brief summary of the pre-funded warrants and is still subject in all respect to the provisions contained in the form of pre-funded warrant.

Duration and Exercise Price

The pre-funded warrants offered hereby will have an exercise price of $0.001 per share. The pre-funded warrants will be immediately exercisable and may be exercised at any time until the pre-funded warrants are exercised in full. The exercise prices and numbers of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock.

~~FDA Regulation~~Exercisability

~~In the~~The ~~United~~pre-funded ~~States,~~warrants ~~medical~~will ~~devices~~be ~~are~~exercisable, ~~strictly regulated by~~ at the ~~FDA.~~option ~~Under~~of ~~the~~each ~~FDCA~~holder, ain ~~medical~~whole ~~device~~or isin ~~defined as “an instrument~~part, ~~apparatus,~~ ~~implement,~~by ~~machine,~~delivering ~~contrivance,~~to ~~implant,~~us ina ~~vitro~~duly ~~reagent,~~executed orexercise ~~other~~notice ~~similar~~accompanied orby ~~related~~payment ~~article,~~in ~~including~~full ~~a component, part~~for orthe ~~accessory~~number ~~which~~of ~~is,~~shares ~~among~~of ~~other~~our ~~things:~~common ~~intended~~stock ~~for~~purchased ~~use~~upon insuch ~~the~~exercise. ~~diagnosis~~A ofholder ~~disease~~(together orwith ~~other~~its ~~conditions,~~affiliates) ormay innot ~~the~~exercise ~~cure,~~any ~~mitigation,~~portion ~~treatment,~~of orsuch ~~prevention~~holder’s ofpre-funded ~~disease,~~warrants into ~~man~~the orextent ~~other~~that ~~animals;~~the orholder ~~intended~~would toown ~~affect~~more ~~the~~than ~~structure~~4.99% (or ~~any~~9.99%, ~~function~~at of the ~~body~~holder’s election) of ~~man or~~our ~~other~~outstanding ~~animals,~~common ~~and~~stock ~~which~~immediately ~~does~~after ~~not~~exercise, ~~achieve~~except ~~its~~that ~~primary~~upon ~~intended~~notice ~~purposes~~from ~~through~~the ~~chemical~~holder ~~action~~to ~~within~~us, ~~or on~~ the ~~body~~holder ofmay ~~man~~decrease or ~~other~~ ~~animals~~increase ~~and~~the ~~which~~limitation isof ~~not~~ownership ~~dependent~~of ~~upon~~outstanding ~~being~~stock ~~metabolized~~after ~~for~~exercising the ~~achievement~~holder’s ofpre-funded ~~any~~warrants ofup ~~its~~to ~~primary intended purposes~~9.”99% ~~This~~of ~~definition~~the number ~~provides~~of ashares ~~clear~~of ~~distinction~~our ~~between~~common astock ~~medical~~outstanding ~~device~~immediately ~~and~~after ~~other~~giving ~~FDA~~effect ~~regulated~~to ~~products~~the ~~such~~exercise, as ~~drugs.~~such Ifpercentage ~~the~~ownership ~~primary~~is ~~intended use of~~determined ain ~~medical~~accordance ~~product~~with isthe ~~achieved~~terms ~~through~~of ~~chemical~~the ~~action~~pre-funded orwarrants, byprovided ~~being~~that ~~metabolized~~any byincrease ~~the~~in ~~body,~~such ~~the~~limitation ~~product~~shall isnot ~~usually~~be aeffective ~~drug~~until ~~or biologic.~~61 Ifdays ~~not,~~following itnotice isto ~~generally a medical device~~us.

~~We are~~Fundamental currently developing an insulin pump delivery system, which is regulated by the FDA as a medical device under the FDCA, as implemented and enforced by the FDA. The FDA regulates the development, testing, manufacturing, labeling, packaging, storage, installation, servicing, advertising, promotion, marketing, distribution, import, export, and market surveillance of our medical devices.Transactions

~~Device~~In the event we consummate a merger or consolidation ~~Premarket~~with ~~Regulatory~~or ~~Requirements~~into another person or other reorganization event in which our common stock is converted or exchanged for securities, cash or other property, or we sell, lease, license, assign, transfer, convey or otherwise dispose of all or substantially all of our assets or we or another person acquire 50% or more of our outstanding shares of common stock, then following such event, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the same kind and amount of securities, cash or property which the holders would have received had they exercised the pre-funded warrants immediately prior to such fundamental transaction. Any successor to us or surviving entity shall assume the obligations under the pre-funded warrants.

Before being introduced into the U.S. market, each medical device must obtain marketing clearance or approval from the FDA through the premarket notification (or 510(k)) process, the de novo classification process, or the premarket approval, or “PMA,” process, unless they are determined to be Class I devices or to otherwise qualify for an exemption from one of these available forms of premarket review and authorization by the FDA. Under the FDCA, medical devices are classified into one of three classes - Class I, Class II or Class III - depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurance of safety and effectiveness. Classification of a device is important because the class to which a device is assigned determines, among other things, the necessity and type of FDA review required prior to marketing the device. Class I devices are those for which reasonable assurance of safety and effectiveness can be maintained through adherence to general controls which include compliance with the applicable portions of the FDA’s Quality System Regulation (the “QSR”), as well as regulations requiring facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials. The Class I designation also applies to devices for which there is insufficient information to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but that are not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and that do not present a potential, unreasonable risk of illness or injury.Transferability

~~Class II~~Subject ~~devices are those for which general controls alone are insufficient~~ to ~~provide~~applicable ~~reasonable~~laws ~~assurance of safety~~ and ~~effectiveness~~the ~~and~~restriction ~~there~~on istransfer ~~sufficient~~set ~~information~~forth to establish “special controls.” These special controls can include performance standards, post-market surveillance requirements, patient registries and FDA guidance documents describing device-specific special controls. While most Class I devices are exempt from the premarket notification requirement, most Class II devices require a premarket notification prior to commercialization in the ~~United~~pre-funded ~~States; however~~warrant, the ~~FDA~~pre-funded ~~has~~warrant ~~the~~may ~~authority~~be totransferred ~~exempt~~at ~~Class II devices from~~ the ~~premarket~~option ~~notification requirement under certain circumstances. As a result, manufacturers~~ of ~~most Class II devices must submit premarket notifications to~~ the ~~FDA~~ ~~under~~holder ~~Section~~upon ~~510(k)~~ surrender of the FDCA (21 U.S.C. § 360(k)) in order to obtain the necessary clearance to market or commercially distribute such devices. To obtain 510(k) clearance, manufacturers must submit to the FDA adequate information demonstrating that the proposed device is “substantially equivalent” to a “predicate device” that is already on the market. A predicate device is a legally marketed device that is not subject to PMA, meaning, (i) a device that was legally marketed prior to May 28, 1976 (“pre-~~amendments device”)~~funded ~~and~~warrant ~~for which a PMA is not required, (ii) a device that has been reclassified from Class III~~ to ~~Class~~us IItogether orwith ~~I or (iii) a device that was found substantially equivalent through~~ the ~~510(k)~~appropriate ~~process.~~instruments Ifof the FDA agrees that the device is substantially equivalent to the predicate device identified by the applicant in a premarket notification submission, the agency will grant 510(k) clearance for the new device, permitting the applicant to commercialize the devicetransfer. ~~Premarket notifications are subject to user fees, unless a specific exemption applies.~~

Exchange Listing

There is no established trading market for the pre-funded warrants. In addition, we do not intend to apply for the listing of the pre-funded warrants on any national securities exchange. Without an active trading market, the liquidity of the pre-funded warrants will be limited.

Right as a Stockholder

Except as otherwise provided in the pre-funded warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the pre-funded warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their pre-funded warrants.

Waivers and Adjustments

Subject to certain exceptions, any terms of the pre-funded warrants may be amended or waived with our written consent and the written consent of the holder.

~~If there~~PLAN isOF no adequate predicate to which a manufacturer can compare its proposed device, the proposed device is automatically classified as a Class III device. In such cases, a device manufacturer must then fulfill the more rigorous PMA requirements or can request a risk-based classification determination for its device in accordance with the de novo classification process.DISTRIBUTION

~~Devices that~~Pursuant ~~are intended~~ to bea ~~life~~placement ~~sustaining~~agency ~~or life supporting~~agreement, ~~devices that are implantable, devices that present a potential unreasonable~~dated ~~risk~~as of ~~harm or are of substantial importance in preventing impairment of health~~[●],2026, ~~and~~we ~~devices~~have ~~that~~engaged ~~are~~Maxim ~~not substantially equivalent~~ to a ~~predicate~~act ~~device~~as ~~and~~our ~~for~~exclusive ~~which~~placement ~~safety~~agent ~~and~~to ~~effectiveness~~solicit ~~cannot~~offers beto ~~assured~~purchase ~~solely by~~ the ~~general~~securities ~~controls and special controls are placed~~offered inby ~~Class~~this ~~III~~prospectus. ~~Such~~The ~~devices~~placement ~~generally~~agent ~~require~~is ~~FDA~~not ~~approval~~purchasing ~~through~~or ~~the~~selling ~~PMA~~any ~~process~~securities, ~~unless~~nor ~~the device~~ is ait ~~pre-amendments~~required ~~device not yet subject~~ to aarrange ~~regulation~~for ~~requiring premarket approval. The PMA process is more demanding than~~ the ~~510(k)~~purchase ~~process. For a PMA, the manufacturer~~and ~~must~~sale ~~demonstrate~~of ~~through~~any ~~extensive~~specific ~~data,~~number ~~including data from preclinical studies and one~~ or ~~more~~dollar ~~clinical~~amount ~~trials~~of securities, ~~that~~other ~~the~~than ~~device~~to ~~is safe~~use ~~and effective for~~ its ~~proposed~~“reasonable ~~indication.~~best ~~The~~efforts” ~~PMA~~to ~~must~~arrange ~~also~~for the ~~contain~~sale ~~a full description~~ of the ~~device~~securities ~~and~~by ~~its~~us. ~~components~~Therefore, awe ~~full description~~may ofnot sell the ~~methods,~~entire ~~facilities~~amount ~~and~~of ~~controls~~securities ~~used~~being ~~for manufacturing, and proposed labeling~~offered. ~~Following~~The ~~receipt~~terms of athis ~~PMA submission,~~offering ~~the~~are ~~FDA~~subject ~~determines~~to ~~whether~~market ~~the~~conditions ~~application~~and isnegotiations ~~sufficiently~~between ~~complete~~us, tothe ~~permit~~placement aagent ~~substantive~~and ~~review~~prospective investors. IfThe ~~the~~placement ~~FDA~~agent ~~accepts the application~~does ~~for~~not ~~review,~~guarantee that it ~~has~~will ~~180~~be ~~days~~able ~~under the FDCA~~ to ~~complete~~raise ~~its~~new ~~review~~capital ~~and determine whether the proposed device can be approved for commercialization, although~~ in ~~practice,~~any ~~PMA~~prospective ~~reviews~~offering. ~~often~~The ~~take~~placement ~~significantly~~agent ~~longer,~~may ~~and~~engage itsub-agents ~~can~~or ~~take~~selected dealers up to ~~several~~assist ~~years~~with ~~for~~ the ~~FDA~~offering. toThe ~~issue~~placement aagency ~~final~~agreement ~~decision. Before~~provides ~~approving~~that ~~a PMA,~~ the ~~FDA~~placement ~~generally~~agent’s ~~also~~obligations ~~performs~~are ansubject to ~~on-site~~conditions ~~inspection~~contained ofin ~~manufacturing facilities for~~ the ~~product~~placement toagency ~~ensure compliance with the QSR~~agreement.

~~The~~Investors depurchasing ~~novo~~securities ~~classification~~offered ~~process allows~~hereby awill ~~manufacturer~~have ~~whose~~the ~~novel~~option ~~device~~to isexecute ~~automatically~~a ~~classified~~securities ~~into~~purchase ~~Class~~agreement ~~III~~with us. In addition to ~~request~~the ~~down-classification~~rights ofand ~~its~~remedies ~~device~~available to ~~Class~~all ~~I or~~investors ~~Class~~in ~~II,~~this onoffering ~~the~~under ~~basis~~federal ~~that~~and ~~the~~state ~~device~~securities ~~presents~~laws, ~~low~~the orinvestors ~~moderate~~who ~~risk,~~enter asinto ana ~~alternative~~securities topurchase ~~following~~agreement ~~the~~will ~~typical~~also ~~Class~~be ~~III device pathway~~able ~~requiring~~to ~~the~~bring ~~submission~~claims ~~and~~of ~~approval~~breach of acontract ~~PMA~~against ~~application~~us. WeInvestors ~~expect~~who ~~our~~do ~~MODD1~~not ~~insulin~~enter ~~pump~~into ~~product~~a ~~candidate~~securities topurchase beagreement ashall ~~Class~~rely IIsolely ~~device,~~on ~~and~~this weprospectus doin ~~not~~connection ~~expect~~with tothe bepurchase ~~required~~of toour ~~apply~~securities ~~for~~in ~~down-classification~~this ~~under the de novo classification process~~offering.

~~Clinical~~There ~~trials~~is ~~are~~no ~~almost~~minimum ~~always~~number ~~required to support PMAs and are sometimes required to support 510(k) and de novo classification submissions. All clinical investigations~~ of ~~devices~~shares to ~~determine safety and effectiveness must~~ be ~~conducted in accordance with the FDA’s investigational device exemption (“IDE”) regulations~~sold ~~that~~or ~~govern~~minimum ~~investigational~~aggregate ~~device~~offering ~~labeling,~~proceeds ~~prohibit~~for ~~promotion~~this ofoffering ~~investigational~~to ~~devices, and specify recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators~~close. IfWe ~~the~~expect ~~device~~this ~~presents~~offering ~~a “significant risk,” as defined by the FDA, the agency requires the study sponsor~~ to ~~submit~~be ancompleted ~~IDE~~not ~~application~~later tothan ~~the~~two ~~FDA, which must become effective prior to commencing~~trading ~~human clinical trials. The IDE will automatically become effective 30~~ days ~~after~~following ~~receipt by~~ the ~~FDA,~~commencement ~~unless~~of ~~the~~this ~~FDA~~offering ~~denies the application or notifies the sponsor that the investigation is on hold~~ and ~~may~~we ~~not~~will ~~begin~~deliver ~~until~~all ~~the~~securities ~~sponsor~~issued ~~provides~~in ~~supplemental~~connection ~~information about the investigation that satisfies the agency’s concerns. If the FDA determines that there are deficiencies or other concerns~~ with an ~~IDE~~this ~~that~~offering ~~require~~delivery ~~modification of the study, the FDA may permit a clinical trial to proceed under a conditional approval. The FDA may~~versus ~~also~~payment ~~notify~~(“DVP”)/receipt ~~the~~versus ~~sponsor~~payment ~~that~~(“RVP”) ~~the~~upon ~~study~~our isreceipt ~~approved as proposed or approved with specific requested modification. Furthermore, the agency may withdraw approval~~ of aninvestor ~~IDE under certain circumstances~~funds. ~~In addition~~Accordingly, ~~the~~neither ~~study~~we ~~must be approved by, and conducted under the oversight~~nor ~~of, an institutional review board, or IRB, for each clinical site. If~~ the ~~device~~placement ~~presents~~agent ahas ~~non-significant~~made ~~risk~~any toarrangements ~~the patient according~~ to ~~criteria~~place ~~established~~investor byfunds ~~the~~in ~~FDA~~an asescrow ~~part~~account ofor ~~the~~trust ~~IDE~~account ~~regulations,~~since ~~a sponsor may begin~~ the ~~clinical~~placement ~~trial after obtaining approval for~~agent ~~the~~will ~~trial~~not byreceive ~~one~~investor orfunds ~~more~~in ~~IRBs~~connection ~~without separate authorization from the FDA, but must still comply~~ with ~~abbreviated IDE requirements, such as monitoring~~ the ~~investigation,~~sale ~~ensuring~~of ~~that~~securities ~~the~~offered ~~investigators obtain informed consent, and labeling and record-keeping requirements~~hereunder.

