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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended: December 31, ~~2024~~2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________ to _____________

Commission File No. 000-41092

FIREFLY NEUROSCIENCE, INC.

(Exact name of registrant as specified in its charter)

Delaware		54-1167364
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

1100 Military Road, Kenmore, NY		14217
(Address of principal executive offices)		(Zip Code)

(888) 237-6412

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		AIFF		Nasdaq Capital Market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

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

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

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Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

~~The~~As ~~registrant~~of ~~was~~June ~~not~~30, a2025 ~~public company as of~~ (the last business day of ~~its~~the registrant’s most recently completed second fiscal quarter ~~and~~), ~~therefore, cannot calculate~~ the aggregate market value of ~~its~~the ~~voting~~registrant’s ~~and~~shares ~~non-voting~~of common ~~equity~~stock, par value $0.0001 per share (“Common Stock”), held by non-affiliates (based upon the closing price of such shares as reported on the Nasdaq Capital Market ) was approximately $31,304,976. Shares held by each executive officer and director and by each person known to have owned more than 10% of the outstanding shares of Common Stock have been excluded from the calculation in that such ~~date~~persons may be deemed to be affiliates of the registrant. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

As of March 25, ~~2025~~2026, there were a total of 1114,~~622~~793,~~952~~075 shares of the registrant’s Common Stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

None.

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FIREFLY NEUROSCIENCE, INC.

Annual Report on Form 10-K

Year Ended December 31, ~~2024~~2025

TABLE OF CONTENTS

PART I

PART I

Item 1.	Business	6
Item 1A.	Risk Factors	20
Item 1B.	Unresolved Staff Comments	47
Item 1C.	Cybersecurity	47
Item 2.	Properties	48
Item 3.	Legal Proceedings	48
Item 4.	Mine Safety Disclosures	48

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	49
Item 6.	[Reserved]	50
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	50
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	61
Item 8.	Financial Statements and Supplementary Data	61
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.	61
Item 9A.	Controls and Procedures	61
Item 9B.	Other Information	62
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	62

PART III

Item 10.	Directors, Executive Officers and Corporate Governance	63
Item 11.	Executive Compensation	67
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	79
Item 13.	Certain Relationships and Related Transactions, and Director Independence	81
Item 14.	Principal Accountant Fees and Services	85

PART IV

Item 15.	Exhibit and Financial Statement Schedules	86
Item 16.	Form 10-K Summary	91

Signatures		92

Item 1.	Business	6
Item 1A.	Risk Factors	21
Item 1B.	Unresolved Staff Comments	50
Item 1C.	Cybersecurity	50
Item 2.	Properties	51
Item 3.	Legal Proceedings	51
Item 4.	Mine Safety Disclosures	51
PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	51
Item 6.	[Reserved]	52
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	52
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	58
Item 8.	Financial Statements and Supplementary Data	58
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.	58
Item 9A.	Controls and Procedures	58
Item 9B.	Other Information	59
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	59
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	59
Item 11.	Executive Compensation	64
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	77
Item 13.	Certain Relationships and Related Transactions, and Director Independence	79
Item 14.	Principal Accountant Fees and Services	84
PART IV
Item 15.	Exhibit and Financial Statement Schedules	85
Item 16.	Form 10-K Summary	88
Signatures		90

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INTRODUCTORY NOTES

Use of Terms

“2024 Plan” means the Firefly Neuroscience, Inc. 2024 Long-Term Incentive Plan, as amended by Amendment No.1 to the Firefly Neuroscience, Inc. 2024 Long-Term Incentive Plan.

“ADHD” means Attention-Deficit/Hyperactivity Disorder

“AI” means artificial intelligence.

“Arena” refers to Arena Business Solutions Global SPC II, Ltd, an exempted company limited by shares incorporated under the laws of the Cayman Islands.

“BNA Platform” means Firefly’s FDA-510(k) cleared Brain Network Analytics software platform.

“Board” means the Board of Directors of Firefly.

“Broker Warrants” means the warrants to purchase shares of Common Stock issued to certain brokers as compensation in connection with certain transactions consummated prior to the Merger.

“Bylaws” means the Amended and Restated Bylaws of Firefly Neuroscience, Inc.

“Charter” means the Amended and Restated Certificate of Incorporation of Firefly Neuroscience, Inc., as amended from time to time.

“Closing Date” means August 12, 2024, the closing date of the Merger.

“Common Stock” means the shares of common stock of Firefly Neuroscience, Inc., par value $0.0001 per share.

“December 2024 Purchase Agreement” means that certain Securities Purchase Agreement, dated as of December 20, 2024, between the Company and Helena.

“EEG” means electroencephalograms.

“Effectiveness Date” means February 6, 2024, the date on which the SEC declared the registration statement on Form S-4 (File No. 333-276649) effective.

“~~ELOC Purchase Agreement~~Evoke” means Evoke ~~that~~Neuroscience ~~Purchase Agreement, dated as of December 20, 2024, by and between the Company and Arena~~Inc.

“Evoke System” means our FDA-510(k) cleared EEG and ERP acquisition hardware

“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended.

“Exchange Ratio” means 0.1040, the ratio in which the shares of WaveDancer Common Stock were converted to shares of Firefly Common Stock.

“FDA” means the U.S. Food and Drug Administration.

“FD&C Act” means the Federal Food, Drug, and Cosmetic Act

“Firefly” means Firefly Neuroscience, Inc., a Delaware corporation (formerly known as WaveDancer, Inc. prior to the consummation of the Merger).

“Firefly System” means Firefly’s FDA-510(k) cleared Brain Network Analytics software platform.

“FFN” or “Merger Sub” means FFN Merger Sub, Inc., a Delaware corporation.

“GAAP” means U.S. generally accepted accounting principles.

“Helena” refers to Helena Special Opportunities LLC, an affiliate of Helena Partners Inc., a Cayman-Islands based advisor and investor.

“Merger” means the reverse merger transaction contemplated by the Merger Agreement.

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“Merger Agreement” means that certain Agreement and Plan of Merger, dated as of November 15, 2023, as amended by that certain Amendment No. 1 on January 12, 2024, and that certain Amendment No. 2 on June 17, 2024, by and among Firefly Neuroscience, Inc. (formerly known as WaveDancer, Inc.), FFN Merger Sub, Inc. and Firefly Neuroscience 2023, Inc. (formerly known as Firefly Neuroscience, Inc.)

“Merger Closing Date” means August 12, 2024, the closing date of the Merger.

“MCI” means Mild Cognitive Impairment

“Nasdaq” means the Nasdaq Capital Market.

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“FFN” or “Merger Sub” means FFN Merger Sub, Inc., a Delaware corporation.

“Firefly” means Firefly Neuroscience, Inc., a Delaware corporation (formerly known as WaveDancer, Inc. prior to the consummation of the Merger).

“PIPE Investors” means the investors signatory to the Securities Purchase Agreement in the Private Placement.

“PIPE Shares” means the shares of Common Stock issued and sold in the Private Placement pursuant to the Securities Purchase Agreement.

“Pre-Funded Warrants” means the pre-funded warrants to purchase up to an aggregate of 504,324 shares of Common Stock at an exercise price of $0.0001 per share, issued to the PIPE Investors in the Private Placement.

“Private Firefly” means Firefly Neuroscience, Inc. a company incorporated under the State of Delaware

“Private Placement” means the private placement transaction contemplated by the Securities Purchase Agreement, which closed on August 12, 2024, simultaneously with the closing of the Merger.

“PTSD” means Post-traumatic stress disorder

“SEC” means the U.S. Securities and Exchange Commission.

“Securities Act” means the U.S. Securities Act of 1933, as amended.

“Securities Purchase Agreement” means that certain Securities Purchase Agreement to purchase shares of Common Stock, Pre-Funded Warrants and Warrants of Firefly, dated as of July 26, 2024, by and between Firefly and the purchasers named therein.

“Series C Financing” means a series of private placement transactions of Series C Units conducted by Private Firefly between October 17, 2023, and June 30, 2024.

“Series C Preferred Stock” means the shares of Series C Preferred Stock, par value $0.0001 per share, issued to investors to Series C Financing.

“Series C Units” means the shares of Series C Preferred Stock and Series C Warrants issued in connection with the Series C Financing.

“Series C Warrants” means the warrants to purchase shares of Common Stock issued as part of the Series C Units to investors in Series C Financing.

“Series D Warrants” means the warrants to purchase shares of Common Stock issued as compensation to certain consultants of Private Firefly for prior consulting services rendered.

“Warrants” means the warrants to purchase up to an aggregate of 823,530 shares of Common Stock at an exercise price of $0.71 per share, issued to the PIPE investors in the Private Placement.

“Warrant Shares” means, collectively, the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants, the Warrants, the Series C Warrants, the Series D Warrants and the Broker Warrants.

“WaveDancer” means WaveDancer, Inc., a Delaware corporation (which was renamed Firefly Neuroscience, Inc. in connection with the Merger).

Note Regarding Trademarks, Trade Names and Service Marks

We use various trademarks, trade names and service marks in our business. For convenience, we may not include the ℠, ® or ™ symbols, but such omission is not meant to indicate that we would not protect our intellectual property rights to the fullest extent allowed by law. Any other trademarks, trade names or service marks referred to in this report are the property of their respective owners.

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Note Regarding Industry and Market Data

We are not responsible for the ~~information~~third-party ~~contained~~industry data cited in this report. This report includes industry and market data that we obtained from independent third-party surveys, market research, publicly available information, reports of governmental agencies and industry publications and surveys. These sources generally state that the information they provide has been obtained from sources believed to be reliable, but that the accuracy and completeness of the information are not guaranteed. The forecasts and projections are based on historical market data, and there is no assurance that any of the forecasts or projected amounts will be achieved. Industry and market data could be wrong because of the method by which sources obtained their data and because information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties. The market and industry data used in this report involve risks and uncertainties that are subject to change based on various factors, including those discussed in Part III. Item 1A. “Risk Factors”. These and other factors could cause results to differ materially from those expressed in, or implied by, the estimates made by independent parties and by us. Furthermore, we cannot assure you that a third party using different methods to assemble, analyze or compute industry and market data would obtain the same results.

Cautionary Note Regarding Forward-Looking Statements

This report contains forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

● fluctuation and volatility in market price of our Common Stock due to market and industry factors, as well as general economic, political and market conditions; ● the availability of and our ability to continue to obtain sufficient funding to conduct planned operations and realize potential profits; ● the impact of dilution on our stockholders, including through the issuance of additional equity securities in the future; ● the impact of our ability to realize the anticipated tax impact of the Merger; ● the outcome of litigation or other proceedings may become subject to in the future; ● delisting of our Common Stock from Nasdaq or the failure for an active trading market to develop; ● the failure of our altered business operations, strategies and focus to result in an improvement for the value of our Common Stock; ● ~~the availability of and~~ our ~~ability to continue to obtain sufficient funding to conduct planned operations and realize potential profits; ● our~~ limited operating history; ● the impact of the complexity of the regulatory landscape on our ability to seek and obtain regulatory approval for ~~its~~the ~~BNA~~Firefly ~~Platform~~System & Evoke Systems, both within and outside of the U.S.; ● challenges that we may face with maintaining regulatory approval, if achieved; ● the ~~impact of the concertation of capital stock ownership with our insiders on stockholders’ ability to influence corporate matters. ● the~~ impacts of future acquisitions of businesses or products and the potential to fail to realize intended benefits of such acquisition; ● the potential impact of changes in the legal and regulatory landscape, both within and outside of the U.S.; ● our dependence on third parties; ● challenges we may face with respect to our ~~BNA~~products ~~Platform~~ achieving market acceptance; ● the impact of pricing of our ~~BNA Platform~~products; ● patient and product variability may produce misleading ~~BNA~~ results ● emerging competition and rapidly advancing technology in our industry; ● our ability to obtain, maintain and protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on its proprietary rights; ● our ability to maintain adequate cyber security and information systems; ● our ability to generate sufficient revenue to achieve and sustain profitability; ● the risk that our significant increased expenses and administrative burdens as a public company could have an adverse effect on our business, financial condition and results of operations; and ● the other factors set forth in the section of this report in Part III. Item 1A. “Risk Factors”.

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In some cases, you can identify forward-looking statements by terms such as “may,” “could,” “will,” “should,” “would,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “project” or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part III. Item 1A. “Risk Factors” and elsewhere in this report. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

The forward-looking statements made in this report relate only to events or information as of the date on which the statements are made in this report. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason.

Summary of Risk Factors

The following is a summary of material risks that could affect our business. This summary may not contain all of our material risks, and it is qualified in its entirety by the more detailed risk factors set forth under Part III. Item 1A. “Risk Factors”.

● We are infacing ~~the~~significant ~~development~~liquidity ~~stage~~risks ~~with~~that ~~minimum~~raise ~~revenues~~substantial ~~and~~doubt about our ability to continue as a going concern. ● We have noengaged, ~~operating~~and ~~history~~may continue to engage, in ~~the~~strategic ~~broad~~acquisitions ~~commercialization~~or oftransactions, ~~medical~~which ~~devices~~could orhave ~~platforms~~a ~~for~~material ~~consumer~~adverse ~~use.~~effect ●on ~~Our~~our ~~financial~~business, ~~statement~~results ~~footnotes~~of operations, financial condition and ~~auditors~~cash ~~opinion~~flows. ~~include~~● ~~disclosure~~We ~~regarding~~may not realize the ~~substantial~~anticipated ~~doubt~~benefits ~~about~~of ~~our~~past ~~ability~~or tofuture ~~continue~~acquisitions asand aintegration ~~going~~of ~~concern~~these acquisitions may disrupt our business. ● WeOur ~~may~~products beand ~~unable~~information technology systems are critical to ~~raise~~our ~~additional~~business. ~~capital~~Issues with product development or enhancements, ~~which~~IT system integration, implementation, updates and upgrades could ~~harm~~disrupt our ~~ability~~operations toand ~~compete.~~have ●a Wematerial ~~are~~impact ~~subject~~on toour business and operating ~~risks~~results. ● Escalation of geopolitical conflicts, including ~~excess~~the orongoing ~~constrained~~conflict ~~capacity~~involving Iran, Israel and ~~operational~~the ~~inefficiencies~~United States, ~~which~~ could adversely affect our ~~results~~operations, ofemployees ~~operations~~and business. ● IfAny wehostilities ~~are~~involving ~~not~~Israel ~~successful~~could inadversely ~~enhancing~~affect ~~awareness~~our operations and results of ~~our~~operations. ~~BNA~~Shelter-in-place ~~platform,~~and ~~driving~~work-from-home ~~adoption~~measures, ~~across~~government-imposed ~~our~~restrictions ~~current~~on ~~target~~movement ~~population~~and travel and ~~expanding~~other ~~the~~precautions ~~population~~taken ofto ~~eligible~~address ~~patients,~~the ~~our~~ongoing ~~sales,~~conflict ~~business,~~may ~~financial~~temporarily ~~condition~~disrupt ~~and~~our ~~results~~employees’ ofability ~~operations~~to ~~will~~effectively beperform ~~negatively~~their ~~affected~~daily tasks. ● Our ~~commercial~~operations ~~success~~depend ~~will~~in ~~depend~~part on ~~the~~third-party ~~future~~software ~~adoption~~platforms ofand ~~the~~artificial ~~BNA~~intelligence ~~platform~~services, ~~into~~and ~~patient~~disruptions ~~work~~to ~~streams~~those inservices, ~~clinics~~including interruptions resulting from government actions or policy decisions, could adversely affect our business. ● If we ~~are~~fail ~~unable~~ to successfully ~~drive~~initiate ~~interest~~our inbroad commercialization program, market and sell our ~~BNA~~products ~~Platform~~cost-effectively, our sales, business, financial condition and results of operations ~~would~~will be ~~harmed~~negatively affected. ● We may be unable to compete successfully with competitive technologies, which could harm our sales, business, financial condition and results of operations. ● Use of our ~~BNA~~platform ~~Platform~~ requires appropriate training and inadequate training may lead to negative clinician experiences, which could harm our business, financial condition, and results of operations. ● We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success. ● We may not be able to achieve or maintain satisfactory pricing and margins for our ~~BNA Platform~~products, which could harm our business and results of operations. ● Future sales of our ~~BNA~~products ~~Platform~~ may depend on healthcare providers’ or patients’ ability to obtain reimbursement from third-party payors, such as insurance carriers. ● Complying with regulations enforced by FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties. ● We may not receive the necessary authorizations to market our ~~BNA~~products ~~Platform~~ or any future new products, and any failure to timely do so may adversely affect our ability to grow our business. ● ~~Since~~Our ~~our~~success ~~BNA~~depends ~~Platform~~in ~~uses~~part ~~cloud-based~~on ~~information~~our ~~systems~~proprietary ~~and~~technology, ~~the exchange of information between patents~~ and ~~doctors,~~if we ~~will~~are beunable ~~subject~~ to ~~numerous~~successfully ~~U.S.~~enforce ~~federal~~our ~~and~~intellectual ~~state~~property ~~laws~~rights, ~~and~~our ~~regulations~~competitive ~~related~~position tomay ~~the~~be ~~privacy~~harmed. ~~and~~● ~~security~~Economic ofand ~~personally~~trade ~~identifiable information~~policy, including ~~health information. ● The implementation of~~ tariffs ~~on foreign countries may increase operating costs~~ and ~~costs~~customs toregulations, ~~acquire necessary equipment ● The formation of the Department of Government Efficiency ("DOGE") may impact the FDA and other agencies that~~ could have a ~~negative~~material ~~impact~~and adverse effect on our ~~product~~business. ~~development~~ ● ~~The~~Since ~~formation of the Department of Government Efficiency ("DOGE") may impact funding~~ our ~~customers~~products ~~rely~~use ~~upon~~cloud-based ●information Ifsystems weand ~~fail~~the toexchange ~~maintain an effective system~~ of ~~internal~~information ~~control~~between ~~over~~patents ~~financial~~and ~~reporting~~doctors, we ~~may~~will ~~not~~ be ~~able~~subject to ~~accurately~~numerous ~~report our financial results or prevent fraud~~U.S. Asfederal aand ~~result,~~state ~~shareholders~~laws ~~could lose confidence in our financial~~ and ~~other~~regulations ~~public~~related ~~reporting,~~to ~~which~~the ~~would~~privacy ~~harm our business~~ and ~~the~~security ~~trading price~~ of ~~our~~personally ~~Common~~identifiable ~~Stock. ● Our success depends in part on our proprietary technology~~information, ~~and~~including ifhealth ~~we are unable to successfully enforce our intellectual property rights, our competitive position may be harmed~~information. ● We use AI in our business, and challenges with properly managing its use could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations. ● ItOur islimited ~~not~~access ~~possible~~ to ~~predict~~sufficient ~~the~~funding ~~actual~~may ~~number~~hinder ofour ~~shares~~ability ~~of the Common Stock we will sell under the ELOC Purchase Agreement~~ to ~~Arena,~~conduct orplanned ~~the~~operations ~~actual~~and ~~gross~~realize ~~proceeds~~potential ~~resulting from those sales~~profits. ● ~~The~~We ~~sale~~may ~~and~~not ~~issuance~~continue ~~of our Common Stock~~ to ~~Arena~~meet ~~will~~the ~~cause~~continued ~~dilution~~listing torequirements ~~our~~of ~~existing shareholders~~Nasdaq, ~~and~~which ~~the sale of Common Stock acquired by Arena or the perception that such sales may occur~~ could ~~cause~~result ~~the~~in ~~price~~a delisting of our Common Stock ~~to fall~~. ● ~~Arena~~If ~~will~~we ~~pay~~fail ~~less~~to ~~than~~maintain ~~the~~an ~~then-prevailing~~effective ~~market~~system ~~price~~of ~~for~~internal ~~the~~control ~~Common~~over ~~Stock~~financial reporting, ~~which~~we ~~could~~may ~~cause~~not ~~the~~be ~~price~~able ~~of the Common Stock~~ to ~~decline.~~accurately ●report ~~Our~~our ~~management~~financial ~~team~~results ~~will~~or ~~have~~prevent ~~broad~~fraud. ~~discretion~~As ~~over~~a ~~the~~result, ~~use~~shareholders ofcould ~~the~~lose ~~net~~confidence ~~proceeds~~in ~~from the sales of~~ our ~~Common~~financial ~~Stock~~and toother ~~Arena,~~public ~~if any~~reporting, ~~and~~which ~~investors~~would ~~may~~harm ~~not~~our ~~agree~~business ~~with how we use the proceeds,~~ and the ~~proceeds~~trading ~~may~~price ~~not~~of beour ~~invested~~Common ~~successfully~~Stock. ● Substantial future sales or issuances of the Common Stock or securities convertible into, or exercisable or exchangeable for, the Common Stock, or the perception in the public markets that these sales or issuances may occur, may depress our stock price. Also, future issuances of the Common Stock or rights to purchase Common Stock could result in additional dilution of the percentage ownership of our shareholders and could cause our stock price to fall.

Table of Contents

PART I

ITEM 1. BUSINESS.

Overview

WeFirefly ~~are~~Neuroscience, an Artificial Intelligence (“AI”) technology company developing innovative neuroscientific solutions with goals to improve brain health outcomes for patients with mental illnesses and neurological disordersInc. ~~Our FDA-510(k) cleared BNA™, or Brain Network Analytics,~~ is an ~~advanced~~artificial ~~neurophysiological~~intelligence ~~assessment~~company ~~tool~~advancing ~~that~~precision ~~uses~~neuroscience, applying AI and ~~machine~~large-scale ~~learning~~electrophysiological ~~to analyze EEG~~ data ~~recorded~~to ~~during~~give ~~rest~~clinicians ~~and~~a ~~cognitive~~more ~~activity.~~complete, ~~It may enhance neurological assessments by providing~~ objective, ~~data-driven~~picture ~~insights that allow for the early and longitudinal detection~~ of ~~neurophysiological~~how ~~deviations.~~an ~~These~~individual ~~insights into brainwave patterns underlying cognitive function may help in tailoring personalized treatment plans and improving~~ patient's ~~outcomes~~brain ~~more~~is ~~effectively than traditional EEG analysis~~functioning.

~~Most~~Firefly ~~neurological~~Neuroscience, ~~disorders affect the neurophysiological state of brain networks~~Inc. ~~BNA™~~is ~~has~~rebuilding the ~~potential~~foundation ~~to detect these subtle changes, aiding the management~~ of ~~various~~how ~~cognitive~~electrophysiological ~~and~~data ~~neurological~~flows ~~disorders~~into ~~where~~clinical ~~cognitive~~decision-making ~~functions~~for ~~are~~brain ~~impacted~~health. ~~This~~We ~~can~~believe ~~include~~the ~~but~~brain is ~~not~~the ~~limited~~most ~~to:~~under-measured ~~Mood~~organ ~~and~~in ~~anxiety~~medicine, ~~disorders as well as neurodevelopmental~~ and ~~neurodegenerative~~that ~~diseases~~the ~~and~~tools ~~brain~~to ~~injuries.~~change ~~While~~this ithave, ~~offers~~until ~~significant benefits in these areas~~now, ~~BNA™~~been isinaccessible ~~may~~to bethe ~~most~~clinicians ~~effective~~who ~~when~~need ~~integrated~~them ~~into a comprehensive diagnostic and treatment approach~~most.

We have ~~taken~~built athe ~~period~~Firefly ofPlatform: 15a ~~years~~vertically ~~and~~integrated ~~an investment of more than $60 million~~hardware, ~~to develop the~~ software, ~~compile~~and ~~the~~data ~~requisite~~infrastructure ~~database~~that ofcaptures ~~brain~~standardized ~~wave~~electroencephalographic ~~tests,~~(EEG) ~~gain patent protection,~~ and ~~receive~~event-related ~~Federal~~potential ~~Drug Administration~~ (~~“FDA”~~ERP) ~~clearance~~assessments toat ~~market and sell~~ the ~~BNA~~point ~~Platform.~~of ~~The~~care, ~~BNA~~analyzes ~~Platform is a software as a medical solution~~ that ~~was~~data ~~developed using AI~~ through ~~unsupervised machine learning (via clustering analysis) on~~ our ~~extensive~~ proprietary ~~database~~analytics ~~of standardized~~engine, ~~high-definition~~and ~~longitudinal~~delivers ~~electroencephalograms (“EEG”) of over 18~~structured,~~000~~ ~~patients~~clinician-ready ~~representing~~reports ~~twelve~~back ~~disorders,~~to ~~as well as clinically healthy normal patients. The AI algorithms underlying~~ the ~~BNA~~provider, ~~platform~~all ~~play~~within a ~~crucial~~single ~~role~~seamless ~~throughout the~~ workflow. byEvery ~~automating~~scan ~~complex~~expands ~~computational~~and ~~tasks~~enriches ~~during~~our ~~the~~database. ~~following~~Every ~~steps~~clinic ofthat ~~data~~joins ~~analysis:~~our ~~(1)~~network ~~data~~increases ~~pre-processing, (2) data segmentation, (3) clustering data, (4) functional modeling of~~ the ~~data~~depth and ~~(5)~~diversity ~~single~~of ~~subject~~our ~~matching and scoring~~data. ~~These~~We ~~algorithms~~describe ~~find~~this ~~and~~compounding ~~measure~~relationship ~~patterns~~between ofclinical ~~brain activity~~deployment, ~~identify locations and measure intensity over time and lastly compare the~~ data ~~generated~~acquisition, ~~to an age-matched normative database. Clustering data further aids in breaking down the dataset by grouping subjects based on EEG outputs~~ and ~~identifying~~report ~~key~~quality ~~characteristics~~as of the ~~cluster~~Firefly ~~such as age, gender, alertness or dominant hand~~Flywheel.

AsOur ofFDA-510(k) ~~the~~cleared ~~date~~Evoke ~~of this filing~~System, ~~the~~commercially ~~BNA~~deployed ~~Platform~~as ~~has~~the ~~been~~Evoke ~~developed~~System, ~~and~~ is in ~~the~~active ~~early~~use ~~stages~~across ofmore athan ~~commercial~~85 ~~launch. We believe there is potential for such commercialization, both with respect to pharmaceutical companies in their drug research and~~ clinical ~~trial~~sites ~~activities, as well as medical practitioners~~ in ~~their clinics. In concert with~~ the commercialization of BNA Platform, we are collaborating with neuroscience drug development companies to support their clinical strategies. We plan to generate revenue through two segments: through the use of BNA Platform by United States ~~health~~as ~~care professionals and through collaborations with pharmaceutical companies in support~~ of ~~neuroscience~~December ~~drug~~31, ~~development~~2025. ~~The~~Clinicians ~~proposed~~use ~~business model for healthcare provider clinics consists of a base service fee for licensing~~ the ~~product~~system ~~and a per use fee based on volume. The proposed business model for pharmaceutical companies will be tailored~~ to ~~each~~perform ~~customer~~EEG ~~based on the volume~~ and ~~costs~~ERP ~~associated to provide such services. In order to commercially launch to the medical community~~assessments, ~~the~~which ~~company~~are ~~has~~analyzed ~~hired~~by ~~sales~~our ~~staff,~~cloud-based ~~conducted~~platform ~~soft launches into a number of strategic accounts~~ and ~~plans~~returned toas ~~continue~~structured ~~marketing~~reports ~~efforts~~designed to ~~secure~~support ~~new~~clinical ~~accounts~~decision-making. InOur ~~the~~subscription-based ~~first~~commercial ~~half~~model ofcreates ~~2025,~~a ~~the~~recurring ~~company~~revenue ~~will~~stream ~~focus~~that onscales ~~targeted outreach and client engagement to commercialize the BNA Platform~~ in ~~the~~lockstep ~~clinics segment. Using its database of potential customers and external lead generating services, the company will identify key targets in select markets and connect~~ with ~~them~~clinical ~~through personalized emails and calls to schedule meetings with decision-makers. The sales team~~utilization, ~~equipped~~meaning ~~with~~that ~~marketing~~the ~~materials,~~more ~~case~~deeply ~~studies,~~clinicians ~~peer-reviewed~~integrate ~~publications,~~electrophysiological ~~and~~assessment ~~knowledge~~into ~~gained~~their ~~from our current research partners~~practice, ~~will present~~ the ~~platform’s~~more ~~benefits~~revenue ~~and~~we ~~practical~~generate ~~applications during these meetings. Follow-up efforts, including addressing questions~~ and ~~offering~~the ~~assistance~~more by our ~~Clinical~~database ~~Support Team, will aim to build strong client relationships and drive adoption of the platform~~grows.

~~The~~Figure ~~clinical~~1: ~~utility~~The ofFirefly ~~EEG~~Flywheel ~~technology~~— toeach ~~support~~clinical ~~better~~assessment ~~outcomes~~simultaneously ~~for~~generates ~~patients~~revenue ~~with mental illnesses~~ and ~~cognitive~~expands ~~disorders~~our ~~has~~proprietary ~~been well documented. Historically~~database, ~~clinical~~compounding ~~adoption of EEG by medical professionals, including psychiatrists, neurologists, nurse practitioners and general practitioners, has been limited due to~~ the ~~complexity~~intelligence of ~~interpreting~~every ~~EEG~~future ~~recordings and the inability to practically compare a patient’s brain electrophysiology to that of a clinically normal age-matched patient~~report. Firefly believes that without defining a standard deviation to the norm, it is not possible to objectively assess brain electrophysiology. By establishing an objective baseline measurement of brain electrophysiology, the BNA Platform enables clinicians to optimize patient care, leading to improved outcomes for people suffering from mental illnesses and cognitive disorders.

Table of Contents

~~Our~~The ~~value~~Problem proposition is supported by real-world use of the BNA Platform. Incorporating the BNA Platform as part of a patient management protocol demonstrated improved response rates, enhanced therapy compliance, reduced non-responder rates and a reduction in need for medication switching among patients. Further, we believe that our extensive clinical database, when combined with advanced AI, provides the opportunity to identify clinically relevant biomarkers that will support better patient outcomes through precision medicine and companion diagnostics. We ~~expect~~Are toSolving gather additional data through the clinical deployments and clinical studies conducted by drug companies. This additional data should allow us to discover new biomarkers and objectively measure the impact of therapeutic interventions on patients of different types, further enhancing our platform’s effectiveness. We believe that we will be able to enhance accurate diagnosis and predict what therapy or drug, or a combination thereof, is best suited to optimize patient outcomes. This represents a paradigm shift in how clinicians manage patients with mental illnesses and cognitive disorders holding the potential to transform brain health.

~~Our~~Clinicians ~~Strategy~~treating neurological and psychiatric conditions have access to a range of assessment tools, including standardized cognitive and behavioral rating instruments such as the Montreal Cognitive Assessment (MoCA), the Mini-Mental State Examination (MMSE), the Generalized Anxiety Disorder scale (GAD-7), and the Patient Health Questionnaire (PHQ-9). These tools provide valuable, reproducible data points and play an important role in clinical evaluation. However, they assess behavior, self-reported symptoms, and observable cognitive performance; they do not directly measure the underlying functional activity of the brain. As a result, clinicians may have a clear picture of how a patient is presenting clinically, but limited visibility into what is occurring at the neural level: which regions of the brain are deviating from expected activity for a patient of that age, and in which direction. The Evoke System is designed to provide exactly this additional layer of insight; to add a direct electrophysiological signal that complements other testing modalities and gives clinicians a more complete biological picture to inform treatment planning.

We ~~are~~believe ~~dedicated~~four tostructural ~~transforming~~problems ~~brain~~define ~~health with~~ the ~~goal~~current state of ~~advancing~~ ~~diagnostic~~brain ~~and~~health ~~treatment approaches for people suffering from neurodegenerative diseases~~diagnostics, ~~disorders,~~ and ~~cognitive impairment and injuries. Firefly’s strategy is to develop state-of-the-art technologies~~ that ~~bridge the gap between neuroscience and clinical practice.~~ Firefly’s next steps to realize this strategy include: Commercially launching the BNA Platform to medical professionals, including neurologists, psychiatrists, nurse practitioners, and general practitioners in the United States. Firefly believes that there are significant clinical, societal, and economic benefits that maybe realized when BNA Platform is ~~used~~uniquely aspositioned ~~part of a regular patient management protocol. Firefly aims~~ to ~~realize~~address ~~these~~each ~~benefits by providing medical professionals and their patients with objective, comparative data~~ of ~~brain~~ ~~electrophysiology. Poor outcomes associated with the treatment of disorders often result from the subjective, trial and error approach to patient treatment.~~them:

~~Firefly~~1. ~~believes~~Adding ~~that~~electrophysiological byinsight ~~providing~~to ~~clinicians~~existing ~~with~~assessments. While ~~the~~standardized ~~ability~~rating toscales ~~compare~~such aas ~~patient’s brain~~the ~~electrophysiology~~MoCA, ~~(as~~MMSE, ~~defined~~GAD-7, byand ~~BNA~~PHQ-9 ~~results~~provide toreproducible ~~its~~and ~~FDA-cleared~~clinically ~~normative~~valuable ~~age-matched~~data, ~~database~~they ~~will~~measure ~~give~~cognitive ~~both~~performance ~~the~~and ~~clinician~~self-reported ~~and~~symptoms ~~the~~rather ~~patient~~than anthe ~~objective~~direct ~~baseline~~electrical ~~comparison~~activity of ~~their~~the brain. ~~electrophysiology~~Electrophysiological ~~that~~assessment ~~could~~captures ~~aid~~what inthese ~~the~~tools ~~diagnosis~~cannot: ~~and~~which ~~optimization~~neural ofcircuits ~~the~~are ~~patient’s~~active, ~~treatment~~how ~~pathway.~~quickly ~~This~~they ~~strategy~~respond, isand ~~supported~~how bya ~~the~~given ~~fact~~patient's ~~that~~brain ~~real-world~~activity ~~clinical~~compares ~~use~~to ofa ~~the~~reference ~~BNA~~group. ~~Platform~~The ~~has~~Evoke ~~shown~~System ~~that,~~adds ~~when~~this ~~used~~direct asbiological ~~part~~signal ofto athe ~~patient~~clinical ~~management protocol~~picture, ~~patients~~helping ~~showed~~clinicians ~~improved~~understand ~~response~~not ~~rates,~~just ~~enhanced~~how ~~therapy~~a ~~compliance,~~patient ~~and~~is ~~reduced~~presenting, ~~non-responder~~but ~~rates~~what ~~and~~is ameasurably ~~reduction~~occurring in ~~the~~their ~~need for medication switching~~brain.

~~There~~2. isPopulation-level acontext ~~strong~~at ~~motivation~~the ~~for~~point ~~medical~~of ~~professionals,~~care. A ~~looking~~clinician toevaluating ~~improve~~a ~~outcomes,~~patient's brain activity in isolation may not have toa ~~integrate~~population-level ~~the~~frame ~~BNA~~of ~~Platform~~reference ~~into~~for ~~their~~what ~~clinics~~they are seeing. ~~The~~Our ~~BNA~~analytics ~~Platform~~platform ~~could~~addresses bethis ~~new~~by ~~recurring~~comparing ~~revenue~~each ~~stream~~patient's ~~opportunity~~electrophysiological ~~for~~data ~~the~~against ~~medical~~a ~~practitioner~~reference ~~while~~group; ~~providing~~giving ~~new~~clinicians a standardized benchmark that reflects what healthy brain activity typically looks like for a patient ~~management~~of ~~strategies~~that age and gender. In ~~addition~~As our database continues to grow, we expect to expand the ~~adoption~~granularity of these reference populations over time, with the ~~BNA~~goal ~~Platform~~of ~~represents~~enabling ancomparisons ~~opportunity~~across toincreasingly ~~offer~~specific aclinical ~~perceived~~subgroups. ~~competitive~~The ~~advantage~~foundation infor ~~their~~that ~~market~~future capability is being built with every assessment performed on our network today.

~~Performing~~3. ~~research~~Late ~~and~~detection ~~clinical~~of ~~studies~~cognitive ~~to identify clinically relevant biomarkers that could support diagnosis~~ and ~~possibly~~neurological ~~identify patients who are most likely to positively respond to a certain drug or treatment~~disease. Many ~~Firefly~~of ~~is continuously improving~~ the ~~BNA~~most ~~Platform~~debilitating byneurological ~~actively~~conditions; ~~analyzing~~including ~~its~~Mild ~~comprehensive~~Cognitive ~~database,~~Impairment ~~which includes clinical and behavioral data~~(MCI), toearly-stage ~~discover~~Alzheimer's ~~biomarkers that may support diagnosis and optimize patient care pathways. In doing so~~disease, ~~Firefly intends to empower the practitioners to apply principles of precision medicine to improve outcomes for people suffering from mental illnesses~~ and ~~cognitive~~prodromal psychiatric disorders.; Byprogress ~~utilizing~~substantially ~~the~~before ~~Company’s~~they ~~ML pipeline to analyze its database, it could be possible to identify patterns (EEG-based biomarkers) that~~ are ~~useful~~clinically ~~for~~detectable ~~predicting~~through ~~treatment~~behavioral ~~outcomes~~observation ~~(predictive biomarkers), predicting disease progression (prognostic biomarkers) and monitoring treatment effects (monitoring biomarkers)~~alone. ~~Leveraging~~Electrophysiological ~~such~~ biomarkers ~~could~~captured ~~inform~~by ~~patient~~EEG ~~selection~~ and ~~stratification~~ERP incan ~~clinical~~surface ~~trials~~neurological inchange ~~a way that could optimize trial design~~earlier, ~~leading~~giving toclinicians ~~improved~~a ~~outcomes~~window ~~while reducing the cost and time it takes~~ to ~~obtain~~intervene ~~approval~~before ~~for~~disease ~~the~~progression ~~drug~~accelerates.

~~Partnering with leading drug development companies in the central nervous system (“CNS”) space in support of clinical research and companion diagnostics~~4. ~~Firefly~~Imprecise istreatment ~~focused on growing its CNS pharmaceutical company partnerships for drug development~~selection. Even ~~Based~~when ona ~~the~~diagnosis ~~work~~is ~~Firefly has done with pharmaceutical companies like Novartis~~established, ~~Takeda~~selecting ~~Pharmaceutical~~the ~~Company~~right ~~Limited,~~treatment ~~Bright~~plan ~~Mind~~often ~~Bioscience~~remains ~~and~~a ~~others,~~process ~~Firefly~~of ~~believes~~elimination. ~~that~~Our ~~EEG~~growing ~~data,~~database ~~processed~~is byenabling the ~~BNA~~identification ~~Platform,~~of ~~may~~electrophysiological besubtypes ~~effective~~within indiagnostic ~~CNS~~categories; ~~drug~~meaning ~~development by providing objectively measured brain activations~~ that ~~indicate~~a ~~normal~~patient's orspecific ~~pathological neuronal processes. The BNA-based~~ EEG/ERP ~~data~~signature may bepredict ~~used~~which astherapy ~~objective~~is ~~endpoints~~most ~~for~~likely ~~pharmacokinetic-pharmacodynamic~~to ~~modelling.~~produce ~~Moreover,~~a bymeaningful ~~measuring electrophysiology commonly associated with cognitive functions~~response, ~~BNA~~potentially ~~biomarkers~~reducing ~~may also assist in understanding~~ the ~~drug’s~~time ~~effects in the cognitive domain~~ and ~~identifying~~cost ~~adverse~~of ~~cognitive events. By enabling a quantitative~~ trial-and-error ~~objective measurement of the change in brain electrophysiology following a treatment, drug developers could further optimize dose selection for next phases of development~~prescribing.

The Firefly System

The Firefly System is a closed-loop system designed to continuously improve with use. It combines three interdependent layers: standardized hardware acquisition through the Evoke System, cloud-based electrophysiological analytics, and a growing proprietary data repository. Each layer reinforces the others, and the system as a whole, we believe, becomes more beneficial with every assessment performed across our network.

Table of Contents

~~Management~~The ~~believes~~Evoke that through integration of the BNA Platform into drug development strategies, CNS pharmaceutical companies may realize significant savings of both cost and time by understanding a drug’s effect better and targeting patients who will respond better to the drug (patient enrichment). Improving patient targeting and effects on patient populations segments could lead to demonstrable improvement in clinical efficacy.System

~~Many~~The ~~new~~Evoke ~~CNS~~System ~~drugs being developed are considered to be high cost, often having annual costs of tens of thousands of dollars. There~~ is ~~considerable~~our ~~resistance~~FDA-510(k) ~~from~~cleared ~~healthcare~~EEG ~~providers, governments,~~ and ~~Insurers~~ERP toacquisition ~~absorb~~hardware ~~the high cost of new CNS drugs without knowing who is most likely to benefit from the drug. Firefly believes that biomarkers represent a significant opportunity for drug development companies~~ and ~~practicing~~associated ~~medical professionals. For drug development companies~~software, ~~conducting~~deployed in clinical ~~trials~~settings ~~with~~across ~~patients who are more likely to respond positively to~~ the ~~drug~~United ~~(patient~~States ~~enrichment)~~under ~~may reduce~~ the ~~clinical~~commercial ~~trial~~brand ~~size~~name ~~required~~Evoke toSystem. ~~show~~The ~~positive~~system ~~clinical~~is ~~outcomes~~purpose-built ~~(efficacy)~~for ~~and~~standardized ~~significantly~~electrophysiological ~~reduce~~assessment ~~the~~in ~~cost and speed of~~ clinical ~~trials.~~environments; ~~Furthermore,~~not ~~the~~limited ~~ability~~ to ~~show~~research ~~increased~~laboratories; ~~efficacy of the drug within a targeted patient group could expedite regulatory approval~~ and ~~provide~~is ~~justification~~designed ~~for the cost of the new drug with payors. In concert with Firefly’s commercialization strategy, medical professionals who integrate the BNA Platform into their clinic maybe able~~ to ~~prescribe~~be ~~the~~operable ~~drug~~by toclinical ~~their~~staff ~~patients~~without ~~who~~specialized ~~will~~neurophysiology ~~benefit the most based on the companion diagnostic criteria~~training.

~~Considering~~The ~~strategic~~Evoke ~~acquisitions.~~System ~~Firefly~~captures ~~may~~brain ~~consider~~activity ~~strategic~~using ~~acquisition~~a ~~opportunities~~19-channel ~~where~~EEG ~~such~~electrode ~~transactions~~array ~~may~~configured ~~accelerate~~according ~~Firefly’s~~to ~~market~~the ~~positioning~~International ~~through~~10-20 ~~horizontal~~system, orthe ~~vertical~~clinical ~~integration~~standard for electrode placement. In addition to the cortical EEG signal, ~~expanding~~the ~~capacity~~system incorporates a Heart Rate Variability (HRV) sensor, orenabling ~~gaining~~simultaneous ~~intellectual~~measurement ~~property~~of ~~that~~autonomic ~~strengthens~~nervous ~~its~~system ~~competitive~~function ~~advantage~~alongside neural activity. This multimodal data capture; cortical EEG across 19 channels plus HRV; provides a richer physiological signal than single-modality approaches, and we believe distinguishes our hardware from more limited EEG-only assessment tools.

~~Firefly~~Figure ~~believes~~2: ~~that~~Evoke itSystem ishardware inconfiguration ~~a position~~— to19 ~~drive~~EEG ~~the~~electrode ~~adoption~~channels of(10-20 ~~objective~~system) ~~assessment~~plus ofintegrated ~~brain~~HRV ~~electrophysiology~~sensor infor ~~clinical~~multimodal ~~practice~~brain ~~by making the BNA Platform accessible to medical professionals in the United States~~ and ~~other~~autonomic ~~countries~~nervous around the world. Initial clinical use of the BNA Platform has demonstrated improvements in patient outcomes. Based on this, Firefly believes that the BNA Platform has the potential to deliver benefits within the healthcare system ~~to a broad range of stakeholders - patients, clinicians, and payors~~measurement.

~~Our~~The ~~Solution~~Evoke System captures two principal categories of electrophysiological data. Resting-state ~~The~~EEG ~~BNA~~records ~~Platform~~spontaneous neural oscillatory activity in the absence of deliberate stimulation, providing a baseline measure of brain network function. Event-Related Potentials (ERPs) are captured during cognitive task paradigms, measuring the brain's time-locked electrical responses to specific stimuli across standardized cognitive task types. Together, resting EEG and ERPs enable assessment of up to 20 distinct cognitive functional measures per session; including early sensory processing, attention, working memory, response inhibition, and executive function.

The standardized nature of the Evoke System's acquisition protocol is a critical design requirement, not merely a technical characteristic. Our ~~Database~~analytics engine compares each patient's data against a reference database. As our database continues to grow, every assessment will add further clinical value. The Evoke System's standardized protocol enables this comparability, ensuring that each record entering our database can meaningfully inform the interpretation of future assessments.

~~The~~Analytics ~~BNA~~Engine ~~Platform~~— isAssessment ~~an FDA 510(k) cleared product~~ and isReporting a direct result of applying data science AI and ML expertise to Firefly’s extensive proprietary database of standardized, high-definition longitudinal EEG recordings of over 18,000 (80,000 BNA assessments) patients spanning 35,000 visits representing twelve disorders, as well as clinically normal patients.

~~Firefly’s~~Electrophysiological ~~proprietary~~data ~~database~~captured ~~will~~by ~~continue~~the toEvoke ~~grow~~System ~~with~~is ~~each~~transmitted ~~use~~to ofour ~~the~~cloud-based ~~BNA~~analytics ~~Platform~~platform infor ~~the~~processing. ~~clinical~~Our ~~and~~proprietary ~~research~~analytics ~~settings,~~engine ~~which,~~analyzes ~~through~~raw ~~its~~EEG ~~application of AI~~ and ~~ML,~~ERP ~~allow~~signals ~~for~~across ~~insights~~captured todimensions ~~continuously evolve~~ and ~~improve~~compares ~~with~~each ~~the~~patient’s ~~goal~~electrophysiological ofprofile ~~continually increasing the value proposition of the BNA Platform~~ to ~~clinicians~~a ~~and~~reference ~~pharmaceutical company clients~~dataset. ~~Firefly~~As ~~believes~~our ~~that~~dataset ~~this~~expands, ~~virtuous~~we ~~cycle~~intend ~~could~~to ~~result~~further instratify ~~future~~and ~~product~~refine ~~development~~reference comparisons, ~~like~~which ~~biomarkers~~may ~~that~~include ~~can~~demographic ~~potentially~~segmentation, ~~drive~~condition-specific ~~the~~cohorts, ~~commercial~~and ~~adoption~~longitudinal ofoutcome ~~the~~data, ~~BNA~~subject ~~Platform~~ to adata ~~wider~~availability ~~universe of medical professionals,~~ and ~~also~~applicable ~~enhance~~regulatory ~~its value proposition to drug development companies~~considerations.

The ~~BNA~~output ~~Platform~~of this analysis is a structured clinical report delivered to the clinician. This report contextualizes the patient's electrophysiological data relative to a reference database, surfacing deviations in signal characteristics that may be relevant to the clinician’s assessment. Reports are delivered through our cloud-based portal and are designed to integrate into clinical workflows.

~~The~~As ~~BNA~~more ~~Platform~~assessments isare ~~intended~~added, ~~for~~ the ~~post-hoc~~database ~~statistical~~becomes ~~analysis~~richer ~~of the human electroencephalogram (EEG), utilizing both resting-state EEG~~ and ~~Event-Related~~more ~~Potentials~~diverse; ~~(“ERP”)~~broadening in a patient’s response to outside stimuli during various states of alertness, disease, diagnostic testing, treatment, surgery, or drug related dysfunction. An ERP is an electrical potential recorded from the ~~nervous~~body ~~system following the presentation~~ of adata ~~stimulus~~against ~~(e.g.,~~which asfuture ~~part~~assessments ofmay abe ~~cognitive~~contextualized ~~task).~~and Ansupporting ~~ERP~~our ~~signal~~longer-term ~~consists~~goal of ~~typical~~developing ~~ERP~~more ~~components~~granular -reference ~~positive~~populations ~~or negative voltage spatiotemporal peaks within the ERP waveform that are measured within one second post-stimulus presentation. Each ERP component reflects the activity of brain networks responsible~~ for ~~different~~specific ~~cognitive~~clinical ~~functions~~subgroups.

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The system consists of the following components: a computer environment; EEG data input software algorithms for BNA calculations; a report generator and a functionality for data transfer and storage. In the first step EEG data is measured using a dedicated, commercially available, and FDA-cleared EEG system, which complies with the BNA Platform specifications. The BNA Platform processes and analyzes the data using Firefly’s ~~BNA~~Database Algorithm (as further described below). Lastly, the results are compiled into individualized reports that provide clinicians with objective insight into brain electrophysiology. Each incremental scan further supports the growth of Firefly’s reference database. The steps are described in further detail below.

~~Figure~~Our 1proprietary database, which includes more than 191,000 standardized EEG and ERP assessment records, represents a significant long-term strategic asset of our business. ~~Overview~~We continue to analyze and expand this dataset to enhance our understanding of electrophysiological patterns associated with cognitive function. Over time, we believe that further analysis of this data may support the ~~BNA~~development ~~Platform~~of ~~Process~~more refined reference populations, including condition-specific cohorts, and may contribute to the identification of potential electrophysiological biomarkers.

~~Measure~~Figure -3: ~~EEG~~Proprietary ~~Data~~database growth — records added quarterly through commercial clinical deployment, research collaborations, and clinical trials

The ~~BNA~~database ~~Platform~~spans isover ~~intended~~12 todistinct ~~analyze~~neurological ~~EEG data recorded at rest (“Resting-EEG”)~~ and ~~during~~psychiatric ~~the~~disorders ~~performance of two conventionally used ERP tasks: the Auditory Oddball (“AOB”)~~ and ~~the~~includes ~~Visual~~records ~~Go-No-Go~~from ~~(“VGNG”).~~more ~~The~~than ~~EEG~~100,000 ~~is recorded continuously while the patient is at rest with eyes-closed or performs one of the ERP tasks~~patients. ~~The~~We ~~acquisition~~believe ~~site~~there ismay ~~asked~~be tovalue ~~provide~~in ~~reliable~~collecting ~~samples~~longitudinal ofdata ~~artifact-free~~that ~~digital~~enables ~~EEG~~analysis ~~for purposes~~ of ~~analysis.~~how ~~After~~electrophysiological ~~the~~signatures ~~recording,~~change ~~the~~with ~~artifact-free~~disease ~~EEG~~progression ~~data is automatically imported into the BNA™ Platform This is useful to clinicians as the information from the Resting-EEG~~ and ~~ERP~~in ~~tasks~~response ~~are complementary~~ to ~~each other in many ways~~treatment. The ~~BNA~~database ~~Platform~~also ~~thus~~includes ~~empowers~~records ~~clinicians~~from byhealthy ~~providing~~individuals ~~them~~across ~~with~~the aage ~~multi-perspective,~~range ~~objective evaluation~~ of ~~the~~12 ~~patient’s~~to ~~brain function in one product~~85.

Figure 2.4: The 12+ neuropsychiatric disorder categories represented in Firefly's proprietary EEG/ERP ~~Data~~database. ~~Inputs~~

~~Analyze~~Each -assessment ~~The~~performed ~~BNA~~at ~~Algorithm~~any site using the Evoke System enters our data pipeline and, subject to appropriate rules and regulations, may be incorporated into our reference database. Commercial deployment and database growth are not separate activities, they are complementary, simultaneously generating subscription revenue and expanding the data asset that makes our platform more valuable over time.

After the recording, the artifact-free EEG data is imported into the BNA Platform and is automatically analyzed by the algorithm (the “BNA Algorithm”). EEG and ERP data quality is assessed through an automatic calculation of various metrics (e.g., correct response, noisy/flat electrodes, length of clean signal, test-retest reliability), followed by a manual review of major issues detected during the previous process.

The BNA Algorithm detects and quantifies the characteristics of EEG and ERP peaks, and behavioral performance: (AOB task: P50, N100, P200, P3a, P3b; VGNG task: P200, N200, P3a, P3b).

EEG spectral analysis – absolute and relative power in delta, theta, alpha and beta frequency bands, and alpha peak frequency.

● Absolute power: the average of the raw PSD within the frequency band of interest, calculated per electrode.

● Relative power: calculated by dividing the power in each frequency band by the total power of all frequencies, per electrode.

● Alpha peak frequency: calculated as the weighted average of the frequency sample points within the alpha band (8-12 Hz), taking the power values as weights, per electrode.

AOB and VGNG Tasks – Event-Related Potential (ERP) and behavioral performance analysis.

● Brain Network Analytics (BNA) is used to detect the following ERP components:

● VGNG: N200, P200, P3a, P3b

● AOB: P50, N100, P200, P3a, P3b

● BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds), and Neural Consistency (1- ERP variability).

● Behavioral performance measurements are extracted from the AOB and VGNG tasks, including mean of accuracy, response times (with standard deviation), omission (missed responses to stimuli that required a response) and commission (incorrect responses to stimuli that did not require a response) errors. These behavioral measures complement the ERP measures in assessing cognitive function and are included in the analysis.

The BNA Algorithm then leverages Firefly’s normative database to extract potentially clinically meaningful clinical information from EEG data.

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~~EEG~~Our ~~recordings~~Commercial ~~are~~Model high-dimensional and complex. This is the result of the dynamic spatiotemporal nature of the neurophysiological signals. For example, the event-related potential wave measured at first, at a relatively focal location in time and space on the scalp, and then it evolves and propagates in the cortex while its amplitude changes simultaneously.

~~Traditional~~We ~~methods~~sell ~~for~~access ~~EEG~~to ~~and ERP analysis follow waveform morphology over time at selected electrode locations, using either time-domain or frequency-domain tools, while neglecting~~ the ~~spatiotemporal~~Firefly ~~dynamics~~Platform ~~associated~~through ~~with~~a ~~the~~tiered ~~electric~~subscription ~~field at the scalp~~model. ~~Moreover,~~Clinics ~~focusing~~pay on a ~~specific~~monthly ~~electrode~~subscription orfee ~~subset~~that ofprovides ~~electrodes,~~access ~~the~~to ~~traditional methods ignore~~ the ~~expected~~Evoke ~~variability~~System, ~~between~~a ~~patients~~defined involume ~~terms~~ of ~~where~~assessments ~~the~~per ~~ERP~~month, ~~component~~and ~~appears~~access ~~on the scalp due~~ to ~~natural~~our ~~differences~~analytics ~~between cortex~~ and ~~scalp~~reporting ~~anatomy~~platform. ~~The~~Assessments ~~aim~~performed ofin ~~the~~excess ~~BNA Algorithm is to improve the accuracy~~ of the ~~ERP~~monthly ~~component~~allotment ~~detection~~are bybilled ~~considering~~at ~~the~~a ~~spatiotemporal~~per-scan ~~nature~~overage ofrate, ~~the~~ensuring ~~signal.~~that Itour ~~achieves~~revenue ~~this~~scales ~~improvement~~proportionally bywith ~~parceling~~clinical ~~the EEG activity into major spatiotemporal events - ERP peaks and their surrounding - spatiotemporal parcels~~utilization.

~~The~~Multiple ~~key~~subscription ~~strengths~~tiers are available to accommodate the diverse utilization profiles of our clinical customers; from individual practitioners performing a modest number of monthly assessments to larger multi-provider clinics or health systems with significantly higher throughput. This structure allows us to serve a broad range of clinical settings while ensuring pricing is calibrated to the ~~BNA~~value ~~Algorithm~~delivered. ~~are:~~As a clinic's utilization grows, the subscription structure encourages migration to higher tiers, providing natural revenue expansion within our existing customer base.

1.Clinical ~~Adaptive~~Applications peak detection - the ERP peaks are detected in a more patient-specific way, by incorporating some degree of freedom in both time and space in a way that is proportional to the normal variability in time and space of the ERP peaks.

2.Supporting ~~Displaying~~Clinical ~~ERP~~Decision-~~peak~~Making location - due to the adaptive peak detection by the BNA Algorithm, the ERP peak is identified and displayed in the BNA report on a topographical map together with the group ERP-peak position. This adds potentially clinically useful information to the physician.

3The Evoke System's primary clinical application is providing an objective electrophysiological layer to complement the assessment tools clinicians already use. ~~Neural~~Standardized instruments such as the MoCA, MMSE, PHQ-~~Consistency~~9, ~~score~~and GAD-7 ~~another~~are ~~unique~~well-established ~~feature~~components of ~~the~~neuropsychiatric ~~BNA~~evaluation, capturing how a patient performs on cognitive tasks and how they report isexperiencing ~~the~~mood, ~~presentation~~anxiety, and daily functioning. The Evoke System adds a direct measurement of the ~~Neural-Consistency~~brain's ~~score~~electrical activity; capturing the speed, amplitude, and pattern of neural responses during rest and cognitive tasks, contextualized against a reference group. ~~Since~~By ~~this~~returning isstructured reports that map a ~~differentiating~~patient's ~~score,~~electrophysiological ~~the~~profile ~~Company~~against ~~will~~our ~~describe~~reference ~~here~~group, ~~shortly~~we ~~what~~give ~~this~~clinicians ~~score~~an isadditional ~~and~~dimension ~~why~~of ~~Firefly~~biological ~~believes~~evidence itto isinform ~~important~~diagnostic and treatment planning decisions.

~~Since~~The ~~the~~database ~~ERP~~includes ~~signal~~over is12 andisorder ~~average~~categories, ofincluding ~~multiple~~depression, ~~single-trial~~anxiety, ~~ERP~~ADHD, ~~signals~~PTSD, ~~which~~MCI, ~~can~~dementia, ~~differ~~Parkinson's ~~largely~~disease, ~~from~~bipolar ~~each~~disorder, ~~other~~schizophrenia, ~~assessing~~schizoaffective ~~the~~disorder, ~~consistency between them may provide complementary functional information to the average measure. As part of the new peak-analysis~~ASD, the algorithm calculates a new score - ‘Neural Consistency’ based on the similarity of the amplitude activation between single-ERP trials. The score is calculated based on averaging the inter-single trials variability of the ERP-peak and ~~its~~traumatic ~~surrounding~~brain ~~points~~injury.

~~Act~~Early -Detection ~~Individualized~~of ~~Reports~~Cognitive Decline

~~The~~We ~~results~~believe a clinically significant application of our platform is the ~~data~~early ~~processed~~identification byof cognitive impairment. Our database includes electrophysiological records spanning the ~~BNA~~spectrum ~~Algorithm~~from ~~are~~clinically ~~compiled~~normal ~~into~~cognition ~~individualized~~through ~~easy-~~Mild Cognitive Impairment (MCI) to confirmed dementia and early Alzheimer's disease. Research utilizing our platform and database; including a peer-~~read~~reviewed ~~reports~~study examining the differential electrophysiological signatures of MCI versus depression; which has demonstrated that ~~provide~~EEG ~~clinicians~~and ~~with~~ERP ~~objective~~biomarkers ~~insight~~can ~~into~~differentiate ~~brain~~between ~~electrophysiology:~~stages of cognitive impairment with meaningful clinical utility.

●The ~~ERP~~ability ~~Report~~to distinguish between conditions with overlapping clinical presentations; such as cognitive decline due to early neurodegeneration versus cognitive symptoms secondary to depression; we believe is a valuable application of our technology. Clinicians already use standardized cognitive assessments such as the MoCA and MMSE to evaluate cognitive performance, and mood instruments such as the PHQ-9 and GAD-7 to assess depressive and anxiety symptoms. These tools are clinically important, but they assess how a patient performs and feels; not what is measurably occurring in the patient's brain. Our platform adds a direct electrophysiological dimension to this clinical picture: identifying the specific frequency bands, neural regions, and response latencies that deviate from norms, and contextualizing those deviations against the electrophysiological signatures of previously assessed patients across both diagnostic categories. This combination of behavioral assessment and direct neural measurement is designed to give clinicians a richer, more complete basis for clinical judgment.

●Early ~~Behavioral~~detection ~~Report~~of MCI and related conditions is particularly impactful because the range of available interventions; lifestyle, pharmacological, and enrollment in clinical trials studying disease-modifying therapies; we believe is broadest in the earliest stages of disease. We believe the Evoke System may enable clinicians to identify electrophysiological changes consistent with early cognitive decline through a non-invasive, cost-effective assessment that can be administered in a standard clinical setting, without the expense or logistical complexity of PET imaging or other advanced neuroimaging modalities.

●Treatment ~~Summary~~Selection ~~Report~~and Longitudinal Monitoring

●As ~~Resting-~~our database scales, we may focus on treatment selection support. Research utilizing our electrophysiological data has begun to identify signatures associated with differential responses to specific therapeutic interventions. For example, EEG-based ~~Report~~endophenotyping in ADHD has demonstrated that patients with excess theta activity in specific frequency bands tend to respond differently to stimulant medications than patients with excess beta activity; an electrophysiological signal that may guide initial treatment selection before a trial-and-error prescribing process begins.

~~Scores~~This ~~are~~capability ~~presented~~may ascontinue ~~z-scores~~to ~~based~~evolve onas ~~comparing~~our ~~the~~database ~~patient~~expands. toWe anare ~~age-matched~~actively ~~relevant~~investing ~~reference~~in ~~group~~research ~~based~~to ondevelop ~~Firefly’s~~and ~~proprietary~~validate ~~standardized~~electrophysiological ~~longitudinal~~biomarkers ~~normative~~of ~~database.~~treatment ~~This~~response ~~presentation~~across ~~expresses~~additional ~~the~~conditions ~~differences~~in ~~between~~our ~~the~~clinical ~~patient~~footprint, and ~~the~~we ~~reference~~believe ~~group.~~as ~~The~~our ~~reports~~database ~~are~~scales, ~~intended~~it tomay beprovide ~~used~~a bystatistical ~~clinicians~~foundation tofor ~~enable~~this ~~the~~research ~~evaluation~~that ofis ~~the~~not ~~patient’s~~replicable ~~brain~~from ~~activity~~smaller, ~~during~~less astandardized ~~specific task compared to an age-range matched reference group~~datasets.

The Evoke System also supports longitudinal monitoring. Repeated assessments of the same patient over time that allow clinicians to track how electrophysiological profiles change in response to treatment. This capability transforms the electrophysiological assessment from a one-time diagnostic event into an ongoing clinical monitoring tool, increasing the frequency with which clinicians engage with our platform and correspondingly increasing both revenue and database contribution per patient.

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~~The~~Research ~~following~~& ~~diagram~~Development ~~breaks down the components of Firefly’s normative database that underpins the BNA Platform:~~

~~Figure~~Scientific 4validation is central to our commercial strategy. ~~Components~~We believe that clinician adoption of electrophysiological assessment as a standard component of neuropsychiatric care depends not only on the ~~BNA~~clinical ~~Platform~~utility ~~normative~~of ~~database~~our platform, but on the depth and quality of the scientific evidence supporting it. Accordingly, we invest in research collaborations, clinical studies, and academic partnerships designed to generate peer-reviewed evidence for the applications of our technology.

~~The~~Combined ~~BNA Platform~~across isFirefly aNeuroscience ~~clinical~~and ~~decision~~the ~~support~~former ~~software~~Evoke ~~tool~~Neuroscience, ~~that~~our ~~assists~~technology ~~with~~and dataset have been the ~~interpretations~~subject of ~~Resting~~more than 20 peer-~~State~~reviewed ~~EEG~~publications ~~and~~in ~~ERP~~indexed ~~results~~scientific journals. These publications span a range of conditions and applications, ~~where~~including ~~EEG~~early-stage Parkinson's disease detection, ADHD endophenotyping and ~~ERP-based~~treatment ~~examinations~~response ~~are~~prediction, ~~indicated~~major depressive disorder and ~~carried~~cognitive ~~out~~biomarkers, bytraumatic abrain ~~qualified~~injury ~~health~~assessment, ~~care~~drug ~~professional~~pharmacodynamics in neuropharmacology trials, and genetic conditions affecting cognitive development.

~~The~~Select ~~core~~highlights of the BNA Platform is a unique reference dataset to which the individual patient is compared. The reference database contains ERP recordings in response to the Auditory Oddball (AOB) and Visual Go No-Go (VGNG) tasks and Resting-State EEG collected from ~~healthy~~our ~~volunteers.~~published ~~The~~research database also includes demographic data and relevant clinical data (based on patient self-report and medical records, neuro-psychological questionnaires when problems were suspected, urine tests to rule out drug abuse and breath tests to rule out alcohol use) enabling adjudication of brain health status. include:

~~The~~• ~~Reference~~Early ~~group~~Parkinson's ~~was~~Detection: ~~generated~~A somachine ~~that~~learning ~~each~~approach ~~age-bin~~utilizing ~~contained a sample size of at least 120 eligible cases. For~~ ERP-derived ~~analysis,~~features ~~groups~~from ~~were~~our ~~divided~~database toidentified ~~reflect~~a ~~normality~~neuromarker ~~for~~discriminating ~~similar electrophysiology The Reference~~early-~~Group~~stage ~~Database~~Parkinson's ~~for~~disease ~~the~~patients ~~AOB~~from ~~and~~healthy ~~VGNG~~controls ~~tasks~~with isan ~~divided~~AUC ~~into~~of ~~the following age groups: 25-35~~0.79, ~~35-50,~~sensitivity ~~50-65,~~of ~~65-75~~0.74, and ~~75-85~~specificity ~~years~~of ~~for~~0.73; ~~VGNG,~~demonstrating ~~and~~the ~~12-14,~~capacity ~~14-16,~~of ~~16-18,~~our ~~18-25,~~electrophysiological ~~25-35,~~dataset ~~35-50,~~to ~~50-65,~~support ~~65-75,~~early ~~and~~detection ~~75-85~~of ~~years~~neurodegenerative ~~for~~disease ~~AOB~~(PLOS ONE, 2022).

~~For~~• ~~the~~MDD ~~Resting-State~~Treatment ~~EEG,~~Monitoring: ~~the~~A ~~high~~pilot ~~volume~~study ofpublished ~~samples~~in ~~permitted~~ the ~~creation~~Journal of ~~reference~~Affective ~~groups~~Disorders inReports a(2024) ~~higher~~demonstrated ~~0.5~~that EEG-~~year~~based ~~resolution.~~assessments ~~Each~~using ~~reference~~our ~~group~~platform ~~includes~~could atobjectively ~~least~~measure ~~200~~cognitive ~~individuals~~changes ~~selected~~in byoutpatients ~~their~~with ~~age~~major ~~proximity~~depressive todisorder ~~the~~during ~~declared~~treatment ~~age-range~~with ofvortioxetine; ~~the~~with ~~group.~~baseline ~~This~~brain ~~resulted~~activation inlatencies ~~133~~normalizing ~~reference~~toward ~~groups~~healthy ~~for~~control ~~the~~levels ~~ages~~following ~~12-85~~treatment, ~~years.~~independent ~~Patients~~of ~~are~~antidepressant ~~compared to the reference group based on their age proximity to the group~~effect.

~~Wherever~~• ~~the~~Neuropharmacology ~~data~~Biomarkers: ~~was~~Collaborative ~~normally~~research ~~distributed,~~with ~~the~~Novartis ~~reports~~evaluated ~~present scores as Z-Scores indicating~~ the ~~differences~~pharmacodynamic ~~between~~effects ~~the~~of ~~patient~~MIJ821 ~~and~~(onfasprodil) ~~the~~using ~~age-matched~~our ~~reference~~EEG ~~group~~analytics ~~selected~~as ~~from~~an ~~Firefly’s~~objective ~~reference~~CNS ~~database.~~biomarker Ain ~~Z-Score is~~ a ~~statistical~~Phase ~~measure~~I ~~indicating how far a specific value is from the mean of the reference group. A positive or negative Z~~first-~~Score~~in-human ~~suggests~~study, ~~that~~published ain ~~score~~Clinical isand ~~bigger~~Translational orScience ~~smaller than the mean of the group, respectively~~(2023).

~~The~~• ~~68%,~~ADHD ~~95%,~~Endophenotyping: ~~99.7%~~Published ~~rule~~research ~~specifies~~demonstrated ~~the percentage of scores~~ that ~~fall~~electrophysiological ~~within~~activity ~~the~~flow ~~ranges~~patterns ofanalyzed ±through 1,our ±platform 2,can ±differentiate 3,ADHD ~~respectively.~~subtypes ~~Figure~~with 24implications ~~illustrates~~for ~~this~~treatment ~~concept.~~selection, Aincluding ~~score~~differential ~~outside~~prediction ~~a range~~ of ±stimulant 2medication isresponse ~~commonly~~(Psychological ~~considered~~Medicine, ~~potentially meaningful in the clinic~~2017). ~~Only about 5% of the population would have a result outside this range.~~

~~Often~~• aConcussion ~~score~~and ~~outside~~TBI: ~~the~~Multiple ~~range~~publications, ofincluding ±work 2conducted isin ~~considered~~collaboration ~~potentially~~with ~~meaningful~~university inathletic programs and the ~~clinic.~~Concussion ~~The~~Assessment, ~~rationale~~Research ~~for~~and ~~this~~Education is(CARE) ~~the~~consortium, ~~statistical~~have ~~definition~~demonstrated the utility of ~~the~~ERP-based ~~central~~assessments ~~95%~~for objective evaluation of asport-related ~~distribution~~concussion asand ~~the~~tracking ~~"normal"~~of ~~range~~post-concussion recovery. Reches, ~~causing~~A., ~~scores~~Kutcher, toJ., ~~fall~~Elbin, ~~outside~~R.J., ~~this~~Or-Ly, ~~range~~H., toSadeh, beB., ~~considered~~Greer, ~~“extreme”~~J., (McAllister, ~~(Crawford~~D.J., ~~2002);~~Geva, ~~(Curtis~~A.B., ~~2016))~~& Kontos, A. P. (2017)

~~Most~~• ofDifferential ~~the~~Diagnosis ~~scores~~— ~~presented~~MCI invs. ~~the~~Dementia: ~~Behavioral~~Published ~~Report~~research ~~showed~~utilizing athe ~~skewed~~Evoke ~~distribution~~platform ~~within~~has examined the ~~reference~~differential ~~groups.~~electrophysiological Assignatures aof ~~conversion~~MCI, ~~into Z~~early-~~Scores~~stage isAlzheimer's ~~not~~disease, ~~appropriate~~and ~~for~~dementia ~~skewed~~— ~~distributions,~~demonstrating the ~~corresponding~~potential ~~scores~~of ~~are~~EEG/ERP ~~presented~~biomarkers asto ~~raw~~support ~~scores~~differential ~~and~~diagnosis ~~the~~in ~~25th-percentile~~conditions ~~limit~~that isare ~~marked~~clinically onchallenging ~~the~~to ~~report~~distinguish. asGanapathi aet ~~reference~~al. ~~value~~(2023). Journal of Alzheimer's Disease, 91(1), 293–305.

~~Figure~~We 5also conduct academic research collaborations, including a collaboration with the Institute of Human Genetics at Heidelberg University Hospital on EEG biomarker research in genetic neurodevelopmental conditions, and with the Pacific Neuroscience Institute Brain Center on a clinical study examining the electrophysiological signatures of Alzheimer's disease. ~~The~~We ~~BNA~~view ~~Platform~~these ~~Database~~collaborations as complementary to our commercial network, generating peer-reviewed scientific evidence that supports clinician adoption of our platform while simultaneously contributing high-quality, protocol-driven records to our database.

~~Real-World~~Pharmaceutical ~~Evidence~~and ~~for~~Research ~~the~~Partnerships ~~BNA Platform Clinical Utility~~

~~The~~In ~~findings~~addition ~~presented~~to inour ~~2023~~clinical ~~white~~subscription ~~paper~~business, ~~study~~we ~~“Brain~~engage ~~Network~~with ~~Analytics~~pharmaceutical ~~(BNA)~~companies inand ~~the~~academic ~~Psychiatric~~research ~~Practice:~~institutions ~~Real-Life~~that ~~Data~~seek ~~Analysis”~~access byto ~~Charlotte~~our ~~Baumeister,~~electrophysiological ~~Ph.D.,~~database ~~with~~and/or ~~analysis~~analytical bycapabilities ~~Offir~~in ~~Laufer, Ph.D.,~~ support ~~the potential~~ of ~~the~~neuroscience ~~BNA~~drug ~~Platform~~development. toThese ~~transform~~engagements ~~psychiatric~~typically ~~care~~involve ~~by automating~~ the ~~analysis~~use of our EEG ~~data.~~and ~~The~~ERP ~~comprehensive~~analytics ~~research~~as ~~involved~~biomarker aendpoints ~~cohort~~in ofclinical 2trials,~~253~~ ~~patients~~providing ~~seeking~~pharmaceutical ~~treatment~~sponsors atwith aan ~~prominent~~objective ~~psychiatric~~electrophysiological ~~and~~measure ~~multispecialty~~of ~~clinic~~drug ineffect ~~the~~on ~~United States. The study demonstrated that~~ the ~~BNA~~central ~~Platform improved~~nervous ~~disease management in psychiatric patients suffering from major depressive disorder (MDD), generalized anxiety disorder (“GAD”), and ADHD~~system.

The use of EEG and ERP as pharmacodynamic biomarkers in CNS drug development is a well-established scientific approach, and the availability of a large, standardized normative and disorder-specific reference dataset we believe significantly enhances the interpretability of electrophysiological biomarker data in drug trials. We believe our database scale and the quality of our analytics engine position us as a preferred partner for pharmaceutical sponsors seeking to incorporate electrophysiological biomarkers into neuropsychiatric drug development programs.

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~~The~~Regulatory ~~study~~Matters ~~has unveiled valuable insights into how the BNA Platform may revolutionize disease management in the field of psychiatry. Key highlights from the research include:~~

●The ~~Enhanced~~Evoke ~~Treatment~~System ~~Compliance:~~has ~~Patients~~received ~~grappling~~FDA ~~with~~clearance ~~depression~~under the 510(k) pathway as a Class II medical device for the acquisition, ~~who~~display, ~~underwent~~and ~~therapy~~storage ~~guided~~of byEEG ~~BNA~~and ERP data, ~~exhibited~~and afor ~~significant~~associated ~~15%~~analytical ~~increase~~and inreporting ~~their~~functions. ~~adherence~~This toclearance ~~MDD~~permits ~~treatment~~commercial ~~protocols,~~marketing ~~encompassing~~and ~~both~~sale ~~antidepressant~~of ~~medications~~the Evoke System for its cleared indications in the United States and ~~Transcranial~~is ~~Magnetic~~a ~~Stimulation~~prerequisite ~~(TMS)~~for our clinical subscription deployment model.

●Our ~~Decreased~~analytics ~~Medication~~platform ~~Alteration~~generates ~~Necessity:~~reports ~~The~~for ~~study~~clinician ~~demonstrated~~review aand ~~noteworthy~~is ~~reduction~~designed ofto ~~over~~operate ~~50%~~as ina ~~the~~decision-support ~~requirement~~tool. toWe ~~switch~~intend ~~antidepressant~~to ~~medications~~engage ~~among~~proactively with the ~~patient~~FDA ~~population.~~as ~~This~~our ~~emphasizes~~analytical ~~the~~capabilities ~~potential~~evolve ofto ~~the~~ensure ~~BNA~~our ~~Platform~~regulatory inposture ~~optimizing~~remains ~~medication~~appropriate ~~selection~~to ~~and~~the ~~dosing~~clinical applications of our platform.

●Competition Amplified Improvements in General Functionality: Individuals diagnosed with MDD, GAD, and ADHD experienced more than double the improvement in their overall general functioning when receiving BNA-guided interventions. This suggests that BNA Platform has the potential to comprehensively enhance patients' quality of life and daily functioning.

●The ~~Elevated~~market ~~Rates~~for ofbrain ~~Antidepressant~~health ~~Response:~~diagnostics ~~The~~and ~~application~~clinical ofdecision-support ~~the~~tools ~~BNA~~includes ~~Platform~~traditional ~~was~~EEG ~~associated~~hardware ~~with~~manufacturers, adigital ~~notable~~health ~~10%~~companies ~~increase~~offering inneurology-focused ~~antidepressant~~software, ~~response~~and ~~rates~~academic medical centers with research-grade electrophysiological assessment capabilities. We believe, ~~signaling~~however, ~~its~~that ~~potential~~the tomost ~~augment~~significant long-term competitive determinant in this market will be the ~~effectiveness~~depth and quality of ~~traditional~~the ~~treatment~~proprietary ~~approaches~~electrophysiological dataset underlying AI-driven analytics; and on this dimension we believe we hold a substantial and growing advantage.

●Structural ~~Reduction~~neuroimaging inmodalities; ~~Non-Responder~~including ~~Rates:~~computed ~~Among~~tomography ~~MDD~~(CT), ~~patients~~magnetic resonance imaging (MRI), ~~the~~and ~~study~~functional ~~observed~~MRI a(fMRI); ~~significant~~are ~~17%~~well-established ~~decrease~~and clinically important tools for evaluating brain structure and, in the ~~rate~~case of ~~treatment~~fMRI, ~~non~~patterns of metabolic activity. CT imaging involves exposure to ionizing radiation and provides excellent resolution of structural abnormalities, but limited visibility into functional neural dynamics. MRI offers superior soft-~~responders~~tissue contrast and structural detail without radiation, ~~indicating~~and fMRI can approximate regional brain activity through blood-oxygen-level-dependent (BOLD) signals. These are valuable tools, and we view them as complementary to, rather than competitive with, electrophysiological assessment. EEG and ERP capture the brain's direct electrical activity at millisecond-level temporal resolution; a dimension of brain function that structural and hemodynamic imaging modalities are not designed to measure. MRI reveals the ~~BNA~~brain’s ~~Platform~~structure, ~~holds~~while ~~promise~~EEG inmeasures ~~mitigating~~its ~~treatment~~real-time ~~resistance~~electrical activity and ~~improving~~the ~~positive~~speed ~~outcomes~~at which it processes information. We believe different test modalities answer different clinical questions and are most powerful when considered together.

~~The~~From ~~study~~a ~~thus~~practical ~~demonstrated~~standpoint, ~~that~~ the ~~BNA~~Evoke ~~Platform~~System ~~represents~~also occupies a ~~potentially~~distinct access tier relative to neuroimaging equipment. MRI and CT scanners require significant ~~advancement~~capital investment, specialized facility infrastructure, and dedicated radiology or imaging staff, making them primarily available in ~~patient~~hospital ~~care~~and large outpatient settings. The Evoke System is designed to operate in astandard ~~real~~clinical ~~world~~environments; ~~setting~~psychiatric practices, neurology offices, and ~~addresses~~behavioral ~~some~~health of clinics; at a cost per assessment that is generally lower than most structural imaging studies. This accessibility profile means the ~~challenges~~Evoke ~~associated~~System ~~with~~may ~~EEG~~be ~~utilization~~able byto ~~medical~~reach ~~professionals~~patient populations and clinical settings where advanced neuroimaging is not routinely available, rather than competing directly for the same clinical indication.

ByWe ~~automating~~believe ~~EEG~~our ~~analysis~~data ~~and~~advantage, ~~providing~~combined ~~comprehensive~~with ~~insights~~our ~~into~~FDA-cleared ~~brain~~hardware ~~electrophysiology,~~platform ~~the~~deployed ~~BNA~~across ~~Platform~~more ~~has~~than ~~the~~85 ~~potential~~clinical ~~to revolutionize disease management~~sites, ~~enhance~~our ~~treatment~~intellectual ~~outcomes~~property portfolio, and ~~improve~~our ~~the~~growing ~~overall~~body ~~well-being~~ of ~~patients~~more ~~with~~than ~~mental~~20 ~~illnesses and cognitive disorders. Based on the real~~peer-~~world~~reviewed ~~results highlighted above~~publications, ~~Management~~leads ~~believes~~us ~~that the societal impact of better outcomes for patients suffering from mental illnesses and cognitive disorders is substantial and the associated cost savings~~ to ~~healthcare~~believe ~~systems~~we ~~and~~occupy ~~payors~~an ~~could~~increasingly bevaluable ~~significant.~~position ~~Firefly~~in ~~intends to study~~ the ~~potential~~brain health ~~economic~~diagnostics ~~benefits associated with the above findings to support rapid adoption of the BNA Platform into standard patient management protocols~~market.

~~Research~~Human ~~and~~Capital ~~Development~~

~~Firefly~~Our ~~focuses~~team ~~its~~spans ~~research~~neuroscience, ~~and~~biomedical ~~development~~engineering, ~~efforts~~signal onprocessing, ~~advancing~~artificial ~~the~~intelligence, ~~treatment~~clinical ofoperations, ~~patients suffering from mental illnesses~~ and ~~cognitive~~healthcare ~~disorders~~commercialization. ~~These~~We ~~efforts~~believe ~~may~~our beability ~~enhanced~~to byattract ~~the relationships~~and ~~that~~retain ~~Firefly~~talent ~~has developed~~ with ~~neurologists,~~deep ~~psychiatrists,~~expertise ~~neuroscientists,~~across ~~and~~these ~~other~~complementary ~~experts.~~disciplines ~~Firefly~~is ~~believes~~essential to the ~~BNA~~continued ~~Platform~~development ~~may~~and ~~drive~~commercialization ~~a better standard~~ of ~~care~~the ~~for~~Firefly ~~patients suffering from mental illnesses and cognitive disorders~~Platform.

Firefly’s research and development activities may encompass basic research and product development. Firefly’s research and development team has biomedical engineering, neuroscience, software development, project management, data science, and AI and ML expertise. Firefly believes the strength and strategic vision of its research and development team will continue to drive Firefly’s leadership position in the category of advancing the understanding of brain electrophysiology in support of better outcome for Firefly’s target patient population leveraging EEG hardware with the BNA Platform.

Firefly’s near-term research and development efforts are focused on continuing to improve the BNA Platform, enhancing the patient and provider experience, and expanding the population of patients that can be assessed with the BNA Platform. Since inception, Firefly’s research and development activities have resulted in significant improvements to the BNA Platform, Firefly’s first clearance and predicate device to the BNA Platform dates back to 2014 when Firefly received Class II medical device 510(k) clearance from FDA for the BNA Analysis System, with indication for use in individuals 14 to 24 years of age. In December 2020, Firefly received Class II medical device 510(k) clearance from the FDA for Firefly’s current product, the BNA Platform, with indication for use in individuals 12 to 85 years of age.

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Additionally, Firefly’s near-term development pipeline includes potential enhancements that leverage its normative database, growing the database, advanced data analysis, ML and AI capabilities to enable medical professionals to enhance their clinical assessments, and to enable drug development companies to improve the success of their drug development programs, potentially bringing new drugs to market faster while reducing the cost and risk.

Market Opportunity

The market for the BNA Platform and Firefly’s future products is vast and growing significantly. According to the World Health Organization, in 2019, 1 in every 8 people, or 970 million people around the world were living with a mental disorder, with anxiety and depressive disorders being the most common. The economic burden of people suffering from depression alone in the United States was estimated at $326.2 billion for the year 2020. As our societies age, the number of cases of mental illness and cognitive disorders is projected to increase, along with the associated economic costs. For example, the number of people with dementia is estimated to increase from 57.3 million cases globally in 2019 more than 150 million cases in 2050. Yet, despite the growing need for effective treatment and substantial unmet treatment needs, CNS drug development remains costly, with the cost of developing a new drug typically ranging from $10 to 15 billion per drug, with CNS drugs having the lowest success rate of all other drug categories.

One of our initial areas of commercial focus will be on the sale of the BNA Platform to neurologists in the United States. Based on assumptions regarding the use of the BNA Platform by neurologists in the United States, this market segment potentially represents a total addressable market (TAM) of approximately $800,000,000 based on the following figures (based on the number of neurologists in the United States currently performing EEGs, the number of times such neurologists may perform a BNA analysis and approximate number of working days per year, summarized as follows).

According to data from Definitive Healthcare for 2023, there are 22,115 neurologists in the United States, of which 8,278 are currently performing EEGs. Our business model and TAM assumes that neurologists in the United Sates currently performing EEGs will perform a BNA analysis on average of two times per day over approximately 250 working days per year. Currently, our model assumes that a clinician will be invoiced approximately $200 for each BNA analysis.

Firefly believes that improving outcomes for people suffering from mental illnesses and cognitive disorders requires objective measurement. The clinical benefit of using EEG to understand how a person’s brain is functioning has been studied for decades. However, Firefly believes that, due to the complexity and time required to analyze and interpret EEG recordings, the inability to compare EEG recordings to what is clinically normal, and the inability to track changes over time, the clinical use of EEG has been limited. The BNA Platform holds the potential to transform brain health by allowing integration of EEG testing and analysis into patient care pathways to provide clinicians with an objective tool that may help them diagnosis and assess treatment efficacy, objectively and quickly. In addition, through Firefly’s research and development initiatives, the Company believes that by introducing biomarkers that could diagnose illnesses or disorders, it would assist in identifying what treatment will provide the most benefit for the patient and may drive adoption by clinicians and payors.

Through ongoing research of Firefly’s growing database, using the BNA Platform, Firefly aspires to enter other markets including, executive medical health and wellness for consumers who want to more actively manage their healthcare and lifestyles.

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Firefly plans to offer its BNA Platform on a recurring revenue model basis. In addition, Firefly plans to provide EEG recording equipment on a monthly rental or purchase basis or as part of a bundle price. Driving adoption in the specialty of neurology may enable Firefly to reach its full potential. For this reason, Firefly plans to initially adopt a direct selling model that is supported by field based clinical specialists and medical affairs personnel. As adoption progresses, supported by clinical validation, biomarkers and improvements to the BNA Platform, Firefly aims to partner with national distributors that complement Firefly’s target markets, including EEG companies and installed bases of EEG systems in use today by medical professionals.

In concert with the commercialization of the BNA Platform to medical professionals, Firefly plans to actively engage with drug development companies and develop extensive strategic partnerships to support their drug development strategies. As of January 1, 2023, there were 187 trials assessing 141 unique treatments for Alzheimer’s disease. As of January 4, 2023, there were more than 160 pharmaceutical companies developing drugs to treat mental illnesses. In order to take full advantage of the opportunity in the CNS drug development market, Firefly intends to invest in business development resources focused on the CNS drug development sector.

Competition

Firefly’s industry is competitive and has been evolving rapidly with the introduction of new products and technologies as well as the market activities of industry participants. The BNA Platform is indicated for use in individuals 12 to 85 years of age for the post-hoc statistical analysis of the human electroencephalogram, including event-related potentials and Firefly currently markets its device to qualified medical professionals. Firefly competes against other companies that have developed AI-driven platforms, in the target market of neurological disorders.

Firefly believes that the BNA Platform is a paradigm shift on the approach to treating cognitive disorders, mental illnesses, injuries to the brain and degenerative diseases. Firefly’s believes its BNA Platform offers distinct advantages, including its FDA-cleared BNA Algorithm for data analysis, its proprietary extensive normative age matched database underpinning the BNA Platform, and the ability of the BNA Platform to generate individual reports that clinicians may use to optimize patient care. Firefly believes the BNA Platform may become a standard of care tool in addressing the primary unmet needs in mental illness and cognitive disorders today. Firefly also believes that the BNA Platform has a wide range of additional applications, including the ability to leverage data gathered through BNA sessions for additional clinical insight, pharmaceutical drug development and new product development. The longitudinal nature of the data, along with clinical disease context, provides many future development opportunities.

Furthermore, EEG technology, in concert with BNA Platform, represents a scalable, low-cost solution when compared to other imaging technologies that assess brain electrophysiology, such as functional magnetic resonance imaging (fMRI).

Intellectual Property

Firefly’s commercial success depends in part on its ability to obtain and maintain intellectual property protection for ~~the~~Firefly’s ~~BNA~~products ~~Platform~~ and any future products, to prevent others from infringing, misappropriating, or otherwise violating its intellectual property rights, to defend and enforce its intellectual property rights, and to operate without infringing, misappropriating, or otherwise violating valid and enforceable intellectual property rights of others. Firefly actively seeks to protect intellectual property that it believes is important to its business, which includes patents covering the components of ~~the~~its ~~BNA~~software ~~Platform~~ and the methods used for optimizing the ~~therapy~~assessments ~~that~~its ~~the~~products ~~BNA Platform delivers~~perform. Firefly also seeks patent protection for other processes and inventions that are commercially or strategically important to developing and maximizing the value of its enterprise. Firefly takes steps to build and maintain the integrity of its brand, for example, with trademarks and service marks, and Firefly seeks to protect the confidentiality of trade secrets that may be important to the development of its business. Firefly relies on a strategy that combines the use of patents, trademarks, trade secrets, know-how, and license agreements, as well as other intellectual property laws, employment, confidentiality and invention assignment agreements, and contractual protections, to establish and protect its intellectual property rights.

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Patents

Our patents and patent applications assert claims generally related methods and systems. Specifically, there are multiple patent families relating to (i) ERP processing algorithms and the comparison to a reference group and estimation of brain electrophysiology based on the comparison; (ii) prediction of TMS treatment outcome; (iii) method and system for estimating brain concussion; (iv) method and system for managing pain; (v) method for brain stimulation tool configuration. As of December 31, ~~2023~~2025, we owned ~~eight~~23 issued U.S. patents, which have expiration dates ranging from November 2028 to November 2037. ~~We own one issued patent in Japan and there are currently patent applications pending in each of Australia, Canada, China, European Union and Israel, which, if issued, are expected to expire in 2037.~~

The anticipated expiration dates are without taking into account all possible patent term adjustments, extensions, or abandonments, and assuming payment of all appropriate maintenance, renewal, annuity, and other governmental fees. We continue to evaluate our intellectual property portfolio as patents reach end of life to determine the optimal course for continuing to protect our technology. We cannot ensure that patents will issue from any of our pending applications or that, if patents are issued, they will be of sufficient scope or strength to provide meaningful protection for our technology.

We recognize that the ability to obtain patent protection and the degree of such protection depends on a number of factors. The patent positions of medical device companies like ours are generally uncertain and involve complex legal, scientific, and factual questions. The protection afforded by a patent varies on a product-by-product basis, from jurisdiction-to-jurisdiction, and depends upon many factors, including the type of patent, the scope of its coverage, the availability of patent term adjustments and extensions, the availability of legal remedies, and the validity and enforceability of the patent.