We will deliver the securities being issued to the investors upon receipt of investor funds for the purchase of the securities offered pursuant to this prospectus. We expect to deliver the securities being offered pursuant to this prospectus on or about [●], 2026, subject to satisfaction of certain conditions.

Placement Agent Fees and Expenses

The following table summarizes the placement agent fees to be paid to the placement agent by us.

Per Share and Accompanying Common Warrant (1)

Per
Pre-Funded Warrant and Accompanying Common Warrant (1)

Total

Public offering price

Placement agent fees (1)

Proceeds to us, before expenses (2)

(1)	We have agreed to provide the placement agent a cash placement commission up to 7.0% of the public offering price. We have also agreed to reimburse the accountable expenses of the placement agent of up to $100,000.

~~Post-Marketing Restrictions~~(2) ~~and~~The ~~Enforcement~~above summary of offering proceeds does not give effect to any proceeds from the exercise of the warrants being issued in this offering.

~~After~~We estimate the total expenses payable by us for athis ~~device~~offering isto ~~placed~~be onapproximately $1,070,000, which amount includes (i) the ~~market~~placement agent fee of approximately $840,000, ~~numerous~~(ii) ~~regulatory~~reimbursement of ~~requirements~~the ~~apply.~~expenses ~~These~~of ~~include~~the placement agent, ~~but~~including ~~are~~the ~~not~~legal ~~limited~~fees of the placement agent, in an amount not to: exceed $100,000 and (iii) other estimated company expenses of approximately $130,000, which includes legal, accounting, printing costs and various fees associated with the registration and listing of our securities.

●The ~~submitting~~securities ~~and~~we ~~updating~~are ~~establishment~~offering ~~registration~~are ~~and~~being ~~device~~offered by ~~listings~~the ~~with~~placement agent subject to certain conditions specified in the ~~FDA;~~placement agency agreement.

● compliance with the QSR, which requires manufacturers to follow stringent design, testing, control, documentation, record maintenance, including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process;Listing

●Our ~~unannounced~~shares ~~routine~~of orcommon ~~for-cause~~stock ~~device~~are ~~facility~~listed ~~inspections~~on by the ~~FDA,~~Nasdaq Capital ~~which~~Market ~~may~~under ~~include~~the ~~our~~symbol ~~suppliers’ facilities; and~~“MODD.”

●The ~~labeling~~last ~~regulations~~reported sale price of our shares of common stock on February 19, ~~which~~2026 ~~prohibit~~was $0.5091 per share. The final public offering price will be determined between us, the ~~promotion~~placement agent and the investors in the offering, and may be at a discount to the current market price of ~~products~~our ~~for~~common ~~uncleared~~stock. orTherefore, ~~unapproved~~the ~~(or~~assumed public ~~“off-label”)~~offering ~~uses~~price used throughout this prospectus may not be indicative of the final public offering price. There is no established public trading market for the warrants, and ~~impose~~we ~~other~~do ~~restrictions~~not ~~relating~~expect such a market to ~~promotional~~develop. ~~activities;~~In addition, we do not intend to apply for a listing of the warrants on any national securities exchange or other nationally recognized trading system.

● corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health; and

● post-market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

In addition, under the FDA medical device reporting (“MDR”) regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or a similar device of such manufacturer were to recur. The decision to file an MDR involves a judgment by the manufacturer. If the FDA disagrees with the manufacturer’s determination, the FDA can take enforcement action.

The MDR requirements also extend to health care facilities that use medical devices in providing care to patients, or “device user facilities,” which include hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, or outpatient treatment facilities, but not physician offices. A device user facility must report any device-related death to both the FDA and the device manufacturer, or any device-related serious injury to the manufacturer (or, if the manufacturer is unknown, to the FDA) within 10 days of the event. Device user facilities are not required to report device malfunctions that would likely cause or contribute to death or serious injury if the malfunction were to recur but may voluntarily report such malfunctions through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

The FDA also has the authority to require the recall of commercialized medical device products in the event of material deficiencies or defects in design or manufacture. The authority to require a recall must be based on an FDA finding that there is a reasonable probability that the device would cause serious adverse health consequences or death. Manufacturers may, under their own initiative, recall a product if any distributed devices fail to meet established specifications, are otherwise misbranded or adulterated under the FDCA, or if any other material deficiency is found. The FDA requires that certain classifications of recalls be reported to the FDA within ten working days after the recall is initiated.

The failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

● warning letters, fines, injunctions or civil penalties;

● recalls, detentions or seizures of products;

● operating restrictions;

● delays in the introduction of products into the market;

● total or partial suspension of production;

● delay or refusal of the FDA or other regulators to grant 510(k) clearance, PMA approvals, or other marketing authorization to new products;

● withdrawals of marketing authorizations; or

● in the most serious cases, criminal prosecution.

To ensure compliance with regulatory requirements, medical device manufacturers are subject to market surveillance and periodic, pre-scheduled and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of subcontractors.

~~Federal Trade~~Lock-up ~~Commission Regulatory Oversight~~Agreements

~~Our~~Each ~~advertising~~of ~~for~~ our ~~products~~officers, directors and ~~services~~each of their isrespective ~~subject~~affiliates toand ~~federal~~associated ~~truth-in-advertising~~partners ~~laws~~have ~~enforced~~agreed bywith the ~~Federal~~placement ~~Trade~~agent ~~Commission~~to ~~(the~~be ~~“FTC”)~~subject asto ~~well~~a aslock-up ~~comparable state~~period ~~consumer~~of ~~protection~~90 ~~laws.~~days ~~Under~~ following the ~~Federal~~date ~~Trade~~of ~~Commission~~this ~~Act~~prospectus. ~~(the~~This ~~“FTC~~means ~~Act”)~~that, during the ~~FTC~~applicable islock-up ~~empowered~~period, ~~among~~such ~~other things,~~persons tomay ~~(a)~~not ~~prevent~~offer ~~unfair~~for ~~methods~~sale, ofcontract ~~competition~~to sell, ~~and~~sell, ~~unfair~~distribute, orgrant ~~deceptive~~any ~~acts~~option, right or ~~practices~~warrant into purchase, pledge, hypothecate or ~~affecting~~otherwise ~~commerce;~~dispose ~~(b)~~of, ~~seek~~directly ~~monetary~~or indirectly, ~~redress~~any ~~and~~shares ~~other~~of ~~relief~~our ~~for~~common ~~conduct~~stock ~~injurious~~or toany ~~consumers;~~securities ~~and~~convertible ~~(c)~~into, ~~gather~~or ~~and~~exercisable ~~compile~~or ~~information~~exchangeable ~~and~~for, ~~conduct~~shares ~~investigations~~of ~~relating~~our common stock. Certain tolimited ~~the~~transfers ~~organization,~~are ~~business,~~permitted ~~practices,~~during ~~and~~the ~~management~~lock-up ofperiod ~~entities~~if ~~engaged~~the intransferee ~~commerce.~~agrees ~~The~~to ~~FTC~~these ~~has~~lock-up ~~very~~restrictions. ~~broad~~We ~~enforcement~~have ~~authority~~also agreed, ~~and~~in ~~failure~~the toplacement ~~abide~~agency byagreement, ~~the~~to ~~substantive~~similar ~~requirements~~lock-up ofrestrictions on the ~~FTC~~issuance ~~Act~~ and ~~other~~sale ~~consumer~~of ~~protection~~our ~~laws~~securities ~~can~~from ~~result~~the indate ~~administrative~~of orthis prospectus ~~judicial~~for ~~penalties,~~a ~~including~~period ~~civil~~of ~~penalties,~~45 ~~injunctions~~days ~~affecting~~following the ~~manner~~closing inof ~~which~~this weoffering, ~~would~~subject beto ~~able~~certain toconditions ~~market~~and ~~services~~exceptions. orThe ~~products~~placement agent may, in ~~the~~its ~~future~~sole discretion and without notice, orwaive ~~criminal~~the ~~prosecution~~terms of any of these lock-up agreements.

~~Healthcare~~Additionally, pursuant to the placement agency ~~Law~~agreement, subject to certain conditions and exceptions, ~~Regulation~~we agreed that from the date of such agreement until 45 days following the closing date of this offering, we will not affect or enter into an agreement to effect any issuance by us or our subsidiaries of common stock or common stock equivalents (or a combination of units thereof) involving a Variable Rate Transaction (as defined in such placement agency agreement).

~~United States~~Transfer Agent and Registrar

~~If our~~The ~~MODD1~~transfer ~~product~~agent ~~candidate or our other future product candidates are approved in the United States, we will have to comply with various U.S. federal~~ and ~~state~~registrar ~~laws,~~for ~~rules~~our ~~and regulations pertaining to healthcare fraud and abuse, including anti-kickback laws and physician~~common ~~self-referral~~stock ~~laws,~~is ~~rules~~Colonial ~~and~~Stock ~~regulations.~~Transfer ~~Violations of the fraud and abuse laws are punishable by criminal and civil sanctions~~Company, ~~including, in some instances, exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid~~Inc. ~~These laws include the following:~~

●Determination the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of anOffering ~~individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;~~Price

●Our ~~the~~common ~~federal~~stock ~~False~~is ~~Claims~~currently ~~Act~~traded ~~imposes~~on ~~civil~~The ~~penalties,~~Nasdaq Capital ~~and~~Market ~~provides~~under ~~for~~the ~~civil~~symbol ~~whistleblower~~“MODD.” orOn ~~qui~~February ~~tam actions~~19, ~~against individuals or entities for knowingly presenting~~2026, ~~or causing to be presented, to~~ the ~~federal~~closing ~~government,~~price ~~claims~~of ~~for~~our ~~payment~~common ~~that~~stock ~~are~~was ~~false~~$0.5091 per orshare. We ~~fraudulent~~do ornot ~~making~~intend ~~a false statement~~ to ~~avoid,~~apply ~~decrease~~for orlisting ~~conceal~~of anthe ~~obligation~~warrants toon ~~pay~~any ~~money~~securities toexchange ~~the~~or ~~federal~~other ~~government;~~trading system.

●The ~~the~~public ~~federal~~offering ~~Health~~price ~~Insurance~~of ~~Portability~~the ~~and~~securities ~~Accountability~~offered by ~~Act~~this ofprospectus ~~1996,~~will orbe ~~HIPAA,~~determined ~~imposes~~by ~~criminal~~negotiation ~~and~~between ~~civil~~us ~~liability~~and ~~for~~the ~~executing~~placement aagent. ~~scheme~~Among tothe ~~defraud~~factors ~~any~~that ~~healthcare~~will ~~benefit~~be ~~program~~considered orin determining ~~making~~the ~~false~~public ~~statements~~offering ~~relating to healthcare matters;~~price:

● ~~HIPAA,~~our ashistory ~~amended by the Health Information Technology for Economic~~ and ~~Clinical~~our Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health informationprospects;

● the ~~federal~~industry ~~false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement~~ in ~~connection~~which ~~with~~we ~~the delivery of or payment for healthcare benefits, items or services~~operate;

● ~~the~~our ~~federal~~past ~~transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices, biologics~~ and ~~medical~~present ~~supplies~~operating covered by Medicare or Medicaid to report, on an annual basis, to the Department of Health and Human Services information related to payments and other transfers of value to physicians, teaching hospitals, and certain advanced non-physician health care practitioners and physician ownership and investment interestsresults; ~~and~~

● ~~analogous~~the ~~state~~previous ~~and~~experience ~~foreign~~of ~~laws~~our ~~and~~executive ~~regulations,~~officers; ~~such as state anti-kickback~~ and ~~false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers.~~

●

the general condition of the securities markets at the time of this offering.

~~Some state~~The ~~laws~~public ~~require~~offering ~~pharmaceutical~~price orstated ~~medical~~on ~~device~~the ~~companies~~cover page toof ~~comply~~this ~~with~~prospectus ~~the~~should ~~relevant~~not ~~industry’s~~be ~~voluntary~~considered ~~compliance~~an ~~guidelines and~~indication of the ~~relevant~~actual ~~compliance~~value ~~guidance~~of ~~promulgated~~the byshares ~~the~~of ~~federal~~common ~~government~~stock or warrants sold in ~~addition~~this offering. That price is subject to ~~requiring~~change ~~drug~~as a result of market conditions and ~~device~~other ~~manufacturers~~factors ~~to report~~and ~~information~~we ~~related~~cannot toassure ~~payments~~you tothat ~~physicians~~the shares of common stock and ~~other~~warrants ~~health~~sold ~~care~~in ~~providers~~this offering can be resold at or ~~marketing~~above ~~expenditures~~the public offering price.

~~State and~~Tail foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. We also may be subject to, or may in the future become subject to, U.S. federal and state, and foreign laws and regulations imposing obligations on how we collect, use, disclose, store and process personal information. Our actual or perceived failure to comply with such obligations could result in liability or reputational harm and could harm our business. Ensuring compliance with such laws could also impair our efforts to maintain and expand our customer base and thereby decrease our future revenues.Financing

~~The European~~Upon ~~Union~~a ~~approves~~closing, ~~the~~or ~~use~~if ofthe ~~medical~~engagement ~~devices~~period inends prior to a ~~very~~closing ~~different~~(other ~~way.~~than ~~They~~a ~~have~~termination ~~similar~~for ~~regulations~~“cause”), ~~and~~then ~~requirements~~if towithin ~~adhere to,~~three ~~however~~months afollowing ~~Notified~~such ~~Body~~time, inwe ~~the~~complete ~~form~~any financing of aequity, ~~private company~~equity-linked, ~~will~~convertible ~~represent~~or ~~their~~debt ~~interests~~or ~~and~~other iscapital ~~required~~raising toactivity ~~have~~with, ~~sufficient~~or ~~expertise to~~receives ~~review~~any ~~all~~proceeds ~~applications~~from, ~~and~~any of the ~~company’s~~investors ~~internal~~contacted ~~processes~~or tointroduced ~~ensure~~by the ~~safety~~placement ofagent during the ~~product~~engagement ~~for~~period, ~~which~~then ~~approval~~we iswill ~~being requested.~~pay Wethe ~~are~~placement inagent upon the closing ~~process~~ of ~~identifying~~such afinancing ~~Notified~~or ~~Body~~receipt toof ~~represent~~such ~~us,~~proceeds ~~and~~the wecompensation ~~will~~equivalent ~~follow our FDA submission process with regard~~ to ~~preparing~~ the ~~materials~~commission ~~and~~paid ~~processes~~as ~~required~~part toof ~~meet~~this ~~the regulations and gain clearance~~offering.