In addition, the coverage claimed in a patent application can be significantly narrowed before the patent is issued, and patent claims can be reinterpreted or further altered even after patent issuance. We cannot predict whether the patent applications we are currently pursuing will issue as patents or whether the claims of any issued patents will provide sufficient protection from competitors. A competitor could develop systems, devices, or methods of manufacture or treatment that are not covered by our patents. Accordingly, our ability to stop third parties from commercializing any of our patented inventions, either directly or indirectly, will depend in part on our success in obtaining, maintaining, defending, and enforcing patent claims that adequately cover our inventions.

Our commercial success will also depend, in part, on not infringing, misappropriating, or otherwise violating the intellectual property rights of third parties. Third parties own numerous patents in the U.S. and in jurisdictions outside the U.S. with claims directed to inventions in the fields in which we operate or plan to operate. It is uncertain whether the issuance of any third-party patent would require us to alter our development or commercial strategies, seek licenses, cease certain activities, or participate in US Patent and Trademark Office ("USPTO") proceedings. Moreover, such licenses may not be available on commercially reasonable terms or at all. Our breach of any license agreements or failure to obtain a license necessary to our business may have a material adverse impact on us.

Trademarks

Our trademark portfolio is designed to protect the brands of our ~~BNA~~current ~~Platform~~ and any future products. As of December 31, ~~2024~~2025, we own one trademark registration for “BNA” in the United States and other countries, including Israel, Switzerland, European Union, Canada, and India. The trademark is also registered with World Intellectual Property Organization.

Trade Secrets

We also rely on trade secrets relating to our product and technology, including our data processing algorithms, and we maintain the confidentiality of such proprietary information to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. We seek to protect our trade secrets and know-how by entering into confidentiality and invention assignment agreements with employees, contractors, consultants, suppliers, customers, and other third parties, who have access to such information. These agreements generally provide that all confidential information concerning our business or financial affairs developed or made known to the individual during the course of the individual’s relationship with us are to be kept confidential and not disclosed to third parties except in specific circumstances.

For more information regarding the risks related to our intellectual property, please see “Risk Factors-Risks Related to Our Intellectual Property.”

~~Manufacturing~~13

Our BNA Platform is hardware-agnostic and we do not manufacture any compatible hardware.

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Manufacturing

Our Evoke system is manufactured by a third party contract manufacturer based in the United States.

Employees

As of ~~March~~the ~~31,~~date ~~2025~~of this report, we have ~~thirteen~~ 17 full-time employees ~~and one contractor~~.

None of Firefly’s employees are represented by a labor union or covered by collective bargaining agreements, and Firefly considers its relationship with its employees to be good.

Government Regulation

Our products ~~(including our BNA Platform)~~ are considered medical devices, and, accordingly, are subject to rigorous regulation by government agencies in the United States and other countries in which we intend to sell our products. These regulations vary from country to country but cover, among other things, the following activities with respect to medical devices:

	●	design, development and manufacturing;
	●	testing, labeling, content and language of instructions for use and storage;
	●	product storage and safety;
	●	marketing, sales and distribution;
	●	pre-market clearance and approval;
	●	record keeping procedures;
	●	advertising and promotion;
	●	recalls and field safety corrective actions;
	●	post-market surveillance;
	●	post-market approval studies; and
	●	product import and export.

FDA Regulation

In the U.S., numerous laws and regulations govern the processes by which medical devices are developed, manufactured, brought to market and marketed. These include the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and its implementing regulations issued by FDA, among others. Unless an exemption applies, each medical device commercially distributed in the United States requires FDA clearance of a 510(k) premarket notification (“510(k) clearance”), granting of a de novo request, or approval of an application for premarket approval (“PMA”). In general, under the FD&C Act, medical devices are classified in one of three classes on the basis of the controls necessary to reasonably assure their safety and effectiveness. A medical device’s classification determines the level of FDA review and approval to which the device is subject before it can be marketed to consumers:

● Class I devices, the lowest-risk FDA device classification, include devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to FDA’s medical device general controls, including labeling, establishment registration, device product listing, adverse event reporting, and, for some products, adherence to good manufacturing practices through FDA’s Quality System Regulations. ● Class II devices, moderate-risk devices, also require compliance with general controls and in some cases, special controls as deemed necessary by FDA to ensure the safety and effectiveness of the device. These special controls may include performance standards, particular labeling requirements, or post-market surveillance obligations. While most Class I devices are exempt from the 510(k) premarket notification requirement, typically a Class II device also requires pre-market review and 510(k) clearance as well as adherence to the Quality System Regulations/good manufacturing practices for devices. ● Class III devices, high-risk devices that are often implantable or life-sustaining, also require compliance with the medical device general controls and Quality System Regulations, and generally must be approved by FDA before entering the market through a PMA application. Approved PMAs can include post-approval conditions and post-market surveillance requirements, analogous to some of the special controls that may be imposed on Class II devices.

16 ● Class II devices, moderate-risk devices, also require compliance with general controls and in some cases, special controls as deemed necessary by FDA to ensure the safety and effectiveness of the device. These special controls may include performance standards, particular labeling requirements, or post-market surveillance obligations. While most Class I devices are exempt from the 510(k) premarket notification requirement, typically a Class II device also requires pre-market review and 510(k) clearance as well as adherence to the Quality System Regulations/good manufacturing practices for devices.

●

Class III devices, high-risk devices that are often implantable or life-sustaining, also require compliance with the medical device general controls and Quality System Regulations, and generally must be approved by FDA before entering the market through a PMA application. Approved PMAs can include post-approval conditions and post-market surveillance requirements, analogous to some of the special controls that may be imposed on Class II devices.

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Our BNA Platform isand aEvoke System are Class II medical ~~device~~devices, which ~~was~~were cleared by FDA for commercialization in the U.S. pursuant to the 510(k) notification process ~~for the post-hoc statistical analysis of the human electroencephalogram, including ERP in December 2020~~. The marketing and distribution of ~~the~~Firefly’s ~~BNA~~products ~~Platform,~~are is subject to continuing regulation and enforcement by FDA and other government authorities, which includes product listing requirements, medical device reporting regulations. If FDA finds that we have failed to comply with any legal or regulatory requirements, it or other government agencies may institute a wide variety of enforcement actions against us, ranging from Warning Letters to more severe sanctions, including but not limited to financial penalties, withdrawal of 510(k) clearances already granted, and criminal prosecution.

The 510(k) Process

Under the 510(k) process, the applicant must submit to FDA a premarket notification demonstrating that the device is “substantially equivalent” to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted, and for which a PMA is not required, a device that has been reclassified from Class III to Class II or Class I, or another commercially available device that was cleared through the 510(k) process. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data is sometimes required to support substantial equivalence.

After a 510(k) premarket notification is submitted, FDA determines whether to accept it for substantive review. If it lacks necessary information for substantive review, FDA will refuse to accept the 510(k) notification. If it is accepted for filing, FDA begins a substantive review. By statute, FDA is required to complete its review of a 510(k) notification within 90 days of receiving the 510(k) notification. As a practical matter, clearance often takes longer, and clearance is never assured. FDA may require further information, including clinical data, to make a determination regarding substantial equivalence, which may significantly prolong the review process. If FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market the device.

Post-Market Regulation

After a device is cleared or approved for marketing, numerous and extensive regulatory requirements may continue to apply. These include but are not limited to:

	●	annual and updated establishment registration and device listing with FDA;
	●	restrictions on sale, distribution, or use of a device;
	●	labeling, advertising, promotion, and marketing regulations, which require that promotion is truthful, not misleading, and provide adequate risk disclosures and directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses (i.e., indications that are inconsistent with or beyond the scope of the applicable FDA approval or clearance) and impose other restrictions on labeling;
	●	clearance or approval of product modifications to legally marketed devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use;
	●	correction, removal, and recall reporting regulations, and FDA’s recall authority;
	●	complying with the federal law and regulations requiring Unique Device Identifiers on devices; and
	●	post-market surveillance activities and regulations, which apply when deemed by FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
	●	FDA has broad regulatory compliance and enforcement powers. If FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:
	●	warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties;
	●	recalls, withdrawals, or administrative detention, or seizure of our products;
	●	operating restrictions or partial suspension or total shutdown of production;
	●	refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;
	●	withdrawing 510(k) clearances or PMA approvals that have already been granted;
	●	refusal to grant export or import approvals for our products; or
	●	criminal prosecution.

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International Regulation

Many countries throughout the world have established regulatory frameworks for marketing and commercialization of medical devices. As a designer and marketer of medical devices, we are obligated to comply with the respective frameworks of these countries to obtain and maintain access to these global markets. The frameworks often define requirements for marketing authorizations which vary by country. Failure to obtain appropriate marketing authorization and to meet all local requirements, including specific quality and safety standards in any country in which we currently market our products, could cause commercial disruption and/or subject us to sanctions and fines. Delays in receipt of, or a failure to receive, such marketing authorizations, or the loss of any previously received authorizations, could have a material adverse effect on our business, financial condition and results of operations.

There is currently no premarket government review of medical devices in the European Economic Area (“EEA”). However, all medical devices placed on the market in the EEA must meet the relevant essential requirements laid down in Annex I of Directive 93/42/EEC concerning medical devices, or the Medical Devices Directive. The most fundamental essential requirement is that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others. In addition, the device must achieve the performances intended by the manufacturer and be designed, manufactured, and packaged in a suitable manner. The European Commission has adopted various standards applicable to medical devices. These include standards governing common requirements, such as sterilization and safety of medical electrical equipment, and product standards for certain types of medical devices. There are also harmonized standards relating to design and manufacture. While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the essential requirements as a practical matter. Compliance with a standard developed to implement an essential requirement also creates a rebuttable presumption that the device satisfies that essential requirement.

On April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the EU Medical Device Directive and became effective on May 26, 2021. 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 ensure a high level of safety and health while supporting innovation. The new regulations, among other things:

	●	strengthen the rules on placing devices on the market and reinforce surveillance once they are available;
	●	improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;
	●	set up a central database to provide patients, healthcare professionals, and the public with comprehensive information on products available in the E.U.; and
	●	strengthen 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.

We received our European CE mark, indicating that we affirm our product’s conformity with European health, safety and environmental protection standards, in 2021.

Healthcare Regulatory Laws

Within the United States, our products are subject to extensive regulation by a wide range of federal and state agencies that govern business practices in the medical device industry. These laws include federal and state anti-kickback, fraud and abuse, false claims and physician payment transparency laws and regulations.

The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any good, facility, item or service reimbursable, in whole or part by Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadly interpreted to include anything of value, including cash, improper discounts, and free or reduced price items and services. Among other things, the Anti-Kickback Statute has been interpreted to apply to arrangements between medical device manufacturers on the one hand and prescribers and purchasers on the other. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.

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Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the Anti-Kickback Statute has been violated. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate, in order to have committed a violation. Further, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute also constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Many states have adopted laws similar to the Anti-Kickback Statute. Some of these state prohibitions apply to referral of patients for healthcare items or services reimbursed by any payor, not only the Medicare and Medicaid programs. Commercial payors may also bring a private cause of action for treble damages against a manufacturer for a pattern of causing false claims to be filed under the federal Racketeer Influenced and Corrupt Organizations Act, or RICO.

The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to or approval by the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government. A claim includes “any request or demand” for money or property presented to the U.S. government. The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. In recent years, the number of suits brought against healthcare providers by private individuals has increased dramatically. The government has obtained multi-million and multi-billion dollar settlements under the False Claims Act in addition to individual criminal convictions under applicable criminal statutes. In addition, the federal civil monetary penalties statute imposes penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws. Various states have also enacted false claim laws analogous to the federal civil False Claims Act, although many of these state laws apply where a claim is submitted to any third-party payor and not merely a federal healthcare program.

The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HIPAA, among other things, created two new federal crimes: healthcare fraud and false statements relating to healthcare matters. The HIPAA healthcare fraud statute prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private payors. A violation of this statute is a felony and may result in fines, imprisonment and/or exclusion from government sponsored programs. The HIPAA false statements statute prohibits, among other things, knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or services. A violation of this statute is a felony and may result in fines and/or imprisonment. Similar to the Anti-Kickback Statute, a person or entity does not need to have actual knowledge of these statutes or specific intent to violate them in order to have committed a violation.

Additionally, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers. The ACA, imposed, among other things, new annual reporting requirements for covered manufacturers for certain payments and “transfers of value” provided to physicians and certain other healthcare providers and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. In addition, certain states require implementation of compliance programs and compliance with the device industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, impose restrictions on marketing practices, and/or tracking and reporting of gifts, compensation and other remuneration or items of value provided to physicians and other healthcare professionals and entities.

Health Information Privacy and Security Laws

There are numerous U.S. federal and state laws and regulations related to the privacy and security of Personally Identifiable Information (“PII”), including health information. Among others, the federal Health Insurance Portability and Accountability Act of 1996, as amended by HITECH, and their implementing regulations, which we collectively refer to as HIPAA, establish privacy and security standards that limit the use and disclosure of Protected Health Information (“PHI”) and require covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of individually identifiable health information in electronic form, among other requirements.

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Violations of HIPAA may result in civil and criminal penalties. We must also comply with HIPAA’s breach notification rule which requires notification to affected individuals and HHS, and in certain cases to media outlets, in the case of a breach of unsecured PHI. The regulations also require business associates of covered entities to notify the covered entity of breaches by the business associate.

State attorneys general also have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information. In addition, HIPAA mandates that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance.

Many states also have laws that protect the privacy and security of sensitive and personal information, including health information. These laws may be similar to or even more protective than HIPAA and other federal privacy laws. For example, the laws of the State of California, are more restrictive than HIPAA. Where state laws are more protective than HIPAA, we must comply with the state laws we are subject to, in addition to HIPAA. California passed the California Consumer Privacy Act or CCPA on June 28, 2018, which went into effect January 1, 2020. On November 3, 2020, the California Privacy Rights Act of 2020 (“CPRA”), which amends the CCPA and adds new privacy protections that became effective on January 1, 2023, was enacted through a ballot initiative. While information we maintain that is covered by HIPAA may be exempt from the CCPA, other records and information we maintain on our patients may be subject to the CCPA. In certain cases, it may be necessary to modify our planned operations and procedures to comply with these more stringent state laws. Not only may some of these state laws impose fines and penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused. In addition, state and federal privacy laws subject to frequent change.

In addition to HIPAA and state health information privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain types of activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breach.

Foreign data protection, privacy, and other laws and regulations are often more restrictive than those in the U.S. The E.U., for example, traditionally has imposed stricter obligations under its laws and regulations relating to privacy, data protection and consumer protection than the U.S. In May 2018, the GDPR, governing data practices and privacy in the E.U., became effective and replaced the data protection laws of the individual member states. GDPR requires companies to meet stringent requirements regarding the handling of personal data of individuals in the E.U. These more stringent requirements include expanded disclosures to inform members about how we may use their personal data, increased controls on profiling members, and increased rights for members to access, control and delete their personal data. In addition, there are mandatory data breach notification requirements. The law also includes significant penalties for non-compliance, which may result in monetary penalties of up to 20 million Euros or 4% of a company’s worldwide turnover, whichever is higher. GDPR and other similar regulations require companies to give specific types of notice and informed consent is required for the placement of a cookie or similar technologies on a user’s device for online tracking for behavioral advertising and other purposes and for direct electronic marketing, and the GDPR also imposes additional conditions in order to satisfy such consent, such as a prohibition on pre-checked consents. It remains unclear how the U.K. data protection laws or regulations will develop in the medium to longer term and how data transfer to the U.K. from the E.U. will be regulated. Outside of the E.U., there are many other countries with data protection laws, and new countries are adopting data protection legislation with increasing frequency.

Many of these laws may require consent from individuals for the use of data for various purposes, including marketing, which may reduce our ability to market our products.

There is no harmonized approach to these laws and regulations globally. Consequently, we increase our risk of non-compliance with applicable foreign data protection laws and regulations when we expand internationally. We may need to change and limit the way we use personal information in operating our business and may have difficulty maintaining a single operating model that is compliant. Compliance with such laws and regulations will result in additional costs and may necessitate changes to our business practices and divergent operating models, limit the effectiveness of our marketing activities, adversely affect our business, results of operations, and financial condition, and subject us to additional liabilities.

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Corporate History and Structure

Firefly’s corporate history began in April 2006 with the formation of Elminda Ltd, a company organized under the laws of the State of Israel, for the purpose of developing a system to provide clinicians with an objective assessment of brain electrophysiology to support better outcomes for people with mental illnesses and cognitive disorders.

Firefly spent over ten years building a significant database of standardized longitudinal EEG brain scans using clinically defined paradigms that captured patients brain activity while resting and while activated (evoke response potential). Firefly collected this data in over 100 sites, over 20 countries, and over 40 studies. Significant time and resources went into analyzing and interpreting the data as well as preparing for an FDA 510k application process.

On May 2, 2014, management of Firefly Neuroscience Ltd. incorporated a new wholly owned subsidiary company named “Elminda Inc.” in the State of Delaware for the purpose of initiating the company’s United States marketing and distribution activity.

In July 2014, Firefly received Class II medical device 510(k) clearance from the U.S. Food and Drug Administration (the “FDA”) for the BNA Analysis System, the predicate device to the BNA Platform, with indication for use in individuals 14 to 24 years of age.

In September 2014, the company received the Conformity European approval for the BNA Platform allowing use in European Economic Area.

In December 2020, Firefly received Class II medical device 510(k) clearance from the FDA for ~~Firefly’s current product,~~ the BNA Platform, with indication for use in individuals 12 to 85 years of age.

On April 13, 2022, the name of Elminda Inc. was changed to “Elminda 2022 Inc.”

On April 21, 2022, management of Firefly Neuroscience Ltd. incorporated a new wholly owned subsidiary company named “Elminda Inc.” for the purpose of re-domiciling the company to enhance access to capital markets.

On July 5, 2022, Elminda Ltd. became a subsidiary of Elminda Inc. via a share exchange agreement wherein Elminda Inc. issued shares to shareholders of Elminda Ltd. against shares of Elminda Ltd.

On September 15, 2022 and October 24, 2022 management changed the name from Elminda Inc. and Elminda Ltd, respectively, to “Firefly Neuroscience, Inc.” and “Firefly Neuroscience Ltd.”, respectively.

On ~~the~~ August 12, 2024, pursuant to the Merger Agreement, FFN merged with and into Firefly Neuroscience, Inc., with Firefly Neuroscience, Inc. surviving the merger as a wholly owned subsidiary of WaveDancer, Inc. On the Merger Closing Date (i) pursuant to the Amended and Restated Certificate of Incorporation of WaveDancer, we changed our name to Firefly Neuroscience, Inc. and (ii) pursuant to an amendment to its Certificate of Incorporation, Firefly changed its name to Firefly Neuroscience 2023, Inc. and (iii) Firefly and FFN filed the Certificate of Merger with the State of Delaware.

~~The~~On ~~Amended~~April ~~and~~30, ~~Restated~~2025, ~~Certificate~~Firefly ofcompleted ~~Incorporation and~~ the ~~Amended~~acquisition ~~and Restated Bylaws contain certain provisions relating to limitations~~ of ~~liability~~Evoke ~~and~~Neuroscience ~~indemnification~~Inc. ~~of directors and certain officers~~(“Evoke”), ~~provide~~which ~~advance~~resulted ~~notice~~in ~~procedures~~the ~~for~~acquisition ~~stockholder~~of ~~proposals~~the atEvoke ~~stockholder~~business ~~meetings,~~ and ~~other~~a ~~matters.~~significant ~~See~~expansion ~~“Description~~ of ~~Capital~~business ~~Stock–~~operations ~~Anti-Takeover Provisions” in Exhibit 4.1 to this Annual Report on Form 10-K~~ and ~~Item 10~~headcount. ~~“Directors,~~This ~~Executive~~acquisition ~~Officers~~included ~~and~~the ~~Corporate~~Evoke ~~Governance~~System –which ~~Limitation~~was onEvoke's primary ~~Liability~~commercial ~~and Indemnification of Directors and Certain Officers”~~product.

The Charter and the Bylaws contain certain provisions relating to limitations of liability and indemnification of directors and certain officers, provide advance notice procedures for stockholder proposals at stockholder meetings, and other matters. See “Description of Capital Stock– Anti-Takeover Provisions” in Exhibit 4.1 to this Annual Report on Form 10-K and Item 10. “Directors, Executive Officers and Corporate Governance – Limitation on Liability and Indemnification of Directors and Certain Officers”.

Our fiscal year ends on December 31. Neither we nor any of our predecessors have been in bankruptcy, receivership or any similar proceeding.

~~ITEM 1A. RISK FACTORS.~~19

An investment in our securities involves a high degree of risk. You should carefully read and consider all of the risks described below, together with all of the other information contained or referred to in this report, before making an investment decision with respect to our securities. If any of the following events occur, our financial condition, business and results of operations (including cash flows) may be materially adversely affected. In that event, the market price of our shares could decline, and you could lose all or part of your investment.

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~~Risks~~ITEM ~~Related~~1A. toRISK ~~the Company’s Business, Operations and Industry~~FACTORS.

WeAn ~~are~~investment ~~facing~~in ~~significant~~our ~~liquidity~~securities involves a high degree of risk. You should carefully read and consider all of the risks described below, together with all of the other information contained or referred to in this report, before making an investment decision with respect to our securities. If any of the following events occur, our financial condition, business and results of operations (including cash flows) may be materially adversely affected. In that ~~raise~~event, ~~substantial~~the ~~doubt~~market ~~about~~price of our ~~ability~~shares tocould ~~continue~~decline, asand ayou ~~going~~could ~~concern~~lose all or part of your investment.

WeRisks ~~have~~Related ~~incurred recurring losses and experienced negative cash flows from operations since our inception, and we may continue~~ to ~~incur operating losses. For~~ the ~~fiscal~~Company’s ~~year ended December 31~~Business, ~~2024,~~Operations ~~we had an accumulated deficit of $87.1 million~~ and ~~negative~~Industry cash flows from operating activities of approximately $6.2 million. We have generated minimal revenue to date, and our ability to generate recurring revenue depends on the successful commercialization of our BNA Platform, which remains in the early stages of market adoption.

~~Our~~We ~~financial~~are ~~position~~facing ~~raises~~ significant liquidity ~~concerns.~~risks ~~Our~~that existing capital resources may be insufficient to fund our operations for the next twelve months, and we may be unable to realize our assets or discharge our liabilities in the normal course of business. These conditions raise substantial doubt about our ability to continue as a going concern. To mitigate these risks, we are actively pursuing additional capital through equity or debt financings and implementing cost-reduction measures. However, there is no assurance that we will be able to secure such funding on favorable terms or at all. Failure to obtain additional financing would materially and adversely affect our ability to continue operations and could force us to delay, reduce, or eliminate our commercialization efforts, product development activities, or other key initiatives.

~~Our~~We ~~continued~~have ~~existence~~incurred isrecurring ~~dependent~~losses ~~on our ability to raise additional capital~~ and ~~ultimately~~experienced ~~achieve~~negative ~~and~~cash ~~maintain~~flows ~~profitable~~from operations. ~~Even~~since ~~if we are successful in raising additional funds,~~ our ~~expenses may exceed expectations~~inception, orand we may ~~deplete~~continue ~~our~~to ~~available~~incur ~~capital~~operating ~~resources~~losses. ~~more~~For ~~quickly~~the ~~than~~fiscal ~~anticipated.~~year ~~The~~ended December ~~report~~31, of2025, ~~our~~we ~~independent~~had ~~registered~~an ~~public~~accumulated ~~accounting~~deficit ~~firm~~of $111,615 and ~~for~~negative ~~the~~cash ~~fiscal~~flows ~~year~~from ~~ended~~operating ~~December~~activities ~~31,~~of ~~2024~~approximately $8,194. ~~includes~~We anhave ~~explanatory~~generated ~~paragraph~~minimal ~~expressing~~revenue ~~substantial~~to ~~doubt~~date, ~~about~~and our ability to ~~continue~~generate asrecurring arevenue ~~going~~depends ~~concern,~~on ~~which~~the ~~may~~successful ~~further~~commercialization ~~impair~~of our ~~ability~~products, towhich ~~raise~~remains ~~capital~~in ~~and~~the ~~negatively~~early ~~impact~~stages ~~investor~~of ~~confidence~~market adoption.

WeOur ~~are~~financial ~~subject~~position raises significant liquidity concerns. Our existing capital resources may be insufficient to ~~operating~~fund our operations for the next twelve months, and we may be unable to realize our assets or discharge our liabilities in the normal course of business. These conditions raise substantial doubt about our ability to continue as a going concern. To mitigate these risks, ~~including~~we ~~excess~~are actively pursuing additional capital through equity or ~~constrained~~debt ~~capacity~~financings and ~~operational~~implementing ~~inefficiencies~~cost-reduction measures. However, ~~which~~there ~~could~~is no assurance that we will be able to secure such funding on favorable terms or at all. Failure to obtain additional financing would materially and adversely affect our ~~results~~ability ofto continue operations and could force us to delay, reduce, or eliminate our commercialization efforts, product development activities, or other key initiatives.

WeOur ~~are~~continued ~~subject~~existence tois ~~operating~~dependent ~~risks, including excess or constrained capacity and pressure~~ on our ~~internal~~ability ~~systems~~to ~~and~~raise ~~personnel.~~additional Incapital ~~order~~and toultimately ~~manage~~achieve ~~current~~ and ~~anticipated~~maintain ~~future~~profitable operations. ~~effectively,~~Even if we ~~must~~are ~~continually~~successful ~~implement~~in ~~and~~raising ~~improve~~additional ~~our operational~~funds, ~~financial~~our ~~and~~expenses ~~management~~may ~~information~~exceed ~~systems~~expectations, ~~hire,~~or ~~train,~~we ~~motivate,~~may ~~manage~~deplete ~~and~~our ~~retain~~available ~~employees.~~capital Weresources ~~may~~more bequickly ~~unable~~than toanticipated. ~~balance~~The ~~near-term~~report ~~efforts~~of toour ~~meet~~independent ~~existing~~registered ~~demand~~public ~~with~~accounting ~~future~~firm ~~customer~~for ~~demand,~~the ~~including~~fiscal ~~adding~~year ~~personnel~~ended December 31, ~~creating~~2025 includes ~~scalable,~~an ~~secure~~explanatory ~~and~~paragraph ~~robust~~expressing ~~systems~~substantial ~~and~~doubt ~~operations,~~about ~~and~~our ~~automating~~ability ~~processes~~to ~~needed~~continue ~~for~~as ~~long~~a ~~term~~going ~~efficiencies.~~concern, ~~Any~~which ~~such~~may ~~failure~~further ~~could~~impair ~~have~~our aability ~~material~~to ~~impact~~raise oncapital ~~our~~and ~~business,~~negatively ~~operations~~impact ~~and~~investor ~~prospects~~confidence.

~~Our~~We ~~products~~have engaged, and ~~information~~may ~~technology~~continue ~~systems are critical~~ to ~~our~~engage, ~~business.~~in ~~Issues~~strategic ~~with~~acquisitions ~~product development~~ or ~~enhancements~~transactions, ITwhich ~~system integration, implementation, updates and upgrades~~ could ~~disrupt our operations and~~ have a material ~~impact~~adverse effect on our business, results of operations, financial condition and ~~operating~~cash ~~results~~flows.

WeAcquisitions ~~rely~~involve ona ~~the~~number ~~efficient~~of risks, ~~uninterrupted~~including ~~and~~diversion ~~secure operation~~ of ~~our~~management’s ITattention, ~~systems~~ability ~~and are dependent on key third-party software embedded in our products and IT systems as well as third-party hosted IT systems~~ to ~~support~~finance ~~our~~the ~~operations.~~acquisition ~~All~~on ~~software~~attractive ~~and~~terms, ITfailure ~~systems are vulnerable~~ to ~~damage,~~retain ~~cyber~~key ~~attacks~~personnel or ~~interruption~~valuable ~~from~~customers, alegal ~~variety~~liabilities, ofthe ~~sources.~~need Toto ~~effectively~~amortize ~~manage~~acquired ~~and~~intangible ~~improve our operations~~assets, ~~our IT systems~~ and ~~applications~~intellectual ~~require~~property anownership ~~ongoing commitment of significant expenditures~~ and ~~resources~~infringement ~~to maintain~~risks, ~~protect,~~any ~~upgrade,~~of ~~enhance~~which ~~and~~could ~~restore~~have ~~existing~~a ~~systems~~material ~~and~~adverse ~~develop~~effect ~~new~~on ~~systems~~our ~~to keep pace with continuing changes in information processing technology~~business, ~~evolving~~results ~~industry~~of ~~and regulatory standards~~operations, ~~increasingly~~financial ~~sophisticated~~condition ~~cyber threats,~~ and ~~changing~~cash ~~consumer preferences~~flows. ~~Failure~~Any toadditional ~~adequately~~future ~~protect~~acquisitions ~~and maintain the integrity of our products and IT systems~~ may also result in athe ~~material~~incurrence ~~effect~~of onindebtedness ~~our~~or ~~financial~~the ~~position,~~issuance ~~results~~ of ~~operations~~additional ~~and~~equity ~~cash flows~~securities.

We ~~plan~~could toalso ~~continuously~~experience ~~upgrade~~financial ~~and issue new releases of our products and customer-facing software applications, upon which our operations depend. Software applications and products containing software frequently contain errors~~ or ~~defects,~~other ~~especially~~setbacks ~~when~~if ~~first~~transactions ~~introduced~~encounter orunanticipated ~~when new versions are released. Additionally~~problems, ~~the third-party software integrated into or interoperable with our products and services will routinely reach end of life, and as a consequence, may be exposed to additional vulnerabilities,~~ including ~~increased~~problems ~~security~~related ~~risks, errors and malfunctions that may be irreparable or difficult~~ to ~~repair.~~governmental ~~The discovery of a defect~~approval, ~~error or security vulnerability in our products~~execution, ~~software~~integration ~~applications~~ or ITunderperformance ~~systems,~~relative ~~incompatibility~~to ~~with~~prior ~~future~~expectations. ~~customers’~~Acquisitions ~~computer operating systems and hardware configurations with a new release or upgraded version or the failure of our products or primary IT systems~~ may ~~cause~~not ~~adverse~~result ~~consequences, including: delay or loss of revenues, significant remediation costs, delay~~ in ~~market~~long-term ~~acceptance,~~benefits ~~loss~~to ofus ~~data, disclosure of financial, health~~ or ~~other~~we ~~personal~~may ~~information~~not ofbe ~~any~~able ~~customers or patients, product recalls, damage~~ to ~~our~~further ~~reputation,~~develop orthe ~~increased~~acquired ~~service costs, any of which could have a material effect on our~~ business, ~~financial~~in ~~condition or results of our operations and~~ the ~~operations~~manner ofwe ~~our potential customers or our business partners~~anticipated.

~~Our~~Following ~~operations~~the ~~and~~completion ~~financial~~of ~~performance~~acquisitions, ~~depend~~we onmay ~~global~~have ~~and~~to ~~regional~~rely ~~economic~~on ~~conditions.~~the ~~Inflation,~~seller ~~fluctuations~~to inprovide ~~currency~~administrative ~~exchange~~and ~~rates~~other support, ~~changes~~including infinancial ~~consumer~~reporting ~~confidence~~ and ~~demand~~internal controls, and ~~weakness~~other intransition ~~general~~services ~~economic~~to ~~conditions~~the ~~and~~acquired ~~threats,~~business orfor ~~actual~~a ~~recessions,~~period ~~could~~of ~~materially~~time. ~~affect~~There ~~our~~can ~~business,~~be ~~results~~no ofassurance ~~operations,~~that ~~and~~the ~~financial~~seller ~~condition~~will do so in a manner that is acceptable to us.

~~Macroeconomic~~We ~~conditions~~may ~~impact~~not ~~consumer~~realize ~~confidence~~the ~~and~~anticipated ~~discretionary~~benefits ~~spending,~~of ~~which~~past could adversely affect demand for any products we bring to market. Consumer spending habits are affected by, among other things, inflation, fluctuations in currency exchange rates, weakness in general economic conditions, threats or actual recessions, pandemics, wars and military actions, levels of employment, wages, debt obligations, discretionary income, interest rates, volatility in capital, and consumer confidence and perceptions of current and future ~~economic~~acquisitions ~~conditions. Changes~~ and ~~uncertainty~~integration can, among other things, reduce or shift spending away from treatments and procedures to address mental illness and cognitive disorders, and could drive patients and clinicians towards other options in the marketplace that may cost less than our products, reduce patient traffic in clinicians’ offices or reduce demand for services to treat mental illness and cognitive disorder generally. The recent declines in, or uncertain economic outlooks for, the U.S., European and certain other international economies has and may continue to adversely affect consumer and healthcare practice spending. The increase in the cost of ~~fuel~~these ~~and~~acquisitions energy, food and other essential items along with elevated interest rates could reduce consumers’ disposable income, resulting in less discretionary spending for products like ours. Decreases in disposable income and discretionary spending or change in consumer confidence and spending habits may ~~adversely~~disrupt ~~affect~~ our ~~revenues and operating results~~business.

22 On April 30, 2025, we completed the acquisition of Evoke Neuroscience Inc., which resulted in our acquisition of the Evoke business and a significant expansion of our business operations and headcount. In the future, we may acquire additional companies, project pipelines, products, or technologies, or enter into joint ventures or other strategic initiatives. Our ability as an organization to integrate acquisitions is unproven. We may not realize the anticipated benefits of our acquisitions or any other future acquisition or the acquisition may be viewed negatively by customers, financial markets or investors.

~~Table~~Any ofacquisition ~~Contents~~ has numerous risks, including, but not limited to, the following:

~~Inflation~~● ~~continues~~difficulty toin ~~adversely~~assimilating ~~impact~~the ~~spending~~operations and ~~trade~~personnel ~~activities~~of ~~and we are unable to predict~~ the ~~impacts~~acquired ofcompany; ~~higher~~● ~~inflation~~difficulty onin ~~global~~effectively ~~and~~integrating ~~regional~~the ~~economies.~~acquired ~~Higher~~technologies ~~inflation~~or ~~has~~products ~~also~~with ~~increased~~current ~~domestic~~products and ~~international~~technologies; ~~shipping~~● ~~costs,~~difficulty ~~raw~~in ~~material~~maintaining ~~prices~~controls, procedures and ~~labor~~policies ~~rates,~~during ~~which~~the ~~could~~transition ~~adversely~~and ~~impact~~integration; ~~the~~● ~~costs~~disruption of ~~producing,~~ongoing ~~procuring~~business and ~~shipping~~distraction ~~any~~of ~~products~~management weand ~~bring~~employees tofrom ~~market.~~other Ifopportunities ~~similar~~and ~~trends~~challenges ~~continue~~due ~~once~~to weintegration ~~begin~~issues; ~~marketing~~● ~~our~~difficulty ~~BNA~~integrating ~~Platform,~~the ~~our~~acquired ~~ability~~company’s toaccounting, ~~recover~~management ~~these~~information ~~cost~~and ~~increases~~other ~~through~~administrative ~~price~~systems; ~~increases~~● ~~may~~inability ~~have~~to ~~limited~~retain ~~effectiveness,~~key ~~resulting~~technical inand ~~downward~~managerial ~~pressure~~personnel onof ~~our~~the ~~operating~~acquired ~~results.~~business; ~~Attempts~~● inability to ~~offset~~retain ~~cost~~key ~~increases~~customers, ~~with~~vendors, ~~price~~and ~~increases~~other ~~could~~business ~~reduce~~partners ~~sales,~~of ~~increase~~the ~~customer~~acquired ~~dissatisfaction~~business; or● ~~otherwise~~inability ~~harm~~to ~~our~~achieve ~~reputation.~~the ~~Further,~~financial weand ~~are~~strategic ~~unable~~goals tofor ~~predict~~ the ~~impact~~acquired ofand ~~efforts~~combined bybusinesses; ~~central~~● ~~banks~~incurring ~~and~~acquisition-related ~~federal,~~costs ~~state~~or ~~and~~amortization ~~local~~costs ~~governments~~for toacquired ~~combat~~intangible ~~elevated~~assets ~~levels~~that ofcould ~~inflation.~~impact Ifoperating ~~their~~results; ~~efforts~~● tofailure ~~reduce~~of ~~inflation~~due ~~are~~diligence ~~too~~processes ~~aggressive,~~to ~~they~~identify ~~may~~significant ~~lead~~issues towith aproduct ~~recession. Alternatively~~quality, iflegal ~~they~~and ~~are~~financial ~~insufficient~~liabilities, oramong ~~are~~other ~~not~~things; ~~sustained~~● ~~long~~inability ~~enough~~ to ~~lower~~assert ~~inflation~~that tointernal ~~more~~controls ~~acceptable~~over ~~levels,~~financial ~~consumer~~reporting ~~spending~~are ~~may~~effective; beand ~~adversely~~● ~~impacted~~inability ~~for~~to aobtain, ~~prolonged~~or ~~period~~obtain ofin ~~time.~~a ~~Any~~timely ofmanner, ~~these~~approvals ~~events~~from ~~could~~governmental ~~materially~~authorities, ~~affect~~which ~~our~~could ~~business~~delay ~~and~~or ~~operating~~prevent ~~results~~such acquisitions.

~~Our~~We ~~business~~are ~~could~~subject beto ~~impacted~~operating ~~by political events~~risks, ~~trade~~including ~~and~~excess ~~other~~or ~~international~~constrained ~~disputes,~~capacity ~~war,~~ and ~~terrorism~~operational inefficiencies, ~~including~~which ~~the~~could ~~military~~adversely ~~conflict~~affect ~~between~~our ~~Russia~~results ~~and~~of ~~Ukraine~~operations.

~~Political~~We ~~events~~are subject to operating risks, ~~trade~~including excess or constrained capacity and ~~other~~pressure ~~international~~on ~~disputes~~our internal systems and personnel. In order to manage current and anticipated future operations effectively, ~~war~~we must continually implement and improve our operational, financial and ~~terrorism~~management ~~could~~information ~~harm~~systems, orhire, ~~disrupt~~train, ~~international~~motivate, ~~commerce~~manage and ~~the~~retain ~~global~~employees. ~~economy~~We ~~and~~may ~~could~~be ~~have~~unable ato ~~material~~balance ~~effect~~near-term onefforts ~~our~~to ~~business~~meet asexisting ~~well~~demand aswith ~~our~~future ~~potential~~customer ~~customers~~demand, ~~suppliers~~including adding personnel, ~~contract~~creating ~~manufacturers~~scalable, ~~distributors~~secure and robust systems and operations, and ~~other~~automating processes needed for long term efficiencies. Any such failure could have a material impact on our business, ~~partners~~operations and prospects.

~~Political~~Our ~~events,~~products ~~trade~~ and ~~other~~information ~~international~~technology ~~disputes,~~systems ~~wars,~~are ~~and~~critical ~~terrorism can lead~~ to ~~unexpected tariffs or trade restrictions, which could adversely impact~~ our business. ~~Once~~Issues wewith ~~begin~~product ~~marketing~~development ~~our products, these increased costs could adversely impact our gross margin and make our products less competitive~~ or ~~reduce demand. Countries could also adopt other measures~~enhancements, ~~such~~IT assystem ~~controls on imports or exports of goods~~integration, ~~technology or data~~implementation, ~~that~~updates ~~could adversely impact our operations~~ and ~~supply~~upgrades ~~chain and limit our ability to offer products and services. These measures~~ could ~~require~~disrupt ~~us to take various actions, including changing suppliers or restructuring business relationships. Complying with new or changed trade restrictions is expensive, time-consuming and disruptive to~~ our operations. ~~Such restrictions can be announced with little or no advance notice~~ and wehave ~~may~~a bematerial ~~unable~~impact toon ~~effectively~~our ~~mitigate~~business ~~the adverse impacts of such measures. If disputes~~ and ~~conflicts~~operating ~~escalate in the future, actions by governments in response could be significantly more severe and restrictive and could materially affect our business~~results.

~~Political~~We ~~unrest,~~rely ~~threats,~~on ~~tensions~~the efficient, ~~actions~~uninterrupted and ~~responses~~secure tooperation ~~any~~of ~~social,~~our ~~economic,~~IT ~~business,~~systems ~~geopolitical,~~and ~~military,~~are ~~terrorism,~~dependent oron ~~acts~~key ofthird-party ~~war~~software ~~involving~~embedded ~~key~~in ~~commercial,~~our ~~development~~products orand ~~manufacturing~~IT ~~markets~~systems ~~such~~ as ~~China,~~well ~~Mexico,~~as ~~Israel,~~third-party ~~Europe,~~hosted orIT ~~other~~systems ~~countries~~to orsupport ~~regions~~our ~~could~~operations. ~~materially~~All ~~impact~~software ~~any~~and ~~international~~IT ~~operations~~systems weare ~~undertake.~~vulnerable ~~For~~to ~~example~~damage, ~~our~~cyber-attacks ~~employees~~or ininterruption ~~Israel~~from ~~could~~a bevariety ~~obligated~~of tosources. ~~perform~~To ~~annual~~effectively ~~reserve~~manage ~~duty~~and inimprove ~~the~~our ~~Israeli~~operations, ~~military~~our ~~and~~IT besystems ~~called~~and ~~for~~applications ~~additional~~require ~~active~~an ~~duty~~ongoing ~~under~~commitment ~~emergency~~of ~~circumstances.~~significant Ifexpenditures ~~any~~and ofresources ~~these~~to ~~events~~maintain, ~~or conditions occur~~protect, ~~the impact on us~~upgrade, ~~our~~enhance ~~employees~~ and ~~potential~~restore ~~customers~~existing issystems ~~uncertain,~~and ~~particularly~~develop ifnew ~~emergency~~systems ~~circumstances,~~to ~~armed~~keep ~~conflicts~~pace orwith ancontinuing ~~escalation~~changes in ~~political~~information ~~instability~~processing ortechnology, ~~violence~~evolving ~~disrupts~~industry ~~our~~and ~~product~~regulatory ~~development~~standards, ~~data~~increasingly orsophisticated ~~information~~cyber ~~exchange~~threats, ~~payroll~~and orchanging ~~banking~~consumer ~~operations,~~preferences. ~~product~~Failure orto ~~materials~~adequately ~~shipping~~protect byand usmaintain orthe integrity of our ~~suppliers~~products and ~~other~~IT ~~unanticipated~~systems ~~business~~may ~~disruptions,~~result ~~interruptions and limitations~~ in ~~telecommunication~~a ~~services~~material oreffect ~~critical~~on ~~systems~~our orfinancial ~~applications~~position, ~~reliant~~results onof aoperations ~~stable~~ and ~~uninterrupted~~cash ~~communications infrastructure~~flows.

~~U.S.~~We ~~and~~plan ~~global~~to ~~markets~~continuously ~~are~~upgrade ~~experiencing volatility~~ and ~~disruption~~issue ~~following~~new ~~the~~releases ~~escalation~~ of ~~geopolitical~~our ~~tensions~~products and ~~the~~customer-facing ~~start~~software ofapplications, ~~the~~upon ~~military~~which ~~conflict~~our ~~between~~operations ~~Russia~~depend. Software applications and ~~Ukraine.~~products Oncontaining ~~February~~software ~~24,~~frequently ~~2022,~~contain aerrors ~~full-scale~~or ~~military~~defects, ~~invasion~~especially ofwhen ~~Ukraine~~first byintroduced ~~Russian~~or ~~troops~~when ~~was~~new ~~reported~~versions are released. InAdditionally, ~~response~~any tothird-party ~~the~~software ~~military~~integrated ~~conflict,~~into ~~the~~or ~~United~~interoperable ~~States~~with our products and ~~other~~services ~~North~~will ~~Atlantic~~routinely ~~Treaty~~reach ~~Organization~~end ~~member~~of ~~states~~life, asand ~~well~~ as ~~non-member~~a ~~states~~consequence, ~~announced~~may ~~targeted~~be ~~economic~~exposed ~~sanctions~~to onadditional ~~Russia~~vulnerabilities, including ~~certain~~increased ~~Russian~~security ~~citizens and enterprises~~risks, errors and ~~the~~malfunctions ~~continuation~~that ~~of the conflict~~ may ~~trigger~~be ~~additional~~irreparable ~~economic~~or ~~and~~difficult ~~other~~to ~~sanctions~~repair. The ~~potential~~discovery ~~impacts~~ of ~~the~~a ~~conflict~~defect, ~~and~~error ~~related~~or ~~sanctions~~security ~~could~~vulnerability ~~include~~in ~~supply~~our ~~chain and logistics disruptions~~products, ~~macro~~software ~~financial~~applications ~~impacts~~or ~~resulting~~IT ~~from~~systems, ~~the~~incompatibility ~~exclusion~~with offuture ~~Russian~~customers’ ~~financial~~computer ~~institutions~~operating ~~from~~systems ~~the~~and ~~global~~hardware ~~banking~~configurations ~~system,~~with ~~volatility~~a innew ~~foreign~~release ~~exchange~~or ~~rates~~upgraded ~~and~~version ~~interest~~or ~~rates,~~the ~~inflationary~~failure ~~pressures~~of onour ~~raw~~products ~~materials~~or ~~and~~primary ~~energy~~IT ~~and~~systems ~~heightened~~may ~~cybersecurity~~cause ~~threats.~~adverse Weconsequences, ~~have~~including: nodelay ~~way~~or toloss ~~predict~~of ~~the~~revenues, ~~progress~~significant orremediation ~~outcome~~costs, ofdelay ~~the~~in ~~conflict~~market inacceptance, ~~Ukraine~~loss orof ~~the~~data, ~~reactions~~disclosure byof ~~governments~~financial, ~~businesses~~health or ~~consumers.~~other Apersonal ~~prolonged~~information ~~conflict,~~of ~~intensified~~any ~~military~~customers ~~activities~~ or ~~more~~patients, ~~extensive~~product ~~sanctions~~recalls, ~~impacting~~damage ~~the~~to ~~region~~our ~~and~~reputation, ~~the~~or ~~resulting~~increased ~~economic~~service ~~impact~~costs, any of which could have a material effect on our business, financial condition or results of our operations, ~~financial~~and ~~condition,~~the ~~liquidity,~~operations ~~growth~~of ~~prospects~~our ~~and~~potential customers or our business ~~outlook~~partners.