European Union

EEA

In the European Economic Area, (which is comprised of the 27 member states of the European Union plus Norway, Iceland and Liechtenstein), or EEA, manufacturers of medical devices need to comply with the Essential Requirements laid out in Annex I to the EU Medical Devices Directive (Council Directive 93/42/EEC) or with the General Safety and Performance Requirements (GSPR) of the new EU Medical Devices Regulation (EU 2017/745). Compliance with these requirements is a prerequisite to be able to affix the CE mark to medical devices, without which they cannot be marketed or sold in the EEA. To demonstrate compliance with the Essential Requirements and the GSPR and obtain the right to affix the CE Mark, manufacturers of medical devices must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I with no measuring function and which are not sterile), where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the Essential Requirements and the GSPR, a conformity assessment procedure requires the intervention of a Notified Body, which is an organization designated by a competent authority of an EEA country to conduct conformity assessments. Depending on the relevant conformity assessment procedure, the Notified Body would audit and examine the Technical File and the quality system for the manufacture, design and final inspection of the devices. The Notified Body issues a CE Certificate of Conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the Essential Requirements and GSPR. This Certificate entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity. As a general rule, demonstration of conformity of medical devices and their manufacturers with the Essential Requirements and GSPR must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

All manufacturers placing medical devices into the market in the EEA must comply with the EU Medical Device Vigilance System. Under this system, incidents must be reported to the relevant authorities of the member states of the EEA, and manufacturers are required to take Field Safety Corrective Actions, or FSCAs, to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. An incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient or user or of other persons or to a serious deterioration in their state of health. An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its customers and/or to the end users of the device through Field Safety Notices. Where appropriate, our products commercialized in Europe are CE marked and classified as either Class I or Class II.

In 2017, the European Parliament passed the Medical Devices Regulation, which repeals and replaces the EU Medical Devices Directive. Unlike directives, which must be implemented into the national laws of the EEA member states, the regulations would be directly applicable (i.e., without the need for adoption of EEA member State laws implementing them) in all EEA member states and are intended to eliminate current differences in the regulation of medical devices among EEA member States. The Medical Devices Regulation, among other things, is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and in vitro diagnostic devices and ensure a high level of safety and health while supporting innovation.

The Medical Device Regulation was meant to become applicable three years after publication (in May 2020). However, in April 2020, to allow EEA national authorities, notified bodies, manufacturers and other actors to focus fully on urgent priorities related to the COVID-19 pandemic, the European Council and Parliament adopted Regulation 2020/561, postponing the date of application of the Medical Device Regulation by one year. The Medical Device Regulation became applicable on May 26, 2021. Devices lawfully placed on the market pursuant to the EU Medical Devices Directive prior to May 26, 2021 may generally continue to be made available on the market or put into service until May 26, 2025. The Medical Devices Regulation, among other things:

● strengthens the rules on placing devices on the market and reinforces surveillance once they are available;

● establishes explicit provisions on manufacturers' responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

● improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

● sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and

● strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

Available Information

Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to such reports filed or furnished pursuant to section 13(a) or 15(d) of the Securities Exchange Act of 1934, as well as section 16 reports on Form 3, 4, or 5, are available free of charge on our website at www.modular-medical.com. as soon as it is reasonably practicable after they are filed or furnished with the SEC. Our Code of Business Conduct and Ethics and the charters for the Audit Committee, Compensation Committee and Nominating and Governance Committee are also available on our website. The Code of Business Conduct and charters are also available in print to any stockholder upon request without charge. Requests for such documents should be directed to James Sullivan, at Modular Medical, Inc., 10740 Thornmint Road, San Diego CA 92127. Our Internet website and the information contained on it or connected to it are not part of, or incorporated by, reference into this prospectus. Our filings with the SEC are also available on the SEC’s website at http://www.sec.gov.

Corporate History and Background

We were formed as a corporation under the laws of the State of Nevada in October 1998 under the name Bear Lake Recreation Inc. We had no material business operations from 2002 until July 2017, when we acquired Quasuras, Inc., a Delaware corporation (“Quasuras”), in the Acquisition (as defined below). Prior to the Acquisition, and, since at least 2002, we were a shell company, as defined in Rule 12b-2 promulgated under the Securities Exchange Act of 1934 (the “Exchange Act”).

The Control Block Acquisition. On April 26, 2017, pursuant to a Common Stock Purchase Agreement, dated as of April 5, 2017, by and among Manchester Explorer, LP, a Delaware limited partnership, we and certain persons named therein, Manchester Explorer, LP purchased from us 966,667 shares of our common stock, representing a number of shares in excess of a majority of our then issued and outstanding common stock, for a purchase price of $375,000 (the “Control Block Acquisition”), resulting in a change in control of the Company. In connection with the Control Block Acquisition, James E. Besser was appointed president and a director and Morgan C. Frank was appointed the chief executive officer, chief financial officer, secretary, treasurer and a director of ours and immediately following such appointments, our then officers and directors resigned. Mr. Besser is the managing member of and Mr. Frank is the portfolio manager and a consultant to Manchester Management Company, LLC, a Delaware limited liability company also referred to herein as MMC. MMC is the general partner of Manchester Explorer, LP and Jeb Partners, L.P. (Jeb Partners, and together with Manchester Explorer, LP, collectively, the Purchasing Funds).

The Acquisition. On July 24, 2017, pursuant to a Reorganization and Share Exchange Agreement, by and among us, Paul M. DiPerna, the sole officer, director and a controlling stockholder of Quasuras, Messrs. Besser and Frank (Messrs. Besser, Frank and DiPerna, collectively, the “3 Quasuras Shareholders”), and Quasuras (the “Share Exchange Agreement”), we acquired all of the issued and outstanding shares of Quasuras owned by the 3 Quasuras Shareholders, resulting in Quasuras becoming our wholly-owned subsidiary (the “Acquisition”). Simultaneously with the closing of the Acquisition, Manchester Explorer, LP cancelled the 2,900,000 shares of our common stock purchased in the Control Block Acquisition, Mr. Besser resigned as our president and a director and Mr. Frank resigned as our chief executive officer, chief financial officer, secretary, and treasurer, but remained a director, and Mr. DiPerna was appointed our chairman of the board of directors, chief executive officer, chief financial officer, secretary and treasurer. Mr. DiPerna served as our chief executive officer until August 2021.

Subsidiaries

Quasuras, Inc., a Delaware corporation, is our only subsidiary.

Properties

In January 2023, we entered into a new lease agreement with a 48-month term, effective February 1, 2023, pursuant to which we leased approximately 24,000 square feet of a building located in San Diego, California. We occupied this space in March 2023, as the lease for our former corporate facility in San Diego, California expires June 30, 2023. In addition to the minimum lease payments under these leases, we are responsible for property taxes, insurance and certain other operating costs under. We believe that our existing facilities are adequate to meet our current needs.

Corporate Information

We are a Nevada corporation. Our corporate headquarters and operating facilities are located at 10740 Thornmint Road, San Diego, CA 92127 Our telephone number is (858) 800-3500. We maintain a website at www.modular-medical.com.

MANAGEMENT

The following table sets forth information on our executive officers and directors as of April 24, 2023. The term for each of our directors is generally three years or until their successors are duly elected and qualified. We do not have any promoters or control persons.

Name	Age	Position
James Besser	47	Chief Executive Officer
Paul DiPerna	64	Chief Financial Officer, President, Treasurer and Director (Chairman of the Board of Directors)
William J. Febbo(1)	54	Director
Steven Felsher(2)(3)	74	Director
Morgan C. Frank	50	Director
Philip Sheibley(2)(3)	64	Director
Carmen Volkart(1)(2)	62	Director
Ellen O’ Connor Vos	67	Director

(1)	Member of Compensation Committee
(2)	Member of Audit Committee
(3)	Member of Nominating and Governance Committee

Family Relationships

There are no family relationships between or among any of our officers and members of our Board of Directors.

The principal occupations and positions for at least the past five years of our directors are described below. There are no family relationships among any of our directors or executive officers.

James “Jeb” Besser. Mr. Besser has served as our chief executive officer since February 23, 2022 and combines over 25 years of experience in alternative investments, strategic advisory, corporate strategy and corporate governance. Since 1999, he has been a Managing Member at Manchester Management Company, LLC (“Manchester”), an investment management firm. Mr. Besser is also currently a director of River Stone Biotech, a development stage specialty bioprocessing company. He holds a B.A. in history from Brown University. We believe that Mr. Besser is qualified to serve as member of our board of directors due to his extensive prior experience conducting financial analysis of public companies (certain of which were in the development stage), including such public companies’ management teams, products, including products in the development stage, the potential markets for such products and other factors that could affect the likelihood and timing of success and market penetration of such entities’ products as well as his capital raising activities. We believe this provides us with valuable insights into the financial markets and investment criteria of institutional and other investors as well as capital raising activities.

Paul DiPerna. Mr. DiPerna has been our chairman, chief financial officer, president and treasurer since we acquired Quasuras in July 2017. He also served as our chief executive officer from July 2017 until August 2021, and as our Secretary from July 2017 to October 2021. In 2015, he founded Quasuras, an early-stage medical device company developing an insulin pump product, and, until its acquisition by us, he served as its chief executive officer and chairman. Prior to that, Mr. DiPerna founded Fuel Source Partners, LLC to incubate early stage medical device products and accumulate technical talent. Our current pump product was one of such proposed products and was spun-out to Quasuras in 2015. From 2012 to 2015, he served as a co-inventor at a private company with property rights in a medical device used for blood borne infection control called the Curos Cap, which was acquired by 3M Corporation. In 2003, Mr. DiPerna founded Tandem Diabetes Care, Inc. (“Tandem”) and held various positions, including as director, chief executive officer and chief technology officer and was primarily responsible for the design concept and development of Tandem’s initial insulin pump. Prior to that, he held executive and management positions at Baxter Healthcare Corporation (“Baxter”) where he was tasked with identifying synergistic opportunities in the diabetes industry. As a result, Mr. DiPerna developed substantial expertise and knowledge in the diabetes industry and led attempts by Baxter to acquire three insulin pump manufacturers. Previously, he held mechanical design engineering positions in the automated test equipment and blood separation sciences industries. Mr. DiPerna holds approximately 70 patents in medical device and microfluidic technology and has achieved numerous product clearances with the FDA. He has also achieved multiple successful exits with previous companies. Mr. DiPerna received a Masters in Engineering Management from Northeastern University and a B.S. in Mechanical Engineering from the University of Massachusetts and has spent over 35 years in the medical-device industry. We believe that Mr. DiPerna is qualified to serve as the chairman of our board of directors due to his extensive knowledge and experience in the medical-device industry generally, and, in particular, with regard to insulin pumps and the diabetes industry, as well as his management and leadership experience from holding director and senior executive positions in other public and private companies and leading project development teams of medical device companies.

William J. Febbo. Mr. Febbo was appointed to our board of directors in January 2020. He is currently the Chief Executive Officer and a director of OptimizeRx Corporation, a digital health company focused on bringing life sciences support to patients and providers, having joined the company in 2016. Since April 2022, he has served as member of the board of directors of Augmedix, Inc., a Nasdaq-listed provider of automated medical documentation and data services. Mr. Febbo founded Plexuus, LLC, a payment processing business for medical professionals in September 2015 and remained its Chairman from September 2015 to December 2020. From April 2007 to September 2015, he served as Chief Operating Officer of Merriman Holdings, Inc., an investment banking firm, where he assisted with capital raises in the technology, biotechnology, clean technology, consumer and resources industries. Mr. Febbo was a co-founder of, and from September 2013 to September 2015 served as Chief Executive Officer of, Digital Capital Network, Inc. a transaction platform for institutional and accredited investors. He was a co-founder of, and from January 1999 to September 2015 was Chief Executive Officer of, MedPanel, LLC, a provider of market intelligence and communications for the pharmaceutical, biomedical, and medical device industries. Since 2017, Mr. Febbo has been a faculty member of the Massachusetts Institute of Technology’s linQ program, which is a collaborative initiative focused on increasing the potential of innovative research to benefit society and the economy. Since 2004, he has been a board member of the United Nations Association of Greater Boston, a resource for the citizens of Greater Boston on the broad agenda of critical global issues addressed by the United Nations and its agencies. He holds a B.A. in international studies and Spanish from Dickinson College. We believe that Mr. Febbo is qualified to serve on our board of directors because of his wealth of experience in building and managing health services and financial businesses. Mr. Febbo brings more than 20 years of experience in building and managing health services and financial businesses.

On January 29, 2018, the Financial Industry Regulatory Authority (“FINRA”) accepted a Letter of Acceptance, Waiver and Consent (the “Consent”) submitted by Mr. Febbo. Without admitting or denying the findings, Mr. Febbo consented to the sanctions and to the entry of findings that he permitted Merriman Capital, Inc. to conduct a securities business while below its net capital requirement. From August 2012 to October 2015, he was the Financial and Operations Principal (“FinOp”) for a registered broker-dealer, Merriman Capital, Inc. (“Merriman”). During certain months, while Mr. Febbo was FinOp, FINRA found that certain of Merriman’s net capital filings with FINRA were inaccurate because of the method by which Merriman calculated net capital and that, when corrected, it was retroactively determined that Merriman had operated below its minimum net capital requirements. Mr. Febbo, as FinOp, signed certain of these reports and was thus held responsible. Based on the Consent, in settlement, Mr. Febbo, who was then no longer registered with any broker-dealer, accepted a fine of $5,000, a 10-business day suspension from acting as FinOp for any FINRA member and required to requalify by examination for the Series 27 license before again acting in a FinOp capacity.

Steven Felsher. Mr. Felsher was appointed to our board of directors in November 2021. Mr. Felsher is an experienced executive with respect to finance, administration, governance and other aspects of public and private company management. He has served as a member of the board of directors of Signal Hill Acquisition Corp., a special purpose acquisition company, since March 2021. From August 2018 to July 2020, he served as a member of the board of directors of Sito Mobile, Inc., a publicly-traded company that provided customized, data-driven solutions for brands spanning all forms of media. From January 2011 to June 2019, Mr. Felsher was a senior advisor at Quadrangle Group LLC, a private investment firm focused on the information and communications technology sectors. He spent a substantial portion of his career with Grey Global Group Inc., a global marketing services company, where he served as a senior executive from 1979 until 2007, most recently as vice chairman and chief financial officer. He holds a BA in classical Greek from Dickinson College and a J.D. from Yale University School of Law. We believe that Mr. Felsher is qualified to serve on our board of directors because of his extensive business experience with administration, governance, capital allocation and other aspects of public and private company management.

Morgan C. Frank. Mr. Frank was appointed to our board of directors in April 2017. In August 2022, he was appointed as chairman of the board of directors of SANUWAVE Health, Inc., a publicly-traded provider of wound-care products. Mr. Frank has worked with Manchester, LP since May 2002, and, prior to such time, he was a founder and managing director at First Principles Group, a boutique consultancy and principal investor specializing in corporate restructuring, restarts, intellectual property assessment and salvage, and spin outs. Prior to such time, Mr. Frank spent approximately five years as an analyst and portfolio manager at Hollis Capital, a San Francisco based hedge fund and prior thereto, Mr. Frank worked for an independent private client group at Paine Webber specializing in primary research to develop investment ideas (particularly short sale ideas) for institutional clients. Prior to his employment at Paine Webber, Mr. Frank was a currency trader for Eastern Vanguard. Mr. Frank holds a BA in Economics and in Political Science from Brown University. We believe that Mr. Frank is qualified to serve as member of our board of directors due to his extensive prior experience conducting financial analysis of public companies (certain of which were in the development stage), including such public companies’ management teams, products, including products in the development stage, the potential markets for such products and other factors that could affect the likelihood and timing of success and market penetration of such entities’ products as well as his capital raising activities. We believe this provides us with valuable insights into the financial markets and investment criteria of institutional and other investors as well as capital raising activities.

Philip Sheibley. Mr. Sheibley was appointed to our board of directors in November 2021. Mr. Sheibley is an experienced executive and venture capitalist. Since 2011, he has served as a principal at Alumni Investment Partners, a private equity firm. From 1981 to 2010, Mr. Sheibley served as a management and technology consultant with Accenture, where he focused on the life sciences area, holding a variety of leadership positions, including North American industry director for life sciences and global lead for management consulting. Mr. Sheibley holds a B.S. in industrial and systems engineering with a business minor from Lehigh University. We believe that Mr. Sheibley is qualified to serve on our board of directors because of his extensive business experience in the life sciences area and experience with venture capital investment and consulting, including financing transactions for early-stage and scale-up stage companies, assisting with scale-up strategy/execution, and participating as a board member in the medical products industry.

Carmen Volkart. Ms. Volkart was appointed to our board of directors in December 2019. She has served as chief financial officer of Natureworks LLC, an advanced materials company offering a portfolio of renewably-sourced polymers, since October 2018. Ms. Volkart served as a member of the board of directors, including as a member of the audit committee of Antares Pharma, Inc., a Nasdaq-listed, specialty pharmaceutical company, from October 2021 to May 2022, when it was acquired by another Nasdaq-listed company. From October 2012 to July 2018, she served as chief financial officer and, for a portion of that time, as senior vice president of commercialization for NxThera, Inc., a medical device company pioneering the application of convective radiofrequency thermotherapy to treat endurological conditions. Ms. Volkart served as global chief financial officer of Tornier N.V. from 2010 to 2012, and was chief operating and financial officer, corporate secretary, compliance officer and treasurer of Spine Wave, Inc. from 2006 to 2010. Prior to 2006, she held various executive and financial positions at American Medical Systems, Inc., Medtronic, Inc. and Honeywell, Inc. Ms. Volkart holds a B.S. in accounting from the University of North Dakota and an MBA with a concentration in strategic management from the University of Minnesota. We believe that Ms. Volkart is qualified to serve on our board of directors because of her substantial financial and public-company experience, as she has served as chief financial officer at multiple medical device and other companies.

Ellen O’Connor Vos. Ms. Vos was appointed to our board of directors in May 2021 and served as our chief executive officer from August 2021 until February 23, 2022. Ms. Vos has served as a member of VosHealth LLC since November 2020. Prior to that, she served as the president and chief executive officer of the Muscular Dystrophy Association from October 2017 to November 2020. Previously, Ms. Vos had been chief executive officer of ghg | greyhealth group from 1996 to 2017, and she has been a champion of using digital capabilities to improve the public health. Ms. Vos also serves on the board of OptimizeRX Corporation, a publicly-traded digital health company, and the Jed Foundation, a leading nonprofit dedicated to protecting the emotional health of college students, and was a founding board member of MMRF, a pioneering cancer research foundation. Ms. Vos holds a B.S. in nursing from Alfred University. We believe that Ms. Vos is qualified to serve on our board of directors because of her executive experience and extensive executive skills in digital marketing, commercialization and communications in the healthcare industry.

Involvement in Legal Proceedings

Except as described above with regard to Mr. Febbo, to our knowledge, none of our executive officers or our directors has, during the last ten years:

● had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time;

● been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;

● been found by a court of competent jurisdiction in a civil action or by the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;

● been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or

● been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.

To our knowledge, there are no material proceedings to which any director, officer or affiliate of ours, any owner of record or beneficially of more than 5% of any class of voting securities of us, or any associate of any such director, officer, affiliate of ours, or security holder is a party adverse to us or any of our subsidiaries or has a material interest adverse to us or any of our subsidiaries.

Arrangements for Appointment of Directors and Officers

Pursuant to the Reorganization and Share Exchange Agreement, hereinafter referred to as the Share Agreement, dated as of July 24, 2017, by and among us, Quasuras, Mr. DiPerna and the other stockholders of Quasuras, until July 24, 2022, our board of directors was required to consist of no more than five and no less than two directors of which (i) Manchester Explorer, LP has the right to appoint two directors, pursuant to which Manchester Explorer, LP appointed Mr. Frank and Ms. Volkart, and (ii) Mr. DiPerna, in addition to being our chairman of the board, had the right to appoint two additional directors, pursuant to which he appointed Liam Burns, who resigned from our board of directors in December 2021, and Mr. Febbo. In May 2021, the parties amended the Share Agreement and removed Manchester Explorer, LP’s and Mr. DiPerna’s rights to appoint directors. In addition, the parties agreed that Mr. DiPerna shall remain chairman of our board of directors until July 2022; provided, that in the event Mr. DiPerna resigns or is otherwise replaced as our chief executive officer, Mr. DiPerna shall remain as chairman of our board of directors for an additional period of three years. Following such amendment, our board of directors increased the size of the board to six members and, on May 18, 2021, appointed Ms. Vos as a director to our board.

The DiPerna Employment and Related Agreements

We entered into an employment agreement dated August 1, 2018, with Mr. DiPerna pursuant to which Mr. DiPerna is employed by us as our president for an initial two-year term with automatic one-year renewals. Pursuant to such agreement, we agreed to pay Mr. DiPerna: (i) an annual salary of $200,000 in cash, (ii) $100,000 per year in fully-vested stock options granted monthly at an exercise price determined by our board of directors in its sole discretion and (iii) an annual bonus of $300,000, payable at the discretion of our board of directors, either in shares or in cash. If the board chooses to pay the bonus in shares, such shares will be valued at a price determined by our board of directors. Pursuant to such employment agreement (i) if (a) we terminate Mr. DiPerna’s employment without cause or he resigns with good reason, we will pay Mr. DiPerna a lump sum of $200,000, and (b) we terminate Mr. DiPerna’s employment for cause, we are not obligated to make any severance payment and Mr. DiPerna will receive only his base compensation through the last day of his employment, (ii) upon Mr. DiPerna’s death or disability, he will receive his base compensation through the last day of his employment and will remain eligible for all applicable benefits relative to death or disability pursuant to any plans that we have in place at such time, and (iii) upon a change of control (as defined in the employment agreement), Mr. DiPerna will be paid a lump sum of $100,000 within sixty days of the time at which such change of control takes place.

In May 2020, we amended our employment agreement with Mr. DiPerna to provide that in the event of a change in control:

● within 60 days of the date the change in control occurs, Mr. DiPerna shall be paid by us or our successor in interest a lump sum cash payment equal to 12 months of Mr. DiPerna’s then annual Base Compensation (as defined in the employment agreement); and

● immediately prior to such change of control, any unvested stock options or other unvested securities of ours issued to Mr. DiPerna shall automatically accelerate and immediately become fully vested and exercisable.

In June 2020, our board of directors approved an amendment to the employment agreement to provide that Mr. DiPerna’s base salary would be paid entirely in cash commencing July 1, 2020. The payment of the additional cash component of Mr. DiPerna’s annual base salary ($8,333.33 per month) was initially deferred (the “Deferred Salary”) and accrue for Mr. DiPerna’s benefit until we have received $5,000,000 of cumulative gross proceeds of financing, at which time the Deferred Salary shall be paid to Mr. DiPerna and the salary deferrals will cease. The salary deferrals ceased and the Deferred Salary was paid to Mr. DiPerna in May 2021. In August 2021, Mr. DiPerna resigned as our chief executive officer, and he continues to serve as our president, chief financial officer, treasurer and chairman of our board of directors.

On April 15, 2021, our board of directors authorized a $50,000 bonus for Mr. DiPerna for fiscal 2021.

If a change of control occurred on March 31, 2022, under his employment agreement, Mr. DiPerna would be entitled to the following:

● payment of a lump sum of $300,000 within 60 days of the time at which such change of control takes place; and

● accelerated vesting of 27,778 shares of common stock under an unvested stock option. The value of the shares subject to accelerated vesting is calculated as the intrinsic value per share multiplied by the number of shares that would become fully vested upon a change of control. The intrinsic value per share would be calculated as the excess of the closing price of the common stock of $4.40 on the Nasdaq Capital Market on March 31, 2022 over the exercise price of the option. As of March 31, 2022, the intrinsic value was zero.

In connection with our acquisition of Quasuras, we entered into an Intellectual Property Transfer Agreement dated as of July 24, 2017, with Quasuras and Mr. DiPerna, pursuant to which Mr. DiPerna transferred to us all intellectual property rights owned directly and/or indirectly by him related to our business. Separately, we agreed to pay Mr. DiPerna, as part of his compensation for services to be performed for us, pursuant to a royalty agreement, certain fees based upon future sales, if any, of our potential product subject to a maximum $10,000,000 cap on the aggregate amount of fees that Mr. DiPerna could earn from such arrangement.

The Vos Employment Agreement

On August 11, 2021, we entered into a two-year employment agreement (the “Agreement”) with Ms. Vos for her service as our chief executive officer, and the Agreement renews for one-year terms, unless either party provides the other with 90-day prior written notice of termination. The Agreement provided that Ms. Vos was entitled to total base compensation of $300,000 annually, as follows: a cash salary of $250,000 per year (the “Cash Salary”), plus deferred salary of $50,000 per year (the “Deferred Salary” and, together with the Cash Salary, the “Base Compensation”).

On February 23, 2022, Ellen O’Connor Vos informed the board of directors the Company that she was resigning from her position as chief executive officer of the Company, effective immediately (the “Resignation”). In connection with the Resignation, the Company and Ms. Vos entered into a Severance and Release Agreement dated February 23, 2022 (the “Separation Agreement”). Pursuant to the Separation Agreement, Ms. Vos is entitled to receive separation payments in an aggregate gross amount of $375,000. Under the terms of the Separation Agreement, the vesting of an option to purchase 362,452 shares of the Company’s common stock, which was granted to Ms. Vos on August 11, 2021, ceased on May 24, 2022 and the remaining unvested shares were forfeited.

James Besser

As compensation for his services as Chief Executive Officer, Mr. Besser is paid de minimis compensation of $1.00 per year.

Communications with our Board of Directors

Stockholders who desire to communicate with the board of directors, or a specific director, may do so by sending the communication addressed to either the board of directors or any individual director, c/o Modular Medical, Inc., 10740 Thornmint Road, San Diego, California 92127. These communications will be delivered to the board of directors, or any individual director, as specified.

Corporate Governance

Director Independence

Our Board has undertaken a review of the independence of our directors and considered whether any director has a material relationship with us that could compromise his or her ability to exercise independent judgment in carrying out his or her responsibilities. As a result of this review, our board of directors has determined that William Febbo, Steven Felsher, Philip Sheibley and Carmen Volkart are “independent directors,” as defined under the rules of Nasdaq.

Board Leadership Structure and Role in Risk Oversight

Due to the small size and early stage of the Company, we have not adopted a formal policy on whether the chairman and chief executive officer positions should be separate or combined. Since 2017, Mr. DiPerna has been serving as our chairman, and, since February 23, 2022, Mr. Besser has been serving as our chief executive officer. Our board of directors has oversight responsibility for our risk management processes. Our board of directors receives and reviews periodic reports from management, auditors, legal counsel, and others, as considered appropriate, regarding our assessment of risks. Our board of directors will focus on the most significant risks facing us and our general risk management strategy, and also ensure that risks undertaken by us are consistent with our appetite for risk. While our board of directors oversees our risk management processes, management is responsible for day-to-day risk management processes. We believe this division of responsibilities is the most effective approach for addressing the risks facing us and that the leadership structure of our board of directors supports this approach.

We have established an audit committee, a compensation committee, and a nominating and governance committee. Each committee’s members and functions are described below.

Audit Committee

Our board of directors established the audit committee (the “Audit Committee”) for the purpose of overseeing the accounting and financial reporting processes and audits of our financial statements. The Audit Committee also is charged with reviewing any internal control violations under our whistleblower policy. The responsibilities of our audit committee are described in the Audit Committee Charter adopted by our board of directors, a current copy of which can be found on the investors section of our website, www.modular-medical.com.

Ms. Volkart, Mr. Felsher and Mr. Sheibley are the current members of the Audit Committee. Mr. Felsher serves as the chairperson and has been designated by the board of directors as the “audit committee financial expert,” as defined by Item 407(d)(5) of Regulation S-K under the Securities Act and the Exchange Act. That status does not impose duties, liabilities or obligations that are greater than the duties, liabilities or obligations otherwise imposed on her as a member of the audit committee and the board of directors, however. Our board of directors has determined that each of our Audit Committee members satisfies the “independence” requirements of the Nasdaq listing rules and meets the independence standards under Rule 10A-3 under the Exchange Act.

Compensation Committee

Our board of directors established the compensation committee for the purpose of reviewing, recommending and approving our compensation policies and benefits, including the compensation of all of our executive officers and directors. Mr. Febbo and Ms. Volkart are the current members of the compensation committee, and Mr. Febbo serves as the chairperson. Each of our Compensation Committee members satisfies the “independence” requirements of the Nasdaq listing rules and meets the independence standards under Rule 10A-3 under the Exchange Act.

Our compensation committee is responsible for reviewing, recommending and approving our compensation policies and benefits, including the compensation of all of our executive officers and directors, and it also has the principal responsibility for the administration of our equity incentive plan. The responsibilities of our compensation committee are more fully described in the Compensation Committee Charter adopted by our board of directors, a current copy of which can be found on the investors section of our website, www.modular-medical.com.

Nominating and Corporate Governance Committee.

The Nominating and Governance Committee consists of Mr. Sheibley and Mr. Felsher, and Mr. Sheibley serves as the chairperson. Each of the members of our Nominating and Governance Committee satisfies the “independence” requirements of the Nasdaq listing rules and meets the independence standards under Rule 10A-3 under the Exchange Act. The Nominating and Governance Committee will consider persons recommended by stockholders for inclusion as nominees for election to our board of directors if the information required by our bylaws is submitted in writing in a timely manner addressed and delivered to our secretary at the address of our executive offices.