WeOur ~~conduct~~operations ~~certain~~and offinancial ~~our~~performance ~~operations~~depend inon ~~Israel~~global and regional economic conditions. ~~Conditions~~Inflation, fluctuations in ~~Israel~~currency exchange rates, ~~including~~changes ~~the~~in ~~recent~~consumer ~~attack~~confidence byand ~~Hamas~~demand, tariffs and ~~other~~trade ~~terrorist~~policy ~~organizations~~changes, ~~from~~and ~~the~~weakness ~~Gaza~~in ~~Strip~~general economic conditions and ~~Israel’s~~threats, ~~war~~or ~~against~~actual ~~them~~recessions, ~~may~~could materially affect our business, results of operations, and financial condition.

WeMacroeconomic ~~currently~~conditions ~~have~~impact ~~seven~~consumer ~~full-time~~confidence ~~employees~~and discretionary spending, ~~who~~which ~~are~~could ~~located~~adversely inaffect ~~and/or~~demand ~~reside~~for inany ~~Israel.~~products Aswe abring ~~result,~~to ~~our~~market. ~~business~~Consumer ~~and~~spending ~~operations~~habits are ~~directly~~ affected by, among other things, inflation, fluctuations in currency exchange rates, weakness in general economic conditions, ~~political~~threats or actual recessions, ~~geopolitical~~pandemics, wars and military ~~conditions~~actions, inlevels ~~Israel.~~of ~~Since~~employment, ~~the~~wages, ~~establishment~~debt ofobligations, ~~the~~discretionary ~~State~~income, ofinterest ~~Israel~~rates, volatility in ~~1948~~capital, aand ~~number~~consumer confidence and perceptions of ~~armed~~current ~~conflicts~~and ~~have~~future ~~occurred~~economic ~~between~~conditions. ~~Israel~~Changes and ~~its~~uncertainty ~~neighboring~~can, ~~countries~~among other things, reduce or shift spending away from treatments and ~~terrorist~~procedures ~~organizations~~to ~~active~~address mental illness and cognitive disorders, and could drive patients and clinicians towards other options in the ~~region~~marketplace that may cost less than our products, reduce patient traffic in clinicians’ offices or reduce demand for services to treat mental illness and cognitive disorder generally. ~~These~~The ~~conflicts~~recent ~~have~~declines ~~involved~~in, ~~missile~~or ~~strikes~~uncertain economic outlooks for, ~~hostile~~the ~~infiltrations~~U.S., European and ~~terrorism~~certain ~~against~~other ~~civilian~~international ~~targets~~economies has and may continue to adversely affect consumer and healthcare practice spending. The increase in ~~various~~the ~~parts~~cost of ~~Israel~~fuel and energy, ~~which~~food ~~have~~and ~~negatively~~other ~~affected~~essential ~~business~~items ~~conditions~~along with elevated interest rates could reduce consumers’ disposable income, resulting in ~~Israel~~less discretionary spending for products like ours. Decreases in disposable income and discretionary spending or change in consumer confidence and spending habits may adversely affect our revenues and operating results.

23 20

Table of Contents

In ~~October 2023~~addition, ~~Hamas~~tariffs ~~terrorists~~and ~~infiltrated~~changes ~~Israel’s~~in ~~southern~~trade ~~border~~policy ~~from~~— ~~the~~including ~~Gaza~~new ~~Strip~~or ~~and~~increased ~~conducted~~tariffs aimposed ~~series~~by ofthe ~~attacks~~U.S. or other governments on ~~civilian~~imported ~~and~~goods, ~~military~~components, ~~targets.~~or ~~Hamas~~materials ~~also~~— ~~launched~~could ~~extensive~~increase ~~rocket~~our ~~attacks~~costs onof ~~Israeli~~goods ~~population~~or disrupt our supply chain, and ~~industrial~~may ~~centers~~trigger ~~located~~retaliatory ~~along~~measures ~~Israel’s~~by ~~border~~foreign ~~with~~governments ~~the~~that ~~Gaza~~adversely ~~Strip~~affect ~~and~~our ability to sell products in ~~other~~international ~~areas~~markets. ~~within~~Tariff-related ~~the~~cost ~~State~~increases ofmay ~~Israel.~~be ~~Following~~difficult ~~the~~to ~~attack~~pass on to customers or healthcare providers, ~~Israel’s~~which ~~security~~could ~~cabinet~~compress ~~declared~~our ~~war~~margins. ~~against~~The ~~Hamas~~current uncertainty surrounding trade policy, including the scope, duration, and apotential ~~military~~escalation ~~campaign~~of ~~against~~existing ~~these~~and ~~terrorist~~proposed ~~organizations~~tariffs, ~~commenced~~makes init ~~parallel~~difficult to predict their ~~continued~~ultimate ~~rocket~~impact ~~and~~on ~~terror~~our ~~attacks~~business. ~~Moreover,~~Depending on the ~~clash~~markets ~~between~~in ~~Israel~~which we operate and ~~Hezbollah~~the incountries ~~Lebanon,~~from ~~may~~which ~~escalate~~we inor ~~the~~our ~~future~~suppliers ~~into~~source amaterials ~~greater~~or ~~regional~~components, ~~conflict~~tariff-driven cost increases could be material.

~~Any~~Inflation ~~hostilities~~continues ~~involving~~to ~~Israel~~adversely ~~could~~impact ~~adversely~~spending ~~affect~~and ~~our~~trade ~~operations~~activities and ~~results~~we are unable to predict the impacts of ~~operations~~higher inflation on global and regional economies. ~~Shelter-in-place~~Higher inflation has also increased domestic and ~~work-from-home~~international ~~measures~~shipping costs, ~~government-imposed~~tariffs, ~~restrictions~~raw onmaterial ~~movement~~prices, and ~~travel~~labor rates, which could adversely impact the costs of producing, procuring and ~~other~~shipping ~~precautions~~any ~~taken~~products we bring to ~~address~~market. ~~the~~If ~~ongoing~~similar ~~conflict~~trends continue, our ability to recover these cost increases through price increases may ~~temporarily~~have ~~disrupt~~limited effectiveness, resulting in downward pressure on our ~~employees’~~operating ~~ability~~results. Attempts to ~~effectively~~offset ~~perform~~cost increases with price increases could reduce sales, increase customer dissatisfaction or otherwise harm our reputation. Further, we are unable to predict the impact of efforts by central banks and federal, state and local governments to combat elevated levels of inflation. If their ~~daily~~efforts ~~tasks~~to reduce inflation are too aggressive, they may lead to a recession. Alternatively, if they are insufficient or are not sustained long enough to lower inflation to more acceptable levels, consumer spending may be adversely impacted for a prolonged period of time. Any of these events could materially affect our business and operating results.

~~The~~Our ~~Israel~~business ~~Defense~~could Force (the “IDF”), the national military of Israel, is a conscripted military service, subject to certain exceptions. Several of our employees are subject to military service in the IDF and have been and may be ~~called~~impacted toby ~~serve.~~political ~~It is possible that there will be further or longer military reserve duty call-ups in the future~~events, ~~which~~trade ~~may affect our business due to a shortage of skilled labor~~ and ~~loss~~other ofinternational ~~institutional knowledge~~disputes, ~~and necessary mitigation measures we may take to respond to a decrease in labor availability~~war, ~~such as overtime~~ and ~~third-party outsourcing~~terrorism, ~~for~~including ~~example,~~the ~~which~~military ~~may~~conflict ~~have~~between ~~unintended~~Russia ~~negative effects~~ and ~~adversely impact our results of operations, liquidity or cash flows~~Ukraine.

ItPolitical isevents, ~~currently~~trade ~~not~~and ~~possible~~other tointernational ~~predict~~disputes, ~~the~~war, ~~duration~~and terrorism could harm or ~~severity~~disrupt ofinternational commerce and the ~~ongoing~~global ~~conflict~~economy orand ~~its~~could ~~effects~~have a material effect on our business, ~~operations~~as ~~and~~well ~~financial~~as ~~conditions.~~our ~~The~~potential ~~ongoing~~customers, ~~conflict~~suppliers, iscontract ~~rapidly~~manufacturers, ~~evolving and developing~~distributors, and ~~could~~other ~~disrupt our~~ business ~~and operations~~partners.

~~Our~~Political ~~operations~~events, ~~may~~trade beand ~~impacted~~other byinternational ~~natural~~disputes, ~~disaster~~wars, and ~~may~~terrorism can lead to unexpected tariffs or trade restrictions, which could adversely impact our business. Once we begin marketing our products, these increased costs could adversely impact our gross margin and ~~operating~~make ~~results~~our asproducts ~~well~~less competitive or reduce demand. Countries could also adopt other measures, such as ~~those~~controls on imports or exports of goods, technology or data, that could adversely impact our ~~potential~~operations ~~customers~~and supply chain and limit our ability to offer products and services. These measures could require us to take various actions, including changing suppliers or restructuring business relationships. Complying with new or changed trade restrictions is expensive, time-consuming and disruptive to our operations. Such restrictions can be announced with little or no advance notice and we may be unable to effectively mitigate the adverse impacts of such measures. If disputes and conflicts escalate in the future, actions by governments in response could be significantly more severe and restrictive and could materially affect our business.

~~Natural~~Political ~~disasters~~unrest, ~~and~~threats, ~~other~~tensions, ~~extreme~~actions ~~weather~~and ~~events~~responses ~~may impact~~to usany ~~and~~social, ~~our~~economic, ~~potential~~business, ~~customers~~geopolitical, asmilitary, ~~well~~terrorism, asor ~~suppliers~~acts ~~critical~~of towar ~~our~~involving ~~operations.~~key ~~Natural~~commercial, ~~disasters~~development ~~include~~or ~~earthquakes,~~manufacturing ~~tsunamis,~~markets ~~floods~~such as China, ~~droughts~~Mexico, ~~hurricanes~~Israel, ~~wildfires~~Europe, ~~and~~or other ~~extreme~~countries ~~weather~~or ~~conditions~~regions ~~that~~could ~~can~~materially ~~cause~~impact ~~deaths,~~any ~~injuries~~international operations we undertake. For example, our employees in Israel could be obligated to perform annual reserve duty in the Israeli military and ~~critical~~be ~~health~~called ~~crises~~for additional active duty under emergency circumstances. If any of these events or conditions occur, ~~power~~the ~~outages~~impact on us, ~~restrictions~~our employees and ~~shortages~~potential ofcustomers ~~food~~is uncertain, ~~water~~particularly if emergency circumstances, ~~shelter~~armed conflicts or an escalation in political instability or violence disrupts our product development, ~~and~~data ~~medical~~or ~~supplies~~information exchange, ~~telecommunications~~payroll ~~failures~~or banking operations, product or materials ~~scarcity,~~shipping ~~price~~by ~~volatility~~us or our suppliers and other ~~ramifications~~unanticipated business disruptions, interruptions and limitations in telecommunication services or critical systems or applications reliant on a stable and uninterrupted communications infrastructure.

~~The~~U.S. ~~frequency~~and global markets are experiencing volatility and ~~severity~~disruption following the escalation of ~~such~~geopolitical ~~events~~tensions ~~can~~and ~~vary~~the ~~over~~start ~~time~~of the military conflict between Russia and Ukraine. On February 24, 2022, a full-scale military invasion of Ukraine by ~~region~~Russian troops was reported. ~~Regardless~~In ofresponse ~~their~~to ~~cause~~the military conflict, ~~natural~~the ~~disasters~~United States and ~~extreme~~other ~~weather~~North Atlantic Treaty Organization member states, as well as non-member states, announced targeted economic sanctions on Russia, including certain Russian citizens and enterprises, and the continuation of the conflict may ~~pose~~trigger ~~ongoing~~additional ~~operational~~economic and ~~financial~~other ~~risks~~sanctions. toThe uspotential impacts of the conflict and ~~others~~related ~~within~~sanctions ~~our~~could include supply chain. ~~These~~and ~~events~~logistics ~~can~~disruptions, ~~lead~~macro tofinancial ~~facility~~impacts ~~shutdowns~~resulting from the exclusion of Russian financial institutions from the global banking system, ~~shipping~~volatility in foreign exchange rates and ~~logistics~~interest ~~disruptions~~rates, ~~increased~~inflationary ~~insurance~~pressures on raw materials and energy and heightened cybersecurity threats. We have no way to predict the progress or ~~operating~~outcome ~~costs~~of the conflict in Ukraine or the reactions by governments, businesses or consumers. A prolonged conflict, intensified military activities or more extensive sanctions impacting the region and ~~potential~~the ~~loss~~resulting economic impact could have a material effect on our business, results of ~~revenue~~operations, financial condition, liquidity, growth prospects and business outlook.

InWe ~~addition,~~conduct ~~changes~~certain inof ~~the~~our ~~broader~~operations ~~economic~~in ~~environment~~Israel. ~~due~~Conditions toin ~~environmental~~Israel, ~~factors~~including ~~may affect~~ the ~~supply,~~attack ~~demand,~~by orHamas ~~availability of energy~~ and other ~~critical~~terrorist ~~resources~~organizations ~~used~~from inthe ~~our~~Gaza ~~operations.~~Strip ~~Any~~and ofIsrael’s ~~these~~war ~~factors~~against ~~could~~them, ~~have~~may aaffect ~~material adverse effect on~~ our ~~business, financial condition, or results of~~ operations.

~~Risks~~We ~~Related~~currently tohave five full-time employees, who are located in and/or reside in Israel. As a result, our business and operations are directly affected by economic, political, geopolitical and military conditions in Israel. Since the ~~BNA~~establishment ~~Platform~~of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its neighboring countries and terrorist organizations active in the region. These conflicts have involved missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which have negatively affected business conditions in Israel.

If we are not successful in enhancing awareness of our BNA Platform, driving adoption across our current target population and expanding the population of eligible patients, our sales, business, financial condition and results of operations will be negatively affected.21

~~Our~~Table ~~business currently depends primarily on our ability to successfully market our BNA Platform, which involves successfully launching our commercialization program, increasing adoption~~ of ~~and~~Contents driving utilization our BNA Platform by target clinicians, namely neurologists in the United States. We are aiming to increase awareness about our BNA Platform, as well as grow the number of clinicians that utilize our BNA Platform after the launch of our commercialization program, but there can be no assurance that we will succeed.

~~The~~In ~~commercial~~October ~~success~~2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of ~~our~~attacks ~~BNA~~on ~~Platform~~civilian ~~will~~and ~~continue~~military totargets. ~~depend~~Hamas also launched extensive rocket attacks on aIsraeli ~~number~~population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of ~~factors~~Israel. Following the attack, ~~including~~Israel’s security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks. Moreover, the ~~following:~~clash between Israel and Hezbollah in Lebanon, may escalate in the future into a greater regional conflict.

●The ~~the~~active ~~actual~~military ~~and~~conflict ~~perceived~~involving ~~effectiveness and clinical benefit~~Iran, ofIsrael ~~our~~and ~~BNA Platform; ●~~ the ~~prevalence~~United ~~and~~States ~~severity~~poses ofimmediate ~~any adverse patient events involving our BNA Platform; ● our ability to provide earlier awareness of~~ and ~~education~~material ~~about~~risks ~~our BNA Platform~~ to ~~patients and clinicians; ● the degree to which clinicians and patients adopt~~ our ~~BNA~~operations, ~~Platform; ● the availability~~employees, ~~relative~~financial ~~cost~~condition and ~~perceived~~business. advantages and disadvantages of alternative technologies or treatment methods for cognitive disorders; ● the results of future clinical and other studies relating to the health, economic or other benefits of our BNA Platform; ● whether key thought leaders in the medical community accept that our future clinical utility is sufficiently meaningful to influence their decision to adopt our BNA Platform;

24 The conflict between Iran, Israel and the United States has escalated into an active military war with significant regional and global consequences. On February 28, 2026, the United States and Israel launched coordinated strikes against Iran targeting its nuclear infrastructure, military assets and government leadership. Iran has retaliated with missile and drone attacks against targets in Israel, U.S. military bases across the region, and civilian and commercial infrastructure across multiple Gulf states. The conflict has spread across at least a dozen countries, resulting in the closure of the Strait of Hormuz — the world's major oil artery — and has caused significant casualties throughout the region.

~~Table~~We conduct certain of ~~Contents~~ our operations in Israel and have full-time employees who are located in and/or reside in Israel. The active and expanding nature of this conflict directly heightens the risk to our personnel and operations. Israeli cities, including Tel Aviv, have been targeted by Iranian missile and drone barrages, and the conflict has simultaneously expanded into Lebanon, with Hezbollah launching attacks and Israel conducting military operations there as well. Armed conflicts or heightened security conditions may result in employee absences, evacuation or relocation of personnel, interruptions to communications or transportation infrastructure, or other operational disruptions that could materially affect our ability to conduct business activities in Israel. The conflict has materially disrupted the global economy and financial markets. The war has pushed oil prices sharply higher, disrupted shipping through the Strait of Hormuz and displaced millions of civilians across the region. Broader economic forecasts warn of inflationary pressures and slowed global growth, and a near-total halt of tanker traffic in the Strait of Hormuz has disrupted the supply of fuel and essential commodities, threatening global food security. These developments could lead to sustained volatility in financial markets, increased costs of capital, supply chain disruptions, and reduced investor confidence, each of which could adversely affect our financial condition and access to capital markets.

●Iran ~~the~~has ~~extent~~declared toU.S. ~~which~~financial weinstitutions ~~are~~and ~~successful~~other intechnology ~~educating~~and ~~clinicians~~multinational ~~and~~companies ~~patients~~operating ~~about~~in the ~~benefits~~Middle ofEast ~~our~~as ~~BNA~~justified ~~Platform;~~targets. ●This ~~our~~declaration ~~reputation~~meaningfully ~~among~~increases ~~clinicians and patients; ●~~ our ~~ability~~exposure to ~~predict~~cybersecurity ~~product~~threats ~~performance;~~and ●potential ~~the~~disruptions ~~strength~~to of our ~~marketing~~technology ~~and distribution~~ infrastructure, ~~including~~and ~~our~~operations. ~~ability~~We tomay ~~drive~~face ~~adoption~~increased ~~and~~costs ~~utilization~~associated ofwith ~~our~~protecting ~~BNA Platform; ●~~ our ~~ability to obtain~~systems, ~~maintain,~~personnel ~~protect, enforce~~ and ~~defend our intellectual property rights~~data, ~~including those covering our BNA Platform; ● our ability to maintain compliance with all legal~~ and ~~regulatory~~we ~~requirements,~~cannot ~~including~~guarantee ~~those~~that ~~applicable to~~ our ~~BNA~~defensive ~~Platform;~~measures ~~and~~will ●be ~~our~~sufficient ~~ability~~ to ~~continue~~prevent toa ~~attract~~material ~~and~~cybersecurity ~~retain key talent~~incident.

IfThe weconflict ~~fail~~also tocarries ~~successfully~~significant ~~initiate~~sanctions, ~~our~~export ~~broad~~control ~~commercialization~~and ~~program~~regulatory risk. Expanded U.S. or allied sanctions regimes targeting Iran and its proxies, ~~market~~changes in government policy, and ~~sell~~evolving ~~our~~export ~~BNA~~control ~~Platform~~restrictions ~~cost-effectively~~on technology companies could alter the regulatory environment in which we operate, including with respect to our ~~sales,~~activities ~~business,~~involving ~~financial~~our ~~condition~~Israeli operations and ~~results~~any oftechnology ~~operations~~developed ~~will~~or bedeployed ~~negatively~~in ~~affected~~the region.

~~Our~~There ~~commercial~~is ~~success~~no ~~will~~certainty ~~depend~~as onto the ~~future~~duration, ~~adoption~~geographic scope, or ultimate resolution of the ~~BNA~~conflict. ~~Platform~~The ~~into~~failure ~~patient~~of ~~work~~diplomatic ~~streams~~negotiations inand ~~clinics~~the current military trajectory suggest a prolonged conflict is possible, with an uncertain post-conflict political and economic framework. IfAny wecontinuation ~~are~~or ~~unable~~further toescalation ~~successfully~~of ~~drive~~hostilities ~~interest~~— inincluding ~~our~~the ~~BNA~~potential ~~Platform,~~involvement of additional state or non-state actors — could materially and adversely affect our ~~business~~operations, personnel safety, financial condition and results of operations ~~would~~in beways ~~harmed~~that are difficult to predict or quantify at this time.

~~Our~~Any ~~commercial~~hostilities ~~success~~involving ~~will~~Israel ~~depend~~could inadversely ~~large~~affect ~~part~~our onoperations ~~the~~and ~~future~~results ~~adoption~~ of ~~the~~operations. ~~BNA Platform into patient work streams~~ Shelter-in-place ~~clinics. We cannot predict how quickly, if at all, clinicians~~ and ~~patients~~work-from-home ~~will adopt our BNA Platform. Moreover~~measures, wegovernment-imposed ~~cannot~~restrictions ~~predict~~on ~~how~~movement ~~quickly, if at all, those currently living with mental illness or cognitive disorders but who are not being treated will seek treatment. Our ability to grow sales of our BNA Platform~~ and ~~drive~~travel ~~market acceptance will depend on successfully educating clinicians~~ and ~~patients~~other ofprecautions ~~the~~taken ~~relative benefits of our BNA Platform. If we are unable~~ to ~~successfully~~address ~~drive~~the ~~interest~~ongoing inconflict ~~our~~may ~~BNA~~temporarily ~~Platform,~~disrupt our ~~business,~~employees’ ~~financial~~ability ~~condition~~to ~~and~~effectively ~~results~~perform oftheir ~~operations~~daily ~~would be harmed~~tasks.

WeThe Israel Defense Force (the “IDF”), the national military of Israel, is a conscripted military service, subject to certain exceptions. Several of our employees are subject to military service in the IDF and have been and may be ~~unable~~called to ~~compete~~serve. ~~successfully~~Currently, all male adult citizens and permanent residents of Israel under the age of 40 (or older, depending on their position with ~~competitive~~the ~~technologies~~Israeli Defense Forces reserves), unless exempt, are obligated to perform military reserve duty annually and are subject to being called to active duty at any time under emergency circumstances. It is possible that there will be further or longer military reserve duty call-ups in the future, which ~~could~~may ~~harm~~affect our ~~sales~~business due to a shortage of skilled labor and loss of institutional knowledge, ~~business~~and necessary mitigation measures we may take to respond to a decrease in labor availability, ~~financial~~such ~~condition~~as overtime and third-party outsourcing, for example, which may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.

~~Our~~Also, ~~industry~~in isthe ~~competitive~~event ~~and~~of ~~has~~sustained ~~been~~military ~~evolving~~conflict, ~~rapidly.~~civil ~~Our~~unrest, ~~BNA~~or ~~Platform~~other isdisruptive ~~indicated~~events ~~for~~in ~~use~~Israel, we could face challenges in maintaining normal business operations or communicating with employees in ~~individuals~~the 12region. Our ability to 85recruit ~~years~~and ofretain ~~age~~talent ~~for~~locally ~~the~~could ~~post-hoc~~also ~~statistical~~be ~~analysis~~affected. ofMoreover, ~~the~~government-imposed ~~human~~restrictions, ~~electroencephalogram~~transportation shutdowns, ~~including~~or ~~event-related~~damage ~~potentials~~to infrastructure may inhibit our ability to conduct business activities.

~~Our~~While ~~initial~~our ~~market~~facilities ~~entry~~have ~~strategy~~not isbeen ~~focused~~damaged onduring ~~neurologists in~~ the ~~United~~current ~~States.~~war, ~~Once~~the wehostilities ~~commence~~with aHamas, ~~broad~~Hezbollah, ~~commercialization~~Iran ~~program~~and ofits ~~our~~proxies ~~BNA~~and ~~Platform,~~others wehave ~~will~~caused ~~face~~and ~~competition~~may incontinue ~~the~~to ~~market~~cause ~~for~~damage ~~our~~to ~~BNA~~private ~~Platform~~and ~~from~~public ~~competing~~facilities, ~~technologies~~infrastructure, utilities, and wetelecommunication ~~expect~~networks, ~~competition~~and ~~from~~potentially ~~new~~disrupting ~~companies~~our ~~that~~operations ~~may~~and ~~enter~~supply ~~the~~chains. ~~market~~In oraddition, ~~introduce~~Israeli ~~new~~organizations, ~~technologies~~government inagencies ~~the~~and ~~future.~~companies ~~Third-party~~have ~~payors~~been ~~may~~subject ~~encourage~~to ~~the~~extensive ~~use~~cyber ofattacks. ~~competitors’~~This ~~products~~could ~~due~~lead to ~~lower~~increased costs, ofrisks ~~competing~~to ~~products~~employee ~~or alternatives. Additionally~~safety, ~~treating~~and ~~neurologists~~challenges ~~may~~to ~~promote~~business ~~the~~continuity, ~~use~~with ofpotential ~~other~~financial ~~competitors’ products or alternative therapies~~losses.

Our ~~current~~commercial ~~and~~insurance ~~future~~does ~~competitors~~not cover losses that may ~~include~~occur ~~large,~~as ~~well-capitalized~~a ~~companies~~result ~~with~~of ~~significant~~events ~~market~~associated ~~share~~with war and ~~resources~~terrorism. ~~They~~Although ~~may~~the ~~have~~Israeli ~~more~~government ~~established~~currently ~~sales~~covers ~~and~~the ~~marketing~~reinstatement ~~programs~~value ~~than~~of wedirect dodamages ~~and~~that ~~have~~are ~~greater~~caused ~~name~~by ~~recognition.~~terrorist Inattacks ~~addition~~or toacts ~~competing~~of ~~for~~war, ~~market~~we ~~share,~~cannot ~~competitors~~assure ~~may~~you ~~develop~~that orthis ~~acquire~~government ~~patents~~coverage orwill ~~other~~be ~~rights~~maintained or that ~~may~~it ~~limit~~will sufficiently cover our ~~ability~~potential todamages. ~~compete~~Any losses or damages incurred by us could have a material adverse effect on our business.

Our ~~current~~operations ~~and future competitors~~ may ~~include~~be ~~large,~~impacted ~~well-capitalized~~by ~~companies~~natural ~~with~~disaster ~~significant market share~~ and ~~resources. They~~ may ~~have~~adversely ~~more~~impact ~~established~~our ~~sales~~business and ~~marketing~~operating ~~programs~~results ~~than~~as wewell doas ~~and~~those ~~have~~of ~~greater name recognition. In addition to competing for market share, competitors may develop or acquire patents or other rights that may limit~~ our ~~ability~~potential tocustomers ~~compete~~and suppliers.

WeNatural ~~believe~~disasters ~~that~~and ~~the~~other ~~competitive~~extreme ~~advantages~~weather ofevents may impact us and our ~~BNA~~potential ~~Platform~~customers, ~~will~~as bewell ~~important~~as ~~factors~~suppliers incritical to our ~~future success~~operations. ~~Our~~Natural ~~continued~~disasters ~~success~~include ~~depends~~earthquakes, ontsunamis, ~~among~~floods, droughts, hurricanes, wildfires, and other ~~things~~extreme weather conditions that can cause deaths, ~~our~~injuries, ~~ability~~and ~~to:~~critical health crises, power outages, restrictions and shortages of food, water, shelter, and medical supplies, telecommunications failures, materials scarcity, price volatility and other ramifications.

●The ~~successfully~~frequency ~~launch~~and ~~our~~severity ~~commercialization~~of ~~program~~such toevents ~~target~~can ~~clinicians~~vary ~~(i.e.~~over ~~neurologists~~time inand ~~the~~by ~~United~~region. ~~States);~~Regardless ●of ~~drive~~their ~~awareness~~cause, tonatural ~~increase~~disasters ~~the~~and ~~number~~extreme ofweather ~~mental~~may ~~illness~~pose ~~and~~ongoing ~~cognitive~~operational ~~impairment~~and ~~patients~~financial ~~referred~~risks to ~~target~~us ~~clinicians,~~and ~~namely~~others ~~neurologists~~within inour ~~the~~supply ~~United~~chain. ~~States;~~These ●events ~~attract~~can ~~and~~lead ~~retain~~to ~~skilled~~facility ~~research~~shutdowns, ~~development,~~shipping ~~sales, marketing~~ and ~~clinical~~logistics ~~personnel;~~disruptions, ●increased ~~continue~~insurance toor ~~innovate~~operating incosts, ~~order to improve our BNA Platform~~ and ~~enhance~~potential ~~the~~loss ~~patient~~of ~~and provider experience; ● adequately predict product performance;~~revenue.

25 In addition, changes in the broader economic environment due to environmental factors may affect the supply, demand, or availability of energy and other critical resources used in our operations. Any of these factors could have a material adverse effect on our business, financial condition, or results of operations.

~~Table~~Risks ofRelated ~~Contents~~ to our Software Platform

●Our ~~obtain~~operations ~~and~~depend ~~maintain~~in ~~regulatory~~part ~~clearances~~on ~~and approvals, including for expanded indications; ● cost~~third-~~effectively~~party ~~market~~software platforms and ~~sell~~artificial ~~our~~intelligence ~~BNA Platform; ● obtain~~services, ~~maintain, protect, enforce~~ and ~~defend~~disruptions ~~our~~to ~~intellectual~~those ~~property rights and operate our business without infringing~~services, including ~~misappropriating~~interruptions orresulting ~~otherwise~~from ~~violating~~government ~~the~~actions ~~intellectual property rights of others; and ● acquire products~~ or ~~technologies~~policy ~~complementary~~decisions, could toadversely oraffect ~~necessary for~~ our business.

~~The~~We ~~medical~~rely ~~device~~on ~~industry~~various isthird-party ~~intensely~~software ~~competitive~~tools, ~~subject~~cloud toinfrastructure ~~rapid~~providers ~~change~~ and ~~significantly~~artificial ~~affected~~intelligence byplatforms ~~new~~to ~~product~~support ~~introductions~~our ~~and~~research, ~~other~~development, ~~market~~and ~~activities~~operational ~~of industry participants~~activities. ~~There~~These ~~can~~services may be noprovided ~~assurance~~by ~~that~~large ~~other~~technology companies or ~~institutions~~emerging ~~will~~AI ~~not~~providers. ~~succeed~~Our inability ~~developing~~to oraccess ~~marketing~~and ~~devices~~use ~~and~~such ~~products~~services ~~that~~may ~~are~~be ~~more~~affected ~~effective~~by ~~than~~technical ~~our~~outages, ~~BNA~~service ~~Platform~~interruptions, orcontractual ~~that~~disputes, ~~would~~regulatory ~~render~~actions, ~~our~~or ~~BNA~~government ~~Platform~~policy ~~obsolete~~decisions oraffecting ~~noncompetitive~~technology providers.

~~Patient~~For ~~and~~example, ~~product~~government ~~variability~~actions or policy decisions affecting AI providers or technology supply chains may ~~produce~~result ~~misleading~~in ~~BNA results~~ service interruptions, restricted access, or changes to the availability of certain platforms. Recent developments have demonstrated that government determinations regarding technology supply chain risks can lead to restrictions on the use of certain AI providers in government or commercial environments.

~~Misled~~If ~~clinical~~any ~~decision~~of ~~due~~the tothird-party ~~incorrect~~services ~~score~~on ~~results~~which iswe arely ~~known~~were ~~risk~~to ~~and~~become isunavailable, ~~continually~~experience ~~mitigated.~~prolonged ~~EEG~~outages, isimpose ~~subject~~usage torestrictions, ~~external~~significantly ~~“noise”~~increase pricing, or ~~artifact~~otherwise ~~that~~change ~~contaminates~~their ~~waveforms~~service ~~such~~terms, aswe ~~Electrical~~may ~~grid;~~experience ~~nearby~~operational ~~medical/other~~disruptions, ~~devices~~delays ~~which cause interference~~ in ~~frequencies~~product ~~near~~development, ~~EEG~~increased ~~frequencies.~~costs, or ~~excessive~~reduced ~~patient movement~~efficiency. ~~Artifact-free~~Although ~~data~~we ~~cannot~~may ~~always~~seek bealternative ~~guaranteed.~~providers ~~This~~where ~~variability~~possible, ~~may~~transitioning ~~lead~~ to ~~customer~~substitute ~~dissatisfaction which~~platforms could ~~harm~~require ~~our~~significant ~~sales~~time, ~~business,~~cost ~~financial condition,~~ and ~~results~~technical ~~of operations~~effort.

~~Use~~Any ofinterruption ~~our~~or ~~BNA~~limitation ~~Platform~~in ~~requires~~our ~~appropriate~~access ~~training~~to ~~and~~critical ~~inadequate~~software ~~training~~or ~~may~~AI ~~lead~~services tocould ~~negative~~adversely ~~clinician~~affect ~~experiences~~our operations, ~~which~~research ~~could~~and ~~harm~~development ~~our business~~activities, ~~financial condition,~~ and ~~results~~overall ~~of operations~~business.

~~The~~If ~~successful~~we ~~use~~are ofnot ~~our~~successful ~~BNA Platform depends~~ in ~~part~~enhancing onawareness ~~the training and skill~~ of the clinician performing EEG recording and reading BNA reports. Clinicians could experience difficulty interpreting the results of BNA reports. Moreover, clinicians rely on their previous medical training and experience when recommending or utilizing our ~~BNA Platform~~products, ~~and~~driving weadoption ~~cannot~~across ~~guarantee that all clinicians will have the necessary skills to properly utilize the BNA Platform. We cannot be certain that clinicians that will use~~ our ~~BNA~~current ~~Platform~~target ~~will~~markets ~~have received sufficient training,~~ and ~~clinicians~~expanding who have not received adequate training may nonetheless attempt to use our BNA Platform with their patients. If clinicians utilize our BNA Platform incorrectly, or without adhering to or completing all relevant training, their patient outcomes may not be consistent with the ~~outcomes~~population ~~achieved in our research studies and any future clinical studies. Adverse safety outcomes that arise from improper or incorrect use~~ of ~~our~~eligible ~~BNA Platform may negatively impact the perception of patient benefit and the safety of our BNA Platform~~patients, ~~notwithstanding results from~~ our ~~research studies and any future clinical studies. These results could limit adoption of our BNA Platform, which would harm our~~ sales, business, financial condition, and results of operations will be negatively affected.

WeOur ~~are~~business ~~highly~~currently ~~dependent~~depends primarily on our ~~senior~~ability ~~management~~to ~~team~~successfully ~~and~~market ~~key~~our ~~personnel~~products, which involves successfully executing our commercialization program, increasing adoption of and driving utilization our ~~business~~products ~~could~~by beclinicians, ~~harmed~~in ifthe weUnited ~~are~~States. ~~unable~~We continue to ~~attract~~increase ~~and~~awareness ~~retain~~of ~~personnel~~our ~~necessary~~products, ~~for~~as well as grow the number of clinicians that utilize our ~~success~~products, but there can be no assurance that we will succeed.

~~We are highly dependent on our senior management and key personnel.~~ Our commercial success will ~~depend~~continue ~~on our ability~~ to ~~retain~~depend ~~senior~~on ~~management~~a ~~and~~number toof ~~attract and retain qualified personnel in the future~~factors, including ~~sales~~the ~~and marketing professionals, engineers, scientists, data science specialists and other highly skilled personnel and to integrate current and additional personnel in all departments.~~following:

~~Competition~~● ~~for~~the ~~skilled~~actual ~~personnel in our market is intense~~ and ~~may~~perceived ~~limit~~effectiveness ~~our ability to hire~~ and ~~retain~~clinical ~~highly qualified personnel on acceptable terms~~benefit, orof ~~at all. To induce valuable employees to remain at~~ our ~~company,~~products; in● ~~addition~~the toprevalence ~~salary~~ and ~~cash~~severity ~~incentives,~~of weany ~~have~~adverse ~~issued~~patient ~~stock~~events ~~options~~involving ~~that~~our ~~vest~~products; ~~over~~● ~~time,~~our ~~restricted~~ability ~~share~~to ~~units~~provide ~~subject~~earlier toawareness ~~vesting~~of ~~conditions,~~ and ~~certain~~education ~~performance~~about ~~warrants.~~our ~~The~~products ~~value~~ to ~~employees~~patients ofand ~~stock~~clinicians; ~~options~~● ~~that~~the ~~vest~~degree ~~over~~to ~~time~~which ~~may~~clinicians beand ~~significantly~~patients ~~affected~~adopt ~~by fluctuations in~~ our ~~stock~~products; ~~price~~● ~~that~~the ~~are~~availability, ~~beyond~~relative ~~our~~cost ~~control,~~ and ~~may~~perceived atadvantages ~~any~~and ~~time~~disadvantages beof ~~insufficient~~alternative totechnologies ~~counteract~~or ~~more~~treatment ~~lucrative~~methods ~~offers~~for ~~from~~cognitive ~~other~~disorders; ~~companies.~~● ~~Despite~~the ~~our~~results ~~efforts to retain valuable employees, members~~ of ~~our~~future ~~management~~clinical and other ~~key~~studies ~~personnel~~relating ~~may~~to ~~terminate~~the ~~their employment with us on short notice. Our employment arrangements with our employees provide for at-will employment~~health, ~~which~~economic ~~means~~or ~~that~~other ~~any~~benefits of our ~~employees~~products; ~~could~~● ~~leave~~whether ~~our~~key ~~employment~~thought atleaders ~~any~~in ~~time,~~the ~~with~~medical orcommunity ~~without~~accept ~~notice.~~that Weour ~~also~~future doclinical ~~not~~utility ~~maintain~~is ~~“key~~sufficiently ~~man”~~meaningful ~~insurance~~to ~~policies~~influence ontheir ~~the~~decision ~~lives~~to ofadopt ~~these individuals or the lives of any of~~ our ~~other employees.~~products;

As we launch the commercialization program for our BNA Platforms, expand our product offerings in the future and increase our future marketing efforts, we will need to build and expand the reach of our marketing and sales networks. Our future success will depend largely on our ability to continue to hire, train, retain and motivate skilled employees with significant technical knowledge in various areas. An inability to attract, hire, train and retain employees will harm our sales, business, financial condition, and results of operations.22

26 Table of Contents

~~Table~~● the extent to which we are successful in educating clinicians and patients about the benefits of ~~Contents~~ our products; ● our reputation among clinicians and patients; ● our ability to predict product performance; ● the strength of our marketing and distribution infrastructure, including our ability to drive adoption and utilization of our products; ● our ability to obtain, maintain, protect, enforce and defend our intellectual property rights, including those covering our products; ● our ability to maintain compliance with all legal and regulatory requirements, including those applicable to our products; and ● our ability to continue to attract and retain key talent.

WeIf ~~expect~~we fail to ~~increase~~successfully ~~the~~initiate ~~size of~~ our ~~organization~~broad incommercialization ~~the future~~program, market and wesell ~~may~~our ~~experience~~products ~~difficulties~~cost-effectively, ~~in managing the operational elements or timing of this growth. If we are unable to manage or appropriately time the anticipated growth of~~ our sales, business, ~~our~~financial ~~future~~condition ~~revenue~~ and ~~operating~~ results ~~may~~of operations will be ~~harmed~~negatively affected.

AsOur ofcommercial success will depend in large part on the ~~date~~future adoption of ~~this~~our ~~report,~~products weinto ~~have~~patient ~~thirteen~~work ~~full~~streams ~~time~~in ~~employees~~clinics. ~~and~~We ~~one contractor.~~cannot Aspredict ~~our~~how ~~sales~~quickly, ~~and~~if ~~marketing~~at ~~strategies~~all, ~~evolve~~clinicians and aspatients wewill ~~launch~~adopt ~~commercialization of~~ our ~~BNA~~product. ~~Platform~~Moreover, we ~~may~~cannot ~~need~~predict ~~additional~~how ~~managerial~~quickly, ~~operational,~~if ~~sales,~~at ~~marketing~~all, ~~financial~~those ~~and~~currently ~~other~~living ~~personnel~~with mental illness or cognitive disorders but who are not being treated will seek treatment. ~~Future~~Our ~~growth~~ability ~~would~~to ~~impose~~grow ~~significant~~sales ~~added~~of ~~responsibilities~~our products and drive market acceptance will depend on ~~members~~successfully educating clinicians and patients of ~~management~~the relative benefits of our products. If we are unable to successfully drive interest in our products, ~~including:~~our business, financial condition and results of operations would be harmed.

●We ~~identifying,~~may ~~recruiting,~~be ~~integrating,~~unable ~~maintaining~~to ~~and~~compete ~~motivating~~successfully ~~additional~~with ~~employees;~~competitive ~~● managing our internal development efforts effectively~~technologies, ~~while~~which ~~complying~~could ~~with~~harm our ~~contractual~~sales, ~~obligations to contractors and other third parties; and ● improving our operational~~business, financial condition and ~~management~~results ~~controls,~~of ~~reporting systems and procedures~~operations.

Our ~~future~~industry ~~financial~~is ~~performance~~competitive and ~~our~~has ~~ability~~been toevolving ~~successfully~~rapidly. ~~market~~Our ~~and~~current ~~sell~~customer ~~our~~base ~~BNA~~includes ~~Platform~~neurology ~~will depend, in part, on our ability to effectively manage or time any future growth,~~ and ~~our~~psychiatric ~~management~~clinics ~~may also have to divert a disproportionate amount of attention away from day-to-day activities~~ in ~~order~~the toUnited ~~devote a substantial amount of time to managing these growth activities~~States.

AsWe ~~demand~~will ~~for~~face ~~our~~competition ~~BNA Platform increases~~ in the ~~future,~~market wefor ~~will~~our ~~need~~products tofrom ~~expand~~competing ~~customer service~~technologies, ~~billing~~ and ~~systems~~we ~~processes~~expect ~~and~~competition ~~enhance~~from ~~our~~new ~~internal~~companies ~~quality~~that ~~assurance~~may ~~program.~~enter Wethe ~~cannot~~market beor ~~certain~~introduce ~~that~~new ~~any~~technologies ~~increases~~ in ~~scale,~~the ~~related~~future. ~~improvements~~Third-party ~~and~~payors ~~quality~~may ~~assurance~~encourage ~~will~~the beuse ~~successfully~~of ~~implemented~~competitors’ orproducts ~~that~~due ~~appropriate personnel will be available~~ to ~~facilitate~~lower ~~the~~costs ~~growth~~ of ~~our~~competing ~~business.~~products ~~If we encounter difficulty meeting market demand, quality standards~~ or ~~clinician expectations, our reputation will be harmed and our business will suffer~~alternatives. Additionally, ~~additional~~treating ~~growth~~neurologists may ~~result~~promote ~~in higher fixed costs and may slow our ability to reduce costs in~~ the ~~face~~use of aother ~~sudden~~competitors’ ~~decline~~products inor ~~demand~~alternative ~~for our products~~therapies.

WeOur current and future competitors may ~~not~~include belarge, ~~able~~well-capitalized tocompanies ~~achieve~~with orsignificant ~~maintain~~market ~~satisfactory~~share ~~pricing~~and resources. They may have more established sales and ~~margins~~marketing ~~for~~programs ~~our~~than ~~BNA~~we ~~Platform~~do and have greater name recognition. In addition to competing for market share, ~~which~~competitors ~~could~~may ~~harm~~develop ~~our~~or ~~business~~acquire ~~and~~patents ~~results~~or ofother ~~operations~~rights that may limit our ability to compete.

~~The~~We ~~medical~~believe ~~device industry has a history of price competition, and we can give no assurance~~ that wethe ~~will be able to maintain satisfactory prices for our BNA Platform or any future products at~~ competitive ~~levels.~~advantages ~~The pricing~~ of our products ~~could~~will be ~~impacted~~important ~~by several~~ factors, ~~including pressure to reduce prices by our customers due to a decline~~ in ~~the amount that third-party payors reimburse for EEG tests for clinicians utilizing~~ our ~~BNA~~future ~~Platform~~success. IfOur wecontinued ~~are~~success ~~forced~~depends ~~to lower or are unable to increase the price we charge for our BNA Platform~~on, ~~our~~among ~~gross~~other ~~margins will decrease~~things, ~~which will harm~~ our ability to invest in and grow our business. If we are unable to maintain our prices, or if our costs increase and we are unable to offset such increase with an increase in our prices, our margins could erode, which could harm our business and results of operations.:

~~Future~~● ~~sales~~successfully ofscale our ~~BNA~~commercialization ~~Platform~~program ~~may~~to ~~depend~~target onclinicians ~~healthcare~~(i.e. ~~providers’~~neurologists orin the United States); ● drive awareness to increase the number of mental illness and cognitive impairment patients’ ~~ability~~referred to ~~obtain~~target ~~reimbursement~~clinicians, ~~from~~namely ~~third-party~~neurologists ~~payors~~in the United States; ● attract and retain skilled research, ~~such~~development, assales, ~~insurance~~marketing ~~carriers.~~and clinical personnel; ● continue to innovate in order to improve our software platform and enhance the patient and provider experience; ● adequately predict product performance;

Future sales of our BNA Platform may depend on healthcare providers’ or patients’ ability to obtain reimbursement from third-party payors, such as insurance carriers. Where such insurance or third-party reimbursement becomes available in the future, any reduction in insurance or other third-party payor reimbursement for our BNA Platform may cause negative price pressure, which would reduce our revenues. Without a corresponding reduction in the cost to produce such products, the result would be a reduction in our overall gross profit. Similarly, any increase in the cost of such products would reduce our overall gross profit unless there was a corresponding increase in third-party payor reimbursement. Failure by our patients or healthcare provider customers to obtain or maintain coverage or to secure adequate reimbursement for our treatment by third-party payors could have an adverse effect on our business, results of operations, and financial condition. 23

~~Our~~Table ~~results~~ of ~~operations~~Contents ~~may be harmed if we are unable to accurately forecast clinician demand for our BNA Platform or any future products.~~

~~Our~~● ~~ability~~obtain toand ~~accurately~~maintain ~~forecast~~regulatory ~~demand~~clearances ~~for~~and ~~our~~approvals, ~~BNA~~including ~~Platform~~for orexpanded ~~our~~indications; ~~future~~● ~~our~~cost-effectively ~~products~~market ~~could~~and besell ~~negatively affected by many factors, including~~ our ~~failure~~products; to● ~~accurately manage our expansion strategy~~obtain, ~~product introductions by competitors~~maintain, ~~our inability to forecast the lifecycle of our products~~protect, anenforce ~~increase~~and ordefend ~~decrease in customer demand for~~ our ~~products~~intellectual orproperty ~~for~~rights ~~competitor~~and ~~products,~~operate our ~~failure~~business towithout ~~accurately forecast customer adoption of new products~~infringing, ~~unanticipated~~misappropriating ~~changes in general market conditions~~ or ~~regulatory~~otherwise ~~matters~~violating ~~and~~the ~~weakening~~intellectual ofproperty ~~economic~~rights ~~conditions or consumer confidence in future economic conditions. Inventory levels in excess~~ of ~~customer~~others; ~~demand~~and ~~may~~● ~~result~~acquire inproducts ~~inventory write-downs~~ or ~~write-offs,~~technologies ~~which~~complementary ~~would cause our gross margin~~ to beor ~~adversely~~necessary ~~affected~~for ~~and could impair the strength of~~ our ~~brand, which may negatively affect our~~ business~~, financial condition, and results of operations~~.

27 The medical device industry is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants. There can be no assurance that other companies or institutions will not succeed in developing or marketing devices and products that are more effective than ours or that would render our products obsolete or noncompetitive.

~~Table~~Patient ofand ~~Contents~~ product variability may produce misleading report results

~~Adoption~~Misled ofclinical ~~our~~decision ~~BNA~~due ~~Platform~~to ~~depends~~incorrect onscore ~~positive~~results ~~clinical~~is ~~data~~a asknown ~~well~~risk and is continually mitigated. EEG is subject to external “noise” or artifact that contaminates waveforms such as ~~clinician~~Electrical ~~acceptance~~grid; ofnearby ~~the~~medical/other ~~data~~devices ~~and~~which ~~our~~cause ~~products~~interference in frequencies near EEG frequencies., ~~and~~or ~~negative~~excessive ~~clinical~~patient movement. Artifact-free data orcannot ~~perceptions~~always ~~among~~be ~~these~~guaranteed. ~~clinicians~~This ~~would~~variability may lead to customer dissatisfaction which could harm our sales, business, financial condition, and results of operations.

~~The~~Use ~~rate~~ of ~~adoption and sales of~~ our ~~products~~platform isrequires ~~heavily~~appropriate ~~influenced~~training byand ~~clinical~~inadequate ~~data.~~training ~~Although~~may welead ~~have positive research data from a 2023 white paper study, there can be no assurance that future clinical studies, including those~~ to demonstrate the efficacy of our BNA Platform or future products in current target patient populations and those to support label retention and expansion for our products, will demonstrate clinical utility and effectiveness. Unfavorable or inconsistent clinical data from future clinical studies conducted by us, our competitors, or third parties, or the negative ~~interpretation~~clinician ~~of our clinical data internally and externally~~experiences, ~~including~~which ~~by customers, competitors, patients, and regulators~~ could harm our business, financial condition, and results of operations.

The ~~rate~~successful use of ~~adoption~~our products depends in part on the training and ~~sales~~skill of ~~our~~the ~~products~~clinician ~~are~~performing ~~also~~EEG ~~influenced~~recording byand ~~clinician~~reading ~~perceptions~~our reports. ~~Negative~~Clinicians ~~perceptions~~could experience difficulty interpreting the results of our ~~products~~reports. byMoreover, clinicians rely on their previous medical training and experience when recommending or utilizing our software platform, ~~including~~and ~~due~~we cannot guarantee that all clinicians will have the necessary skills to ~~negative~~properly ~~clinical~~utilize ~~data,~~the ~~could~~platform. ~~result~~We incannot ~~decreased~~be ~~adoption~~certain orthat ~~use~~clinicians ofthat will use our ~~products~~platform will have received sufficient training, ~~which~~and ~~would~~clinicians ~~harm~~who have not received adequate training may nonetheless attempt to use our ~~business,~~platform ~~financial~~with ~~condition~~their patients. If clinicians utilize our platform incorrectly, ~~and~~or ~~results~~without ofadhering ~~operations.~~to ~~Further~~or completing all relevant training, iftheir wepatient ~~are~~outcomes may not ~~able~~be toconsistent ~~attain~~with ~~strong~~the ~~working~~outcomes ~~relationships~~achieved ~~with~~in ~~clinicians~~our research studies and ~~receive~~any ~~their~~future ~~advice~~clinical ~~and~~studies. ~~input,~~Adverse safety outcomes that arise from improper or incorrect use of our software platform may negatively impact the ~~marketing~~perception of patient benefit and the safety of our ~~products~~software platform, notwithstanding results from our research studies and any future clinical studies. These results could ~~suffer~~limit adoption of our platform, which ~~could~~would harm our sales, business, financial condition, and results of operations.

~~Our~~We ~~future~~are ~~success~~highly ~~also~~dependent ~~depends~~on ~~upon patients having an experience with~~ our ~~products~~senior ~~that~~management ~~meets~~team ~~their~~and ~~expectations~~key inpersonnel, ~~order~~and ~~to increase clinician demand for~~ our ~~products~~business ascould ~~a result of positive feedback and word-of-mouth. Patients may~~ be ~~dissatisfied~~harmed if ~~their~~we ~~expectations of the BNA Platform~~ are ~~not~~unable met or if the performing clinicians are not adequately trained on use of our BNA Platform. If the results of our products do not meet the expectations of the patient it could discourage the patient and/or their healthcare provider from continuing to ~~use~~attract ~~our device or referring our products to others. Dissatisfied patients may express negative opinions through social media, advocacy, or other publicity. Any failure to meet patient expectations~~ and ~~any~~retain ~~resulting~~personnel ~~negative~~necessary ~~publicity~~for ~~could harm~~ our ~~reputation and future sales~~success.

We ~~may~~are ~~acquire~~highly ~~businesses~~dependent oron ~~products,~~our orsenior ~~form~~management ~~strategic~~and ~~alliances,~~key personnel. Our success will depend on our ability to retain senior management and to attract and retain qualified personnel in the future, including sales and ~~may~~marketing ~~not~~professionals, ~~realize~~engineers, ~~the~~scientists, ~~benefits~~data ofscience ~~such~~specialists ~~acquisitions~~and other highly skilled personnel and to integrate current and additional personnel in all departments.

WeCompetition ~~may~~for ~~acquire~~skilled ~~additional~~personnel ~~businesses~~in orour ~~products,~~market ~~form~~is ~~strategic~~intense ~~alliances,~~and ormay ~~create~~limit ~~joint~~our ~~ventures~~ability ~~with~~to ~~third~~hire ~~parties~~and ~~that~~retain wehighly ~~believe~~qualified ~~will~~personnel ~~complement~~on oracceptable ~~augment~~terms, ~~our~~or ~~existing~~at ~~business~~all. IfTo weinduce ~~acquire~~valuable ~~businesses~~employees ~~with~~to ~~promising~~remain ~~markets~~at orour ~~technologies~~company, wein ~~may~~addition ~~not~~to besalary ~~able~~and tocash ~~realize~~incentives, ~~the~~we ~~benefit~~have ofissued ~~acquiring~~stock ~~such~~options ~~businesses~~that ifvest weover ~~are~~time, ~~unable~~restricted share units subject to ~~successfully~~vesting ~~integrate~~conditions, ~~them~~and ~~with~~certain ~~its~~performance ~~existing~~warrants. ~~operations~~The ~~and~~value ~~company~~to ~~culture.~~employees Weof stock options that vest over time may ~~encounter~~be ~~numerous~~significantly ~~difficulties~~affected by fluctuations in ~~developing,~~our ~~manufacturing~~stock price that are beyond our control, and ~~marketing~~may at any ~~new~~time ~~products~~be ~~resulting~~insufficient ~~from~~to acounteract ~~strategic~~more ~~alliance~~lucrative oroffers ~~acquisition~~from ~~that~~other ~~delay~~companies. orDespite ~~prevent~~our itefforts ~~from~~to ~~realizing~~retain valuable employees, members of our ~~expected~~management ~~benefits~~and orother ~~enhancing~~key ~~our~~personnel ~~business~~may terminate their employment with us on short notice. ~~There~~Our isemployment noarrangements ~~assurance~~with ~~that~~our employees provide for at-will employment, ~~following~~which means that any ~~such~~of ~~acquisition~~our employees could leave our employment at any time, wewith ~~will~~or ~~achieve~~without ~~the~~notice. ~~synergies~~We ~~expected~~also todo ~~justify~~not maintain “key man” insurance policies on the ~~transaction,~~lives ~~which~~of ~~could~~these ~~result~~individuals inor athe ~~material~~lives ~~adverse~~of ~~effect~~any onof our ~~business~~other ~~and prospects~~employees.

~~Risks~~As ~~Related~~we scale, the commercialization program for our platform, expand our product offerings in the future and increase our future marketing efforts, we will need to ~~Legal~~build and expand the reach of our marketing and sales networks. Our future success will depend largely on our ability to continue to hire, ~~Regulatory~~train, retain and ~~Compliance~~motivate ~~Matters~~skilled employees with significant technical knowledge in various areas. An inability to attract, hire, train and retain employees will harm our sales, business, financial condition, and results of operations.

~~Complying with regulations enforced by FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties.~~24

~~Our~~Table product, the BNA Platform (for which we have obtained FDA 510(k) clearance), and our future products are considered medical devices and, accordingly, are subject to rigorous regulation by government agencies in the U.S. and other countries in which we intend to sell our products. Compliance with these rigorous regulations will affect capital expenditures, earnings and the competitive position of ~~the~~Contents ~~Company. These regulations vary from country to country but cover, among other things, the following activities with respect to medical devices:~~

●We ~~design,~~expect ~~development~~to ~~and~~increase ~~manufacturing;~~the ●size ~~testing, labeling, content and language~~ of ~~instructions~~our ~~for~~organization ~~use~~in ~~and~~the ~~storage;~~future, ~~● product storage~~ and ~~safety;~~we ●may ~~marketing,~~experience ~~sales~~difficulties ~~and~~in ~~distribution;~~managing ●the ~~pre-market~~operational ~~clearance~~elements ~~and~~or ~~approval;~~timing ●of ~~record~~this ~~keeping~~growth. ~~procedures;~~If ●we ~~advertising~~are ~~and~~unable ~~promotion;~~to ●manage ~~recalls~~or ~~and~~appropriately ~~field~~time ~~safety~~the ~~corrective~~anticipated ~~actions;~~growth ●of ~~post-market~~our ~~surveillance;~~business, ●our ~~post-market~~future ~~approval~~revenue ~~studies;~~ and ●operating ~~product~~results ~~import~~may ~~and~~be ~~export~~harmed.

28 As of the date of this report, we have 17 full time employees. As our sales and marketing strategies evolve and as we launch commercialization of our software platform, we may need additional managerial, operational, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management, including:

~~Table~~● ofidentifying, ~~Contents~~ recruiting, integrating, maintaining and motivating additional employees; ● managing our internal development efforts effectively, while complying with our contractual obligations to contractors and other third parties; and ● improving our operational, financial and management controls, reporting systems and procedures.

~~The~~Our ~~regulations~~future tofinancial ~~which~~performance weand ~~are~~our ~~subject~~ability ~~are~~to ~~complex.~~successfully ~~Regulatory~~market ~~changes~~and ~~could~~sell ~~result~~our software platform will depend, in ~~restrictions~~part, on our ability to ~~carry~~effectively onmanage or ~~expand~~time ~~our~~any ~~operations,~~future ~~higher than anticipated costs~~growth, orand ~~lower~~our ~~than~~management ~~anticipated~~may ~~sales.~~also ~~Our~~have ~~failure~~ to ~~comply~~divert ~~with~~a ~~applicable~~disproportionate ~~regulatory~~amount ~~requirements~~of ~~could~~attention ~~result~~away infrom ~~enforcement~~day-to-day ~~action~~activities byin ~~FDA~~order orto ~~state~~devote ~~agencies,~~a ~~which~~substantial ~~may~~amount ~~include~~of ~~any~~time ofto ~~the~~managing ~~following~~these ~~sanctions:~~growth activities.

●As ~~warning~~demand ~~letters,~~for ~~fines,~~our ~~injunctions~~platform increases in the future, ~~consent~~we ~~decrees~~will need to expand customer service, billing and ~~civil~~systems ~~penalties;~~processes ●and ~~repair,~~enhance ~~replacement,~~our ~~refunds,~~internal ~~recall~~quality assurance program. We cannot be certain that any increases in scale, orrelated ~~seizure~~improvements ofand ~~our~~quality ~~products;~~assurance ●will ~~operating~~be ~~restrictions~~successfully implemented or ~~partial~~that ~~suspension~~appropriate orpersonnel ~~total~~will ~~shutdown~~be ofavailable ~~production;~~to ●facilitate ~~refusing~~the growth of our ~~requests~~business. ~~for~~If ~~510(k)~~we ~~clearance~~encounter ordifficulty ~~pre-~~meeting market ~~approval~~demand, ofquality ~~new~~standards ~~products~~or clinician expectations, ~~new~~our ~~intended~~reputation ~~uses,~~will orbe ~~modifications~~harmed toand ~~existing~~our ~~products;~~business ●will ~~withdrawing~~suffer. ~~clearance~~Additionally, oradditional ~~pre-market~~growth ~~approvals~~may ~~that~~result ~~have~~in ~~already~~higher ~~been~~fixed ~~granted;~~costs and ●may ~~criminal~~slow ~~prosecution~~our ability to reduce costs in the face of a sudden decline in demand for our products.

IfWe ~~any~~may ofnot ~~these~~be ~~events~~able ~~were~~ to ~~occur~~achieve or maintain satisfactory pricing and margins for our products, ~~they~~which could harm our business and results of operations.

WeThe ~~may~~medical ~~not~~device ~~receive~~industry ~~the~~has ~~necessary~~a ~~authorizations~~history of price competition, and we can give no assurance that we will be able to ~~market~~maintain ~~our~~satisfactory ~~BNA~~prices ~~Platform~~for our products or any future ~~new~~products at competitive levels. The pricing of our products could be impacted by several factors, ~~and~~including ~~any~~pressure ~~failure~~to reduce prices by our customers due to ~~timely~~a dodecline soin ~~may~~the ~~adversely~~amount ~~affect~~that third-party payors reimburse for EEG tests for clinicians utilizing our products. If we are forced to lower or are unable to increase the price we charge for our products, our gross margins will decrease, which will harm our ability to invest in and grow our business. If we are unable to maintain our prices, or if our costs increase and we are unable to offset such increase with an increase in our prices, our margins could erode, which could harm our business and results of operations.

~~Before~~Future wesales ~~can~~of ~~sell~~our aproducts ~~new~~may ~~medical~~depend ~~device~~on inhealthcare ~~the~~providers’ ~~U.S.,~~ or ~~market~~patients’ aability ~~new use of, new claim for, or significant modification~~ to ~~a legally marketed device, we must first~~ obtain ~~either~~reimbursement ~~FDA~~from 510(k) clearance or approval, unless an exemption applies. In the 510(k) clearance process, before a device may be marketed, the applicant must submit a premarket notification to FDA under Section 510(k) of the FD&C Act, and FDA must determine that a proposed device is “substantially equivalent” to a legallythird-~~marketed~~party ~~“predicate” device. To be “substantially equivalent~~payors,” ~~the~~such ~~proposed device must have the same intended use~~ as ~~the~~insurance predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics, not raise different questions of safety or effectiveness than the predicate device, and be as safe and as effective as the predicate devicecarriers. The 510(k) clearance process can be expensive and uncertain and typically takes from three to 12 months, but may last significantly longer. Clinical data may be required in connection with an application for 510(k) clearance. Furthermore, even if we are granted regulatory clearances or approvals, they may include limitations on the indications for use or intended uses of the device, which may limit the market for the device.

~~Our~~Future ~~BNA~~sales ~~Platform~~of isour aproducts ~~Class~~may IIdepend ~~medical~~on ~~device~~healthcare providers’ or patients’ ability to obtain reimbursement from third-party payors, ~~which~~such ~~was~~as ~~cleared~~insurance bycarriers. ~~FDA~~Where ~~for~~such ~~commercialization~~insurance or third-party reimbursement becomes available in the ~~U.S.~~future, ~~pursuant~~any toreduction ~~the~~in ~~510(k)~~insurance ~~notification~~or ~~process~~other third-party payor reimbursement for our products may cause negative price pressure, which would reduce our revenues. Without a corresponding reduction in the ~~post-hoc~~cost ~~statistical~~to ~~analysis~~produce ofsuch products, the ~~human~~result ~~electroencephalogram~~would be a reduction in ~~December~~our ~~2020~~overall ~~for~~gross ~~use~~profit. Similarly, any increase in ~~individuals~~the 12cost of such products would reduce our overall gross profit unless there was a corresponding increase in third-party payor reimbursement. Failure by our patients or healthcare provider customers to 85obtain ~~years~~or maintain coverage or to secure adequate reimbursement for our treatment by third-party payors could have an adverse effect on our business, results of ~~age~~operations, and financial condition.

~~FDA~~Our ~~can~~results ~~delay,~~of ~~limit,~~operations ormay ~~deny~~be ~~510(k)~~harmed ~~clearance,~~if orwe ~~other~~are ~~approval~~unable orto ~~reclassification,~~accurately offorecast aclinician ~~device~~demand for ~~many~~our ~~reasons,~~products ~~including:~~or any future products.

●Our weability ~~may~~to accurately forecast demand for our products or our future our products could be ~~unable~~negatively toaffected ~~demonstrate~~by many factors, including our failure to ~~FDA’s~~accurately ~~satisfaction~~manage ~~that~~our ~~the~~expansion ~~products~~strategy, orproduct ~~modifications~~introductions ~~are~~by ~~substantially~~competitors, ~~equivalent~~our inability to aforecast ~~proposed~~the ~~predicate~~lifecycle ~~device~~of our products, an increase or ~~safe~~decrease ~~and~~in ~~effective~~customer demand for ~~their~~our ~~intended~~products ~~uses;~~or ●for wecompetitor ~~may~~products, beour ~~unable~~failure to ~~demonstrate~~accurately ~~that~~forecast ~~the~~customer ~~clinical~~adoption ~~and~~of ~~other~~new ~~benefits~~products, ofunanticipated ~~the~~changes ~~device~~in ~~outweigh~~general ~~the~~market ~~risks;~~conditions or regulatory matters and ●weakening ~~the~~of ~~applicable~~economic ~~regulatory~~conditions ~~authority~~or ~~may~~consumer ~~identify~~confidence ~~deficiencies~~in future economic conditions. Inventory levels in ~~our~~excess ~~submissions~~of orcustomer demand may result in ~~the~~inventory ~~facilities~~write-downs or ~~processes~~write-offs, which would cause our gross margin to be adversely affected and could impair the strength of our ~~third~~brand, ~~party~~which ~~contract~~may ~~manufacturers~~negatively affect our business, financial condition, and results of operations.

Any delay or failure to obtain necessary regulatory clearances or approvals could harm our business. For example, if we decide to market the BNA Platform for a broader or additional indication(s) for use and/or make any material modifications to any element of the device and/or the manufacturing or distribution thereof in the future, an additional 510(k) submission, and FDA clearance thereof, will be required prior to making any promotional communications expressly or impliedly claiming that the device may be used for such indication(s) and/or prior to making such modification, respectively.25

InTable addition, FDA may change its policies, adopt additional regulations, revise existing regulations, or take other actions, or Congress may enact different or additional statutory requirements, which may prevent or delay clearance of ~~our~~Contents future products under development or impact our ability to modify our currently marketed products on a timely basis. Such policy, statutory, or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict our ability to maintain our current marketing authorizations.

WeAdoption ~~received~~of our ~~European~~products CEdepends ~~mark,~~on ~~indicating~~positive ~~that~~clinical wedata ~~affirm~~as ~~our~~well ~~product’s~~as ~~conformity~~clinician ~~with~~acceptance ~~European~~of ~~health,~~the ~~safety~~data and ~~environmental protection standards, in 2021. We will also need to obtain regulatory approval in other foreign jurisdictions in which we plan to market and sell~~ our products~~. The time required to obtain registrations or approvals~~, ~~if required by other countries, may be longer than that required for FDA clearance,~~ and ~~requirements~~negative ~~for~~clinical ~~such~~data ~~registrations, clearances,~~ or ~~approvals~~perceptions ~~may~~among ~~significantly~~these ~~differ~~clinicians ~~from~~would ~~FDA~~harm ~~requirements. If we modify~~ our ~~products~~sales, webusiness, ~~may~~financial ~~need to apply for additional regulatory approvals before we are permitted to sell the modified product. In addition~~condition, ~~we may not continue to meet the quality~~ and ~~safety~~results ~~standards~~of ~~required to maintain the authorizations that we have received~~operations. ~~If we are unable to maintain our authorizations in a particular country, we will no longer be able to sell the applicable product in that country.~~

29 The rate of adoption and sales of our products is heavily influenced by clinical data. Although we have positive research data from our publications, there can be no assurance that future clinical studies, including those to demonstrate the efficacy of our current products or future products in current target patient populations and those to support label retention and expansion for our products, will demonstrate clinical utility and effectiveness. Unfavorable or inconsistent clinical data from future clinical studies conducted by us, our competitors, or third parties, or the negative interpretation of our clinical data internally and externally, including by customers, competitors, patients, and regulators could harm our business, financial condition, and results of operations.

~~Table~~The rate of ~~Contents~~ adoption and sales of our products are also influenced by clinician perceptions. Negative perceptions of our products by clinicians, including due to negative clinical data, could result in decreased adoption or use of our products, which would harm our business, financial condition, and results of operations. Further, if we are not able to attain strong working relationships with clinicians and receive their advice and input, the marketing of our products could suffer, which could harm our business, financial condition and results of operations.

~~Failure~~Our tofuture ~~comply~~success ~~with~~also ~~these~~depends ~~rules,~~upon ~~regulations,~~patients ~~self-regulatory~~having ~~codes,~~an ~~circulars,~~experience ~~and~~with ~~orders~~our ~~could~~products ~~result~~that inmeets ~~significant~~their ~~civil~~expectations ~~and~~in ~~criminal~~order ~~penalties~~to ~~and~~increase ~~costs~~clinician ~~and~~demand ~~could~~for ~~have~~our products as a ~~material~~result ~~adverse~~of ~~impact~~positive onfeedback ~~our~~and ~~business~~word-of-mouth. ~~Also,~~Patients ~~these regulations~~ may be ~~interpreted~~dissatisfied orif ~~applied~~their byexpectations aof ~~prosecutorial,~~the ~~regulatory,~~products orare ~~judicial~~not ~~authority~~met inor aif ~~manner~~the ~~that~~performing ~~could~~clinicians ~~require~~are usnot toadequately ~~make~~trained ~~changes~~on inthe ~~our~~use ~~operations~~of orour ~~incur~~products. ~~substantial~~If ~~defense~~the ~~and~~results ~~settlement~~of ~~expenses.~~our ~~Even~~products ~~unsuccessful~~do ~~challenges~~not bymeet ~~regulatory~~the ~~authorities~~expectations orof ~~private~~the ~~relators~~patient, it could ~~result~~discourage inthe ~~reputational~~patient ~~harm~~ and/or ~~the~~their ~~incurring~~healthcare ofprovider ~~substantial~~from ~~costs.~~continuing Into ~~addition,~~use ~~many~~our ofdevice ~~these~~or ~~laws~~referring ~~are~~our ~~vague~~products orto ~~indefinite~~others. ~~and~~Dissatisfied ~~have~~patients ~~not~~may ~~been~~express ~~interpreted~~negative byopinions ~~the~~through ~~courts~~social ~~and~~media, ~~have~~advocacy, ~~been~~or ~~subject~~other publicity. Any failure to ~~frequent~~meet ~~modification~~patient expectations and ~~varied~~any ~~interpretation~~resulting bynegative ~~prosecutorial~~publicity ~~and~~could ~~regulatory~~harm ~~authorities,~~our ~~increasing~~reputation ~~compliance~~and ~~risks~~future sales.

~~Certain~~Risks ~~modifications~~Related to ~~our~~the ~~products~~Integration ~~may~~of ~~require~~the ~~new~~Evoke ~~510(k)~~and ~~clearance~~Firefly orBusinesses ~~other marketing authorizations.~~

~~Once~~The aintegration ~~medical~~of ~~device~~the isEvoke ~~permitted~~and toFirefly businesses may be ~~legally~~complex, ~~marketed~~time-consuming inand costly, and we may not realize the Uanticipated benefits of the combination.S. ~~pursuant~~We toare ain ~~510(k)~~the ~~clearance~~process of integrating the operations, aproducts, ~~medical~~personnel, ~~device~~technology ~~developer~~platforms, ~~may~~databases and regulatory frameworks of the Evoke and Firefly businesses. The integration efforts will be ~~required~~completed tosuccessfully ~~notify~~or ~~FDA~~on the anticipated timeline, or that we will achieve the expected strategic, operational or financial benefits of the combination. Integration of product platforms and databases may require additional development work, validation, testing and, in certain ~~modifications~~cases, regulatory review or new regulatory submissions. Any delays in product harmonization, data migration, system interoperability, or regulatory approvals could adversely affect our ability to ~~the~~commercialize ~~device~~integrated solutions, expand our customer base or realize anticipated synergies. ~~Medical~~The ~~device~~integration ~~developers~~process ~~determine~~may also result in ~~the~~increased ~~first~~expenses, ~~instance~~diversion ~~whether~~of amanagement ~~change~~attention, disruption to aour ~~product~~ongoing ~~requires~~operations aor ~~new~~difficulties ~~premarket~~in ~~submission~~retaining customers and key employees. If we fail to effectively integrate the Evoke and Firefly businesses, ~~but~~our ~~FDA~~business, ~~may~~financial ~~review~~condition ~~any~~and ~~such~~results ~~decision~~of operations could materially adversely affected.

~~While~~We ~~our~~may ~~BNA~~acquire ~~Platform~~businesses ~~received~~or ~~510(k)~~products, ~~clearance~~or inform ~~December~~strategic ~~2020~~alliances, ~~we may~~ in the future ~~apply for 510(k) clearance for updated components of our BNA Platform~~, ~~which must, then, be found by the FDA to be substantially equivalent to the cleared BNA Platform~~ and, ~~thus,~~ may not berealize ~~lawfully marketed in~~ the ~~U.S.~~benefits ~~until FDA make a substantial equivalence determination and issues the requisite 510(k) clearance for the updated BNA Platform. Although the development~~ of our BNA Platform has been carefully monitored and documented by professionals who are experienced in the FDA clearance process, there is no assurance that the FDA will agree that an updated component of our BNA Platform is substantially equivalent to the cleared BNA Platform and allow the updated BNA Platform to be marketed in the United States. The FDA may determine that the device is not substantially equivalent and require a premarket approval (“PMA”) or, more likely, a de novo reclassification, and/or require further information, such ~~as additional test data, including data from clinical studies, before it is able to make a determination regarding substantial equivalence~~acquisitions. By requesting additional information, the FDA can delay market introduction of an updated BNA Platform. Delays in receipt of or failure to receive any necessary 510(k) clearance, de novo classification, or PMA, or the imposition of stringent restrictions for our BNA Platform, could have a material adverse effect on our business, results of operations and financial condition.

InWe ~~the~~may ~~future~~acquire additional businesses or products, weform ~~may~~strategic ~~make~~alliances, ~~other~~or ~~modifications~~create tojoint ~~our~~ventures ~~products,~~with ~~including~~third ~~our~~parties ~~BNA~~that ~~Platform,~~we ~~and~~believe ~~determine,~~will ~~based~~complement onor augment our ~~review~~existing ofbusiness. ~~the~~If ~~applicable~~we ~~FDA~~acquire ~~regulations~~businesses ~~and~~with ~~guidance~~promising markets or technologies, ~~that~~we inmay ~~certain~~not ~~instances~~be ~~new~~able ~~510(k)~~to ~~clearances~~realize orthe ~~other~~benefit ~~premarket~~of ~~submissions~~acquiring such businesses if we are ~~not~~unable ~~required.~~to Ifsuccessfully ~~FDA~~integrate ~~disagrees~~them with ~~our~~its ~~determinations,~~existing weoperations ~~may~~and becompany ~~subject~~culture. toWe amay ~~wide~~encounter ~~range~~numerous ofdifficulties ~~enforcement~~in ~~actions~~developing, ~~including~~manufacturing, ~~for~~and ~~example,~~marketing aany ~~warning~~new ~~letter,~~products ~~among~~resulting ~~other~~from ~~consequences,~~a ~~after~~strategic ~~which~~alliance weor ~~will~~acquisition ~~likely~~that ~~have~~delay toor ~~cease~~prevent ~~marketing~~it ~~the~~from ~~applicable~~realizing ~~modified~~our ~~product~~expected ~~and/~~benefits or toenhancing ~~recall~~our ~~distributed~~business. ~~units~~There ofis ~~such~~no ~~modified~~assurance ~~product~~that, ~~until~~following any such acquisition, we ~~obtain~~will achieve the ~~requisite~~synergies ~~clearance~~expected orto ~~approval~~justify the transaction, which could result in a material adverse effect on our business and prospects.

~~Ongoing~~Risks ~~changes~~Related into ~~healthcare regulation could negatively affect our revenues~~Legal, ~~business~~Regulatory and ~~financial~~Compliance ~~condition.~~Matters

WeComplying ~~could~~with beregulations ~~affected~~enforced by ~~potential~~FDA ~~changes to healthcare laws, rules~~ and ~~regulations,~~other ~~including~~regulatory ~~changes~~authorities tois ~~subsidies,~~expensive ~~healthcare insurance marketplaces~~ and ~~Medicaid~~time ~~expansion and contraction. All federal and state government health care programs~~consuming, ~~including for example Medicare, Medicaid~~ and ~~the~~failure ~~ACA, may be subject~~ to ~~change~~comply ascould a result of political, legislative, regulatory, and administrative developments, as well as judicial proceedings. The results of the 2024 federal election, including the election of President Trump and Republican control of both houses of Congress, may result in ~~significant~~substantial ~~changes in, and have resulted in uncertainty with respect to, legislation, regulation, implementation or repeal of laws and rules related to government health programs, including Medicare and Medicaid~~penalties. In addition, the staff of the Department of Government Efficiency (the "DOGE"), an executive administrative agency created by the second Trump Administration, have been provided access to key payment and contracting systems at CMS to look for opportunities for improving efficiency and to identify fraud and ineffective use of resources. While we cannot predict the actions of the DOGE, there is a possibility that changes will be made to CMS spending, which could ultimately affect our financial condition and results of operation.

~~Healthcare~~Our ~~reform~~current ~~initiatives~~and ~~will~~potentially ~~continue~~future toproducts beare ~~proposed~~considered medical devices and, ~~may~~accordingly, ~~reduce~~are ~~healthcare~~subject ~~related~~to ~~funding.~~rigorous Itregulation isby ~~impossible~~government toagencies ~~predict~~in the ~~ultimate~~U.S. ~~content~~ and ~~timing~~other ofcountries ~~any~~in ~~healthcare~~which ~~reform~~we ~~legislation~~intend ~~and~~to ~~its~~sell ~~resulting~~our ~~impact on us~~products. IfCompliance ~~significant~~with ~~reforms~~these ~~are~~rigorous ~~made~~regulations towill ~~the~~affect ~~healthcare~~capital ~~system~~expenditures, inearnings and the ~~United~~competitive ~~States,~~position orof inthe ~~other~~Company. ~~jurisdictions,~~These ~~those~~regulations ~~reforms~~vary ~~may~~from ~~increase~~country ~~our~~to ~~costs~~country orbut ~~otherwise~~cover, ~~negatively~~among ~~effect~~other onthings, ~~our~~the ~~business,~~following ~~results~~activities ofwith ~~operations,~~respect ~~and~~to ~~financial~~medical ~~condition.~~devices:

30 ● design, development and manufacturing; ● testing, labeling, content and language of instructions for use and storage; ● product storage and safety; ● marketing, sales and distribution; ● pre-market clearance and approval; ● record keeping procedures; ● advertising and promotion; ● recalls and field safety corrective actions; ● post-market surveillance; ● post-market approval studies; and ● product import and export.

~~Table of Contents~~ 26

OnTable April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the EU Medical Device Directive and became effective on May 26, 2021. 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 ensure a high level of ~~safety~~Contents ~~and health while supporting innovation. The new regulations, among other things:~~

●The ~~strengthen~~regulations ~~the~~to ~~rules~~which onwe ~~placing~~are ~~devices~~subject onare ~~the~~complex. ~~market~~Regulatory ~~and~~changes ~~reinforce~~could ~~surveillance~~result ~~once~~in ~~they~~restrictions ~~are~~on ~~available;~~our ●ability ~~establish~~to ~~explicit~~carry ~~provisions~~ on ~~manufacturers’~~or ~~responsibilities~~expand ~~for~~our ~~the~~operations, ~~follow-up~~higher ofthan ~~the~~anticipated ~~quality~~costs, ~~performance and safety of devices placed on the market; ● improve the traceability of medical devices throughout the supply chain to the end-user~~ or ~~patient~~lower ~~through~~than aanticipated ~~unique~~sales. ~~identification~~Our ~~number;~~failure ~~● set up a central database~~ to ~~provide~~comply ~~patients, healthcare professionals and the public~~ with ~~comprehensive~~applicable ~~information~~regulatory onrequirements ~~products~~could ~~available~~result in ~~the~~enforcement ~~European~~action ~~Union;~~by ~~and~~FDA ●or ~~strengthen~~state ~~rules for the assessment of certain high-risk devices~~agencies, ~~such as implants,~~ which may ~~have~~include toany ~~undergo~~of ~~an additional check by experts before they are placed on~~ the ~~market.~~following sanctions:

~~These~~● ~~modifications~~warning ~~may~~letters, ~~have~~fines, aninjunctions, ~~effect~~consent ondecrees, ~~the~~and ~~way~~civil wepenalties; ~~conduct~~● repair, replacement, refunds, recall, or seizure of our ~~business~~products; in● ~~the~~operating ~~EEA~~restrictions or partial suspension or total shutdown of production; ● refusing our requests for 510(k) clearance or pre-market approval of new products, new intended uses, or modifications to existing products; ● withdrawing clearance or pre-market approvals that have already been granted; and ● criminal prosecution.

~~Any~~If ~~change~~any inof ~~the~~these ~~laws~~events orwere ~~regulations that govern the clearance and approval processes relating~~ to ~~our current~~occur, ~~planned~~they ~~and future products~~ could ~~make~~harm it more difficult and costly to obtain clearance or approval for new products or to produce, market and distribute existing products. Significant delays in receiving clearance or approval or the failure to receive clearance or approval for our ~~new products would have an adverse effect on our ability to expand our~~ business.

~~Our~~We ~~products~~ may ~~cause~~not orreceive ~~contribute~~the tonecessary ~~adverse~~authorizations ~~medical events that we are required~~ to ~~report~~market toany ~~FDA~~future ~~and~~new ~~other governmental authorities~~products, and ifany wefailure ~~fail~~ to timely do so, wemay ~~would~~adversely beaffect ~~subject~~our ability to ~~sanctions~~grow ~~that could harm~~ our ~~reputation,~~ business~~, results of operations, and financial condition~~. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of FDA or another governmental authority, could have a negative impact on us.

WeBefore ~~are~~we ~~required~~can tosell ~~timely~~a ~~file~~new ~~various~~medical ~~reports~~device ~~with~~in ~~FDA~~the U.S., ~~including~~or ~~reports~~market ~~required~~a bynew ~~the~~use ~~medical~~of, ~~device~~new ~~reporting~~claim ~~regulations~~for, ~~which~~or ~~require~~significant usmodification to ~~report~~a tolegally ~~FDA~~marketed ~~when~~device, we ~~receive~~must first obtain either FDA 510(k) clearance or ~~become~~approval, ~~aware~~unless ofan ~~information~~exemption ~~that~~applies. ~~reasonably~~In ~~suggests~~the ~~that~~510(k) ~~one~~clearance ofprocess, ~~our~~before ~~products~~a device may ~~have~~be ~~caused~~marketed, orthe ~~contributed~~applicant tomust submit a ~~death~~premarket ornotification ~~serious~~to ~~injury~~FDA orunder ~~malfunctioned~~Section in510(k) aof ~~way~~the ~~that~~FD&C Act, ifand ~~the~~FDA ~~malfunction~~must ~~were~~determine tothat ~~recur~~a inproposed ~~the~~ device oris “substantially equivalent” to a ~~similar~~legally-marketed “predicate” device. ~~that~~To webe ~~market~~“substantially equivalent,” ~~could~~the ~~cause~~proposed ordevice ~~contribute~~must tohave athe ~~death~~same orintended ~~serious~~use ~~injury.~~as Ifthe wepredicate ~~fail~~device, toand ~~comply~~either ~~with~~have ~~our~~the ~~reporting~~same ~~obligations,~~technological ~~FDA~~characteristics oras ~~other~~the ~~governmental~~predicate ~~authorities~~device ~~could~~or ~~take~~have ~~action~~different technological characteristics, ~~including~~not ~~warning~~raise ~~letters,~~different ~~untitled~~questions ~~letters,~~of ~~administrative~~safety ~~actions,~~or ~~criminal~~effectiveness ~~prosecution~~than the predicate device, ~~imposition~~and ofbe ~~civil~~as ~~monetary~~safe ~~penalties,~~and ~~revocation~~as ofeffective ~~our~~as the predicate device. The 510(k) clearance, ~~seizure~~process ofcan ~~our~~be ~~products~~expensive and uncertain and typically takes from three to 12 months, orbut ~~delay~~may last significantly longer. Clinical data may be required in ~~clearance~~connection ofwith ~~future~~an ~~products~~application for 510(k) clearance. ~~FDA~~Furthermore, ~~and~~even ~~certain~~if ~~foreign~~we are granted regulatory ~~bodies~~clearances ~~have~~or ~~the~~approvals, ~~authority~~they tomay ~~require~~include limitations on the ~~recall~~indications for use or intended uses of ~~commercialized~~the ~~products~~device, ~~under~~which ~~certain~~may ~~circumstances~~limit the market for the device.

AOur ~~government-mandated~~Evoke orSystem ~~voluntary~~and ~~recall~~BNA byPlatform usare ~~could~~Class ~~occur~~II asmedical a result of an unacceptable risk to health, component failures, malfunctions, labeling or design deficiencies, packaging defects, or other deficiencies, or failures to comply with applicable regulations. If we do not adequately address problems associated with our devices, wewhich ~~may~~were ~~face~~cleared ~~additional~~by ~~regulatory requirements or enforcement action, including required new marketing authorizations,~~ FDA ~~warning~~for ~~letters,~~commercialization ~~product~~in ~~seizure,~~the ~~injunctions,~~U.S. ~~administrative~~pursuant ~~penalties,~~to orthe ~~civil~~510(k) ornotification ~~criminal proceedings~~process.

WeFDA ~~may~~can ~~initiate voluntary withdrawals~~delay, ~~removals~~limit, or ~~corrections~~deny ~~for~~510(k) ~~our products in the future that we determine do not require notification of FDA because no material compliance issue or safety risk is involved. If FDA disagrees with our determinations~~clearance, ~~it could require us to report those actions and we may be subject to enforcement action. A future recall announcement~~ or other ~~corrective~~approval ~~action~~or ~~could harm our financial results and reputation~~reclassification, ~~potentially~~of ~~lead~~a todevice ~~product~~for ~~liability~~many ~~claims against us~~reasons, ~~require the dedication of our time and capital, and negatively affect our sales.~~including:

In● ~~addition,~~we ~~FDA’s and other regulatory authorities’ policies~~ may ~~change,~~be ~~and~~unable ~~additional~~to ~~government~~demonstrate ~~regulations~~to ~~may~~FDA’s besatisfaction ~~enacted~~ that ~~could~~the ~~prevent,~~products ~~limit,~~ or ~~delay~~modifications ~~regulatory~~are ~~approval~~substantially ofequivalent ~~our~~to ~~future~~a ~~products.~~proposed ~~For~~predicate ~~example,~~device inor ~~November~~safe ~~2018,~~and ~~FDA~~effective ~~announced~~for ~~that~~their itintended ~~plans~~uses; to● ~~develop~~we ~~proposals~~may tobe ~~drive~~unable ~~manufacturers~~to ~~utilizing~~demonstrate that the ~~510(k)~~clinical ~~pathway~~and ~~toward~~other ~~the~~benefits ~~use~~ of ~~newer~~the ~~predicates.~~device Itoutweigh ~~is unclear~~ the ~~extent~~risks; toand ~~which~~● ~~any~~the ~~proposals,~~applicable ~~if adopted, could impose additional~~ regulatory ~~requirements~~authority onmay usidentify ~~that~~deficiencies ~~could~~in ~~delay~~ our ~~ability~~submissions toor ~~obtain~~in ~~new 510(k) clearances, increase~~ the ~~costs~~facilities ~~of compliance,~~ or ~~restrict~~processes of our ~~ability~~third toparty ~~maintain~~contract ~~our current clearances~~manufacturers.

31 Any delay or failure to obtain necessary regulatory clearances or approvals could harm our business. For example, if we decide to market our products for a broader or additional indication(s) for use and/or make any material modifications to any element of the device and/or the manufacturing or distribution thereof in the future, an additional 510(k) submission, and FDA clearance thereof, will be required prior to making any promotional communications expressly or impliedly claiming that the device may be used for such indication(s) and/or prior to making such modification, respectively.

~~Table~~In addition, FDA may change its policies, adopt additional regulations, revise existing regulations, or take other actions, or Congress may enact different or additional statutory requirements, which may prevent or delay clearance of ~~Contents~~ our future products under development or impact our ability to modify our currently marketed products on a timely basis. Such policy, statutory, or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict our ability to maintain our current marketing authorizations.

We may also ~~cannot~~need ~~predict~~to ~~the~~obtain ~~likelihood,~~regulatory ~~nature,~~approval orin ~~extent~~other offoreign ~~government~~jurisdictions ~~regulation~~in ~~that~~which we may ~~arise~~plan ~~from~~to ~~future~~market ~~legislation~~and orsell ~~administrative~~our orproducts. ~~executive~~The ~~action,~~time ~~either~~required into ~~the~~obtain ~~U.S.~~registrations or ~~abroad. For example~~approvals, ~~the~~if ~~Trump~~required ~~Administration~~by ~~previously~~other ~~enacted~~countries, ~~several~~may ~~executive~~be ~~actions~~longer than that ~~could~~required ~~impose~~for ~~significant~~FDA ~~burdens on~~clearance, orand ~~otherwise~~requirements ~~materially~~for ~~delay~~such registrations, ~~FDA’s~~clearances, ~~ability~~or toapprovals ~~engage~~may insignificantly ~~routine~~differ ~~regulatory~~from ~~and~~FDA ~~oversight activities~~requirements. ItIf iswe ~~difficult~~modify toour ~~predict~~products, ~~how~~we ~~these executive actions and executive actions that~~ may beneed ~~taken~~to ~~under~~apply ~~the~~for ~~Biden~~additional ~~Administration~~regulatory ~~may~~approvals ~~affect~~before ~~FDA’s~~we ~~ability~~are permitted to ~~exercise~~sell ~~its~~the ~~regulatory~~modified ~~authority~~product. IfIn ~~these~~addition, ~~executive~~we ~~actions~~may ~~impose~~not ~~constraints~~continue ~~on FDA’s ability~~ to ~~engage~~meet inthe ~~oversight~~quality and ~~implementation~~safety ~~activities~~standards inrequired ~~the~~to ~~normal~~maintain ~~course,~~the ~~our~~authorizations ~~business~~that ~~may~~we behave ~~negatively impacted~~received.