The Nominating and Governance Committee will identify and evaluate nominees for our board of directors, including nominees recommended by stockholders, based on numerous factors it considers appropriate, some of which may include strength of character, mature judgment, career specialization, relevant technical skills, diversity, and the extent to which the nominee would fill a present need on our board of directors. The responsibilities of our Nominating and Governance committee are more fully described in the Nominating and Governance Committee Charter adopted by our board of directors, a current copy of which can be found on the investors section of our website, www.modular-medical.com.

Code of Business Conduct and Ethics for Employees, Executive Officers and Directors

We have adopted a Code of Business Conduct and Ethics, or the Code of Conduct, applicable to all of our employees, executive officers and members of our board of directors. The Code of Conduct is available on our website at www.modular-medical.com. Our Nominating and Governance Committee is responsible for overseeing the Code of Conduct, and our board of directors must approve any waivers of the Code of Conduct. In addition, we intend to post on our website all disclosures that are required by law concerning any amendments to, or waivers from, any provision of the Code of Conduct.

Board Diversity

We seek diversity in experience, viewpoint, education, skill, and other individual qualities and attributes to be represented on our board of directors. We believe directors should have various qualifications, including individual character and integrity; business experience; leadership ability; strategic planning skills, ability, and experience; requisite knowledge of our industry and finance, accounting, and legal matters; communications and interpersonal skills; and the ability and willingness to devote time to our company. We also believe the skill sets, backgrounds, and qualifications of our directors, taken as a whole, should provide a significant mix of diversity in personal and professional experience, background, viewpoints, perspectives, knowledge, and abilities. Nominees are not to be discriminated against on the basis of race, religion, national origin, sex, sexual orientation, disability, or any other basis proscribed by law. The assessment of prospective directors is made in the context of the perceived needs of our board of directors from time to time.

All of our directors have held high-level positions in business or professional service firms and have experience in dealing with complex issues. We believe that all of our directors are individuals of high character and integrity, are able to work well with others, and have committed to devote sufficient time to the business and affairs of our company. In addition to these attributes, the description of each director’s background set forth above indicates the specific qualifications, skills, perspectives, and experience necessary to conclude that each individual should continue to serve as a director of ours.

Executive Compensation

Summary Compensation Table

The following table sets forth compensation information for the years ended March 31, 2022 and 2021 for each of our named executive officers.

Name and Principal Position	Year	Salary ($)			Stock Awards ($)		Option Awards ($)(1)		Non-Equity Incentive Plan Compensation ($)		All Other Compensation ($)			Total ($)
Paul DiPerna, President, Chief Financial Officer,	2022		370,833	(3)		—		—		—		—			370,833
Treasurer and Chairman(2)	2021		200,000			—		25,000		—		50,000	(4)		275,000
James E. Besser, Chief Executive Officer(5)	2022		—			—		—		—		—			—
Ellen O’Connor Vos, Chief Executive Officer(6)	2022		133,654			—		4,414,645		—		409,662	(7)		4,957,961
Stephen Daly, Chief Commercial Officer(8)	2022		59,395			—		—		—		6,046			65,441
	2021		234,000			—		—		—		—			234,000

(1)	Award amounts reflect the aggregate grant date fair value with respect to awards granted, as determined pursuant to FASB ASC Topic 718. The assumptions used to calculate the aggregate grant date fair value of option awards are set forth in the notes to the consolidated financial statements included in this Registration Statement. These amounts do not reflect actual compensation earned or to be earned by our named executive officers.
(2)	From August 2018 until June 30, 2020, Mr. DiPerna’s $300,000 annual salary was paid $200,000 in cash and $100,000 in fully-vested stock options granted monthly.
(3)	Includes payment of $70,833 of deferred salary.
(4)	Earned as a bonus of which $22,000 was paid on April 30, 2021, and the remainder was paid in quarterly installments commencing on July 15, 2021.
(5)	Ms. Besser was appointed our chief executive officer in February 2022 and is paid de minimis compensation of $1.00 per year.
(6)	Ms. Vos was appointed our chief executive officer in August 2021 at an annual cash salary of $250,000 per year plus deferred salary of $50,000 per year. She resigned as our chief executive officer in February 2022. The compensation amounts disclosed in the table above exclude amounts paid to Ms. Vos for her service as a non-employee director.
(7)	Represents payment during fiscal 2022 of i) accrued holiday and vacation pay, ii) deferred salary and iii) three months of salary for the notice period and accrued severance of $300,000 that will be paid in fiscal 2023.
(8)	Mr. Daly became our chief commercial officer in March 2020 at an annual base salary of $250,000. In February 2021, Mr. Daly converted to part time, and his annual base salary was reduced to $125,000. Mr. Daly resigned as our Chief Commercial Officer in September 2021, and we and Mr. Daly entered into a consulting arrangement pursuant to which Mr. Daly provides services to us on a part-time basis.

Outstanding Equity Awards at Fiscal Year-End

The following table shows certain information regarding outstanding equity awards held by our named executive officers as of March 31, 2022.

Name	Number of Securities Underlying Unexercised Options (#) Exercisable			Number of Securities Underlying Unexercised Options (#) Unexercisable		Option Exercise Price($)		Option Expiration Date(1)
Paul DiPerna		1,155	(2)		—		9.48	6/1/2030
		1,169	(3)		—		9.48	5/1/2030
		1,170	(4)		—		9.48	4/1/2030
		1,660	(5)		—		7.44	3/2/2030
		1,745	(6)		—		7.44	2/1/2030
		1,727	(7)		—		7.44	1/1/2030
		1,809	(8)		—		6.75	12/1/2029
		1,811	(9)		—		6.75	11/1/2029
		1,721	(10)		—		6.75	10/1/2029
		1,662	(11)		—		6.75	9/15/2029
		1,666	(12)		—		6.75	8/15/2029
		1,660	(13)		—		6.75	7/15/2029
		1,650	(14)		—		6.75	6/15/2029
		1,677	(15)		—		6.75	5/15/2029
		1,624	(16)		—		6.75	4/15/2029
		1,694	(17)		—		6.75	3/15/2029
		1,641	(18)		—		6.75	2/15/2029
		1,603	(19)		—		6.75	1/15/2029
		1,775	(20)		—		6.75	12/15/2028
		1,775	(21)		—		6.75	11/15/2028
		6,005	(22)		—		1.98	10/15/2028
		6,005	(23)		—		1.98	09/15/2028
		6,005	(24)		—		1.98	08/15/2028
		2,222	(25)		27,778		6.75	11/25/2029

(1) The standard option term is ten years, but all of the options expire automatically unless exercised within 90 days after the cessation of service as an employee, director or consultant.

(2) The option was granted on June 1, 2020, and the shares subject to this option were fully vested on the grant date.

(3) The option was granted on May 1, 2020, and the shares subject to this option were fully vested on the grant date.

(4) The option was granted on April 1, 2020, and the shares subject to this option were fully vested on the grant date.

(5) The option was granted on March 2, 2020, and the shares subject to this option were fully vested on the grant date.

(6) The option was granted on February 1,2020, and the shares subject to this option were fully vested on the grant date.

(7) The option was granted on January 1, 2020, and the shares subject to this option were fully vested on the grant date.

(8) The option was granted on December 1, 2019, and the shares subject to this option were fully vested on the grant date.

(9) The option was granted on November 1, 2019, and the shares subject to this option were fully vested on the grant date.

(10) The option was granted on October 1, 2019, and the shares subject to this option were fully vested on the grant date.

(11) The option was granted on September 15, 2019, and the shares subject to this option were fully vested on the grant date.

(12) The option was granted on August 15, 2019, and the shares subject to this option were fully vested on the grant date.

(13) The option was granted on July 15, 2019, and the shares subject to this option were fully vested on the grant date.

(14) The option was granted on June 15, 2019, and the shares subject to this option were fully vested on the grant date.

(15) The option was granted on May 15, 2019, and the shares subject to this option were fully vested on the grant date.

(16) The option was granted on April 15, 2019, and the shares subject to this option were fully vested on the grant date.

(17) The option was granted on March 15, 2019, and the shares subject to this option were fully vested on the grant date.

(18) The option was granted on February 15, 2019, and the shares subject to this option were fully vested on the grant date.

(19) The option was granted on January 15, 2019, and the shares subject to this option were fully vested on the grant date.

(20) The option was granted on December 15, 2018, and the shares subject to this option were fully vested on the grant date.

(21) The option was granted on November 15, 2018, and the shares subject to this option were fully vested on the grant date.

(22) The option was granted on October 15, 2018, and the shares subject to this option were fully vested on the grant date.

(23) The option was granted on September 15, 2018, and the shares subject to this option were fully vested on the grant date.

(24) The option was granted on August 15, 2018, and the shares subject to this option were fully vested on the grant date.

(25) The option was granted on November 25, 2019, and the shares subject to this option vest monthly over three years commencing January 1, 2020, subject to continued service as an employee, director or consultant.

Employment Agreements

We have entered into our standard form of employment, confidential information and invention assignment agreement with each of our named executive officers. We also have entered into agreements to indemnify our directors and certain executive officers, in addition to the indemnification provided for in our articles of incorporation and bylaws. These agreements, among other things, provide for indemnification of our directors and certain executive officers for many expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by any such person in any action or proceeding, including any action by or in the right of us, arising out of such person’s services as a director or executive officer of ours, any subsidiary of ours or any other company or enterprise to which such person provided services at our request.

Director Compensation

Effective April 1, 2021, our board of directors approved our outside (non-employee) director compensation plan (the “Director Plan”). Pursuant to the Director Plan, outside directors are paid the following annual retainers:

● $25,000 for service as a member of the board of directors;

● $5,000 for service as chair of the audit committee; and

● $5,000 for service as chair of the compensation committee.

The annual retainers will be paid in quarterly installments in either cash, options to purchase shares of our common stock or in shares of our common stock, as directed by each director based on an annual election. In addition, under the Director Plan, each director will also receive an annual service equity award of $100,000 paid in quarterly installments in either options to purchase shares of our common stock or shares of our common stock, as directed by each director based on an annual election.

In addition, upon appointment to our board of directors, we award our non-employee directors a stock option grant under our Amended 2017 Equity Incentive Plan (the “2017 Plan”). During fiscal 2022, we awarded each of the new non-employee directors a stock option to purchase 16,667 shares of our common stock. These options vest annually over three years from the date of appointment to our board of directors.

The following table summarizes the compensation we paid to our non-employee directors for the year ended March 31, 2022:

Name	Fee Compensation ($)		Restricted Stock Awards ($)		Option Awards ($)(1)(2)		All Other Compensation (3)		Total ($)
Liam Burns(4)		18,750		—		222,291		—		241,041
William Febbo		30,000		—		—		100,000		130,000
Steven Felsher(5)		—		—		194,981		8,657		203,638
Morgan Frank		—		—		375,105		—		375,105
Philip Sheibley(5)		8,424		—		169,588		33,696		211,078
Carmen Volkart		—		—		296,423		29,671		326,094
Ellen O’Connor Vos(6)		2,953		—		281,339		—		284,292

(1) Award amounts reflect the aggregate grant date fair value with respect to awards granted, as determined pursuant to FASB ASC Topic 718. The assumptions used to calculate the aggregate grant date fair value of option awards are set forth in the notes to the consolidated financial statements included in this Registration Statement. These amounts do not reflect actual compensation earned or to be earned by our directors.

(2) As of March 31, 2022, our non-employee directors each held outstanding options to purchase the following number of shares of our common stock: William Febbo, 66,667; Steven Felsher, 38,084; Morgan Frank, 100,699; Philip Sheibley, 16,667; Carmen Volkart; 90,558 and Ellen O’Connor Vos, 111,873.

(3) Represents stock awards; we calculated the estimated fair value of the stock awards issued to our non-employee directors using the closing price per share of our common stock on the day prior to the grant date in accordance with the Director Plan.

(4) Mr. Burns resigned as a director on December 31, 2021.

(5) Messrs. Felsher and Sheibley were appointed to our board of directors on November 29, 2021.

(6) Ms. Vos was appointed to our board of directors in May 2021 and as our chief executive officer in August 2021. In February 2022, Ms. Vos resigned as our chief executive officer.

Equity Compensation Plan Information

The following table shows the number of securities to be issued upon exercise or vesting of outstanding equity awards under the 2017 Plan as of March 31, 2022.

Plan Category		Number of securities to be issued upon exercise or vesting of outstanding equity awards (a)				Weighted- average exercise price of outstanding options (b)				Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column(a)) (c)
Equity compensation plans not approved by security holders			1,650,705			$	6.58				989,466

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

Related Party Transactions

Manchester as the general partner of Manchester Explorer, L.P. (“Explorer”), combined with the holdings of its affiliates, JEB Partners LP, Mr. Besser and Mr. Frank, owns approximately 25% of the Company’s outstanding shares of common stock. Mr. Besser is our chief executive officer and a managing member of Manchester. Mr. Frank is one of our directors and serves as the portfolio manager of Explorer and as a managing member of Manchester.

Mr. DiPerna’s daughter is an employee of ours, and, during the year ended March 31, 2022, we paid her $169,589, which includes the aggregate grant date fair value, as determined pursuant to FASB ASC Topic 718, of a stock option granted in November 2021.

In October 2021, we issued a secured promissory note (the “Bridge Note”) to Explorer that provided the Company with a $3,000,000 revolving credit facility with all amounts being drawn down by us thereunder being due and payable, subject to acceleration in the event of a default, on March 15, 2022. Interest at the rate of 12% was payable on each amount drawn down without regard to the draw-down date or the date when interest is paid. During the period from October 2021 to February 2022, we made draws of $2,100,000 on the Bridge Note, and we repaid to Explorer the draws and accrued interest in the amount of $2,352,000 in February 2022.

In October 2021, we sold 12,346 shares of common stock to Mr. DiPerna and 18,519 shares to Ms. Vos at a price per share of $8.10 in a private placement.

In May 2021, Mr. Febbo purchased $200,000 aggregate principal amount of our convertible notes and received a warrant to purchase 23,229 shares of our common stock (the “Director Warrant”). In connection with a public offering of our equity securities in February 2022, the convertible note held by Mr. Febbo was converted into our equity securities. Upon conversion, Mr. Febbo received 45,586 shares of our common stock and a warrant to purchase 45,586 shares of our common stock at an exercise price of $6.60 per share. In addition, the exercise price of the Director Warrant was reduced to $6.00 per share.

In February 2021, Mr. DiPerna and Explorer (the “Related Party Holders”), which is represented by Mr. Frank on our board of directors, purchased $100,000 and $1,000,000, aggregate principal amount of our convertible notes and received warrants to purchase 119,237 and 11,924 shares of our common stock (the “Note Warrants”), respectively. Effective April 30, 2021, the Related Party Holders entered into revocation agreements with the Company pursuant to which their collective $1,100,000 aggregate principal amount of convertible notes and accrued interest of $50,091 were replaced with new convertible notes. In connection with a public offering of our equity securities in February 2022, the convertible notes and accrued interest held by the Related Party Holders were converted into our equity securities and Mr. DiPerna received 23,429 shares of our common stock and a warrant to purchase 23,429 shares of our common stock at an exercise price of $6.60 per share and Explorer received 234,274 shares of our common stock and a warrant to purchase 234,274 shares of our common stock at an exercise price of $6.60 per share. In addition, the exercise prices of the Note Warrants were reduced to $6.00 per share.