~~Changes in internet regulations could adversely affect our business.~~27

~~Laws,~~Table ~~rules, and regulations governing internet communications, advertising, and e-commerce are dynamic, and the extent~~ of ~~future~~Contents government regulation is uncertain. Federal and state regulations govern various aspects of our online business, including intellectual property ownership and infringement, trade secrets, the distribution of electronic communications, marketing and advertising, user privacy and data security, search engines, and internet tracking technologies. Future taxation on the use of the internet or e-commerce transactions could also be imposed. Existing or future regulation or taxation could increase our operating expenses and expose us to significant liabilities.

~~Disruptions~~Failure atto ~~the~~comply ~~FDA~~with these rules, ~~other~~regulations, ~~agencies~~self-regulatory orcodes, ~~notified~~circulars, ~~bodies~~and ~~caused~~orders bycould ~~funding~~result ~~shortages~~in orsignificant ~~global~~civil ~~health~~and ~~concerns~~criminal penalties and costs and could ~~hinder~~have ~~their~~a ~~ability~~material toadverse ~~hire,~~impact ~~retain~~on our business. Also, orthese ~~deploy~~regulations ~~key~~may ~~leadership~~be ~~and~~interpreted ~~other~~or ~~personnel~~applied by a prosecutorial, regulatory, or ~~otherwise~~judicial ~~prevent~~authority ~~new~~in ora ~~modified~~manner ~~products~~that ~~from~~could ~~being~~require ~~developed,~~us ~~cleared~~to make changes in our operations or ~~approved,~~incur substantial defense and settlement expenses. Even unsuccessful challenges by regulatory authorities or ~~commercialized~~private relators could result in areputational ~~timely~~harm ~~manner~~and the incurring of substantial costs. In addition, many of these laws are vague or atindefinite ~~all,~~and ~~which~~have ~~could~~not ~~negatively~~been ~~impact~~interpreted ~~our~~by ~~business~~the courts and have been subject to frequent modification and varied interpretation by prosecutorial and regulatory authorities, increasing compliance risks.

~~The~~Certain ~~ability~~modifications ~~of the FDA, other agencies and notified bodies~~ to ~~review~~our ~~and authorize or certify for marketing new~~ products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, agency’s or notified body’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may ~~otherwise~~require affect the agency’s or notified body’s ability to perform routine functions. Average review times at the FDA and other agencies and notified bodies have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA, other agencies and notified bodies may also slow the time necessary for new ~~medical~~510(k) ~~devices~~clearance or modifications to be reviewed and/or cleared, approved or certified by necessary agencies or notified bodies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, in recent years, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points in response to the global COVID-19 pandemic. If a prolonged government shutdown occurs, or if global health concerns, including pandemics, were to prevent the FDA or other ~~regulatory~~marketing authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our businessauthorizations.

InOnce ~~the~~a ~~EU,~~medical ~~notified~~device ~~bodies~~is ~~must~~permitted ~~be officially designated~~ to ~~certify~~be ~~products~~legally ~~and~~marketed ~~services~~ in ~~accordance with~~ the ~~MDR, which regulates the development and sale of medical devices in Europe~~U.S. ~~While~~pursuant ~~several~~to ~~notified~~a ~~bodies~~510(k) ~~have been designated~~clearance, ~~the COVID-19 pandemic significantly slowed down their designation process and the current designated notified bodies are facing~~ a ~~large~~medical ~~amount~~device ofdeveloper ~~requests~~may ~~with~~be ~~the~~required ~~new~~to ~~regulation,~~notify asFDA ~~a consequence~~ of ~~which~~certain ~~review~~modifications ~~times~~to ~~have lengthened although a regulation amending~~ the ~~EU MDR was adopted in March 2023, extending existing transitional provisions to December 31, 2028~~device. ~~This~~Medical ~~situation~~device ~~could~~developers ~~significantly~~determine ~~impact~~in the ~~ability~~first ofinstance ~~notified~~whether ~~bodies~~a change to ~~timely~~a ~~review~~product ~~and~~requires ~~process~~a ~~our~~new ~~regulatory~~premarket ~~submissions~~submission, ~~which~~but ~~could~~FDA ~~have~~may areview ~~material~~any ~~adverse~~such ~~effect on our business in the EU and EEA (which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland)~~decision.

~~The~~While ~~misuse~~our orproducts ~~off-label~~have ~~use~~received of510(k) ~~our~~clearance, ~~BNA~~we ~~Platform~~may in the future apply for 510(k) clearance for updated components, which must, then, be found by the FDA to be substantially equivalent to the existing cleared product and, thus, may ~~harm~~not be lawfully marketed in the U.S. until FDA make a substantial equivalence determination and issues the requisite 510(k) clearance for the updated product. Although the development of our ~~reputation~~products have been carefully monitored and documented by professionals who are experienced in the ~~marketplace~~FDA clearance process, ~~result~~there inis ~~injuries~~no assurance that ~~lead~~the FDA will agree that an updated component of our product is substantially equivalent to the cleared product ~~liability~~and ~~suits~~allow orthe ~~result~~updated product to be marketed in ~~costly~~the ~~investigations~~United States. The FDA may determine that the device is not substantially equivalent and require a premarket approval (“PMA”) or, ~~fines~~more likely, a de novo reclassification, and/or ~~sanctions~~require byfurther ~~regulatory~~information, ~~bodies~~such as additional test data, ~~particularly~~including ifdata wefrom ~~are~~clinical ~~deemed~~studies, before it is able to ~~have~~make ~~engaged~~a indetermination regarding substantial equivalence. By requesting additional information, the ~~promotion~~FDA can delay market introduction of ~~these~~an ~~uses,~~updated product. Delays in receipt of or failure to receive any necessary 510(k) clearance, de novo classification, or PMA, or the imposition of ~~which~~stringent restrictions for our products, could behave ~~costly~~a tomaterial adverse effect on our business, results of operations and financial condition.

~~Our~~In ~~BNA~~the ~~Platform~~future, iswe amay ~~Class~~make IIother ~~medical~~modifications ~~device cleared by FDA for commercialization in the U.S. pursuant~~ to ~~the~~our ~~510(k)~~products, ~~notification~~and ~~process~~determine, ~~for~~based ~~the~~on ~~post-hoc~~our ~~statistical~~review ~~analysis~~ of the ~~human~~applicable ~~electroencephalogram~~FDA inregulations ~~December~~and ~~2020 for use in individuals 12 to 85 years of age. We~~guidance, ~~thus, are not currently able to promote the BNA Platform for any other indications for use or make any promotional claims~~ that ~~are~~in ~~inconsistent~~certain ~~with,~~instances ornew ~~outside the scope of, such FDA clearance~~ 510(~~often referred to as “off-label” claims~~k). ~~However,~~clearances ~~the~~or ~~assessment~~other ofpremarket ~~whether~~submissions aare ~~given claim is or is~~ not ~~consistent~~required. ~~with~~If ~~a given~~ FDA ~~clearance~~disagrees ~~or approval can often be subjective, and we cannot guarantee that FDA will always agree~~ with our ~~position regarding a particular claim or that all of our employees~~determinations, ~~representatives, and agents will abide by our marketing policies. If FDA determines that~~ we ~~have~~may ~~promoted~~be ~~any~~subject ~~product~~to ~~without~~a ~~the~~wide ~~requisite~~range ~~clearance or approval and/or for an off-label or unapproved use, it could take any number~~ of enforcement actions ~~against us~~, including, ~~(among~~for ~~others)~~example, ~~issuing~~a ~~untitled or~~ warning ~~letters and/or pursuing an injunction~~letter, ~~seizure,~~among ~~civil fine and/or criminal penalties. It is also possible that~~ other ~~federal~~consequences, ~~state~~after orwhich ~~foreign~~we ~~enforcement~~will ~~authorities~~likely ~~might~~have ~~take~~to ~~action~~cease ~~under~~marketing ~~other~~the ~~regulatory~~applicable ~~authority,~~modified ~~such~~product asand/or ~~laws~~to ~~prohibiting~~recall ~~false~~distributed ~~claims~~units ~~for reimbursement, any~~ of ~~which~~such ~~would~~modified ~~have~~product auntil ~~material~~we ~~adverse~~obtain ~~effect~~the onrequisite ~~our~~clearance ~~financial condition and/~~or ~~business as a whole~~approval.

32 Our acquisition of Evoke increases our exposure to 510(k) regulatory risks due to the expansion of our medical device portfolio.

~~Table~~With our acquisition of ~~Contents~~ Evoke, we have expanded our product portfolio to include additional medical devices that are subject to regulation by the FDA under the 510(k) premarket notification process. As a result, we are now responsible for ensuring ongoing regulatory compliance, post-market surveillance, and reporting obligations for multiple Class II medical devices, including both our BNA Platform and the products acquired from Evoke. This expansion increases our exposure to FDA 510(k) regulatory risks in several ways. Each product line may have unique technical characteristics, intended uses, and regulatory histories, which increases the complexity of our compliance management and the likelihood of regulatory scrutiny. Any compliance issue, adverse event, or regulatory deficiency associated with any product in our expanded portfolio could trigger FDA enforcement actions, including warning letters, product recalls, or withdrawal of marketing clearance, any of which could materially and adversely affect our business, financial condition, and results of operations. Furthermore, modifications to any of the acquired products, or efforts to expand their indications for use, may require new 510(k) submissions, increasing the risk of delays, denials, or additional data requirements from the FDA. The integration of Evoke’s regulatory processes and quality systems into our existing compliance infrastructure may also present challenges, and any gaps or deficiencies in Evoke’s historical compliance could expose us to legacy risks or require remediation efforts. As a result, the addition of Evoke’s products to our portfolio has heightened our overall risk profile with respect to FDA 510(k) regulatory compliance, and any failure to effectively manage these increased risks could have a material adverse effect on our ability to commercialize our products and achieve our strategic objectives.

~~Additionally,~~Ongoing wechanges must have competent and reliable scientific evidence or, where applicable, other adequate substantiation for each reasonable interpretation of every promotional claim we make. In particular, comparative or superiority claims generally require adequate, well controlled, head-to-head clinical studies, comparing the product to the applicable competing products. To the extent we make any claims, or are otherwise held responsible for third-party claims about any product we may market in ~~the~~healthcare ~~United~~regulation ~~States, without the requisite clinical substantiation, we~~ could benegatively ~~subject~~affect to enforcement action by FDA and/or the Federal Trade Commission (FTC), as well as a competitor challenge via the National Advertising Division (NAD) of the Better Business Bureau. Our plans to utilize social media as a primary promotional tool for our ~~device(s) increases the applicable enforcement risk~~revenues, asbusiness ~~it makes it easier for our employees, affiliates,~~ and ~~any~~financial third parties with which we may have a relationship and/or arrangement under which we are deemed responsible for such party’s claims about our product(s) to disseminate promotional claims about our product(s) that may be inconsistent with applicable regulations governing device promotionscondition. Further, consumers can bring private false-advertising lawsuits, including class actions, against us for any material misrepresentations and/or deceptive or unsubstantiated claims (among other similar causes of action) in our promotional materials or other advertising. Any of the foregoing could have a material adverse effect on our business.

WeThe ~~may~~United beStates ~~subject~~healthcare tosystem ~~certain~~has been continually evolving at the federal, and state level due to comprehensive reforms relating to the payment for, the availability of and ~~foreign~~reimbursement ~~fraud~~for healthcare services. Key reforms have ranged from fundamentally changing federal and ~~abuse~~state ~~laws~~healthcare reimbursement programs, ~~health~~including ~~information~~providing ~~privacy~~comprehensive healthcare coverage to the public under government-funded programs, to minor modifications to existing programs, and ~~security~~many ~~laws~~have been challenged (with some being overturned or modified) along the way. One example, among countless others, is the Patient Protection and ~~transparency~~Affordable ~~laws~~Care Act (the “Affordable Care Act”), which was the most significant federal healthcare reform law enacted in the U.S. in recent history. The Affordable Care Act has undergone substantial challenges and changes since its enactment in 2010, ifand ~~violated~~numerous other federal healthcare reform legislation, ~~could~~executive ~~subject~~orders, usand tojudicial ~~substantial~~rulings ~~penalties.~~have ~~Additionally~~been implemented in the years since, most of which have been or are aimed at lowering healthcare costs in the U.S. To the extent any ~~challenge~~such toreform measures or ~~investigation~~any ~~into~~future ~~our~~initiatives ~~practices~~reduce ~~under~~reimbursement ~~these~~or ~~laws~~coverage ~~could~~eligibility ~~cause~~or ~~adverse~~any ~~publicity~~amounts ~~and~~or befunds ~~costly~~available to(such ~~respond~~as by reductions in reimbursement to, our healthcare provider customers) for our Systems and/or ~~thus~~any ~~could~~future ~~harm~~products we may market in the U.S. (if any), our business may be adversely affected.

~~There~~Healthcare ~~are~~reform ~~numerous~~initiatives ~~U.S.~~will ~~federal~~continue ~~and state, as well as foreign, laws pertaining~~ to ~~healthcare~~be ~~fraud~~proposed and ~~abuse,~~may ~~including~~reduce ~~anti-kickback,~~healthcare ~~false~~related ~~claims,~~funding. ~~and~~It ~~physician~~is ~~transparency~~impossible ~~laws. Efforts~~ to ~~ensure~~predict ~~that~~the ~~our~~ultimate ~~business~~content ~~arrangements~~and ~~with~~timing ~~third~~of ~~parties~~any ~~will comply with applicable~~ healthcare ~~laws~~reform legislation and ~~regulations~~its ~~may~~resulting ~~involve~~impact ~~substantial~~on ~~costs~~us. ~~Our~~If ~~business~~significant ~~practices~~reforms ~~and relationships with providers and patients~~ are ~~subject~~made to ~~scrutiny~~the ~~under~~healthcare ~~these~~system ~~laws.~~in Wethe ~~may~~United ~~also~~States, beor ~~subject~~in toother ~~patient~~jurisdictions, ~~information~~those ~~privacy~~reforms ~~and~~may ~~security~~increase ~~regulation~~our bycosts ~~both~~or ~~the~~otherwise ~~federal~~negatively ~~government~~effect ~~and~~on ~~the states and foreign jurisdictions in which we conduct~~ our business., ~~The~~results ~~healthcare~~of ~~laws~~operations, and ~~regulations~~financial ~~that may affect our ability to operate include:~~condition.

	●	the federal healthcare Medicare and Medicaid Patient Protection Act of 1987 (the “Anti-Kickback Statute”), which prohibits, among other things, persons, and entities 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 an individual for, or the purchase, lease, order, or arrange for or recommend a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid. The term “remuneration” has been broadly interpreted to include anything of value. The government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to violate. Moreover, the government may assert that a claim including items or services resulting from a violation of the federal healthcare Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration to those who prescribe, purchase, or recommend medical device products, including discounts, or engaging individuals as speakers, consultants, or advisors, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti- kickback liability. Moreover, there are no safe harbors for many common practices, such as reimbursement support programs, educational or research grants, or charitable donations;
	●	the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment of federal government funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. Private individuals, commonly known as “whistleblowers,” can bring civil False Claims Act qui tam actions, on behalf of the government and such individuals and may share in amounts paid by the entity to the government in recovery or settlement. False Claims Act liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties for each false or fraudulent claim or statement. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the federal civil False Claims Act. Many pharmaceutical and medical device manufacturers have been investigated and have reached substantial settlements under the federal civil False Claims Act in connection with alleged off-label promotion of their products and allegedly providing free products to customers with the expectation that the customers would bill federal health care programs for the product. In addition, manufacturers can be held liable under the federal civil False Claims Act even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims. There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government;

33 Table of Contents

~~Table~~On April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the EU Medical Device Directive and became effective on May 26, 2021. 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 ensure a high level of ~~Contents~~ safety and health while supporting innovation. The new regulations, among other things:

● ~~Health~~strengthen ~~Insurance~~the ~~Portability~~rules ~~and~~on ~~Accountability~~placing ~~Act~~devices ofon ~~1996~~the ~~(“HIPAA”),~~market ~~which created additional federal criminal statutes that prohibit, among other things, knowingly~~ and ~~willfully~~reinforce ~~executing~~surveillance oronce ~~attempting~~they toare ~~execute~~available; a● ~~scheme~~establish toexplicit ~~defraud~~provisions ~~any~~on ~~healthcare~~manufacturers’ ~~benefit~~responsibilities ~~program,~~for ~~including~~the ~~private third~~follow-~~party~~up ~~payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation~~ of athe ~~healthcare offense~~quality, ~~and~~performance ~~knowingly~~ and ~~willfully~~safety falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, ordevices ~~payment~~placed ~~for,~~on ~~healthcare benefits, items or services. Similar to~~ the ~~federal healthcare Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation~~market; ● ~~the~~improve ~~federal Physician Payments Sunshine Act under~~ the ~~Affordable~~traceability ~~Care Act, which requires certain manufacturers~~ of ~~drugs,~~medical devices, ~~biologics~~throughout ~~and medical supplies for which payment is available under Medicare, Medicaid or~~ the ~~Children’s~~supply ~~Health~~chain ~~Insurance Program (with certain exceptions)~~ to ~~report annually to~~ the ~~United~~end-user ~~States~~or ~~Department~~patient ofthrough ~~Health~~a ~~and~~unique ~~Human~~identification Services, Centers for Medicare and Medicaid Services, information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and applicable manufacturers and group purchasing organizations, as well as ownership and investment interests held by physicians and their immediate family members. Since January 2022, applicable manufacturers are also required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwivesnumber; ● ~~HIPAA,~~set asup ~~amended~~a bycentral ~~Health~~database Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations, which imposes privacy, security, and breach reporting obligations with respect to ~~Protected~~provide ~~Health Information (“PHI”)~~patients, ~~upon entities subject to the law, such as health plans,~~ healthcare ~~clearinghouses~~professionals and ~~certain~~the ~~healthcare~~public ~~providers,~~with ~~and~~comprehensive ~~their~~information ~~respective business associates that perform services~~ on ~~their~~products ~~behalf~~available that involve PHI. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make HIPAA compliance as well as civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in ~~federal courts to enforce~~ the ~~HIPAA~~European ~~laws and seek attorneys’ fees and costs associated with pursuing federal civil actions~~Union; and ● ~~analogous~~strengthen ~~state~~rules ~~and~~for ~~foreign~~the ~~law~~assessment ~~equivalents~~ of ~~each~~certain ~~of the above federal laws, such as anti~~high-~~kickback~~risk ~~and false claims laws which may apply to items or services reimbursed by any third-party payer~~devices, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and local laws that require the licensure of sales representatives; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as ~~the EU~~implants, which adopted the General Data Protection Regulation, which became effective in May 2018); state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may ~~not~~ have ~~the~~to ~~same~~undergo ~~effect,~~an ~~thus~~additional ~~complicating~~check ~~compliance~~by ~~efforts;~~experts ~~and~~before ~~state~~they ~~laws~~are ~~related~~placed toon ~~insurance fraud in~~ the ~~case of claims involving private insurers~~market.

These ~~laws~~modifications ~~and regulations, among other things,~~ may ~~constrain our business, marketing, and other promotional activities by limiting the kinds of financial arrangements, including sales programs, we may~~ have ~~with~~an ~~physicians~~effect oron ~~other potential purchasers of our products and consulting agreements we enter into with physicians. Further, while we do not submit claims and our future customers will make~~ the ~~ultimate~~way ~~decision on whether or how to submit any potential claims,~~ we ~~may~~conduct ~~provide reimbursement guidance and support regarding~~ our ~~products, to the extent reimbursement may be available, which could implicate these laws~~business. Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws.

34 Any change in the laws or regulations that govern the clearance and approval processes relating to our current, planned and future products could make it more difficult and costly to obtain clearance or approval for new products or to produce, market and distribute existing products. Significant delays in receiving clearance or approval or the failure to receive clearance or approval for our new products would have an adverse effect on our ability to expand our business.

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

ToWe ~~enforce~~are ~~compliance~~required ~~with~~to ~~healthcare~~timely ~~regulatory~~file ~~laws,~~various ~~certain~~reports ~~enforcement~~with ~~bodies~~FDA, ~~have~~including ~~recently~~reports ~~increased~~required ~~their~~by ~~scrutiny~~the ofmedical ~~interactions~~device ~~between~~reporting ~~healthcare~~regulations ~~companies and healthcare providers,~~ which ~~has~~require ~~led~~us to areport ~~number~~to ofFDA ~~investigations,~~when ~~prosecutions,~~we ~~convictions~~receive ~~and~~or ~~settlements~~become inaware ~~the~~of ~~healthcare~~information ~~industry.~~that ~~For~~reasonably ~~example,~~suggests ~~U.S.~~that ~~federal~~one ~~and state regulatory and enforcement agencies continue to actively investigate violations~~ of ~~healthcare~~our ~~laws~~products ~~and~~may ~~regulations,~~have ~~including~~caused ~~pursuing~~or ~~novel~~contributed ~~theories~~to ofa ~~liability~~death ~~under~~or ~~these~~serious ~~laws.~~injury ~~These~~or ~~government~~malfunctioned ~~agencies~~in ~~recently~~a ~~have~~way ~~increased~~that, ~~regulatory~~if ~~scrutiny~~the ~~and~~malfunction ~~enforcement~~were ~~activity~~to ~~with~~recur ~~respect~~in tothe ~~manufacturer~~device ~~reimbursement~~or ~~support~~a ~~activities~~similar ~~and~~device ~~patient~~that ~~support~~we ~~programs~~market, ~~including~~could ~~bringing~~cause ~~criminal charges~~ or ~~civil~~contribute ~~enforcement~~to ~~actions~~a ~~under~~death ~~the~~or ~~federal~~serious ~~healthcare~~injury. ~~Anti-Kickback~~If ~~statute,~~we ~~federal~~fail ~~civil~~to ~~False~~comply ~~Claims~~with ~~Act,~~our ~~the~~reporting ~~health care fraud statute~~obligations, ~~and~~FDA ~~HIPAA~~or ~~privacy~~other ~~provisions.~~governmental ~~Responding~~authorities tocould ~~investigations~~take ~~can~~action, beincluding ~~time~~warning ~~and~~letters, ~~resource~~untitled ~~consuming~~letters, ~~and~~administrative ~~can~~actions, ~~divert~~criminal ~~management’s~~prosecution, ~~attention~~imposition ~~from~~of ~~the~~civil ~~business.~~monetary ~~Any~~penalties, ~~such~~revocation ~~investigation~~of orour ~~settlement~~device ~~could~~clearance, ~~increase~~seizure of our ~~costs~~products, or ~~otherwise~~delay ~~have~~in anclearance ~~adverse~~of ~~effect~~future ~~on our business~~products. ~~Even~~FDA anand ~~unsuccessful~~certain ~~challenge~~foreign orregulatory ~~investigation~~bodies ~~into~~have ~~our~~the ~~practices~~authority ~~could~~to ~~cause~~require ~~adverse~~the ~~publicity,~~recall ~~and~~of becommercialized ~~costly~~products tounder ~~respond~~certain tocircumstances.

IfA ~~our~~government-mandated ~~operations~~or ~~are~~voluntary ~~found~~recall toby beus incould ~~violation~~occur ofas ~~any~~a result of ~~the~~an ~~healthcare~~unacceptable ~~laws~~risk ~~or regulations described above or any other healthcare regulations that may apply~~ to ushealth, wecomponent ~~may~~failures, ~~be subject to administrative~~malfunctions, ~~civil~~labeling ~~and~~or ~~criminal~~design ~~penalties~~deficiencies, ~~damages,~~packaging ~~fines~~defects, ~~disgorgement,~~or ~~substantial~~other ~~monetary penalties~~deficiencies, ~~exclusion~~or ~~from~~failures ~~participation~~to incomply ~~government~~with ~~healthcare~~applicable ~~programs,~~regulations. ~~such~~If aswe ~~Medicare~~do ~~and~~not ~~Medicaid,~~adequately ~~imprisonment,~~address ~~additional~~problems ~~reporting~~associated ~~obligations,~~with ~~and~~our ~~oversight~~devices, if we ~~become~~may ~~subject~~face toadditional aregulatory ~~corporate~~requirements ~~integrity agreement~~ or ~~other~~enforcement ~~agreement~~action, toincluding ~~resolve~~required ~~allegations~~new ofmarketing ~~non-compliance~~authorizations, ~~with~~FDA ~~these~~warning ~~laws~~letters, ~~reputational~~product ~~harm~~seizure, ~~and~~injunctions, ~~the~~administrative ~~curtailment~~penalties, or ~~restructuring~~civil ofor ~~our~~criminal ~~operations~~proceedings.

~~Since~~We ~~our~~may ~~BNA~~initiate ~~Platform~~voluntary ~~will~~withdrawals, ~~utilize~~removals, ~~cloud-based~~or ~~information~~corrections ~~systems~~for ~~and~~our products in the ~~exchange~~future that we determine do not require notification of ~~information~~FDA ~~between~~because ~~patents~~no ~~and~~material ~~doctors~~compliance issue or safety risk is involved. If FDA disagrees with our determinations, it could require us to report those actions and we ~~will~~may be subject to ~~numerous~~enforcement Uaction.S. ~~federal~~A ~~and~~future ~~state~~recall ~~laws~~announcement or other corrective action could harm our financial results and ~~regulations~~reputation, ~~related~~potentially lead to ~~the~~product ~~privacy~~liability ~~and~~claims ~~security~~against us, require the dedication of ~~personally~~our ~~identifiable~~time ~~information~~and capital, ~~including~~and ~~health~~negatively ~~information~~affect our sales.

~~Among~~In ~~other~~addition, ~~data-privacy~~FDA’s and~~/or~~ ~~confidentiality~~other ~~laws~~regulatory toauthorities’ ~~which~~policies wemay change, and additional government regulations may be ~~subject~~enacted that could prevent, ~~HIPAA~~limit, ~~establishes~~or ~~privacy~~delay ~~and~~regulatory ~~security~~approval ~~standards~~of our future products. For example, in November 2018, FDA announced that ~~limit~~it plans to develop proposals to drive manufacturers utilizing the ~~use~~510(k) ~~and~~pathway ~~disclosure~~toward ofthe ~~PHI~~use ~~and~~of ~~require~~newer ~~covered~~predicates. ~~entities~~It ~~and~~is ~~business~~unclear ~~associates~~the extent to ~~implement~~which ~~administrative~~any proposals, ~~physical~~if adopted, ~~and~~could ~~technical~~impose ~~safeguards~~additional regulatory requirements on us that could delay our ability to ~~ensure~~obtain ~~the~~new ~~confidentiality,~~510(k) ~~integrity~~clearances, ~~and~~increase ~~availability~~the costs of ~~individually~~compliance, ~~identifiable~~or ~~health~~restrict ~~information~~our inability ~~electronic~~to ~~form,~~maintain ~~among~~our ~~other~~current ~~requirements~~clearances.

~~Violations~~We also cannot predict the likelihood, nature, or extent of ~~HIPAA~~government regulation that may ~~result~~arise from future legislation or administrative or executive action, either in ~~civil~~the ~~and~~U.S. ~~criminal~~or ~~penalties~~abroad. WeFor ~~must~~example, ~~also~~the ~~comply~~Trump ~~with~~Administration ~~HIPAA’s~~previously ~~breach~~enacted ~~notification~~several ~~rule~~executive ~~which~~actions ~~requires~~that ~~notification~~could impose significant burdens on, or otherwise materially delay, FDA’s ability to ~~affected~~engage ~~individuals~~in routine regulatory and ~~the~~oversight ~~Secretary~~activities. ofIt ~~Health~~is ~~and~~difficult ~~Human~~to ~~Services~~predict ~~(“HHS”),~~how these executive actions and inexecutive ~~certain~~actions ~~cases~~that tomay ~~media~~be ~~outlets,~~taken inunder the ~~case~~Biden ofAdministration amay ~~breach~~affect ofFDA’s ~~unsecured~~ability ~~PHI~~to exercise its regulatory authority. ~~The~~If ~~regulations~~these ~~also~~executive ~~require~~actions ~~business~~impose ~~associates~~constraints ofon ~~covered~~FDA’s ~~entities~~ability to ~~notify~~engage ~~the~~in ~~covered~~oversight ~~entity~~and ofimplementation ~~breaches~~activities byin the normal course, our business ~~associate~~may be negatively impacted.

~~Many~~Table ~~states also have laws that protect the privacy and security~~ of ~~sensitive~~Contents and personal information, including health information. These laws may be similar to or even more protective than HIPAA and other federal privacy laws. For example, the laws of the State of California are more restrictive than HIPAA. Where state laws are more protective than HIPAA, we must comply with the state laws we are subject to, in addition to HIPAA. For example, California passed the California Consumer Privacy Act or CCPA on June 28, 2018, which went into effect January 1, 2020. On November 3, 2020, the California Privacy Rights Act of 2020 (“CPRA”), which amends the CCPA and adds new privacy protections that became effective on January 1, 2023, was enacted through a ballot initiative. While information we maintain that is covered by HIPAA may be exempt from the CCPA, other records and information we maintain related to patients or personnel may be subject to the CCPA. In certain cases, it may be necessary to modify our planned operations and procedures to comply with these more stringent state laws. Not only may some of these state laws impose fines and penalties upon violators, but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused. In addition, state and federal privacy laws subject to frequent change.

InChanges ~~addition~~in tointernet ~~HIPAA~~regulations ~~and~~could ~~state~~adversely ~~health~~affect ~~information~~our privacy laws, we may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain types of activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breachbusiness.

~~Cybersecurity~~Laws, ~~incidents~~rules, ~~including~~and ~~data~~regulations ~~security~~governing ~~breaches~~internet orcommunications, ~~computer~~advertising, ~~viruses~~and e-commerce are dynamic, ~~could~~and ~~harm~~the extent of future government regulation is uncertain. Federal and state regulations govern various aspects of our online business, byincluding ~~disrupting~~intellectual ~~our~~property ~~delivery~~ownership and infringement, trade secrets, the distribution of ~~services~~electronic communications, ~~damaging~~marketing ~~our~~and ~~reputation~~advertising, user privacy and data security, search engines, and internet tracking technologies. Future taxation on the use of the internet or ~~exposing~~e-commerce transactions could also be imposed. Existing or future regulation or taxation could increase our operating expenses and expose us to ~~liability~~significant liabilities.

WeDisruptions ~~receive,~~at ~~process,~~the ~~store~~FDA, ~~and~~other ~~transmit,~~agencies ~~often electronically, data of our customers and others which may be confidential. Unauthorized access to our computer systems~~ or ~~stored~~notified ~~data~~bodies ~~could~~caused ~~result~~by infunding ~~the~~shortages ~~theft~~ or ~~improper~~global ~~disclosure~~health ofconcerns ~~confidential information, the deletion or modification of records, or~~ could ~~cause~~hinder ~~interruptions~~their inability ~~our operations. These cybersecurity risks increase when we transmit information from one location~~ to ~~another~~hire, ~~including transmissions over the Internet or other electronic networks. Despite implemented security measures~~retain, ~~our facilities, systems, and procedures, and those of our third-party service providers, may be vulnerable to security breaches, phishing scams, acts of vandalism, software viruses, misplaced~~ or ~~lost~~deploy ~~data,~~key ~~programming~~leadership and~~/or~~ ~~human~~other ~~errors~~personnel, or ~~other~~otherwise ~~similar~~prevent ~~events~~new ~~which may disrupt our delivery of services~~ or ~~expose~~modified ~~the~~products ~~confidential~~from ~~information~~being ~~of the Company~~developed, ~~our~~cleared ~~customers~~or ~~and others. Any security breach involving the misappropriation~~approved, ~~loss,~~ or ~~other~~commercialized ~~unauthorized~~in ~~disclosure or use of confidential information of our customers or others, whether by us or~~ a ~~third~~timely ~~party~~manner, ~~could: (i) subject us to civil and criminal penalties; (ii) have a negative impact on our reputation;~~ or ~~(iii)~~at ~~expose us to liability to our customers~~all, ~~third~~which ~~parties, or government authorities. Any of these developments~~ could ~~have~~negatively aimpact ~~material adverse effect on~~ our business~~, financial condition, and results of operations~~.

35 The ability of the FDA, other agencies and notified bodies to review and authorize or certify for marketing new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policy changes, agency’s or notified body’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the agency’s or notified body’s ability to perform routine functions. Average review times at the FDA and other agencies and notified bodies have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA, other agencies and notified bodies may also slow the time necessary for new medical devices or modifications to be reviewed and/or cleared, approved or certified by necessary agencies or notified bodies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, in recent years, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points in response to the global COVID-19 pandemic. If a prolonged government shutdown occurs, or if global health concerns, including pandemics, were to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

~~Table~~In the EU, notified bodies must be officially designated to certify products and services in accordance with the MDR, which regulates the development and sale of ~~Contents~~ medical devices in Europe. While several notified bodies have been designated, the COVID-19 pandemic significantly slowed down their designation process and the current designated notified bodies are facing a large amount of requests with the new regulation, as a consequence of which review times have lengthened although a regulation amending the EU MDR was adopted in March 2023, extending existing transitional provisions to December 31, 2028. This situation could significantly impact the ability of notified bodies to timely review and process our regulatory submissions, which could have a material adverse effect on our business in the EU and EEA (which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland).

~~Foreign data protection, privacy, and other laws and regulations are often more restrictive than those in the U.S.~~ The ~~E.U.,~~misuse ~~for~~or ~~example,~~off-label ~~traditionally~~use has imposed stricter obligations under its laws and regulations relating to privacy, data protection and consumer protection than the U.S. In May 2018, the GDPR, governing data practices and privacy in the E.U., became effective and replaced the data protection laws of ~~the~~our ~~individual~~products ~~member~~may ~~states.~~harm ~~GDPR~~our ~~requires~~reputation ~~companies to meet stringent requirements regarding the handling of personal data of individuals~~ in the ~~E.U. These more stringent requirements include expanded disclosures to inform members about how we may use their personal data~~marketplace, increased controls on profiling members, and increased rights for members to access, control and delete their personal data. In addition, there are mandatory data breach notification requirements. The law also includes significant penalties for non-compliance, which may result in ~~monetary~~injuries ~~penalties~~that oflead up to 20product ~~million~~liability ~~Euros~~suits or 4%result ofin acostly ~~company’s worldwide turnover~~investigations, ~~whichever~~fines isor ~~higher.~~sanctions ~~GDPR~~by ~~and~~regulatory ~~other similar regulations require companies to give specific types of notice~~bodies, ~~and~~particularly ~~informed~~if ~~consent~~we isare ~~required~~deemed for the placement of a cookie or similar technologies on a user’s device for online tracking for behavioral advertising and other purposes and for direct electronic marketing. The GDPR also imposes additional conditions in order to ~~satisfy~~have ~~such~~engaged ~~consent, such as a prohibition on pre-checked consents. It remains unclear how the U.K. data protection laws or regulations will develop~~ in the ~~medium~~promotion ~~to longer term and how data transfer to the U.K. from the E.U. will be regulated. Outside~~ of ~~the~~these ~~E.U.~~uses, ~~there~~any ~~are~~of ~~many~~which ~~other~~could ~~countries~~be ~~with~~costly ~~data~~to ~~protection~~our ~~laws, and new countries are adopting data protection legislation with increasing frequency~~business.

~~Many~~Our ofproducts ~~these~~are ~~laws~~Class ~~may~~II ~~require~~medical ~~consent~~devices ~~from~~cleared ~~individuals~~by FDA for commercialization in the U.S. pursuant to the 510(k) notification process. We, thus, are not currently able to promote the products for any other indications for use or make any promotional claims that are inconsistent with, or outside the scope of, ~~data~~our respective FDA clearances (often referred to as “off-label” claims). However, the assessment of whether a given claim is or is not consistent with a given FDA clearance or approval can often be subjective, and we cannot guarantee that FDA will always agree with our position regarding a particular claim or that all of our employees, representatives, and agents will abide by our marketing policies. If FDA determines that we have promoted any product without the requisite clearance or approval and/or for ~~various~~an ~~purposes~~off-label or unapproved use, it could take any number of enforcement actions against us, including ~~marketing~~(among others), issuing untitled or warning letters and/or pursuing an injunction, seizure, civil fine and/or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority, such as laws prohibiting false claims for reimbursement, any of which ~~may~~would ~~reduce~~have ~~our~~a ~~ability~~material toadverse ~~market~~effect on our ~~products~~financial condition and/or business as a whole.

~~Our~~Table ~~business~~of ~~could~~Contents ~~be adversely affected by professional and legal challenges to our business model or by new state actions restricting our ability to provide our products and services in certain states.~~

~~Since~~Additionally, ~~the~~we ~~success~~must have competent and reliable scientific evidence or, where applicable, other adequate substantiation for each reasonable interpretation of ~~our~~every ~~business~~promotional ~~will~~claim bewe ~~dependent~~make. onIn particular, comparative or superiority claims generally require adequate, well controlled, head-to-head clinical studies, comparing the ~~widespread~~product ~~adaptation~~to ofthe ~~our~~applicable ~~BNA~~competing ~~Platform~~products. asTo athe ~~valid~~extent ~~method~~we make any claims, or are otherwise held responsible for ~~statistical~~third-party ~~analysis~~claims ofabout ~~EEG~~any ~~scans~~product we may market in the United States, ~~neurologists~~without ~~across~~the ~~multiple~~requisite ~~geographies~~clinical ~~will~~substantiation, we could be ~~needed~~subject to ~~use~~enforcement ~~our~~action ~~BNA~~by ~~Platform~~FDA and/or ~~provide~~the ~~positive~~Federal ~~feedback~~Trade ~~and~~Commission ~~results.~~(FTC), ~~This~~as ~~will~~well ~~expose~~as usa tocompetitor ~~legal~~challenge ~~risk~~via the National Advertising Division (NAD) of ~~patients~~the orBetter ~~neurologists~~Business ~~who~~Bureau. ~~may~~Our ~~have~~plans to utilize social media as a ~~negative~~primary ~~experience~~promotional ~~with~~tool for our ~~BNA~~device(s) ~~Platform~~increases ~~filing~~the ~~lawsuits~~applicable ~~claiming~~enforcement ~~damages~~risk, oras ~~other~~it ~~claims.~~makes ~~Although~~it easier for our employees, affiliates, and any third parties with which we ~~will~~may ~~seek~~have ~~insurance~~a ~~coverage~~relationship and/or arrangement under which we are deemed responsible for such ~~legal~~party’s ~~actions,~~claims ~~there~~about isour noproduct(s) ~~assurance~~to ~~that~~disseminate ~~the~~promotional ~~amount~~claims ofabout ~~coverage~~our ~~will~~product(s) that may be ~~sufficient~~inconsistent towith ~~cover~~applicable ~~these~~regulations ~~claims~~governing device promotions. InFurther, ~~addition~~consumers can bring private false-advertising lawsuits, ~~such~~including ~~legal~~class actions, ~~from~~against ~~consumers~~us for any material misrepresentations and/or ~~neurologists~~deceptive ~~may~~or ~~result~~unsubstantiated inclaims ~~material~~(among ~~and~~other ~~adverse~~similar ~~effects~~causes onof action) in our ~~ability~~promotional tomaterials ~~continue~~or toother ~~conduct~~advertising. ~~business~~Any ~~due~~of tothe ~~negative~~foregoing ~~press~~could have a material adverse effect on our business.

~~Security~~We ~~breaches,~~may ~~data~~be ~~breaches,~~subject ~~cyber~~to ~~attacks~~certain federal, ~~other~~state, ~~cybersecurity~~and ~~incidents~~foreign orfraud ~~the~~and ~~failure~~abuse tolaws, ~~comply~~health ~~with~~information privacy, and security laws, and ~~data~~transparency ~~protection~~ laws, which, if violated, could ~~materially~~subject ~~impact~~us ~~our~~to ~~operations~~substantial penalties. Additionally, ~~patient~~any ~~care~~challenge ~~could~~to ~~suffer,~~or weinvestigation ~~could~~into beour ~~liable~~practices ~~for~~under ~~damages,~~these laws could cause adverse publicity and ~~our~~be ~~business,~~costly ~~operations~~to respond to, and ~~reputation~~thus could beharm ~~harmed~~our business.

WeThere ~~expect~~are tonumerous ~~retain~~U.S. ~~confidential~~federal ~~customer personal~~ and ~~financial~~state, ~~patient~~as ~~health~~well ~~information~~as ~~and our own proprietary information and data essential to our business operations. We will rely upon the effective operation of our IT systems~~foreign, ~~and~~laws ~~those~~pertaining ~~of our service providers, vendors, and other third parties~~ to ~~safeguard~~healthcare ~~the~~fraud ~~information~~ and ~~data. Additionally~~abuse, ~~our~~including ~~success may be dependent on the success of healthcare providers~~anti-kickback, ~~many~~false ~~of whom are comprised of individual or small operations with limited IT experience and inadequate or untested security protocols~~claims, ~~in managing data privacy~~ and ~~data~~physician ~~security~~transparency ~~requirements~~laws. ItEfforts isto ~~critical~~ensure that ~~the facilities, infrastructure and IT systems on which we depend to run~~ our business ~~and~~arrangements ~~the~~with ~~products~~third weparties ~~develop~~will ~~remain~~comply ~~secure~~with ~~and~~applicable behealthcare ~~perceived~~laws ~~by the marketplace~~ and ~~our~~regulations ~~potential~~may ~~customers~~involve tosubstantial ~~be secure~~costs. ~~Despite~~Our ~~the~~business ~~implementation~~practices ~~of security features in our products~~ and ~~security~~relationships ~~measures~~with ~~in our IT systems, we and our service~~ providers, ~~vendors,~~ and ~~other~~patients ~~third~~are ~~parties may become~~ subject to ~~physical~~scrutiny ~~break-ins,~~under ~~computer~~these ~~viruses~~laws. orWe ~~other~~may ~~malicious~~also ~~code,~~be ~~unauthorized~~subject orto ~~fraudulent~~patient ~~access,~~information ~~programming~~privacy ~~errors~~and orsecurity ~~other~~regulation ~~technical~~by ~~malfunctions,~~both ~~hacking~~the orfederal ~~phishing~~government ~~attacks,~~and ~~malware,~~the ~~ransomware,~~states ~~employee error or malfeasance, cyber attacks,~~ and ~~other~~foreign ~~breaches~~jurisdictions ofin ITwhich ~~systems~~we orconduct ~~similar~~our ~~disruptive~~business. ~~actions,~~The ~~including~~healthcare bylaws ~~organized groups~~ and ~~nation-state~~regulations ~~actors.~~that ~~For example, we~~ may ~~experience~~affect ~~cybersecurity~~our ~~incidents~~ability ~~and~~to ~~unauthorized~~operate ~~internal employee exfiltration of company information.~~include:

	●	the federal healthcare Medicare and Medicaid Patient Protection Act of 1987 (the “Anti-Kickback Statute”), which prohibits, among other things, persons, and entities 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 an individual for, or the purchase, lease, order, or arrange for or recommend a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid. The term “remuneration” has been broadly interpreted to include anything of value. The government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to violate. Moreover, the government may assert that a claim including items or services resulting from a violation of the federal healthcare Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration to those who prescribe, purchase, or recommend medical device products, including discounts, or engaging individuals as speakers, consultants, or advisors, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti- kickback liability. Moreover, there are no safe harbors for many common practices, such as reimbursement support programs, educational or research grants, or charitable donations;
	●	the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment of federal government funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. Private individuals, commonly known as “whistleblowers,” can bring civil False Claims Act qui tam actions, on behalf of the government and such individuals and may share in amounts paid by the entity to the government in recovery or settlement. False Claims Act liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties for each false or fraudulent claim or statement. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the federal civil False Claims Act. Many pharmaceutical and medical device manufacturers have been investigated and have reached substantial settlements under the federal civil False Claims Act in connection with alleged off-label promotion of their products and allegedly providing free products to customers with the expectation that the customers would bill federal health care programs for the product. In addition, manufacturers can be held liable under the federal civil False Claims Act even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims. There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government;

~~Table of Contents~~ 31

~~Further,~~Table ~~the frequency~~ of ~~third-party~~Contents cyber-attacks has increased over the last several years. The military conflict in Ukraine may cause nation-state actors or hackers sympathetic to either side of the conflict to carry out cyber-attacks to achieve their goals, which may include espionage, information gathering operations, monetary gain, ransomware, disruption, and destruction. Significant service disruptions, breaches in our infrastructure and IT systems or other cybersecurity incidents could expose us to litigation or regulatory investigations, impair our reputation and competitive position, be distracting to our management, and require significant time and resources to address. Affected parties or regulatory agencies could initiate legal or regulatory action against us, which could prevent us from resolving the issues quickly or force us to resolve them in unanticipated ways, cause us to incur significant expense and liability, or result in judicial or governmental orders forcing us to cease operations or modify our business practices in ways that could materially limit or restrict the products and services we provide. Concerns over our privacy practices could adversely affect others’ perception of us and deter potential customers, patients and partners from using our products. In addition, patient care could suffer, and we could be liable if our products or IT systems fail to deliver accurate and complete information in a timely manner. We have internal monitoring and detection systems as well as cybersecurity and other forms of insurance coverage related to a breach event covering expenses for notification, credit monitoring, investigation, crisis management, public relations and legal advice. However, damages and claims arising from such incidents may not be covered or may exceed the amount of any coverage and do not cover the time and effort we may incur investigating and responding to any incidents, which may be material. The costs to eliminate, mitigate or recover from security problems and cyber attacks and incidents could be material and depending on the nature and extent of the problem and the networks or products impacted, may result in network or systems interruptions, decreased product sales, or data loss that may have a material impact on our operations, net revenues and operating results.

~~Our~~● ~~business~~Health ~~will~~Insurance ~~expose~~Portability usand Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing or attempting to ~~potential~~execute ~~liability~~a scheme to defraud any healthcare benefit program, including private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, healthcare benefits, items or services. Similar to the ~~quality~~federal healthcare Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; ● the federal Physician Payments Sunshine Act under the Affordable Care Act, which requires certain manufacturers of drugs, devices, biologics and ~~safety~~medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of ~~our~~Health ~~products~~and Human Services, Centers for Medicare and ~~services~~Medicaid Services, ~~how~~information werelated ~~advertise~~to payments and ~~market~~other ~~those~~transfers ~~products~~of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and applicable manufacturers and group purchasing organizations, as well as ownership and investment interests held by physicians and their immediate family members. Since January 2022, applicable manufacturers are also required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives; ● HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations, which imposes privacy, security, and breach reporting obligations with respect to Protected Health Information (“PHI”), upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, and their respective business associates that perform services on their behalf that involve PHI. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make HIPAA compliance as well as civil and ~~how~~criminal penalties directly applicable to business associates, and gave state attorneys general new authority to ~~whom~~file wecivil ~~sell~~actions ~~them~~for damages or injunctions in federal courts to enforce the HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; and ● analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and wefalse claims laws which may ~~incur~~apply ~~substantial~~to ~~expenses~~items or services reimbursed by any third-party payer, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be ~~found~~made ~~liable~~to ~~for~~healthcare ~~substantial~~providers ~~damages~~and other potential referral sources; state and local laws that require the licensure of sales representatives; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or ~~penalties~~marketing ifexpenditures weand ~~are~~pricing ~~subject~~information; data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the EU, which adopted the General Data Protection Regulation, which became effective in May 2018); state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims orinvolving ~~litigation~~private insurers.

~~Our~~These ~~products~~laws and ~~services~~regulations, ~~involve~~among another ~~inherent~~things, ~~risk~~may ofconstrain ~~claims~~our ~~concerning their design~~business, ~~manufacture~~marketing, ~~safety~~ and ~~performance,~~other ~~how~~promotional ~~they~~activities ~~are~~by ~~marketed~~limiting ~~and~~the ~~advertised~~kinds ~~in a complex framework~~ of ~~highly~~financial ~~regulated~~arrangements, ~~domestic~~including ~~and~~sales ~~international laws and regulations~~programs, ~~how~~ we ~~package, bundle or sell them to potential customers, who~~ may behave ~~private~~with ~~individuals~~physicians or ~~companies~~other orpotential ~~public~~purchasers ~~entities~~of ~~such~~our asproducts ~~hospitals~~ and ~~clinics,~~consulting ~~and~~agreements ~~how~~ we ~~train~~enter ~~and~~into ~~support~~with ~~doctors, their staffs and patients who administer or use our products~~physicians. ~~Moreover~~Further, ~~consumer~~while ~~products~~we ~~and~~do ~~services~~not ~~are~~submit ~~routinely subject to~~ claims ~~of false, deceptive or misleading advertising, consumer fraud~~ and ~~unfair~~our ~~business~~future ~~practices.~~customers ~~Additionally,~~will wemake ~~may~~the beultimate ~~held~~decision ~~liable~~on ifwhether ~~any product we develop~~ or ~~manufacture~~how orto ~~services~~submit weany ~~offer~~potential ~~or perform causes injury or is otherwise found unhealthy. If our products are safe but they are promoted for off-label usage~~claims, we may beprovide ~~investigated,~~reimbursement ~~fined~~guidance orand ~~have~~support regarding our products, orto ~~services~~the ~~enjoined~~extent orreimbursement ~~approvals rescinded or we~~ may be ~~required~~available, towhich ~~defend~~could ~~ourselves~~implicate inthese ~~litigation~~laws. ~~Although~~Due weto ~~maintain~~the ~~insurance~~breadth ~~for~~of ~~product~~these ~~liability~~laws, ~~business~~the ~~practices~~narrowness ~~and other types~~ of ~~activities~~statutory weexceptions ~~make~~and orregulatory ~~offer,~~safe ~~coverage~~harbors ~~may not be~~ available ~~on acceptable terms~~, ~~if at all,~~ and ~~may~~the berange ~~insufficient~~of ~~for~~interpretations ~~actual~~to ~~liabilities.~~which ~~Any~~they ~~claim~~are ~~for product liability~~subject, ~~sales,~~it ~~advertising~~is ~~and~~possible ~~business~~that ~~practices,~~some ~~regardless~~ of ~~its~~our ~~merit~~current or ~~eventual~~future ~~outcome,~~practices ~~could~~might ~~result~~be inchallenged ~~material~~under ~~legal~~one ~~defense~~or ~~costs~~more ~~and~~of ~~damage~~these ~~our reputation, increase our expenses and divert management’s attention~~laws.

Increased focus on current and anticipated environmental, social and governance (“ESG”) laws and increased scrutiny of our ESG policies and practices may materially increase our costs, expose us to potential liability, adversely impact our reputation, employee retention, willingness of potential customers and suppliers to do business with us and willingness of investors to invest in us.32

~~Our~~Table ~~operations are subject to a variety~~ of ~~existing~~Contents local, regional and global ESG laws and regulations, and we will likely be required to comply with new, broader, more complex and more costly laws and regulations that focus on ESG matters. Our compliance obligations will likely span all aspects of our business and operations, including product design and development, materials sourcing and other procurement activities, product packaging, product safety, energy and natural resources usage, facilities design and utilization, recycling and collection, transportation, disposal activities and workers’ rights.

~~Environmental~~To ~~regulations~~enforce ~~related~~compliance towith ~~greenhouse~~healthcare ~~gases~~regulatory ~~are~~laws, ~~expected~~certain toenforcement bodies have anrecently ~~increasingly~~increased ~~larger~~their ~~impact~~scrutiny onof ~~our~~interactions orbetween ~~our~~healthcare ~~suppliers’~~companies ~~energy~~and ~~sources.~~healthcare ~~Many~~providers, ~~U.S.~~which ~~and~~has ~~foreign~~led ~~regulators~~to ~~have~~a ~~enacted~~number orof ~~are~~investigations, ~~considering~~prosecutions, ~~enacting~~convictions ~~new~~and orsettlements ~~additional~~in ~~disclosure~~the ~~requirements~~healthcare orindustry. ~~limits~~For onexample, ~~the~~U.S. ~~emissions~~federal ofand ~~greenhouse~~state ~~gases,~~regulatory ~~including,~~and ~~but~~enforcement ~~not~~agencies ~~limited~~continue to, ~~carbon~~actively ~~dioxide~~investigate ~~and~~violations ~~methane,~~of ~~from~~healthcare ~~power~~laws ~~generation~~and ~~units~~regulations, ~~using~~including ~~fossil~~pursuing ~~fuels.~~novel ~~The~~theories ~~effects~~ of ~~greenhouse~~liability ~~gas~~under ~~emission~~these ~~limits~~laws. onThese ~~power~~government ~~generation~~agencies ~~are~~recently ~~subject~~have toincreased ~~significant~~regulatory ~~uncertainties,~~scrutiny ~~including~~and ~~the~~enforcement ~~timing~~activity ofwith ~~any~~respect ~~new~~to ~~requirements,~~manufacturer ~~levels~~reimbursement ofsupport ~~emissions~~activities ~~reductions~~ and ~~the~~patient ~~scope~~support ~~and~~programs, ~~types~~including ofbringing ~~emissions~~criminal ~~regulated.~~charges ~~These~~or ~~limits~~civil ~~may~~enforcement ~~have~~actions under the ~~effect~~federal ofhealthcare ~~increasing~~Anti-Kickback ~~our~~statute, ~~costs~~federal ~~and~~civil ~~those~~False ofClaims ~~our~~Act, ~~suppliers~~the ~~and~~health ~~could~~care ~~result~~fraud ~~in manufacturing~~statute, ~~transportation~~ and ~~supply~~HIPAA ~~chain~~privacy ~~disruptions~~provisions. ~~and~~Responding ~~delays~~to ifinvestigations ~~clean~~can ~~energy~~be ~~alternatives~~time ~~are~~and ~~not~~resource ~~readily~~consuming ~~available~~and incan ~~adequate~~divert ~~amounts~~management’s ~~when~~attention ~~required.~~from ~~Moreover,~~the ~~alternative~~business. ~~energy~~Any ~~sources,~~such ~~coupled~~investigation ~~with~~or ~~reduced~~settlement ~~investments~~could inincrease ~~traditional~~our ~~energy~~costs ~~sources~~or ~~and~~otherwise ~~infrastructure,~~have ~~may~~an ~~fail~~adverse toeffect ~~provide~~on ~~the~~our ~~predictable,~~business. ~~reliable,~~Even ~~and~~an ~~consistent~~unsuccessful ~~energy~~challenge ~~that~~or ~~we,~~investigation into our ~~suppliers~~practices could cause adverse publicity, and ~~other~~be ~~businesses~~costly ~~need~~to ~~for~~respond ~~operations~~to.

37 If our operations are found to be in violation of any of the healthcare laws or regulations described above or any other healthcare regulations that may apply to us, we may be subject to administrative, civil and criminal penalties, damages, fines, disgorgement, substantial monetary penalties, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, additional reporting obligations, and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, reputational harm, and the curtailment or restructuring of our operations.

~~Table~~Since our software platform will utilize cloud-based information systems and the exchange of ~~Contents~~ protected information, we will be subject to numerous U.S. federal and state laws and regulations related to the privacy and security of personally identifiable information, including health information.

~~Meeting~~Among ~~our~~other ~~obligations~~data-privacy ~~under~~and/or ~~existing~~confidentiality ~~ESG~~ laws, ~~rules, or regulations is already costly~~ to uswhich ~~and our suppliers, and~~ we ~~expect~~may ~~those~~be ~~costs to increase as new laws are enacted~~subject, ~~possibly~~HIPAA ~~materially.~~establishes ~~Additionally,~~privacy ~~we expect regulators to perform investigations, inspections~~ and ~~periodically~~security ~~audit~~standards ~~our compliance with these laws and regulations, and we cannot provide assurance~~ that ~~our~~limit ~~efforts~~the oruse ~~operations will be compliant. If we fail to comply with any requirements, we could be subject to significant penalties or liabilities~~ and wedisclosure ~~may~~of bePHI ~~required to implement new~~ and ~~materially~~require ~~more~~covered ~~costly~~entities ~~processes~~ and ~~procedures~~business toassociates ~~come into compliance. Further, these laws are subject~~ to ~~unpredictable~~implement ~~changes. Even if we successfully comply with these laws and regulations~~administrative, ~~our suppliers may fail to comply. We may also suffer financial and reputational harm if future customers require~~physical, and wetechnical ~~are~~safeguards ~~unable~~ to ~~deliver,~~ensure ~~certification~~the ~~that our products are conflict free. In all of these situations~~confidentiality, ~~our future customers may stop purchasing products from us~~integrity, and ~~may~~availability ~~take~~of ~~legal~~individually ~~action~~identifiable ~~against~~health ~~us,~~information ~~which~~in ~~could~~electronic ~~harm our reputation~~form, ~~revenues~~among ~~and~~other ~~results of operations~~requirements.

~~Investor~~Violations ~~advocacy~~of ~~groups,~~HIPAA ~~institutional~~may ~~investors,~~result ~~investment~~in ~~funds,~~civil ~~proxy advisory services, stockholders,~~ and ~~consumers~~criminal ~~are also increasingly focused on corporate ESG practices~~penalties. ~~Additionally,~~We ~~public~~must ~~interest~~also ~~and~~comply ~~legislative~~with ~~pressure related to public companies~~HIPAA’s ~~ESG~~breach ~~practices~~notification ~~continues~~rule towhich ~~grow.~~requires Ifnotification ~~our ESG practices fail~~ to ~~meet~~affected ~~investors’~~individuals ~~or other industry stakeholders’ evolving expectations~~ and ~~standards,~~the ~~including~~Secretary ~~environmental stewardship, support for local communities, board~~ of ~~director~~Health and ~~employee~~Human ~~diversity,~~Services ~~human capital management~~(“HHS”), ~~employee health~~ and ~~safety practices, product quality, supply chain management, corporate governance and transparency and employing ESG strategies~~ in ~~our~~certain ~~operations,~~cases ~~our~~to ~~brand,~~media ~~reputation and employee retention may be negatively impacted~~outlets, ~~potential customers and suppliers may be unwilling to do business with us and investors may be unwilling to invest~~ in ~~us.~~the Incase ~~addition,~~of asa webreach ~~work~~of tounsecured ~~align our ESG practices with industry standards, we have expanded and will likely continue to expand our disclosures in these areas~~PHI. WeThe regulations also ~~expect to incur additional costs and~~ require ~~additional~~business ~~resources~~associates toof ~~monitor,~~covered ~~report,~~entities ~~and comply with our various ESG practices. If we fail~~ to ~~adopt~~notify ~~ESG standards or practices as quickly as stakeholders desire, report on our ESG efforts or practices accurately, or satisfy~~ the ~~disclosure~~covered ~~and~~entity ~~other expectations~~ of ~~stakeholders,~~breaches ~~our~~by ~~reputation,~~the business, ~~financial performance, growth, and stock price may be adversely impacted~~associate.

WeState ~~are~~attorneys ~~subject~~general also have the right to ~~consumer~~prosecute ~~protection~~HIPAA ~~laws~~violations ~~that~~committed ~~regulate~~against ~~our~~residents ~~marketing~~of ~~practices~~their states, and ~~prohibit~~HIPAA ~~unfair~~standards orhave ~~deceptive~~been ~~acts~~used oras ~~practices.~~the ~~Our~~basis ~~actual~~for orthe ~~perceived~~duty ~~failure~~of tocare ~~comply~~in ~~with~~state civil suits, such ~~obligations~~as ~~could~~those ~~harm~~for ~~our~~negligence ~~business~~or recklessness in misusing personal information. In addition, ~~and~~HIPAA ~~changes~~mandates inthat ~~such~~HHS ~~regulations~~conduct orperiodic ~~laws~~compliance ~~could~~audits ~~require~~of usHIPAA tocovered ~~modify~~entities ~~our~~and ~~products,~~their ~~marketing~~business orassociates ~~advertising~~for ~~efforts~~compliance.

InMany ~~connection~~states ~~with~~also have laws that protect the ~~marketing~~privacy orand ~~advertisement~~security of ~~our~~sensitive ~~products~~ and ~~services~~personal information, weincluding ~~could~~health information. These laws may be similar to or even more protective than HIPAA and other federal privacy laws. For example, the ~~target~~laws of ~~claims~~the ~~relating~~State toof ~~false~~California are more restrictive than HIPAA. Where state laws are more protective than HIPAA, ~~misleading~~we must comply with the state laws we are subject to, ~~deceptive~~in addition to HIPAA. For example, orCalifornia ~~otherwise~~passed ~~noncompliant~~the ~~advertising~~California Consumer Privacy Act or ~~marketing~~CCPA ~~practices~~on June 28, ~~including~~2018, ~~under~~which went into effect January 1, 2020. On November 3, 2020, the ~~auspices~~California Privacy Rights Act of 2020 (“CPRA”), which amends the ~~FTC~~CCPA and ~~state~~adds ~~consumer~~new ~~protection~~privacy ~~statutes~~protections that became effective on January 1, 2023, was enacted through a ballot initiative. IfWhile information we ~~rely~~maintain onthat ~~third~~is ~~parties~~covered toby ~~provide~~HIPAA ~~any~~may ~~marketing~~be ~~and~~exempt ~~advertising~~from ofthe ~~our~~CCPA, ~~products~~other records and ~~services,~~information we ~~could~~maintain related to patients or personnel may be ~~liable~~subject ~~for~~to the CCPA. In certain cases, orit ~~face~~may ~~reputational~~be ~~harm~~necessary asto amodify ~~result~~our planned operations and procedures to comply with these more stringent state laws. Not only may some of, ~~their~~these ~~marketing~~state ~~practices~~laws ifimpose fines and penalties upon violators, ~~for~~but ~~example~~also some, ~~they~~unlike ~~fail~~HIPAA, may afford private rights of action to ~~comply~~individuals ~~with~~who ~~applicable~~believe ~~statutory~~their personal information has been misused. In addition, state and ~~regulatory~~federal ~~requirements~~privacy laws subject to frequent change.

IfIn weaddition ~~are found~~ to ~~have~~HIPAA ~~breached~~and ~~any~~state ~~consumer~~health ~~protection,~~information ~~advertising,~~privacy ~~unfair competition, or other~~ laws ~~or regulations~~, we may be subject to ~~enforcement~~other ~~actions~~state ~~that~~and ~~require~~federal usprivacy tolaws, ~~change~~including ~~our~~laws ~~marketing~~that prohibit unfair privacy and ~~business~~security practices inand adeceptive ~~manner~~statements ~~which~~about ~~may~~privacy ~~negatively~~and ~~impact~~security, ~~us.~~laws ~~This~~that ~~could~~place ~~also~~specific ~~result~~requirements inon ~~litigation,~~certain ~~fines,~~types ~~penalties~~of activities, ~~and~~such ~~adverse~~as ~~publicity~~data ~~that~~security ~~could~~and ~~cause~~texting, ~~reputational~~and ~~harm~~laws ~~and~~requiring ~~loss~~holders of ~~patient~~personal ~~trust,~~information ~~which~~to ~~could~~maintain ~~have~~safeguards anand ~~adverse~~to ~~effect~~take oncertain ~~our~~actions ~~business~~in response to a data breach.

~~Risks~~Our ~~related~~subsidiary, Firefly Neuroscience Ltd., has received Israeli governmental grants to ~~out~~assist ~~Intellectual~~in ~~Property~~the funding of its research and development activities. The IIA grants which Firefly Neuroscience Ltd.’s technology has received for research and development expenditures restrict its ability to manufacture products and transfer (including by way of license for R&D purposes) know-how outside of Israel and require it to satisfy specified conditions.

~~Our~~Firefly ~~success~~Neuroscience ~~depends~~Ltd.’s technologies were developed, in part, onwith ~~our~~grants ~~proprietary~~from ~~technology~~the Israel Innovation Authority, or IIA (formerly known as the Office of the Chief Scientist of the Ministry of Economy and ifIndustry) wein ~~are~~the ~~unable~~aggregate amount of approximately $4.60 million. As of December 31, 2025, Firefly Neuroscience Ltd. has paid royalties to ~~successfully~~the ~~enforce~~IIA ~~our~~and ~~intellectual~~had ~~property~~a ~~rights~~contingent obligation to the IIA (including interest) of $6.043 million. The requirements and restrictions for such grants are set forth in the Encouragement of Research, ~~our~~Development ~~competitive~~and ~~position~~Technological ~~may~~Innovation bein ~~harmed~~Industry Law, 5744-1984 (formerly known as the Law for the Encouragement of Research and Development in Industry, 5744-1984), or the Innovation Law, the IIA’s rules and guidelines and the terms of these grants.

~~Our~~In ~~success~~general, ~~will~~the ~~depend~~recipients inof ~~part~~IIA ongrants ~~our~~are ~~ability~~obligated to ~~maintain~~pay ~~existing~~the ~~intellectual~~IIA ~~property~~royalties ~~and~~from tothe ~~obtain~~revenues generated from the sale of products and ~~maintain~~related ~~further~~services ~~intellectual~~developed ~~property~~as ~~protection~~a ~~for~~result ~~our~~of ~~products~~a research and ~~services~~development program funded, ~~both~~in whole or in part, by the ~~U.S.~~IIA, ~~and~~at inrates ~~other~~which ~~countries.~~are Wedetermined ~~intend~~under tothe ~~protect~~IIA’s ~~our~~rules ~~intellectual~~and ~~property~~guidelines ~~rights,~~(generally ~~including~~of ~~our~~3% AIto ~~technology~~6% ~~and~~on sales of IIA-funded products or related ~~algorithms~~services, ~~through~~which arates ~~combination~~may be increased under certain circumstances) up to the aggregate amount of ~~patent,~~the ~~trademark,~~total ~~copyright,~~grants ~~and~~received ~~trade~~by ~~secret~~the ~~laws~~IIA (which may be increased under certain circumstances, as ~~well~~described below), plus annual interest (as ~~third-party~~determined ~~confidentiality~~in ~~and~~the ~~assignment~~IIA’s ~~agreements~~rules and guidelines). ~~Our~~Following ~~inability~~the tofull dopayment soof ~~could~~such ~~harm~~royalties ~~our~~and ~~competitive~~interest, ~~position~~there is generally no further liability for royalty payments; however, other restrictions under the Innovation Law continue to apply, as described below.

WeUnder ~~rely~~the onIIA’s ~~our~~rules ~~portfolio~~and guidelines, Firefly Neuroscience Ltd. is generally prohibited from manufacturing products developed using the IIA funding outside of ~~issued~~the ~~and~~State ~~pending~~of ~~patent~~Israel ~~applications~~without the prior approval of the IIA (except for the transfer of less than 10% of the manufacturing capacity in the ~~U.S.~~aggregate which requires only a notice) and ~~other~~subject ~~countries~~to payment of increased royalties (up to ~~protect~~300% aof ~~large~~the ~~part~~grant amount plus accrued interest, depending on the manufacturing volume that is performed outside of ~~our~~Israel). Additionally, under the IIA’s rules and guidelines, Firefly Neuroscience Ltd. is prohibited from transferring the IIA-funded know-how and related intellectual property ~~and~~rights ~~our~~outside ~~competitive~~of ~~position;~~the ~~however~~State of Israel, ~~our~~except ~~currently~~under ~~pending~~limited orcircumstances ~~future~~and ~~patent~~only ~~filings~~with ~~may~~the ~~not~~prior ~~result~~approval inof the ~~issuance~~IIA. ofFirefly ~~patents~~Neuroscience Ltd. ~~While~~may wenot ~~generally~~receive ~~apply~~the required approvals for ~~patents~~any inproposed ~~those~~transfer, ~~countries~~and ~~where~~even weif ~~intend~~received, Firefly Neuroscience Ltd. may be required to ~~make~~pay the IIA a redemption fee of up to 600% of the grant amounts (less paid royalties, ~~have~~if ~~made~~any, ~~use~~and depreciation, orbut ~~sell~~no ~~patented~~less ~~products~~than the total grants received) plus accrued interest. Approval of the transfer of know-how to an Israeli company is also required, weand may ~~not~~be ~~accurately~~granted ~~predict~~if the recipient assumes all of our responsibilities towards the ~~countries~~IIA, ~~where~~including ~~patent~~the ~~protection~~restrictions ~~will~~on ~~ultimately~~the betransfer ~~desirable.~~of Ifknow-how weand ~~fail~~the manufacturing rights outside of Israel and the obligation to ~~timely~~pay ~~file~~royalties, ~~for~~and, although such transfer will not be subject to the payment of a ~~patent~~redemption fee, wethere ~~may~~will be ~~precluded~~an obligation to pay royalties to the IIA from ~~doing~~the soincome atof asuch ~~later~~sale ~~date~~transaction as part of the royalty payment obligation. No assurance can be given that approval for any such transfer, if requested, will be granted.

~~Economic~~These restrictions may impair our ability to perform or outsource manufacturing outside of Israel or otherwise transfer or sell Firefly Neuroscience Ltd.’s IIA funded know-how outside of Israel, without the approval of the IIA. Furthermore, the consideration available to Firefly Neuroscience Ltd.’s and/or ~~trade~~our ~~policy~~shareholders in a transaction involving the transfer outside of Israel of know-how developed with IIA funding (such as a merger or similar transaction) may be reduced by any amounts that Firefly Neuroscience Ltd. is required to pay to the IIA. If Firefly Neuroscience Ltd. fails to comply with the requirements of the Innovation Law and the IIA’s rules and guidelines, ~~including~~Firefly ~~tariffs~~Neuroscience Ltd. may become subject to financial sanctions, be required to return certain grants previously received along with interest and ~~customs~~penalties ~~regulations~~and may become subject to criminal proceedings. In addition, ~~could~~the ~~have~~Government aof ~~material~~Israel may, from time to time, audit sales of products which it claims incorporate technology funded via IIA programs and ~~adverse~~this ~~effect~~may lead to additional royalties being payable on ~~our~~additional ~~business~~products, and may subject such products to the restrictions and obligations specified hereunder.

~~The~~It U.S. has established free trade laws and regulations that set certain duties and tariffs for qualifying imports and exports, subject to compliance with the applicable classification and other requirements. Changes in laws or policies governing the terms of foreign trade, and in particular increased trade restrictions, tariffs or taxes on imports from countries where components of our products may be ~~sourced,~~difficult ~~such~~to asenforce ~~China, could have~~ a ~~material adverse effect on our business and financial results. In recent years, the~~ U.S. ~~and~~judgment ~~Chinese~~against ~~governments~~our ~~have~~subsidiary, ~~imposed~~Firefly aNeuroscience ~~series of significant incremental retaliatory tariffs to certain imported products~~Ltd. ~~Most notably with respect to the automotive industry~~, ~~the U.S. imposed tariffs on imports of certain steel, aluminum~~ and ~~automotive~~our ~~components,~~officers and ~~China~~directors ~~imposed retaliatory tariffs on imports of U.S. vehicles and certain automotive components. Further, the U.S. administration recently has proposed and begun to enact additional or enhanced tariffs~~ in ~~various~~Israel ~~jurisdictions relevant to our business. Implementation of tariffs~~ or ~~other~~otherwise ~~restrictive~~outside ~~trade measures by~~ the United States, ~~and potentially reciprocally by other countries subject~~ to ~~such~~assert ~~to tariffs remains highly uncertain~~U.S. ~~Due~~securities tolaws ~~the~~claims ~~global nature of our business, specifically~~ in ~~the~~Israel jurisdictions impacted by the recent tariffs announcements, if the actual and potential tariffs and reciprocal tariffs are implemented as currently proposed, our results of operations could be materially negatively impacted, both directly and indirectly through negative effects to our supply chain, as a result of increased costs, decreased demand and other adverse economic impacts, and we may not be able to successfully mitigate or ~~offset such impacts. Depending upon their implementation and duration, as well as our ability~~ to ~~mitigate~~serve ~~their~~process ~~impact, these tariffs and any other future regulatory actions implemented~~ on ~~a broader range of products or raw materials could materially affect~~ our ~~business,~~officers ~~including in the form of increased cost of goods sold, decreased margins, increased pricing for customers, reduced sales~~ and ~~disruption in our supply chain~~directors. Furthermore, additional trade restrictions could be adopted with little to no advanced notice, and we may not be able to effectively mitigate the adverse impacts from such measures, which could further increase the cost of our products, disrupt our supply chain and impair our ability to effectively operate and compete in the countries where we do business.

38 While we are incorporated in Delaware, our subsidiary, Firefly Neuroscience Ltd. is incorporated in Israel. Some of our executive officers and directors reside outside of the United States, and many of our assets and most of the assets of our executive officers and directors are located outside of the United States. Therefore, a judgment obtained in the United States against us or such executive officers and our directors, including one based on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the United States, and it may be difficult for you to affect service of process on these persons in the United States. In addition, it may be difficult to obtain a judgment in Israel based on the civil liability provisions of U.S. federal securities laws. Israeli courts might not enforce judgments obtained in the United States against us or our non-U.S. directors and executive officers, which may make it difficult to collect on judgments rendered against us or our non-U.S. officers and directors by either a U.S. or foreign court. Moreover, an Israeli court will not enforce a non-Israeli judgment if it was given in a state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional cases), if its enforcement is likely to prejudice the sovereignty or security of the State of Israel, if it was obtained by fraud or in the absence of due process, if it is at variance with another valid judgment that was given in the same matter between the same parties, or if a suit in the same matter between the same parties was pending before a court or tribunal in Israel at the time the foreign action was brought.

~~Table~~Cybersecurity incidents, including data security breaches or computer viruses, could harm our business by disrupting our delivery of ~~Contents~~ services, damaging our reputation, or exposing us to liability.

InWe ~~addition~~receive, ~~various~~process, ~~countries~~store, ~~regulate~~and ~~cross-border~~transmit, ~~transactions~~often electronically, data of ~~certain~~our ~~products~~customers ~~through~~and ~~import~~others ~~permitting~~which ~~and~~may ~~licensing~~be ~~requirements~~confidential. ~~The~~Unauthorized ~~exportation,~~access ~~re-exportation,~~to ~~transfers~~our ~~within~~computer ~~foreign~~systems ~~countries~~or ~~and~~stored ~~importation~~data ofcould ~~our~~result ~~products,~~in ~~including~~the bytheft ~~our~~or ~~suppliers~~improper ~~and~~disclosure ~~vendors,~~of ~~must~~confidential ~~comply~~information, ~~with~~the ~~these~~deletion ~~laws~~or ~~and~~modification ~~regulations~~of records, ~~and~~or ~~any~~could ~~violations~~cause ~~may~~interruptions ~~result~~ in ~~reputational~~our ~~harm,~~operations. ~~government~~These ~~investigations~~cybersecurity ~~and~~risks ~~penalties,~~increase ~~and~~when awe ~~denial~~transmit orinformation ~~curtailment~~from one location ofto ~~importing~~another, including transmissions over the Internet or ~~exporting~~other ~~activities~~electronic networks. ~~Complying~~Despite ~~with~~implemented ~~U.S.~~security ~~export~~measures, ~~sanctions and~~our ~~import~~facilities, ~~laws~~systems, ~~including~~and ~~ongoing~~procedures, and ~~rapidly~~those ~~changing~~of ~~sanctions~~our ~~against~~third-party ~~certain~~service ~~countries~~providers, ~~regions,~~may ~~governments~~be ~~and~~vulnerable ~~related~~to ~~persons~~security ~~and~~breaches, ~~entities~~phishing scams, ~~may~~acts beof ~~time~~vandalism, ~~consuming~~software viruses, ~~may~~misplaced ~~increase~~or ~~our~~lost ~~costs~~data, programming and/or ~~may~~human ~~result~~errors, inor ~~the~~other ~~delay~~similar orevents ~~loss~~which ofmay ~~sales~~disrupt ~~opportunities.~~our Ifdelivery weof ~~are~~services ~~found~~or toexpose bethe inconfidential ~~violation~~information of ~~U.S.~~the ~~export~~Company, ~~sanctions~~our orcustomers ~~import~~and ~~laws,~~others. orAny ~~similar~~security ~~laws~~breach ininvolving ~~other~~the ~~jurisdictions~~misappropriation, weloss, ~~and~~or ~~the~~other ~~individuals~~unauthorized ~~working~~disclosure ~~for~~or ususe ~~could~~of ~~incur~~confidential ~~substantial~~information ~~fines~~of ~~and~~our ~~penalties.~~customers ~~Changes~~or ~~in export~~others, ~~sanctions~~whether orby ~~import~~us ~~laws~~ or ~~regulations~~a ~~may~~third ~~delay~~party, ~~the sale~~could: of(i) ~~complementary~~subject ~~products~~us into ~~the~~civil ~~U.S.~~ and ~~international~~criminal ~~markets,~~penalties; ~~and~~(ii) ~~require~~have usa tonegative ~~spend~~impact ~~resources~~on toour ~~seek~~reputation; ~~necessary alternatives,~~ or, in(iii) ~~some~~expose ~~cases,~~us ~~prevent~~to ~~the~~liability ~~export~~to orour ~~import~~customers, ofthird ~~complementary~~parties, ~~products~~or togovernment ~~certain~~authorities. ~~countries,~~Any ~~regions,~~of ~~governments,~~these ~~persons~~developments orcould ~~entities,~~have ~~which~~a ~~could~~material ~~adversely~~adverse ~~affect~~effect on our business, financial condition, and ~~operating~~ results of operations.

Patent rights are territorial, and patent protection extends only to those countries where we have issued patents. Filing, prosecuting and defending patents on our products and our future products in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States. Many countries do not protect intellectual property to the same extent as the U.S. or Europe, and their litigation processes differ. Competitors may successfully challenge or avoid our patents, or manufacture products in countries where we have not applied for patent protection. Changes in the patent laws in the U.S. or other countries may diminish the value of our patent rights. As a result of these and other factors, the scope, validity, enforceability, and commercial value of our patent rights are uncertain and unpredictable.33

~~Furthermore,~~Table ~~the patent positions~~ of ~~medical~~Contents device companies involve complex legal and factual questions, and, therefore, the issuance, scope, validity and enforceability of any patent claims that we may obtain cannot be predicted with certainty. The issuance of a patent, while presumed valid and enforceable, is not conclusive as to its validity or its enforceability and it may not provide us with adequate proprietary protection or competitive advantages against competitors with similar products. Any patents issued to us may be challenged, invalidated, held unenforceable, circumvented, or may not be sufficiently broad to prevent third parties from producing competing products similar in design to our products. In addition, any protection afforded by foreign patents may be more limited than that provided under U.S. patent and intellectual property laws. There can be no assurance that any of our patents, any patents licensed to us, or any patents which we may be issued in the future, will provide us with a competitive advantage or afford us protection against infringement by others, or that the patents will not be successfully challenged or circumvented by third parties, including our competitors. Further, there can be no assurance that we will have adequate resources to enforce our patents. Competitors may also be able to design around our patents. Other parties may develop and obtain patent protection for more effective technologies, designs or methods.

~~Our~~Foreign ~~ability~~data toprotection, ~~enforce~~privacy, ~~our~~and ~~patent~~other ~~rights~~laws ~~depends~~and onregulations ~~our~~are ~~ability~~often tomore ~~detect~~restrictive ~~infringement~~than those in the U.S. ItThe isE.U., ~~difficult~~for example, traditionally has imposed stricter obligations under its laws and regulations relating to ~~detect~~privacy, ~~infringers~~data ~~who~~protection doand ~~not~~consumer ~~advertise~~protection than the ~~components~~U.S. ~~that~~In ~~are~~May ~~used~~2018, the GDPR, governing data practices and privacy in ~~their~~the ~~products~~E. ~~Moreover~~U., itbecame ~~may~~effective beand ~~difficult~~replaced orthe ~~impossible~~data protection laws of the individual member states. GDPR requires companies to ~~obtain~~meet ~~evidence~~stringent requirements regarding the handling of ~~infringement~~personal data of individuals in athe ~~competitor’s~~E.U. orThese ~~potential~~more ~~competitor’s~~stringent ~~product~~requirements include expanded disclosures to inform members about how we may use their personal data, ~~particularly~~increased incontrols ~~litigation~~on inprofiling ~~countries~~members, ~~other~~and ~~than~~increased ~~the~~rights Ufor members to access, control and delete their personal data.S. ~~that~~In doaddition, ~~not~~there ~~provide~~are anmandatory ~~extensive~~data ~~discovery~~breach ~~procedure~~notification requirements. ~~Any~~The ~~litigation~~law also includes significant penalties for non-compliance, which may result in monetary penalties of up to ~~enforce~~20 million Euros or ~~defend~~4% ~~our~~of ~~patent~~a ~~rights,~~company’s ifworldwide ~~any~~turnover, ~~even~~whichever ifis wehigher. ~~were~~GDPR and other similar regulations require companies to ~~prevail,~~give ~~could~~specific betypes ~~costly~~of notice, and ~~time-consuming~~informed ~~and~~consent ~~would~~is ~~divert~~required for the ~~attention~~placement of ~~our~~a ~~management~~cookie or similar technologies on a user’s device for online tracking for behavioral advertising and ~~key~~other ~~personnel~~purposes ~~from~~and ~~our~~for ~~business~~direct ~~operations~~electronic marketing. WeThe ~~may~~GDPR ~~not~~also ~~prevail~~imposes additional conditions in ~~any~~order ~~lawsuits~~to ~~that~~satisfy wesuch ~~initiate~~consent, ~~and~~such as a prohibition on pre-checked consents. It remains unclear how the ~~damages~~U.K. data protection laws or ~~other~~regulations ~~remedies~~will ~~awarded~~develop ifin wethe ~~were~~medium to ~~prevail~~longer ~~may~~term ~~not~~and how data transfer to the U.K. from the E.U. will be ~~commercially~~regulated. ~~meaningful~~Outside of the E.U., there are many other countries with data protection laws, and new countries are adopting data protection legislation with increasing frequency.

~~Moreover,~~Many ~~advances~~of inthese AIlaws ~~technology~~ may ~~generate~~require ~~developments~~consent ~~that~~from ~~existing~~individuals IPfor ~~laws~~the douse ~~not~~of ~~adequately~~data ~~protect.~~for ~~The~~various ~~legislative and regulatory environment is out of our control~~purposes, ~~may~~including ~~change rapidly and unpredictably~~marketing, ~~and~~which may ~~negatively~~reduce ~~influence~~ our ~~revenue,~~ability ~~costs, earnings, and growth. Some rules and regulations may be subject~~ to ~~litigation~~market orour ~~other challenges that delay or modify their implementation and impact on us~~products.

WeThere ~~also~~is ~~may~~no ~~seek~~harmonized approach to ~~rely~~these onlaws ~~protection of copyright, trade secrets, know how,~~ and ~~confidential~~regulations ~~and proprietary information~~globally. WeConsequently, ~~generally~~we ~~enter~~increase ~~into~~our ~~confidentiality~~risk ~~and~~of non-~~compete~~compliance ~~agreements~~ with ~~our~~applicable ~~employees,~~foreign ~~consultants,~~data ~~and~~protection ~~collaborative~~laws ~~partners~~and ~~upon~~regulations ~~their~~when ~~commencement~~we ofexpand ~~a relationship with us~~internationally. ~~However,~~We ~~these agreements~~ may ~~not~~need ~~provide~~to ~~meaningful~~change ~~protection~~and ~~against~~limit the ~~unauthorized~~way we use orpersonal ~~disclosure~~information ofin operating our ~~trade~~business ~~secrets or other confidential information,~~ and ~~adequate remedies~~ may ~~not~~have ~~exist~~difficulty ifmaintaining ~~unauthorized~~a ~~use~~single oroperating ~~disclosure~~model ~~were~~that tois ~~occur~~compliant. ~~The~~Compliance ~~exposure~~with ofsuch ~~our~~laws ~~trade secrets~~ and ~~other~~regulations ~~proprietary~~will ~~information~~result ~~would~~in ~~impair~~additional ~~our~~costs ~~competitive advantages~~ and ~~could~~may ~~have~~necessitate achanges ~~material~~to ~~adverse effect on~~ our ~~operating~~business ~~results,~~practices ~~financial condition,~~ and ~~future~~divergent ~~growth~~operating ~~prospects. In particular~~models, alimit ~~failure~~the toeffectiveness ~~protect~~of our ~~proprietary~~marketing ~~rights might allow competitors to copy our technology~~activities, ~~which could~~ adversely affect our ~~pricing~~business, ~~and~~results ~~market share. We may not be able to prevent the unauthorized disclosure or use~~ of ~~our technical knowledge or trade secrets by consultants~~operations, ~~vendors, former employees~~ and ~~current~~financial ~~employees. Further~~condition, ~~other~~and ~~parties~~subject ~~may~~us ~~independently~~to ~~develop~~additional ~~substantially equivalent know-how and technology~~liabilities.

WeOur ~~currently~~business ~~own~~could ~~registered~~be ~~trademarks~~adversely ~~for~~affected ~~our~~by ~~BNA~~professional ~~Platform,~~ and welegal ~~intend~~challenges to ~~rely on both registered and common law rights for~~ our ~~trademarks~~business inmodel ~~the future. There can be no assurance that our future trademark applications will be approved. Third parties may also oppose our trademark applications,~~ or ~~otherwise~~by ~~challenge~~new ~~our~~state ~~use~~actions ofrestricting ~~the trademarks. In the event that~~ our ~~trademarks~~ability ~~are successfully challenged, we could be forced~~ to ~~rebrand~~provide our products and services, ~~which could result~~ in ~~loss~~certain ~~of brand recognition, and could require us to devote resources to advertising and marketing new brands~~states. ~~Further, there can be no assurance that competitors will not infringe our trademarks, or that we will have adequate resources to enforce our trademarks.~~

~~Litigation,~~Since ~~interferences,~~the ~~oppositions,~~success ~~re-exams,~~of ~~inter~~our ~~partes~~business ~~reviews,~~will ~~post grant reviews, or other proceedings are, have been, and may in the future~~ be ~~necessary~~dependent inon ~~some instances to determine~~ the ~~validity~~widespread ~~and~~adaptation ~~scope~~ of ~~certain of~~ our ~~proprietary~~software ~~rights,~~platform ~~and~~as ina ~~other~~valid ~~instances~~method tofor ~~determine~~statistical ~~the~~analysis ~~validity, scope, or non-infringement~~ of ~~certain~~EEG ~~proprietary~~scans, ~~rights~~neurologists ~~claimed~~across bymultiple ~~third~~geographies ~~parties~~will to be ~~pertinent~~needed to ~~the manufacture,~~ use, ~~or sale of~~ our ~~products~~software orplatform ~~provision~~and ofprovide ~~our~~positive ~~services.~~feedback ~~These types of proceedings are unpredictable~~ and ~~may~~results. beThis ~~protracted,~~will ~~expensive,~~expose ~~and~~us ~~distracting~~ to ~~management.~~legal ~~The~~risk ~~outcome~~ of ~~such~~patients ~~proceedings~~or ~~could~~neurologists ~~adversely~~who ~~affect~~may ~~the~~have ~~validity~~a ~~and~~negative ~~scope~~experience ofwith our ~~patent~~software orplatform ~~other~~filing ~~proprietary~~lawsuits ~~rights,~~claiming ~~hinder~~damages ~~our~~or ~~ability~~other toclaims. ~~manufacture~~Although ~~and~~we ~~market~~will ~~our products and provide our services, require us to~~ seek ainsurance ~~license~~coverage for ~~the~~such ~~infringed~~legal ~~product~~actions, orthere ~~technology,~~is orno ~~result~~assurance inthat the ~~assessment~~amount of ~~significant~~coverage ~~monetary~~will ~~damages.~~be Ansufficient ~~unfavorable~~to ~~ruling~~cover ~~could~~these ~~include~~claims. ~~monetary~~In ~~damages or~~addition, insuch ~~cases~~legal ~~where~~actions ~~injunctive~~from ~~relief~~consumers isand ~~sought,~~neurologists anmay ~~injunction~~result ~~prohibiting~~in usmaterial ~~from~~and ~~selling~~adverse ~~our~~effects ~~products~~on ~~or providing~~ our ~~services.~~ability ~~Any~~to ofcontinue ~~these~~to ~~results~~conduct ~~from litigation could adversely affect our~~ business, ~~financial~~due ~~condition,~~to ~~and~~negative ~~results of operations~~press.

39 Security breaches, data breaches, cyber-attacks, other cybersecurity incidents or the failure to comply with privacy, security and data protection laws could materially impact our operations, patient care could suffer, we could be liable for damages, and our business, operations and reputation could be harmed.

~~Table~~We expect to retain confidential customer personal and financial, patient health information and our own proprietary information and data essential to our business operations. We will rely upon the effective operation of ~~Contents~~ our IT systems, and those of our service providers, vendors, and other third parties to safeguard the information and data. Additionally, our success may be dependent on the success of healthcare providers, many of whom are comprised of individual or small operations with limited IT experience and inadequate or untested security protocols, in managing data privacy and data security requirements. It is critical that the facilities, infrastructure and IT systems on which we depend to run our business and the products we develop remain secure and be perceived by the marketplace and our potential customers to be secure. Despite the implementation of security features in our products and security measures in our IT systems, we and our service providers, vendors, and other third parties may become subject to physical break-ins, computer viruses or other malicious code, unauthorized or fraudulent access, programming errors or other technical malfunctions, hacking or phishing attacks, malware, ransomware, employee error or malfeasance, cyber-attacks, and other breaches of IT systems or similar disruptive actions, including by organized groups and nation-state actors. For example, we may experience cybersecurity incidents and unauthorized internal employee exfiltration of company information.