See “Management” above for other related party transactions involving our executive officers and directors.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table sets forth certain information as of April 21, 2023 concerning the ownership of our common stock by:

● each stockholder known by us to be the beneficial owner of more than 5% of the outstanding shares of our common stock (currently our only class of voting securities);

● each of our directors;

● each of our executive officers; and

● all directors and executive officers as a group.

Beneficial ownership is determined in accordance with Rule 13d-3 of the Exchange Act, and includes all shares over which the beneficial owner exercises voting or investment power. Shares that are issuable upon the exercise of options, warrants and other rights to acquire common stock that are presently exercisable or exercisable within 60 days of April 21, 2023 are reflected in a separate column in the table below. These shares are taken into account in the calculation of the total number of shares beneficially owned by a particular holder and the total number of shares outstanding for the purpose of calculating percentage ownership of the particular holder. We have relied on information supplied by our officers, directors and certain stockholders and on information contained in filings with the SEC. Except as otherwise indicated, and subject to community property laws where applicable, we believe, based on information provided by these persons, that the persons named in the table have sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them. The percentage of beneficial ownership is based on 10,949,389 shares of common stock outstanding as of April 21, 2023.

Unless otherwise stated, the business address of each of our directors and executive officers listed in the table is 10740 Thornmint Road, San Diego, California 92127.

Name and principal position	Number of Shares Beneficially Owned (Excluding Outstanding Options and warrants)(1)			Number of Shares Issuable on Exercise of Outstanding Options and Warrants(2)			Percent of Class
JEB Partners, L.P.		2,720,577	(3)		653,511			29.08
Manchester Explorer, L.P.		2,720,577	(3)		653,511			29.08
Manchester Management LLC		2,720,577	(3)		653,511			29.08
Sio Capital Management, LLC		689,352	(4)		402,127	(5)		9.62
Directors and officers:
James Besser		2,720,577	(3)		653,511			29.08
Paul DiPerna		2,553,586	(6)		202,012			24.71
Kevin Schmid		—			—			*
William J. Febbo		89,105			135,482			2.03
Steven Felsher		5,877			56,973			*
Morgan C. Frank		2,720,577	(3)		793,469			29.92
Philip Sheibley		21,139			5,556			*
Carmen Volkart		7,085			120,558			1.15
Ellen O’Connor Vos		18,519			124,910			1.30
All current directors and executive officers as a group (9 persons)		5,415,888			1,438,959			59.92

* Represents less than 1%

(1) Excludes shares subject to outstanding options and warrants to acquire common stock that are exercisable within 60 days of April 21, 2023.

(2) Represents the number of shares subject to outstanding options and warrants to acquire common stock that are exercisable within 60 days of April 21, 2023.

(3) Includes (i) 124,750 shares directly held by Mr. Besser, of which: (a) 60,277 shares were received in exchange for Mr. Besser’s shares as a result of our acquisition of Quasuras; (b) 29,630 shares purchased in a private placement in 2018 (the “2018 Placement”) and (c) 34,843 shares were purchased in a private placement in 2020 (the “2020 Placement”); (ii) 2,218,077 held by Manchester Explorer, L.P. of which: (a) 1,515,152 shares were purchased in a private placement in 2017 (the “2017 Placement”), (b) 157,037 shares were purchased in the 2018 Placement, (c) 11,614 were purchased in the 2020 Placement, (d) 300,000 shares were purchased in a public offering in February 2022, and (e) 234,274 shares were acquired upon the conversion of a convertible note in February 2022; (iii) 317,473 shares held by JEB Partners, L.P. of which (a) 252,526 shares were purchased in the 2017 Placement, (b) 53,333 shares were purchased in the 2018 Placement and (c) 11,614 shares were purchased in the 2020 Placement; and (iv) 60,277 shares held by Mr. Frank, which shares were received in our acquisition of Quasuras in exchange for Mr. Frank’s shares of Quasuras. Mr. Besser, as the managing member, and Mr. Frank, as the portfolio manager and consultant of Manchester Management, LLC, (“MMC”) the general partner of Manchester Explorer, L.P. and JEB Partners, L. P., have shared voting and dispositive power over shares held by Manchester Explorer, L.P. and JEB Partners, L.P. The address for Manchester Explorer, L.P is c/o MMC, 2 Calle Candina, No. 1701, San Juan, Puerto Rico 00907.

(4) Based on information reported by Sio Capital Management, LLC (“Sio”) on Schedule 13G filed with the SEC on February 15, 2023. Sio and Sio GP, LLC (the “GP”) act as investment advisor and general partner, respectively, to various clients that are the record owners of the shares of our common stock reported on this Schedule 13G. Because Sio’s investment discretion with respect to such clients is subject to oversight by the GP, the GP may be deemed to be the beneficial owner of the common stock of the Issuer owned by such clients. In addition, both Sio and the GP are controlled by Michael Castor. As such, he may be deemed to control the voting and dispositive decisions with respect to, and therefore be the beneficial owner of, the shares of our common stock. The address for Sio, Sio GP and Mr. Castor is 600 Third Avenue, New York, New York 10016.

(5) These shares are issuable upon exercise of outstanding pre-funded warrants to purchase shares of our common stock. As of April 21, 2023, Sio held 1,348,314 pre-funded warrants to purchase shares of our common stock. Pursuant to the terms of the pre-funded warrants, Sio cannot exercise such pre-funded warrants if Sio would beneficially own, after such exercise, more than 9.99% of the outstanding shares of our common stock. Accordingly, pre-funded warrants to purchase 946,187 shares of our common stock have been excluded from the table above.

(6) Includes (i) 2,000,000 shares directly held by the Paul DiPerna Irrevocable Trust, (ii) 333,334 shares directly held by Mr. DiPerna’s adult daughters, Kelsie DiPerna and Alaria DiPerna, which shares Mr. DiPerna has sole voting power over; (iii) 207,906 shares directly held by the Paul DiPerna Trust, of which 101,010 shares were purchased in the 2017 Placement and 23,429 shares were acquired upon the conversion off a convertible note in February 2022 and (iv) 12,346 shares held by Mr. DiPerna. The 2,000,000 shares held by the Paul DiPerna Irrevocable Trust, 333,334 shares held by Mr. DiPerna’s adult daughters and 73,480 shares held by the Paul DiPerna Trust that were issued in 2017 to Mr. DiPerna in the Control Block Acquisition and transferred to such persons in December 2020 by Mr. DiPerna. Mr. DiPerna is the chairman of our board of directors, and also serves as our president, chief financial officer and treasurer. Mr. DiPerna is the trustee of both the Paul DiPerna Irrevocable Trust and the Paul DiPerna Trust.

DESCRIPTION OF SECURITIES WE ARE OFFERING

We are offering units, with each unit consisting of two shares of common stock and one warrant to purchase one share of our common stock. The units have no stand-alone rights and will not be certificated or issued as stand-alone securities. This offering also includes the offer and sale of the shares of common stock issuable from time to time upon exercise of the warrants.

Common Stock

As of December 31, 2022, we had 10,932,098 shares of common stock issued and outstanding, 7,565,588 shares of common Stock issuable upon exercise of outstanding warrants, and 2,174,198 shares of common stock issuable upon exercise of outstanding stock options.

Under the terms of our certificate of incorporation, holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders, including the election of directors, and do not have cumulative voting rights. The holders of outstanding shares of common stock are entitled to receive dividends out of assets or funds legally available for the payment of dividends of such times and in such amounts as our Board of Directors from time to time may determine. Our common stock is not entitled to pre-emptive rights and is not subject to conversion or redemption. Upon liquidation, dissolution or winding up of our company, the assets legally available for distribution to stockholders are distributable ratably among the holders of our common stock after payment of liquidation preferences, if any, on any outstanding payment of other claims of creditors. The rights, preferences and privileges of holders of common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.

Warrants

The following summary of certain terms and provisions of the warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisions of the warrants, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of warrant for a complete description of the terms and conditions of the warrants.

Duration and Exercise Price. Each warrant offered hereby will have an initial exercise price per share equal to $ . The warrants will be immediately exercisable and will expire on the fifth anniversary of the original issuance date. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price. The warrants will be issued separately from the common stock and may be transferred separately immediately thereafter. One warrant to purchase one share of our common stock will be issued for every two shares of common stock purchased in this offering.

Exercisability. The warrants will be exercisable, at the option of each holder, in whole or in part, by delivering a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the warrants. No fractional shares of common stock will be issued in connection with the exercise of a warrant.

Cashless Exercise. If, at the time a holder exercises its warrants, a registration statement registering the issuance of the shares of common stock underlying the warrants under the Securities Act is not then effective or available and an exemption from registration under the Securities Act is not available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the warrants.

Transferability. Subject to applicable laws, a warrant in book entry form may be transferred at the option of the holder through the facilities of the Depository Trust Company and warrants in physical form may be transferred upon surrender of the warrant to the Warrant Agent together with the appropriate instruments of transfer. Pursuant to a warrant agency agreement between us and the Warrant Agent, the warrants initially will be issued in book-entry form and will be represented by one or more global certificates deposited with The Depository Trust Company (“DTC”) and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.

Exchange Listing. There is no established public trading market for the warrants, and we do not expect a market to develop. In addition, we do not intend to list the warrants on any securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the warrants will be limited.

Right as a Stockholder. Except as otherwise provided in the warrants or by virtue of such holder’s ownership of shares of our common stock, the holders of the warrants do not have the rights or privileges of holders of our common stock, including any voting rights, until they exercise their warrants.

Fundamental Transaction. In the event we consummate a merger or consolidation with or into another person or other reorganization event in which shares of our common stock are converted or exchanged for securities, cash or other property, or we sell, lease, license, assign, transfer, convey or otherwise dispose of all or substantially all of our assets or we or another person acquire 50% or more of our outstanding common shares (each, a “Fundamental Transaction”), then following such Fundamental Transaction the holders of the warrants will be entitled to receive upon exercise of the warrants the same kind and amount of securities, cash or property which the holders would have received had they exercised the warrants immediately prior to such Fundamental Transaction. Any successor to us or surviving entity will assume the obligations under the warrants.

UNDERWRITING

Newbridge Securities Corporation (“Newbridge” or the “underwriter”) is acting as sole underwriter of this offering. We entered into an underwriting agreement with Newbridge with respect to the securities subject to this offering. Subject to the terms and conditions stated in the underwriting agreement dated the date of this prospectus, the underwriter has agreed to purchase, and we have agreed to sell to the underwriter, the number of units shown in the table below.

Underwriter Number of Units Newbridge Securities Corporation Total

The underwriting agreement provides that the obligations of the underwriter to purchase the units included in this offering are subject to approval of legal matters by counsel and to other conditions. The underwriting agreement provides that the underwriter will purchase all of the units if any of them are purchased.

Units sold by the underwriter to the public will initially be offered at the public offering price set forth on the cover of this prospectus. In addition, the underwriter may offer some of the securities to other securities dealers at such price less a concession of $ per unit. After the initial offering of the units, the public offering price or any other term of the offering may be changed by the underwriter.

Underwriting discounts and commissions

We are offering units pursuant to this prospectus. Each unit comprises two shares of common stock and one warrant to purchase one share. The following table shows the effective public offering price per share of common stock and accompanying warrant and total public offering price, underwriting discounts and commissions, and proceeds before expenses to us.

Effective Price Per Share and accompanying Warrant

Total Without Option

Total With Option

Public offering price(1)

Underwriting discounts and commissions(2)

Proceeds, before expenses, to us

(1) Based on a price of $ per unit comprising two shares of common stock and one warrant to purchase one share of common stock.

(2) We have agreed to pay the underwriters a commission of 7% of the gross proceeds of this offering.

Over-Allotment Option

In addition to the discount set forth in the above table, we have granted to the underwriters an option, exercisable not later than 30 days after the date of this prospectus, to purchase up to a number of additional shares of common stock equal to 15% of the shares of common stock included in the units sold in this offering and/or a number of additional warrants equal to 15% of the warrants included in the units sold in this offering, in any combination thereof, firmly committed in this offering at a price of $ per share or $0.01 per warrant to purchase one share of common stock, in each case, less the underwriting discounts and commissions. The underwriters may exercise the option solely to cover over-allotments, if any, made in connection with this offering. If any additional shares of our common stock and/or warrants are purchased pursuant to the over-allotment option, the underwriters will offer these additional shares of our common stock and/or warrants on the same terms as those on which the other shares of common stock and Warrants are being offered hereby.

Underwriter’s Warrants

Upon the closing of this offering, we have agreed to issue to Newbridge, or its designees, warrants (the “underwriter’s warrants”) to purchase a number of shares of common stock equal to an aggregate of 7% of the total shares sold in this public offering. The underwriter’s warrants will be exercisable at a per share exercise price equal to 125% of the public offering price per share of common stock sold in this offering. The underwriter’s warrants are exercisable at any time and from time to time, in whole or in part, during the three and one-half-year period commencing six months after the effective date of the registration statement related to this offering.

We are registering hereby the issuance of the underwriter’s warrants and the shares of common stock issuable upon exercise of such warrants. The underwriter’s warrants and the shares of common stock underlying the underwriter’s warrants have been deemed compensation by the Financial Industry Regulatory Authority, or FINRA, and are therefore subject to a 180-day lock-up pursuant to Rule 5110(g)(1) of FINRA. Neither Newbridge or its permitted assignees under such rule, may sell, transfer, assign, pledge, or hypothecate the underwriter’s warrants or the securities underlying the underwriter’s warrants, nor will Newbridge engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the underwriter’s warrants or the underlying shares for a period of 180 days from the effective date of the registration statement.

Additionally, the underwriter’s warrants may not be sold, transferred, assigned, pledged or hypothecated for a 180-day period following the effective date of the registration statement except to any underwriter and selected dealer participating in this offering and their bona fide officers or partners. The underwriter’s warrants will provide for adjustment in the number and price of the underwriter’s warrants and the shares of common stock underlying such underwriter’s warrants in the event of recapitalization, merger, stock split or other structural transaction, or a future financing undertaken by us.

Lock-Ups

Our officers, directors and holders of more than 5.0% of our outstanding shares of common stock have agreed that, for a period of 90 days from the date of this prospectus, they will not, subject to certain exceptions, offer, pledge, sell, contract to sell, sell any option, right or warrant to purchase, lend or otherwise transfer or dispose, directly or indirectly, any shares of our capital stock or any securities convertible into or exercisable or exchangeable for shares of capital stock without the prior written consent of Newbridge. Additionally, we have also agreed that, for a period of 90 days from the date of this prospectus, we will not, subject to certain exceptions, offer, pledge, sell, contract to sell, sell any option, right or warrant to purchase, lend or otherwise transfer or dispose, directly or indirectly, any shares of our capital stock or any securities convertible into or exercisable or exchangeable for shares of capital stock without the prior written consent of Newbridge. Newbridge, in its sole discretion, may release any of the securities subject to these lock-up agreements at any time without notice.

Nasdaq Capital Market Listing

Our common stock is listed on Nasdaq Capital Market under the symbol “MODD.” There is no established trading market for the warrants, and we do not intend to apply for listing of the Warrants on The Nasdaq Capital Market or on any national securities exchange. Without a trading market, the liquidity of the warrants will be extremely limited.

Expenses and Reimbursements

We estimate that our portion of the total expenses of this offering will be $400,000, which includes the fees and expenses for which we have agreed to reimburse the underwriter, including the fees and disbursements of counsel for the underwriter, in connection with the offering in an amount not to exceed $150,000.

Price Stabilization, Short Positions and Penalty Bids

Until the distribution of shares of common stock in this offering is complete, SEC rules may limit the ability of the underwriter to bid for and purchase shares of our common stock. As an exception to these rules, underwriters are permitted to engage in certain transactions which stabilize the price of the shares of common stock, which may include short sales, covering transactions and stabilizing transactions. Short sales involve sales of shares of common stock in excess of the number of shares to be purchased by the underwriter in the offering, which creates a short position. “Covered” short sales are sales made in an amount not greater than the underwriter’s option to purchase additional shares of common stock from us in the offering. An underwriter may close out any covered short position by either exercising its option to purchase additional shares of common stock or purchasing shares of common stock in the open market. In determining the source of shares of common stock to close out the covered short position, the underwriter will consider, among other things, the price of shares of common stock available for purchase in the open market as compared to the share price at which the underwriter may purchase through its option to purchase additional shares. “Naked” short sales are any sales in excess of such option. The underwriter must close out any naked short position by purchasing shares of common stock in the open market. A naked short position is more likely to be created if the underwriter is concerned that there may be downward pressure on the price of the shares of common stock in the open market after pricing that could adversely affect investors who purchase in the offering. Stabilizing transactions consist of various bids for or purchases of the shares of common stock made by the underwriters in the open market prior to the completion of the offering.

The underwriter may also impose a penalty bid. This occurs when a particular underwriter repays to another underwriter a portion of the underwriting discount received by it because the representative has repurchased shares sold by or for the account of such underwriter in stabilizing or short covering transactions.

Neither we nor the underwriter make any representation or prediction as to the direction or magnitude of any effect that the transactions described above might have on our shares of common stock. Any of these activities may have the effect of preventing or retarding a decline in the market price of our shares of common stock. They may also cause the price of the shares of common stock to be higher than the price that would otherwise exist in the open market in the absence of these transactions. If an underwriter commences any of these transactions, it may discontinue them at any time without notice.

We expect that delivery of the shares will be made to investors on or about , 2023 (such settlement being referred to as “T+2”).

Electronic Distribution

In connection with the offering, the underwriter or any securities dealers may distribute prospectuses by electronic means, such as e-mail.

Other Relationships

~~The~~From ~~underwriter~~time isto atime, ~~full~~the ~~service~~placement ~~financial~~agent ~~institution~~and its ~~engaged~~affiliates ~~in various activities, which~~ may ~~include~~provide ~~securities~~in ~~trading,~~the ~~commercial and investment banking~~future, ~~financial~~various advisory, investment ~~management,~~ ~~principal investment, hedging, financing~~ and ~~brokerage~~commercial ~~activities.~~banking ~~The underwriter~~ and ~~its~~other ~~affiliates~~services ~~may, from time~~ to ~~time, engage in transactions with and perform services for~~ us in the ordinary course of ~~its~~ business, for which itthey ~~may~~will receive customary fees ~~and~~ ~~reimbursement of expenses. In the ordinary course of its various business activities, the underwriter~~ and its affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (which may include bank loans and/or credit default swaps) for its own account and for the accounts of its customers and may at any time hold long and short positions in such securities and instrumentscommissions. ~~Such investments and securities activities may involve securities and/or instruments of ours or our affiliates.~~ The ~~underwriter~~placement ~~and~~agent ~~its affiliates~~ may ~~also~~receive ~~make~~additional ~~investment~~compensation ~~recommendations and/or publish or express independent research views~~ in ~~respect of such securities or financial instruments and may hold, or recommend to clients that they acquire,~~connection ~~long~~with ~~and/or~~advisory ~~short positions in such securities and instruments~~services.

~~Sales Outside the United States~~Indemnification

NoWe ~~action~~have ~~has~~agreed ~~been~~to ~~taken~~indemnify inthe ~~any~~placement ~~jurisdiction (except~~agent inagainst ~~the~~certain ~~United~~liabilities, ~~States)~~including ~~that~~certain ~~would~~liabilities ~~permit~~arising aunder ~~public~~the ~~offering~~Securities ~~of our common stock or accompanying warrants~~Act, or ~~the~~to ~~possession,~~contribute ~~circulation or distribution of this prospectus or any other material relating~~ to uspayments ~~or our common stock in any jurisdiction where action for~~ that ~~purpose~~ ~~is required. Accordingly,~~ the ~~shares of common stock and accompanying warrants may not be offered or sold, directly or indirectly,~~placement ~~and~~agent ~~neither this prospectus nor any other offering material or advertisements in connection with our common stock and accompanying warrants~~ may be ~~distributed~~required orto ~~published,~~make infor orthese ~~from any country or jurisdiction, except in compliance with any applicable rules and regulations of any such country or jurisdiction~~liabilities.

~~The~~Electronic underwriter may arrange to sell the common stock and accompanying warrants offered hereby in certain jurisdictions outside the United States, either directly or through affiliates, where it is permitted to do so. Distribution

73A prospectus in electronic format may be made available on the websites maintained by the placement agent, if any, participating in this offering and the placement agent may distribute prospectuses electronically. Other than the prospectus in electronic format, the information on these websites is not part of this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us or the placement agent, and should not be relied upon by investors.

LEGAL MATTERS

The validity of the shares of common stock and warrants offered byhereby ~~this~~will ~~prospectus~~be ~~has been~~ passed upon for us by Lucosky Bookman LLP, Woodbridge, New Jersey. ~~McGuireWoods~~Ellenoff ~~LLP~~Grossman & Schole LLP is acting as counsel for the ~~underwriters~~placement agent in connection with this offering.

EXPERTS

The consolidated ~~balance~~financial ~~sheets~~statements of Modular Medical, Inc. as of and for the years ended March 31, ~~2022~~2025 and ~~2021~~2024, ~~and~~appearing ~~the~~in ~~related~~Modular ~~consolidated statements of operations~~Medical, ~~changes~~Inc.’s inAnnual ~~stockholders’~~Report ~~equity~~on ~~(deficit)~~Form ~~and~~10-K ~~cash flows~~ for the ~~years~~fiscal ~~then~~year ended March 31, 2025, have been audited by ~~Farber~~Faber Hass ~~Harley~~Hurley LLP., an independent registered public accounting firm, as ~~stated~~set forth in their report therein, which isincludes ~~incorporated~~an ~~herein~~explanatory paragraph regarding the Company’s ability to continue as a going concern. Such consolidated financial statements ~~have~~are ~~been~~ incorporated herein by reference in reliance on upon the report of such firm given ~~upon~~ their authority as experts in ~~accounting~~auditing and ~~auditing~~accounting.

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC, under the Securities Act, a registration statement on Form S-1, ~~including~~relating ~~and~~to ~~schedules, under~~ the ~~Securities Act that registers the offer and sale of the~~ securities tooffered ~~be sold in this offering~~hereby. This prospectus does not contain all of the information set ~~contained~~forth in the registration statement and the exhibits and schedules ~~filed~~ ~~as part of the registration statement~~thereto. For further information with respect to ~~us and~~ our ~~common~~company ~~stock~~ and ~~warrants, we refer you~~ to the ~~registration~~securities ~~statement~~we ~~and~~are ~~the~~offering ~~exhibits~~by ~~and~~this ~~schedules~~prospectus ~~filed~~you asshould ~~part~~refer ofto the registration statement., ~~Statements~~including ~~contained in this prospectus as to~~ the ~~contents~~exhibits ofand ~~any contract or any other document are not necessarily complete~~schedules thereto. IfThe aSEC ~~contract~~also ormaintains ~~document has been filed as~~ an ~~exhibit~~Internet tosite ~~the~~that ~~registration~~contains ~~statement~~reports, weproxy ~~refer~~and ~~you~~information tostatements ~~the~~and ~~copies~~other ofinformation ~~the~~regarding registrants ~~contract~~that orfile ~~document~~electronically ~~that~~with ~~has~~the ~~been filed~~SEC. ~~Each~~The ~~statement in~~SEC’s ~~this~~website ~~prospectus~~address ~~relating to a contract or document filed as an exhibit~~ is ~~qualified in all respects by the filed exhibit~~http://www.sec.gov.

~~You~~We ~~may~~file ~~read~~periodic ~~and~~reports, ~~copy~~proxy ~~all~~statements ~~materials~~and other ~~that~~information ~~we file~~ with the SEC, ~~including~~in accordance with requirements of the ~~registration~~Exchange ~~statement~~Act. ~~and~~These ~~its~~periodic ~~exhibits~~reports, proxy statements and ~~schedules,~~other information onare available at the SEC’s website ~~maintained~~address byreferred ~~the~~to ~~SEC~~above. You may also access our reports and proxy statements free of charge at our website, www.~~sec~~modular-medical.~~gov~~com. ~~Information~~ The information contained on ~~any~~our website ~~referenced~~is innot ~~this~~a prospectus ~~does not~~ and ~~will~~does not constitute a part of this prospectus. orThe ~~the~~prospectus included in this filing is part of a registration statement filed by us with the SEC. The full registration statement oncan ~~Form~~be ~~S-1~~obtained offrom ~~which~~the ~~this~~SEC, ~~prospectus~~as isindicated aabove, ~~part~~or from us. You may request a copy of any of our periodic reports filed with the SEC at no cost, by writing or telephoning us at the following address:

In addition, upon the closing of this offering, we will be subject to the information reporting requirements of the Exchange Act and we will file periodic reports, proxy statements and other information with the SEC. These periodic reports, proxy statements and other information will be available for inspection and copying at the public reference room and the website of the SEC referred to above. We also maintain a website at www.modular-medical.com, at which you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. The information contained in, or that can be accessed through, our website is not a part of, and is not incorporated into, this prospectus. Additionally, you may request a copy of any of our filings with the SEC at no cost, by writing or telephoning us at the following address:

Attn.: CFO

Modular Medical, Inc.

~~10740~~10470 Thornmint Road

San Diego, California 92127

Tel: (858) 800-3500

~~You~~Attention: ~~should~~Chief ~~rely~~Financial only on the information contained in this prospectus or to which we have referred you. We have not and the underwriters have not authorized any person to provide you with different information or to make any representation not contained in this prospectus.Officer

74You should rely only on the information contained in or incorporated by reference or provided in this prospectus. We have not authorized anyone else to provide you with different information. We are not making an offer of these securities in any state where the offer is not permitted. You should not assume the information in this prospectus is accurate as of any date other than the date on the front of this prospectus.

~~INDEX TO FINANCIAL STATEMENTS~~55

	Page
Nine Months ended December 31, 2022 and December 31, 2021
Condensed Consolidated Balance Sheets as of December 31, 2022 (Unaudited) and March 31, 2022	F-2
Condensed Consolidated Statements of Operations for the Three and Nine Months Ended December 31, 2022 and 2021 (Unaudited)	F-3
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Nine Months Ended December 31, 2022 and 2021 (Unaudited)	F-4
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended December 31, 2022 and 2021 (Unaudited)	F-5
Notes to Condensed Consolidated Financial Statements (Unaudited)	F-6
Years ended March 31, 2022 and March 31, 2021
Report of Independent Registered Public Accounting Firm	F-16
Consolidated Balance Sheets as of March 31, 2022 and March 31, 2021	F-18
Consolidated Statements of Operations for the Years Ended March 31, 2022 and March 31, 2021	F-19
Consolidated Statements of Stockholders’ Equity (Deficit) for the Years Ended March 31, 2022 and March 31, 2021	F-20
Consolidated Statements of Cash Flows for the Years Ended March 31, 2022 and March 31, 2021	F-21
Notes to Consolidated Financial Statements	F-22

INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE

FThe SEC allows us to incorporate by reference the information we file with it, which means that we can disclose important information to you by referring you to another document that we have filed separately with the SEC. We hereby incorporate by reference the following information or documents into this prospectus, except for information “furnished” under Item 2.02 or Item 7.01 of Form 8-1K or other information “furnished” to the SEC which is not deemed filed and not incorporated in this prospectus:

~~Modular~~● ~~Medical~~our Annual Report on Form 10-K for the year ended March 31, ~~Inc. Condensed~~2025, ~~Consolidated~~filed ~~Balance~~with ~~Sheets~~the SEC on June 20, 2025;

	December 31, 2022 (Unaudited)			March 31, 2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	7,690,957		$	9,076,372
Prepaid expenses and other		180,164			313,422
Security deposit		100,000			—
TOTAL CURRENT ASSETS		7,971,121			9,389,794
Property and equipment, net		716,409			235,959
Right of use asset, net		51,312			120,693
Security deposit		—			100,000
TOTAL NON-CURRENT ASSETS		767,721			456,652
TOTAL ASSETS	$	8,738,842		$	9,846,446
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable	$	382,080		$	299,951
Accrued expenses		255,545			524,891
Short-term lease liability		77,672			144,857
TOTAL CURRENT LIABILITIES		715,297			969,699
Long-term lease liability		—			39,957
TOTAL LIABILITIES		715,297			1,009,656
Commitments and Contingencies (Note 8)
STOCKHOLDERS’ EQUITY
Preferred Stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding		—			—
Common Stock, $0.001 par value, 50,000,000 shares authorized; 10,932,098 and 10,461,898 shares issued and outstanding as of December 31, 2022 and March 31, 2022, respectively		10,932			10,462
Additional paid-in capital		52,900,066			43,406,099
Accumulated deficit		(44,887,453	)		(34,579,771	)
TOTAL STOCKHOLDERS’ EQUITY		8,023,545			8,836,790
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	8,738,842		$	9,846,446

●

our Definitive Proxy Statement on Schedule DEF 14A filed with the SEC on January 8, 2026;

~~The~~● ~~accompanying~~our ~~notes are~~Quarterly anReport ~~integral~~on ~~part~~Form of10-Q ~~these~~for ~~condensed~~the ~~consolidated~~quarterly ~~financial~~period ~~statements.~~ended June 30, 2025, filed with the SEC on August 14, 2025;

F-2

	●	our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed with the SEC on November 14, 2025;

	●	our Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2025, filed with the SEC on February 17, 2026;

~~Modular~~● ~~Medical~~our Current Reports on Form 8-K filed with the SEC on May 28, ~~Inc.~~2025, July 2, 2025, September 23, 2025, December 11, 2025, December 31, 2025, January 23, 2026, and February 24, 2026; and

~~Condensed~~● ~~Consolidated Statements~~the description of ~~Operations (Unaudited)~~our common stock contained in the “Description of the Registrant’s Securities” filed as Exhibit 4.7 to our Annual Report on Form 10-K for the year ended March 31, 2025, filed with the SEC on June 20, 2025.

	Three Months Ended December 31,						Nine Months Ended December 31,
	2022			2021			2022			2021
Operating expenses
Research and development	$	2,196,546		$	1,849,399		$	6,804,069		$	5,742,911
General and administrative		1,161,351			1,981,665			3,502,029			5,156,152
Total operating expenses		3,357,897			3,831,064			10,306,098			10,899,063
Loss from operations		(3,357,897	)		(3,831,064	)		(10,306,098	)		(10,899,063	)
Other income (expense)		(587	)		4			16			368,876
Interest expense		—			(1,010,247	)		—			(2,204,917	)
Loss on debt extinguishment		—			—			—			(1,321,450	)
Loss before income taxes		(3,358,484	)		(4,841,307	)		(10,306,082	)		(14,056,554	)
Provision for income taxes		—			—			1,600			1,600
Net loss	$	(3,358,484	)	$	(4,841,307	)	$	(10,307,682	)	$	(14,058,154	)
Net loss per share
Basic and diluted	$	(0.31	)	$	(0.76	)	$	(0.95	)	$	(2.22	)
Shares used in computing net loss per share
Basic and diluted		10,925,862			6,354,145			10,863,082			6,331,982

Any information in any of the foregoing documents will automatically be deemed to be modified or superseded to the extent that information in this prospectus or in a later filed document that is incorporated or deemed to be incorporated herein by reference modifies or replaces such information.

~~The~~We ~~accompanying~~also ~~notes~~incorporate by reference any future filings (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are anrelated ~~integral~~to such items unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, including those made (i) on or after the date of the initial filing of the registration statement of which this prospectus forms a part and prior to effectiveness of ~~these~~such ~~condensed~~registration ~~consolidated~~statement, ~~financial~~and (ii) on or after the date of this prospectus but prior to the termination of the offering (i.e., until the earlier of the date on which all of the securities registered hereunder have been sold or the registration statement of which this prospectus forms a part has been withdrawn). Information in such future filings updates and supplements the information provided in this prospectus. Any statements in any such future filings will automatically be deemed to modify and supersede any information in any document we previously filed with the SEC that is incorporated or deemed to be incorporated herein by reference to the extent that statements in the later filed document modify or replace such earlier statements.

FUpon written or oral request, we will provide to you, without charge, a copy of any or all of the documents that are incorporated by reference into this prospectus but not delivered with the prospectus, including exhibits which are specifically incorporated by reference into such documents. Requests should be directed to: Modular Medical, Inc., Attention: Chief Financial Officer, 10470 Thornmint Road, San Diego, California 92127, Tel: (858) 800-33500.

~~Modular Medical, Inc.~~56

~~Condensed~~ Up ~~Consolidated Statements~~to 23,571,007 Shares of ~~Stockholders’~~Common Stock ~~Equity~~and ~~(Deficit) (Unaudited)~~Accompanying

	Common Stock				Additional Paid-In		Common Stock		Accumulated			Stockholders’
	Shares		Amount		Capital		Issuable		Deficit			Equity
Balance as of March 31, 2022		10,461,898	$	10,462	$	43,406,099	$	—	$	(34,579,771	)	$	8,836,790
Shares issued for services		348		—		1,576		—		—			1,576
Issuance of common stock and warrants in equity offering, net		449,438		449		7,371,898		—		—			7,372,347
Issuance of common stock under equity incentive plan		2,664		3		13,747		—		—			13,750
Stock-based compensation		—		—		724,819		—		—			724,819
Net loss		—		—		—		—		(3,498,791	)		(3,498,791	)
Balance as of June 30, 2022		10,914,348	$	10,914	$	51,518,139	$	—	$	(38,078,562	)	$	13,450,491
Issuance of common stock under equity incentive plan		11,375		12		50,368		—		—			50,380
Stock-based compensation		—		—		692,060		—		—			692,060
Net loss		—		—		—		—		(3,450,407	)		(3,450,407	)
Balance as of September 30, 2022		10,925,723	$	10,926	$	52,260,567	$	—	$	(41,528,969	)	$	10,742,524
Issuance of common stock under equity incentive plan		6,375		6		12,737		—		—			12,743
Stock-based compensation		—		—		626,762		—		—			626,762
Net loss		—		—		—		—		(3,358,484	)		(3,358,484	)
Balance as of December 31, 2022		10,932,098	$	10,932	$	52,900,066	$	—	$	(44,887,453	)	$	8,023,545

Common Warrants to Purchase up to 23,571,007 Shares of Common Stock

	Common Stock				Additional Paid-In		Common Stock		Accumulated			Stockholders’
	Shares		Amount		Capital		Issuable		Deficit			Deficit
Balance as of March 31, 2021		6,302,050	$	6,302	$	14,665,559	$	—	$	(15,947,010	)	$	(1,275,149	)
Shares issued for services		20,000		20		172,180		—		—			172,200
Warrants issued with convertible notes		—		—		3,700,632		—		—			3,700,632
Issuance of common stock under equity incentive plan		1,836		2		32,495		—		—			32,497
Stock-based compensation		—		—		623,423		—		—			623,423
Net loss		—		—		—		—		(4,835,091	)		(4,835,091	)
Balance as of June 30, 2021		6,323,886	$	6,324	$	19,194,289	$	—	$	(20,782,101	)	$	(1,581,488	)
Stock-based compensation		3,635		4		862,427		—		—			862,431
Net loss		—		—		—		—		(4,381,757	)		(4,381,757	)
Balance as of September 30, 2021		6,327,521	$	6,328	$	20,056,716	$	—	$	(25,163,858	)	$	(5,100,814	)
Private placement of common stock		30,865		31		249,969		—		—			250,000
Shares issued for services		8,334		8		73,748		—		—			73,756
Shares issuable for services		—		—		—		149,994		—			149,994
Shares issued for reverse stock split		1,211		1		—		—		—			1
Stock-based compensation		5,775		6		1,221,729		—		—			1,221,735
Net loss		—		—		—		—		(4,841,307	)		(4,841,307	)
Balance as of December 31, 2021		6,373,706	$	6,374	$	21,602,162	$	149,994	$	(30,005,165	)	$	(8,246,635	)

~~The~~Up ~~accompanying~~to ~~notes are~~23,571,007 anof ~~integral~~Pre-Funded ~~part~~Warrants ofto ~~these~~Purchase Shares ~~condensed~~of ~~consolidated~~Common ~~financial~~Stock ~~statements.~~and Accompanying

~~F-4~~Common Warrants to Purchase up to 23,571,007 Shares of Common Stock

~~Modular Medical, Inc.~~and

~~Condensed~~Up ~~Consolidated Statements~~to 47,142,014 Shares of ~~Cash~~Common ~~Flows~~Stock Issuable ~~(Unaudited)~~Upon Exercise of the Pre-Funded Warrants and Common Warrants

	Nine Months Ended December 31,
	2022			2021
Net loss	$	(10,307,682	)	$	(14,058,154	)
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on PPP note forgiveness		—			(368,780	)
Loss on debt extinguishment		—			1,321,450
Stock-based compensation expense		2,120,513			2,740,086
Depreciation and amortization		92,616			80,268
Shares issued for services		150,412			388,021
Shares issuable for services		—			149,994
Amortization of lease right-of-use asset		69,381			58,404
Change in lease liability		(107,142	)		(92,826	)
Amortization of debt discount		—			1,454,762
Changes in assets and liabilities:
Other assets and prepaid expenses		(15,577	)		(25,995	)
Accounts payable and accrued expenses		(187,217	)		1,223,983
Net cash used in operating activities		(8,184,696	)		(7,128,787	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property and equipment		(573,066	)		(22,779	)
Net cash used in investing activities		(573,066	)		(22,779	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of common stock and warrants, net		7,372,347			—
Proceed from private placement, net of issuance costs		—			250,000
Proceeds from issuance of convertible notes, net		—			4,137,199
Proceeds from issuance of promissory note		—			1,500,000
Net cash provided by financing activities		7,372,347			5,887,199
Net decrease in cash and cash equivalents		(1,385,415	)		(1,264,367	)
Cash and cash equivalents at beginning of period		9,076,372			1,468,465
Cash and cash equivalents at end of period	$	7,690,957		$	204,098
Supplemental disclosure:
Noncash investing and financing activities:
Fair value of detachable warrants issued with convertible notes	$	—		$	3,700,632

Preliminary Prospectus

~~The accompanying notes~~ ~~are~~, ~~an integral part of these unaudited condensed consolidated financial statements.~~2026

~~F-5~~Sole Placement Agent

~~MODULAR~~Maxim ~~MEDICAL,~~Group ~~INC.~~LLC

~~NOTES~~PART ~~TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)~~II

~~NOTE 1~~INFORMATION ~~– THE~~NOT ~~COMPANY~~REQUIRED ~~AND~~IN ~~SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES~~PROSPECTUS

~~Modular~~ITEM ~~Medical, Inc~~13. ~~(the~~Other ~~Company)~~Expenses ~~was incorporated in Nevada in October 1998 under the name Bear Lake Recreation, Inc. The Company had no material business operations from 2002 until approximately 2017 when it acquired all~~ of ~~the~~Issuance ~~issued~~ and ~~outstanding shares of Quasuras, Inc~~Distribution., a Delaware corporation (Quasuras). As the major stockholder of Quasuras retained control of both the Company and Quasuras, the share exchange was accounted for as a reverse merger. As such, the Company recognized the assets and liabilities of Quasuras acquired in the merger at their historical carrying amounts. Prior to the acquisition of Quasuras and, since at least 2002, the Company was a shell company, as defined in Rule 12b-2 promulgated under the Securities Exchange Act of 1934 (the Exchange Act). In June 2017, the Company changed its name from Bear Lake Recreation, Inc. to Modular Medical, Inc.

The ~~Company is~~following atable ~~development-stage~~sets ~~medical~~forth ~~device company focused on~~ the ~~design,~~fees ~~development~~ and ~~eventual commercialization of an innovative insulin~~expenses ~~pump~~payable toin ~~address~~connection ~~shortcomings~~with ~~and problems represented by~~ the ~~relatively~~registration ~~limited adoption~~ of ~~currently~~the ~~available~~securities ~~pumps for insulin-dependent people with diabetes~~hereunder. ~~The~~All ~~Company~~amounts ~~has~~are ~~developed~~estimates aexcept ~~hardware technology allowing people with insulin-dependent diabetes to receive their daily insulin in two ways, through a continuous “basal” delivery allowing a small amount of insulin to be in~~ the ~~blood~~SEC ~~at all~~registration ~~times~~fee and ~~a “bolus” delivery to address meal time glucose input and to address when the blood glucose level becomes excessively~~ ~~high. By addressing~~ the ~~time~~FINRA ~~and~~filing ~~effort required to effectively treat their condition, the Company believes it can address the less technically savvy, less motivated part of the market~~fee.

In February 2022, the Company completed a public offering of its equity securities, and its common stock was approved to list on the Nasdaq Capital Market under the symbol “MODD” and began trading there on February 10, 2022.

Item	Amount to be paid
SEC registration fee	$	3,314.40
FINRA filing fee	$	4,100.00
Legal fees and expenses	$	200,000
Accounting fees and expenses	$	7,500
Miscellaneous fees and expenses	$	15,085.60
Total	$	230,000

~~Liquidity~~ITEM 14. Indemnification of Directors and Officers.

~~Financial Accounting~~The ~~Standards~~following ~~Board~~summary ~~(FASB)~~is ~~Accounting~~qualified ~~Standard Update (ASU) No. 2014-15 (ASU 2014-15), Going Concern, requires management to evaluate whether there are conditions or events, considered~~ in ~~the~~its ~~aggregate, that raise substantial doubt about the entity’s~~entirety ~~ability~~by reference to ~~continue as a going concern within one year after~~ the ~~date~~complete ~~that~~text ~~the~~of ~~financial~~any ~~statements~~statutes ~~are~~referred ~~issued. If management identifies conditions or events that raise substantial doubt about an entity’s ability~~ to ~~continue~~below asand ~~a going concern, management must consider if there are plans that are probable~~ to beour ~~implemented,~~Amended and ~~whether~~Restated itArticles is probable that the plans will mitigate the conditions or events raising the substantial doubt about the entity’s ability to continue as a going concern. If the substantial doubt is not alleviated after consideration of ~~management’s plans~~Incorporation, ~~the entity must include a statement in the notes to the financial statements indicating that there is substantial doubt about the entity’s ability to continue~~ as ~~a going concern within one year after the date that the~~amended, ~~financial~~and ~~statements are issued including: 1)~~ the ~~principal~~Amended ~~conditions~~and orRestated ~~events~~Bylaws ~~that raise substantial doubt about~~ (the ~~entity’s ability to continue as a going concern, 2~~“Bylaws”) ~~management’s evaluation~~ of the significance of those conditions or events in relation to the entity’s ability to meet its obligations, and 3) management’s plans to attempt to mitigate the conditions or events causing the substantial doubt about the entity’s ability to continue as a going concernCompany.

The Company ~~expects~~ tohas ~~continue~~entered tointo ~~incur~~agreements ~~operating~~with ~~losses for the foreseeable future and incur cash outflows from operations as it continues to invest~~each ~~in the development and subsequent commercialization~~ of its ~~product.~~directors ~~The~~and ~~Company~~executive ~~expects~~officers that, ~~its~~among ~~research~~other ~~and~~things, ~~development~~indemnify ~~and~~them ~~general and~~for ~~administrative~~certain expenses ~~will~~(including ~~continue~~attorneys’ ~~to increase~~fees), ~~and~~ judgments, asfines aand ~~result,~~settlement itamounts ~~will~~incurred ~~eventually~~by ~~need~~them toin ~~generate~~any ~~significant~~action ~~revenue~~or toproceeding, ~~achieve profitability.~~including ~~The~~any ~~Company’s~~action ~~expected~~by ~~operating~~the ~~losses~~Company ~~and~~or ~~cash~~in ~~burn raise substantial doubt about~~ the Company’s ~~ability to~~ ~~continue~~right, asarising aout ~~going concern within one year after the date that these financial statements are issued. Implementation~~ of the ~~Company~~person’s ~~plans~~ ~~and~~services ~~its ability to continue~~ as a ~~going~~director ~~concern~~or ~~will~~officer ~~depend~~of ~~upon~~ the Company’s ~~ability~~or toany ~~raise~~other ~~additional~~company ~~capital, through the sale of additional equity~~ or ~~debt~~enterprise ~~securities,~~ to ~~support its future operations. There can be no assurance that such additional capital,~~which ~~whether in~~ the ~~form~~person ofprovides ~~debt~~services orat ~~equity financing, will be sufficient or available and, if available, that such capital will be offered on terms and conditions acceptable to~~ the Company’s request.

~~F-6~~ITEM 15. Recent Sales of Unregistered Securities.

~~The~~Set ~~Company’s operating~~forth ~~needs~~below ~~include~~is ~~the~~information ~~planned~~regarding ~~costs~~shares of ~~to operate its business, fund working~~ capital ~~and~~stock ~~capital~~issued ~~expenditures.~~by ~~The~~the Company~~’s future~~ ~~capital~~since ~~requirements~~February, ~~and~~2023 ~~the~~that ~~adequacy~~

Filing Compare · Modular Medical, Inc.