Successful cybersecurity attacks, data breaches, unapproved use of machine learning or AI tools, or other security incidents could result in the loss of IP and key technological advantages. Security incidents could result in, for example, unauthorized access to, disclosure, modification, misuse, loss, or destruction of company, patient, or other third party data; theft or import of sensitive, regulated, or confidential data including personal information and IP, such as key innovations in AI; the loss of access to critical data or systems through ransomware; and business delays.34

IfTable ~~we infringe or violate the patents or proprietary rights~~ of ~~other~~Contents ~~parties or are subject to an intellectual property infringement or misappropriation claim, our ability to grow our business may be severely limited.~~

~~Our~~Further, ~~commercial~~the ~~success~~frequency ~~also~~of ~~depends~~third-party ~~upon~~cyber-attacks has increased over the last several years. The military conflict in Ukraine may cause nation-state actors or hackers sympathetic to either side of the conflict to carry out cyber-attacks to achieve their goals, which may include espionage, information gathering operations, monetary gain, ransomware, disruption, and destruction. Significant service disruptions, breaches in our ~~ability~~infrastructure and IT systems or other cybersecurity incidents could expose us to litigation or regulatory investigations, impair our reputation and ~~the~~competitive ~~ability~~position, ofbe ~~any~~distracting ~~third~~to ~~party~~our ~~with~~management, and require significant time and resources to address. Affected parties or regulatory agencies could initiate legal or regulatory action against us, which wecould ~~may~~prevent ~~partner~~us from resolving the issues quickly or force us to resolve them in unanticipated ways, cause us to ~~develop~~incur significant expense and liability, ~~manufacture~~or result in judicial or governmental orders forcing us to cease operations or modify our business practices in ways that could materially limit or restrict the products and services we provide. Concerns over our privacy practices could adversely affect others’ perception of us and deter potential customers, ~~market~~patients and ~~sell~~partners from using our products. In addition, ifpatient ~~approved~~care could suffer, and ~~use~~we could be liable if our ~~patent-protected~~products ~~technologies~~or ~~without~~IT ~~infringing~~systems fail to deliver accurate and complete information in a timely manner. We have internal monitoring and detection systems as well as cybersecurity and other forms of insurance coverage related to a breach event covering expenses for notification, credit monitoring, investigation, crisis management, public relations and legal advice. However, damages and claims arising from such incidents may not be covered or may exceed the ~~patents~~amount of ~~third~~any ~~parties~~coverage and do not cover the time and effort we may incur investigating and responding to any incidents, which may be material. ~~Extensive~~The ~~litigation~~costs ~~over~~to ~~patents~~eliminate, mitigate or recover from security problems and ~~other~~cyber-attacks ~~intellectual~~and ~~property~~incidents ~~rights~~could isbe ~~common~~material inand depending on the ~~medical~~nature ~~device~~and ~~industry~~extent of the problem and the networks or products impacted, may result in network or systems interruptions, decreased product sales, or data loss that may have a material impact on our operations, net revenues and operating results.

WeOur ~~may not have identified all patents, published applications or published literature that affect our~~ business ~~either~~will byexpose ~~blocking~~us ~~our ability~~ to ~~commercialize~~potential ~~our~~liability ~~products,~~for ~~by preventing~~ the ~~patentability~~quality ofand ~~one~~safety ~~or more aspects~~ of our products, orand byservices, ~~covering~~how ~~the~~we ~~same~~advertise orand ~~similar technologies that may affect our ability to~~ market ~~our~~those products. ~~For~~and ~~example,~~services weand ~~may~~how ~~not~~and ~~have conducted a patent clearance search sufficient~~ to ~~identify~~whom ~~potentially~~we ~~obstructing~~sell ~~third party patent rights. Moreover~~them, ~~patent applications in the United States are maintained in confidence for up to 18 months after their filing. In some cases, however, patent applications remain confidential in the U.S. Patent~~ and ~~Trademark~~we ~~Office,~~may orincur ~~the~~substantial ~~USPTO,~~expenses for the entire time prior to issuance as a U.S. patent. Patent applications filed in countries outside of the United States are not typically published until at least 18 months from their first filing date. Similarly, publication of discoveries in the scientific or ~~patent literature often lags behind actual discoveries. We cannot~~ be ~~certain~~found ~~that~~liable wefor ~~were~~substantial ~~the~~damages ~~first to invent,~~ or ~~the~~penalties ~~first to file, patent applications covering our products. We also may not know~~ if ~~our competitors filed patent applications for technology covered by our pending applications or if~~ we ~~were~~are ~~the~~subject ~~first~~ to ~~invent~~claims ~~the technology that is the subject of our patent applications. Competitors may have filed patent applications~~ or ~~received patents and may obtain additional patents and proprietary rights that block or compete with our patents~~litigation.

WeOur ~~may~~products ~~therefore~~and inservices ~~the~~involve ~~future~~an beinherent ~~the~~risk ~~subject~~ of ~~patent~~claims orconcerning ~~other~~their ~~litigation.~~design, ~~From~~manufacture, ~~time~~safety toand ~~time~~performance, wehow ~~may~~they inare ~~the~~marketed ~~future~~and ~~receive~~advertised ~~letters~~in ~~from~~a ~~third~~complex ~~parties~~framework ~~drawing~~of ~~our~~highly ~~attention~~regulated todomestic ~~their~~and ~~patent~~international ~~rights.~~laws ~~While~~and weregulations, dohow ~~not believe that~~ we ~~infringe upon any valid and enforceable rights that have been brought to our attention~~package, ~~and~~bundle weor ~~take~~sell ~~necessary~~them ~~steps~~ to ~~ensure~~potential ~~that we do not infringe on the rights of others~~customers, ~~there~~who may be ~~other~~private ~~more~~individuals ~~pertinent~~or ~~rights~~companies ofor ~~which~~public weentities ~~are~~such ~~presently~~as ~~unaware.~~hospitals ~~The defense~~ and ~~prosecution of intellectual property suits~~clinics, ~~interference proceedings,~~ and ~~related~~how ~~legal~~we train and ~~administrative~~support ~~proceedings~~doctors, ~~could~~their ~~result~~staffs ~~in substantial expense to us~~ and ~~significant~~patients ~~diversion~~who ofadminister ~~effort~~or byuse our ~~technical and management personnel~~products. AnMoreover, ~~adverse~~consumer ~~determination~~products ofand ~~any~~services ~~litigation~~are orroutinely ~~interference~~subject ~~proceeding~~ to ~~which~~claims weof ~~may~~false, ~~become~~deceptive aor ~~party~~misleading ~~could~~advertising, ~~subject~~consumer usfraud toand ~~significant~~unfair ~~liabilities~~business practices. AnAdditionally, ~~adverse~~we ~~determination~~may ofbe ~~this~~held ~~nature~~liable ~~could~~if ~~also~~any ~~put~~product ~~our~~we ~~patents~~develop ator ~~risk~~manufacture ~~of being invalidated~~ or ~~interpreted~~services ~~narrowly~~we offer or ~~require~~perform uscauses toinjury ~~seek~~or ~~licenses~~is ~~from~~otherwise ~~third~~found ~~parties~~unhealthy. ~~Licenses~~If ~~may~~our ~~not~~products beare ~~available~~safe onbut ~~commercially~~they ~~reasonable~~are ~~terms~~promoted orfor atoff-label ~~all~~usage, inwe ~~which~~may ~~event~~be investigated, ~~our~~fined ~~business~~or ~~would~~have beour ~~materially~~products ~~adversely~~or ~~affected.~~services ~~Intellectual~~enjoined ~~property~~or ~~litigation~~approvals rescinded or ~~claims~~we ~~could~~may ~~force~~be usrequired to ~~cease~~defend ~~developing,~~ourselves ~~selling~~in orlitigation. ~~otherwise~~Although ~~commercializing~~we ~~one~~maintain orinsurance ~~more~~for ofproduct ~~our~~liability, ~~products;~~business topractices ~~pay~~and ~~substantial~~other ~~damages~~types ~~for past use~~ of ~~the~~activities ~~asserted~~we ~~intellectual~~make ~~property;~~or ~~and redesign~~offer, orcoverage ~~rename~~may innot ~~the~~be ~~case~~available ofon ~~trademark~~acceptable ~~claims~~terms, ~~our~~if ~~product(s)~~at toall, ~~avoid~~and ~~such~~may ~~third~~be ~~party~~insufficient ~~rights,~~for ~~which~~actual ~~may~~liabilities. ~~not~~Any beclaim ~~possible~~for orproduct ~~which~~liability, ~~could~~sales, beadvertising ~~costly~~ and ~~time-consuming.~~business ~~Any~~practices, regardless of ~~these~~its ~~risks~~merit ~~coming~~or toeventual ~~fruition~~outcome, could ~~have~~result ain material ~~adverse~~legal ~~effect~~defense oncosts and damage our ~~business~~reputation, ~~results~~increase ofour ~~operations,~~expenses ~~financial~~and ~~condition~~divert ~~and~~management’s ~~prospects~~attention.

~~Our~~The ~~failure~~ESG toregulatory ~~secure~~landscape ~~trademark~~has ~~registrations~~shifted ~~could~~materially ~~adversely~~under ~~affect~~the ~~our~~current ~~ability~~U.S. toadministration, ~~market~~and ~~our~~we ~~products~~face risks from both the relaxation of certain federal requirements and ~~operate~~the ~~our~~continued ~~business~~— and potentially intensifying — pressure from state, international, and market-driven ESG expectations.

~~Any~~At ~~future~~the ~~trademark~~federal ~~applications~~level, in the ~~United~~current ~~States~~administration ~~and~~has ~~any~~rolled ~~other~~back ~~jurisdictions~~or ~~where~~suspended wea ~~may~~number ~~file~~of ~~may~~ESG-related ~~not~~regulations. beMost ~~allowed registration~~notably, ~~and~~the weSecurities ~~may~~and ~~not~~Exchange beCommission ~~able~~has toabandoned ~~maintain~~its ordefense ~~enforce~~of ~~our~~its ~~registered~~climate ~~trademarks.~~risk ~~During~~disclosure ~~trademark registration proceedings~~rule, wewhich ~~may~~would ~~receive~~have ~~rejections.~~required ~~Although~~public wecompanies ~~are given an opportunity~~ to ~~respond~~disclose togreenhouse ~~those~~gas ~~rejections,~~emissions weand ~~may~~climate-related befinancial ~~unable to overcome such rejections. In addition~~risks, ~~in the USPTO~~ and inhas ~~corresponding~~revised ~~foreign~~its ~~agencies,~~guidance ~~third~~on ~~parties~~shareholder ~~are~~proposals ~~given~~in anways ~~opportunity~~that tomake ~~oppose~~it ~~pending~~easier ~~trademark~~for ~~applications~~companies ~~and~~ to ~~seek~~exclude toESG-related ~~cancel~~proposals ~~registered~~from ~~trademarks~~proxy materials. ~~Opposition~~The orDepartment ~~cancellation~~of ~~proceedings~~Labor ~~may~~has bealso ~~filed~~initiated ~~against~~rulemaking ~~our~~to ~~applications~~rescind ~~and/~~or ~~registrations,~~replace ~~and~~Biden-era ~~our~~rules ~~applications~~permitting ~~and/or~~pension ~~registrations~~fund ~~may~~managers ~~not survive such proceedings. Failure~~ to ~~secure~~consider ~~such~~ESG ~~trademark~~factors ~~registrations~~ in ~~the~~investment ~~United States and in foreign jurisdictions could adversely affect our ability to market our products and our business~~decisions.

40 Additionally, the administration has revoked billions of dollars in clean energy and transportation funding, rolled back environmental regulations, and taken executive action aimed at limiting the ability of state and local governments to regulate energy and environmental matters.

~~Table~~While these federal rollbacks may provide near-term compliance relief, they introduce new categories of ~~Contents~~ risk. The fragmentation of ESG regulation — with the federal government moving in one direction while many U.S. states and international jurisdictions move in another — creates a complex and potentially more costly compliance environment than a uniform federal framework would. Blue states, including California, have moved aggressively to expand their own ESG disclosure and enforcement regimes, and we expect increased litigation as state attorneys general challenge both federal rollbacks and corporate ESG practices, including on greenwashing theories. We may face claims that our ESG disclosures or commitments were false or misleading, regardless of whether such disclosures were made in response to federal requirements.

~~We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.~~35

AsTable is common in the medical device industry, we may employ individuals who were previously employed at other companies similar to ours, including our competitors or potential competitors. We may become subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of ~~their~~Contents former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

~~Obtaining~~Our global operations remain subject to significant and ~~maintaining~~evolving ~~patent~~ESG ~~protection~~requirements ~~depends~~outside onthe ~~compliance~~United ~~with~~States. ~~various~~The ~~procedures~~European ~~and~~Union's ~~other~~Sustainable ~~requirements~~Finance Disclosure Regulation, Corporate Sustainability Reporting Directive, and ~~our~~related ~~patent~~frameworks ~~protection~~impose ~~could~~disclosure beand ~~reduced~~compliance orobligations ~~eliminated~~that inapply ~~case~~to us regardless of ~~non-~~changes in U.S. federal policy. A growing divergence between U.S. and international ESG standards may increase our compliance costs, require us to maintain different reporting frameworks for different markets, and affect our competitiveness with ~~these~~companies ~~requirements~~subject to more uniform regulatory regimes.

~~Periodic~~We ~~maintenance~~also ~~fees,~~face ~~renewal~~continued ~~fees,~~and ~~annuity~~potentially ~~fees~~increasing ~~and~~pressure ~~various~~from ~~other~~investors, ~~governmental~~proxy ~~fees~~advisory onservices, ~~patents~~ and~~/or~~ ~~applications~~other ~~will~~market beparticipants. ~~due~~Notwithstanding to the ~~relevant~~change ~~patent agencies~~ in ~~several~~federal ~~stages~~policy ~~over~~direction, ~~the~~institutional ~~lifetime~~investors ~~of the patents~~ and ~~/or~~investment ~~applications.~~funds ~~The relevant patent agencies require compliance~~ with aglobal ~~number~~mandates ofcontinue ~~procedural,~~to ~~documentary,~~apply ~~fee~~ESG ~~payment~~screens and ~~other~~engagement ~~provisions during the patent application process~~strategies. InIf ~~many~~our ~~cases,~~ESG anpractices ~~inadvertent~~fail ~~lapse~~to ~~can~~meet beevolving ~~cured~~investor byexpectations ~~payment~~— ofincluding awith ~~late~~respect ~~fee~~to orenvironmental bystewardship, ~~other~~human ~~means~~capital inmanagement, ~~accordance~~supply ~~with~~chain ~~the~~practices, ~~applicable~~board ~~rules. However~~diversity, ~~there~~and ~~are~~corporate ~~situations~~governance in— ~~which~~our ~~the~~access ~~failure~~ to ~~comply~~capital, ~~with~~stock ~~the~~price, ~~relevant~~and ~~requirements~~relationships ~~can~~with ~~result~~key incounterparties ~~the~~may ~~abandonment~~be oradversely ~~lapse~~affected. ~~of the patent or patent application~~Conversely, ~~resulting~~if inwe ~~partial~~maintain or ~~complete~~expand ~~loss~~ESG ofcommitments ~~patent~~that ~~rights~~are inperceived ~~the~~as ~~relevant~~contrary ~~jurisdiction. In such an event, our competitors might be able~~ to ~~use~~the ~~our~~current ~~technologies~~federal ~~and~~regulatory ~~know-how~~environment ~~which~~or ~~could~~the ~~have~~preferences aof ~~material~~certain ~~adverse effect on our business~~investors, ~~prospects,~~we ~~financial~~may ~~condition~~face ~~and~~different ~~results~~reputational ofor ~~operation~~commercial pressures.

~~Patent~~Meeting ~~terms~~our ~~may~~obligations beunder ~~inadequate~~existing ESG laws and regulations — at the state, federal, and international levels — is already costly, and we expect those costs to ~~protect~~remain significant and potentially increase as the regulatory landscape continues to evolve. We cannot provide assurance that we will be in compliance with all applicable requirements at all times, or that our ~~competitive~~suppliers ~~position~~will onbe in compliance. If we or our ~~products~~suppliers ~~for~~fail anto ~~adequate~~comply ~~amount~~with any applicable ESG requirements, we could be subject to penalties, litigation, reputational harm, and loss of ~~time~~customers or business partners.

~~Patents~~Given ~~have a limited lifespan. In~~ the ~~United~~pace ~~States,~~and ifunpredictability ~~all maintenance fees are timely paid, the natural expiration~~ of achanges ~~patent~~in ~~is generally 20 years from its earliest U.S. non~~ESG-~~provisional~~related ~~filing~~laws, ~~date. Various extensions may be available~~regulations, ~~but~~investor ~~the life of a patent~~expectations, and ~~the~~public ~~protection it affords~~sentiment, ~~is limited. Even if patents covering our products are obtained, once the patent life has expired for a product,~~ we may be ~~open~~unable to ~~competition from competitive products. Given the amount of time required for the development~~anticipate, ~~testing~~adapt ~~and regulatory review of new products~~to, ~~patents protecting such products might expire before~~ or ~~shortly~~accurately ~~after~~communicate ~~such~~our ~~products~~ESG ~~are~~practices ~~commercialized.~~in As a ~~result,~~manner ~~our~~that ~~patent~~satisfies ~~portfolio~~all ~~may~~stakeholders. ~~not~~Any ~~provide~~failure usto ~~with~~do ~~sufficient~~so ~~rights~~could toadversely ~~exclude~~affect ~~others~~our ~~from~~business, ~~commercializing~~financial ~~products~~condition, ~~similar~~results orof ~~identical~~operations, toand ~~ours~~stock price.

We ~~may~~are be subject to ~~claims~~consumer ~~challenging~~protection ~~the~~laws ~~inventorship~~that ofregulate our ~~patents~~marketing practices and ~~other~~prohibit ~~intellectual~~unfair ~~property~~or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business, and changes in such regulations or laws could require us to modify our products, marketing or advertising efforts.

WeIn ~~may~~connection bewith ~~subject~~the tomarketing ~~claims that former employees, collaborators~~ or ~~other~~advertisement ~~third~~of ~~parties have an interest in~~ our ~~patents~~products orand ~~other~~services, ~~intellectual~~we ~~property~~could asbe anthe ~~inventor~~target orof ~~co-inventor~~claims orrelating anto ~~author.~~false, ~~For~~misleading, ~~example~~deceptive, weor ~~may~~otherwise ~~have~~noncompliant ~~inventorship~~advertising or ~~ownership~~marketing ~~disputes~~practices, ~~arise~~including ~~from~~under ~~conflicting~~the ~~obligations~~auspices of ~~consultants~~the orFTC ~~others~~and ~~who~~state ~~are~~consumer ~~involved~~protection instatutes. ~~developing~~If ~~our~~we ~~products.~~rely ~~Litigation~~on ~~may~~third beparties ~~necessary~~ to ~~defend~~provide ~~against~~any ~~these~~marketing and ~~other~~advertising ~~claims challenging inventorship or our ownership~~ of our ~~patents~~products orand ~~other~~services, ~~intellectual property. If~~ we ~~fail~~could inbe ~~defending~~liable ~~any such claims~~for, inor ~~addition~~face toreputational ~~paying~~harm ~~monetary damages, we may lose valuable intellectual property rights, such~~ as ~~exclusive~~a ~~ownership~~result of, ortheir ~~right~~marketing topractices ~~use~~if, ~~valuable~~for ~~intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims~~example, ~~litigation~~they ~~could~~fail ~~result~~to incomply ~~substantial~~with ~~costs~~applicable ~~and~~statutory ~~be a distraction to management~~ and ~~other~~regulatory ~~employees~~requirements.

WeIf ~~use~~we AIare infound ~~our~~to ~~business~~have breached any consumer protection, advertising, unfair competition, or other laws or regulations, we may be subject to enforcement actions that require us to change our marketing and ~~challenges~~business ~~with~~practices ~~properly~~in ~~managing~~a ~~its~~manner ~~use~~which may negatively impact us. This could also result in ~~reputational~~litigation, ~~harm~~fines, ~~competitive~~penalties, and adverse publicity that could cause reputational harm, and ~~legal~~loss ~~liability~~of patient trust, ~~and~~which ~~adversely~~could ~~affect~~have ~~our~~an ~~results~~adverse ofeffect ~~operations~~on our business.

WeNew ~~incorporate~~FDA AIQuality ~~solutions~~Management ~~into~~System ~~our~~Regulation ~~BNA~~(“QMSR”) ~~platform,~~requirements ~~services,~~could ~~and~~increase ~~features, and these applications are important in~~ our ~~operations.~~compliance ~~Our~~costs ~~competitors~~and orexpose ~~other third parties may incorporate AI into their products more quickly or more successfully than~~ us, ~~which could impair our ability~~ to ~~compete~~additional ~~effectively~~regulatory ~~and adversely affect our results of operations~~risk.

~~Additionally,~~The ifFDA’s ~~the~~Quality ~~content,~~Management ~~analyses,~~System orRegulation ~~recommendations~~(“QMSR”) ~~that~~becomes AIeffective ~~applications~~on ~~assist~~February in2, ~~producing~~2026 ~~are~~and oramends ~~are~~the ~~alleged~~medical todevice becurrent ~~deficient,~~good ~~inaccurate,~~manufacturing orpractice ~~biased,~~requirements ~~our~~in ~~business,~~21 ~~financial~~CFR ~~condition,~~Part ~~and~~820 ~~results~~by ofincorporating ~~operations~~by ~~may~~reference beISO ~~adversely affected~~13485:2016. ~~Our~~While ~~use~~the ofQMSR ~~AI and machine learning~~ is ~~subject~~intended to ~~risks~~better ~~related~~harmonize toFDA ~~flaws~~quality insystem ~~our~~requirements ~~algorithms~~with ~~and~~international ~~datasets~~standards—which ~~that~~ may befacilitate ~~insufficient~~international orexpansion ~~contain~~over ~~biased~~time—transitioning ~~information.~~our ~~The~~quality ~~development~~management ~~of AI technologies is complex~~system, ~~and there are several challenges associated with achieving the desired level of accuracy~~procedures, ~~efficiency~~documentation, ~~and reliability. The algorithms and models used in our AI systems may have limitations~~training, ~~including~~supplier ~~biases~~controls, ~~errors,~~and orinternal ~~inability~~audit processes to ~~handle~~ensure ~~certain~~full ~~data~~compliance ~~types~~with ~~or scenarios. There is a risk of system failures, disruptions, or vulnerabilities that could compromise~~ the ~~integrity,~~QMSR ~~security,~~may orrequire ~~privacy~~significant ofmanagement ~~our platform. These failures could result in reputational damage~~attention, ~~legal~~additional ~~liabilities,~~personnel orand ~~loss~~consulting ~~of user confidence~~resources, ~~which~~and ~~could~~increased ~~materially~~operating ~~affect our business~~expenses.

41 If we do not implement changes to our quality system in a timely or effective manner, we may be unable to consistently demonstrate compliance during FDA inspections or other regulatory reviews. Noncompliance could result in warning letters, product holds or delays in review of submissions, import/export or distribution restrictions, product seizures, recalls, civil penalties, injunctions, or other enforcement actions, any of which could adversely affect our business, financial condition, results of operations, and cash flows. In addition, regulatory expectations and inspection approaches under the QMSR may evolve as the FDA implements the rule, creating uncertainty and potentially increasing the risk of findings, remediation obligations, and related costs.

~~Table~~Risks ofrelated ~~Contents~~ to Our Intellectual Property

~~The~~Our ~~use~~success ofdepends ~~AI applications has resulted~~ in, ~~and~~part ~~may~~on inour ~~the~~proprietary ~~future result in~~technology, ~~cybersecurity incidents that implicate the personal data of patients~~ and ~~users~~if ofwe ~~such~~are ~~applications.~~unable ~~Any such cybersecurity incidents related~~ to ~~our~~successfully ~~use~~enforce ~~of AI applications could adversely affect~~ our ~~reputation~~intellectual ~~and~~property ~~results of operations. AI also presents emerging ethical issues~~rights, ~~and if~~ our ~~use~~competitive ofposition ~~AI becomes controversial, we~~ may ~~experience~~be ~~brand or reputational harm, competitive harm, or legal liability~~harmed. The rapid evolution of AI, including potential government regulation of AI, will require significant resources to develop, test and maintain our platform, services, and features to help us implement AI ethically in order to minimize unintended, harmful impact.

~~Legislative~~Our ~~and~~success ~~governmental~~will ~~activity~~depend in ~~the~~part ~~privacy~~on ~~area~~our ~~may~~ability ~~result~~to inmaintain ~~new~~existing ~~laws~~intellectual orproperty ~~regulations~~and ~~that are applicable~~ to usobtain and ~~that~~maintain ~~may~~further ~~hinder~~intellectual ~~our~~property ~~business,~~protection for ~~example,~~our byproducts ~~restricting~~and ~~use~~services, orboth ~~sharing~~in ofthe ~~patient~~U.S. ~~data,~~and ~~limiting~~in ~~our~~other ~~ability~~countries. toWe ~~provide~~intend ~~certain data~~ to ~~our~~protect ~~customers, limiting~~ our ~~ability~~intellectual toproperty ~~develop~~rights, orincluding ~~modify~~ our AI ~~systems,~~technology ~~or otherwise regulating AI~~ and ~~machine~~related ~~learning~~algorithms, ~~including~~through ~~the~~a ~~use~~combination of ~~algorithms~~patent, ~~and~~trademark, ~~automated~~copyright, ~~processing~~and intrade ~~ways~~secret ~~that~~laws, ~~could~~as ~~materially~~well ~~affect~~as ~~our~~third-party ~~business,~~confidentiality orand ~~which~~assignment ~~may~~agreements. ~~lead~~Our inability to ~~significant~~do ~~increases~~so incould ~~the~~harm ~~cost~~our ofcompetitive ~~compliance~~position.

~~General~~We ~~Risks~~rely ~~Related~~on Toour Usportfolio of issued and pending patent applications in the U.S. and other countries to protect a large part of our intellectual property and our competitive position; however, our currently pending or future patent filings may not result in the issuance of patents. While we generally apply for patents in those countries where we intend to make, have made, use, or sell patented products, we may not accurately predict all of the countries where patent protection will ultimately be desirable. If we fail to timely file for a patent, we may be precluded from doing so at a later date.

~~Our~~Economic ~~limited~~and ~~access~~trade topolicy, ~~sufficient~~including ~~funding~~tariffs ~~may~~and ~~hinder~~customs ~~our~~regulations, ~~ability~~could tohave ~~conduct~~a ~~planned~~material ~~operations~~ and ~~realize~~adverse ~~potential~~effect ~~profits~~on our business.

ToThe ~~date,~~U.S. wehas ~~have~~established ~~primarily~~free ~~funded~~trade ~~our~~laws ~~operations~~and ~~through~~regulations ~~the~~that ~~sale~~set ofcertain ~~equity~~duties ~~securities~~and tariffs for qualifying imports and exports, subject to compliance with the ~~issuance~~applicable ofclassification ~~convertible~~and ~~notes~~other requirements. ~~These~~Changes ~~funding~~in ~~sources~~laws ~~have~~or ~~been~~policies ~~critical~~governing tothe ~~supporting~~terms ~~our~~of ~~ongoing~~foreign ~~research~~trade, and ~~development~~in ~~initiatives~~particular increased trade restrictions, ~~maintaining~~tariffs or taxes on imports from countries where components of our ~~workforce~~products may be sourced, ~~and~~such ~~financing~~as China, could have a material adverse effect on our ~~early~~business ~~commercialization~~and ~~efforts~~financial results. ~~However~~In recent years, the ~~capital~~U.S. weand Chinese governments have ~~raised~~imposed a series of significant incremental retaliatory tariffs to ~~date~~certain ~~has~~imported ~~not~~products. ~~been~~Most ~~sufficient~~notably with respect to ~~cover~~the ~~our~~automotive ~~long-term~~industry, ~~operational~~the ~~needs~~U.S. imposed tariffs on imports of certain steel, aluminum and weautomotive ~~continue~~components, toand ~~rely~~China imposed retaliatory tariffs on ~~external~~imports ~~funding~~of toU.S. ~~sustain~~vehicles and ~~grow~~certain automotive components. Further, the U.S. administration recently has proposed and begun to enact additional or enhanced tariffs in various jurisdictions relevant to our business. ~~Although~~Implementation weof ~~have~~tariffs ~~had~~or ~~success~~other restrictive trade measures by the United States and potentially reciprocally by other countries subject to such to tariffs remains highly uncertain. Due to the global nature of our business, specifically in ~~raising~~the ~~funds~~jurisdictions ~~previously~~impacted by the recent tariffs announcements, if the ~~availability~~actual and potential tariffs and reciprocal tariffs are implemented as currently proposed, our results of ~~capital~~operations ~~markets~~could isbe ~~subject~~materially negatively impacted, both directly and indirectly through negative effects to our supply chain, as a ~~variety~~result of ~~factors~~increased ~~beyond~~costs, decreased demand and other adverse economic impacts, and we may not be able to successfully mitigate or offset such impacts. Depending upon their implementation and duration, as well as our ~~control~~ability to mitigate their impact, these tariffs and any other future regulatory actions implemented on a broader range of products or raw materials could materially affect our business, including ~~macroeconomic~~in ~~conditions~~the form of increased cost of goods sold, ~~investor~~decreased ~~sentiment~~margins, increased pricing for customers, reduced sales and ~~market~~disruption ~~volatility~~in our supply chain. Furthermore, additional trade restrictions could be adopted with little to no advanced notice, and we may not be able to effectively mitigate the adverse impacts from such measures, which could further increase the cost of our products, disrupt our supply chain and impair our ability to effectively operate and compete in the countries where we do business.

There is no assurance that future financing will be available to us on acceptable terms. Market conditions or changes in our financial performance may limit our ability to attract new investment. If we are unable to raise sufficient funds through equity or debt financing or other strategic alternatives, we may be forced to delay, scale back, or discontinue our product development and commercialization efforts, reduce our workforce, or suspend or curtail planned operations altogether.36

~~Moreover,~~Table ~~the report~~ of ~~our~~Contents independent registered public accounting firm for the fiscal year ended December 31, 2024, includes a statement that substantial doubt exists about our ability to continue as a going concern, which may also limit our ability to access the capital markets or obtain favorable financing terms. The going concern qualification may raise concerns among potential investors, creditors, and business partners, making it more challenging to secure future funding or enter into strategic relationships. Without adequate financing, we may be unable to achieve our planned milestones, capitalize on market opportunities, or execute our growth strategy in a timely and effective manner.

WeIn ~~may~~addition, ~~not~~various ~~continue~~countries toregulate ~~meet~~cross-border ~~the~~transactions ~~continued~~of ~~listing~~certain products through import permitting and licensing requirements. The exportation, re-exportation, transfers within foreign countries and importation of ~~Nasdaq~~our products, ~~which~~including ~~could~~by our suppliers and vendors, must comply with these laws and regulations, and any violations may result in reputational harm, government investigations and penalties, and a ~~delisting~~denial or curtailment of importing or exporting activities. Complying with U.S. export, sanctions and import laws, including ongoing and rapidly changing sanctions against certain countries, regions, governments and related persons and entities, may be time consuming, may increase our ~~Common~~costs, ~~Stock~~and may result in the delay or loss of sales opportunities. If we are found to be in violation of U.S. export, sanctions or import laws, or similar laws in other jurisdictions, we and the individuals working for us could incur substantial fines and penalties. Changes in export, sanctions or import laws or regulations may delay the sale of complementary products in the U.S. and international markets, and require us to spend resources to seek necessary alternatives, or, in some cases, prevent the export or import of complementary products to certain countries, regions, governments, persons or entities, which could adversely affect our business, financial condition and operating results.

~~Our~~Patent ~~Common~~rights ~~Stock is listed on Nasdaq. While we~~ are ~~currently in compliance~~territorial, ~~WaveDancer has been in the past been,~~ and wepatent ~~may~~protection inextends ~~the~~only ~~future be, unable~~ to ~~comply~~those ~~with~~countries ~~certain~~where ~~of the listing standards that~~ we ~~are~~have ~~required~~issued ~~to meet to maintain the listing of our Common Stock on Nasdaq~~patents. ~~For instance~~Filing, onprosecuting ~~August~~and 8,defending ~~2024,~~patents ~~WaveDancer~~on ~~received~~our aproducts ~~letter~~and ~~from~~our ~~the~~future ~~Listing~~products ~~Qualifications Department of the Nasdaq Stock Market LLC (the “Staff”) indicating that~~ in ~~the~~all ~~former~~countries ~~WaveDancer’s~~and ~~Quarterly~~jurisdictions ~~Report~~throughout ~~on Form 10-Q filed with~~ the ~~SEC~~world onwould ~~May~~be ~~14,~~prohibitively ~~2024~~expensive, ~~WaveDancer~~and ~~reported~~our ~~stockholders’~~intellectual ~~equity~~property ofrights ~~$1,708,520~~in ~~for~~some ~~the~~countries ~~period~~outside ~~ended March 31, 2024, which did not comply with Listing Rule 5550(b)(1) (~~the ~~“Minimum~~United ~~Stockholders’~~States ~~Equity~~could ~~Requirement”).~~be ~~Additionally,~~less asextensive ~~previously~~than ~~reported,~~those in ~~a decision dated November 14, 2023, a Nasdaq Hearings Panel (~~the ~~“Panel”)~~United ~~confirmed~~States. ~~that~~Many wecountries ~~had~~do ~~regained~~not ~~compliance~~protect ~~with~~intellectual ~~the~~property ~~Minimum~~to ~~Stockholders’ Equity Requirement for a prior outstanding deficiency under~~ the ~~Minimum~~same ~~Stockholders’~~extent ~~Equity Requirement~~ as ~~related to~~ the ~~WaveDancer’s stockholders’ equity for the period ended March 31, 2023~~U.S. Inor ~~the decision~~Europe, ~~the~~and ~~Panel~~their ~~imposed~~litigation aprocesses ~~Mandatory~~differ. ~~Panel~~Competitors ~~Monitor~~may ~~for~~successfully achallenge ~~period~~or ofavoid ~~one~~our ~~year~~patents, or ~~until~~manufacture ~~November~~products ~~14,~~in ~~2024,~~countries ~~which~~where ~~would~~we ~~require~~have ~~the~~not ~~Staff~~applied tofor ~~issue~~patent aprotection. ~~Delist~~Changes ~~Determination Letter~~ in the ~~event~~patent ~~that~~laws ~~WaveDancer,~~in ~~prior to~~ the ~~consummation~~U.S. ofor ~~the~~other ~~Merger,~~countries ormay ~~we,~~diminish ~~following~~ the ~~consummation~~value of ~~the~~our ~~Merger,~~patent ~~failed to maintain compliance with the Minimum Stockholders’ Equity Rule~~rights. OnAs ~~August 13, 2024, we received~~ a ~~notice~~result ~~from~~of ~~the~~these ~~Nasdaq~~and ~~Stock~~other ~~Market~~factors, ~~LLC indicating that following~~ the ~~Staff’s~~scope, ~~review~~validity, ~~of the Merger~~enforceability, ~~the~~and ~~Staff~~commercial ~~determined~~value ~~that~~of weour ~~now~~patent ~~comply~~rights ~~with~~are ~~the~~uncertain ~~Minimum Stockholders’ Equity Requirement~~ and ~~that the matter is now closed~~unpredictable.

~~While~~Furthermore, wethe ~~have~~patent ~~regained~~positions ~~compliance~~of ~~with~~medical ~~the~~device ~~continued~~companies ~~listing~~involve ~~requirements~~complex ~~for~~legal ~~Nasdaq~~and factual questions, itand, ~~cannot~~therefore, bethe ~~assured~~issuance, scope, validity and enforceability of any patent claims that we ~~will~~may ~~continue~~obtain tocannot dobe ~~so.~~predicted Ifwith ~~Nasdaq~~certainty. ~~delists~~The ~~our~~issuance ~~Common~~of ~~Stock~~a ~~from~~patent, ~~trading~~while onpresumed ~~its~~valid ~~exchange~~and ~~for~~enforceable, ~~failure~~is tonot ~~meet~~conclusive ~~the~~as ~~listing~~to ~~standards,~~its anvalidity ~~investor~~or ~~would~~its ~~likely~~enforceability ~~find~~and it ~~significantly~~may ~~more~~not ~~difficult~~provide tous ~~dispose~~with ofadequate proprietary protection or ~~obtain~~competitive ~~our~~advantages ~~shares,~~against ~~and~~competitors ~~our~~with ~~ability~~similar ~~raise~~products. ~~future~~Any ~~capital~~patents ~~through~~issued ~~the~~to ~~sale~~us ofmay ~~our~~be ~~shares~~challenged, ~~could~~invalidated, held unenforceable, circumvented, or may not be ~~severely~~sufficiently ~~limited.~~broad ~~Delisting~~to ~~could~~prevent ~~also~~third ~~have~~parties ~~other~~from ~~negative~~producing ~~results,~~competing ~~including~~products ~~the~~similar ~~potential~~in ~~loss~~design ofto ~~confidence~~our byproducts. ~~employees~~In addition, ~~the~~any ~~loss~~protection ofafforded ~~institutional~~by ~~investor~~foreign ~~interest~~patents ~~and~~may ~~fewer~~be ~~business~~more ~~development~~limited ~~opportunities~~than that provided under U.S. ~~Additionally,~~patent ifand weintellectual ~~are~~property ~~unable~~laws. toThere ~~list~~can onbe ~~Nasdaq,~~no itassurance ~~would~~that ~~likely~~any beof ~~more~~our ~~difficult~~patents, toany ~~trade~~patents inlicensed to us, or ~~obtain~~any ~~accurate~~patents ~~quotations~~which aswe tomay be issued in the ~~market~~future, ~~price~~will ofprovide ~~our~~us ~~Common~~with ~~Stock.~~a Ifcompetitive ~~our~~advantage ~~securities~~or ~~are~~afford ~~delisted~~us ~~from~~protection ~~trading~~against oninfringement ~~Nasdaq~~by others, ~~and~~or wethat ~~are~~the patents will not ~~able~~be tosuccessfully ~~list~~challenged ~~its~~or ~~securities~~circumvented onby ~~another~~third ~~exchange~~parties, orincluding toour competitors. Further, there can be no assurance that we will have ~~them~~adequate ~~quoted~~resources onto ~~Nasdaq,~~enforce our ~~securities~~patents. ~~could~~Competitors may also be ~~quoted~~able onto ~~the~~design ~~OTC~~around ~~Bulletin~~our ~~Board~~patents. orOther onparties ~~the~~may ~~“pink~~develop ~~sheets.”~~and Asobtain apatent ~~result,~~protection wefor ~~could~~more ~~face~~effective ~~significant~~technologies, ~~adverse~~designs ~~consequences~~or ~~including:~~methods.

●Our aability ~~limited~~to ~~availability~~enforce ofour ~~market~~patent ~~quotations~~rights ~~for~~depends ~~its~~on ~~securities;~~our ●ability ato ~~determination~~detect ~~that~~infringement. ~~our~~It ~~Common~~is ~~Stock~~difficult isto adetect ~~“penny~~infringers ~~stock,”~~who ~~which~~do ~~will~~not ~~require~~advertise ~~brokers~~the ~~trading~~components that are used in ~~our~~their ~~Common~~products. ~~Stock~~Moreover, toit ~~adhere~~may tobe ~~more~~difficult ~~stringent~~or ~~rules~~impossible ~~and~~to ~~possibly~~obtain ~~result~~evidence of infringement in a ~~reduced~~competitor’s ~~level~~or ofpotential ~~trading~~competitor’s ~~activity~~product, particularly in litigation in countries other than the ~~secondary~~U.S. ~~trading~~that ~~market~~do ~~for~~not provide an extensive discovery procedure. Any litigation to enforce or defend our ~~securities;~~patent ●rights, aif ~~limited~~any, ~~amount~~even ofif ~~news~~we were to prevail, could be costly and ~~analyst~~time-consuming ~~coverage~~and ~~for~~would ~~us;~~divert the attention of our management and ●key apersonnel ~~decreased~~from ~~ability~~our tobusiness ~~issue~~operations. ~~additional~~We ~~securities~~may ~~(including~~not ~~pursuant~~prevail toin ~~short-form~~any ~~registration~~lawsuits ~~statements~~that onwe ~~Form~~initiate ~~S-3)~~and the damages or other remedies awarded if we were to ~~obtain~~prevail ~~additional~~may ~~financing~~not inbe ~~the~~commercially ~~future~~meaningful.

42 Moreover, advances in AI technology may generate developments that existing IP laws do not adequately protect. The legislative and regulatory environment is out of our control, may change rapidly and unpredictably, and may negatively influence our revenue, costs, earnings, and growth. Some rules and regulations may be subject to litigation or other challenges that delay or modify their implementation and impact on us.

~~Table~~We also may seek to rely on protection of ~~Contents~~ copyright, trade secrets, know how, and confidential and proprietary information. We generally enter into confidentiality and non-compete agreements with our employees, consultants, and collaborative partners upon their commencement of a relationship with us. However, these agreements may not provide meaningful protection against the unauthorized use or disclosure of our trade secrets or other confidential information, and adequate remedies may not exist if unauthorized use or disclosure were to occur. The exposure of our trade secrets and other proprietary information would impair our competitive advantages and could have a material adverse effect on our operating results, financial condition, and future growth prospects. In particular, a failure to protect our proprietary rights might allow competitors to copy our technology, which could adversely affect our pricing and market share. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, vendors, former employees and current employees. Further, other parties may independently develop substantially equivalent know-how and technology.

~~The~~We ~~market~~currently ~~price~~own ofregistered trademarks for our ~~Common~~BNA ~~Stock~~Platform ~~may~~and beEvoke ~~subject~~Systems, and we intend to ~~significant~~rely ~~fluctuations~~on ~~and~~both ~~volatility,~~registered and common law rights for our trademarks in the ~~stockholders~~future. There can be no assurance that our future trademark applications will be approved. Third parties may also oppose our trademark applications, or otherwise challenge our use of the ~~company~~trademarks. ~~may~~In the event that our trademarks are successfully challenged, we could be ~~unable~~forced to ~~resell~~rebrand ~~their~~our ~~shares~~products atand aservices, ~~profit~~which could result in loss of brand recognition, and ~~may~~could ~~incur~~require ~~losses~~us to devote resources to advertising and marketing new brands. Further, there can be no assurance that competitors will not infringe our trademarks, or that we will have adequate resources to enforce our trademarks.

~~Prior~~Litigation, tointerferences, ~~the~~oppositions, ~~Merger~~re-exams, ~~there~~inter ~~has~~partes ~~not~~reviews, ~~been~~post agrant ~~public~~reviews, ~~market~~or ~~for~~other ~~our~~proceedings ~~Common~~are, ~~Stock.~~have ~~The~~been, ~~market~~and ~~price~~may ofin ~~our~~the ~~Common~~future ~~Stock~~be ~~could~~necessary bein ~~subject~~some instances to ~~significant~~determine ~~fluctuation.~~the ~~The~~validity ~~previous~~and ~~business~~scope of ~~WaveDancer~~certain ~~differs~~of ~~from~~ our ~~business~~proprietary rights, and in ~~important~~other ~~respects~~instances ~~and~~to determine the validity, ~~accordingly~~scope, ~~our~~or ~~results~~non-infringement of ~~operations~~certain ~~and~~proprietary rights claimed by third parties to be pertinent to the ~~market~~manufacture, ~~price~~use, or sale of our ~~Common~~products ~~Stock~~or ~~following~~provision ~~the~~of ~~Merger~~our ~~may~~services. beThese ~~affected~~types byof ~~factors~~proceedings ~~different~~are ~~from~~unpredictable ~~those~~and ~~currently~~may ~~affecting~~be ~~the~~protracted, ~~results~~expensive, ofand ~~operations~~distracting ofto ~~WaveDancer~~management. ~~Market~~The ~~prices~~outcome ~~for~~of ~~securities~~such ofproceedings ~~life~~could ~~sciences~~adversely ~~and~~affect ~~medical~~the ~~technology~~validity ~~companies~~and inscope ~~particular~~of ~~have~~our ~~historically~~patent ~~been~~or ~~particularly~~other ~~volatile~~proprietary ~~and~~rights, ~~have~~hinder ~~shown~~our ~~extreme~~ability ~~price~~to manufacture and ~~volume~~market ~~fluctuations~~our ~~that~~products ~~have~~and ~~often~~provide ~~been~~our ~~unrelated~~services, orrequire ~~disproportionate~~us to ~~the~~seek ~~operating~~a ~~performance~~license offor ~~those~~the ~~companies.~~infringed ~~Broad~~product ~~market~~or ~~and industry factors~~technology, asor ~~well~~result asin ~~general~~the ~~economic,~~assessment ~~political~~of ~~and~~significant ~~market~~monetary ~~conditions~~damages. ~~such~~An asunfavorable ~~recessions~~ruling orcould ~~interest~~include ~~rate~~monetary ~~changes~~damages or, ~~may~~in ~~seriously~~cases ~~affect~~where ~~the~~injunctive ~~market~~relief ~~price~~is ofsought, ~~our~~an ~~Common~~injunction ~~Stock,~~prohibiting ~~regardless~~us offrom selling our ~~actual~~products ~~operating~~or ~~performance~~providing our services. ~~Some~~Any of ~~the~~these ~~factors~~results ~~that~~from ~~may~~litigation ~~cause~~could ~~the~~adversely ~~market~~affect ~~price~~our ofbusiness, ~~our~~financial ~~Common~~condition, ~~Stock~~and toresults ~~fluctuate~~of ~~include:~~operations.

● investors reacting negatively to the effect of our business and prospects from the Merger; ● the announcement of new products, new developments, services or technological innovations by us or our competitors; ● actual or anticipated quarterly increases or decreases in revenue, gross margin or earnings, and changes in our business, operations or prospects; ● announcements relating to strategic relationships, mergers, acquisitions, partnerships, collaborations, joint ventures, capital commitments, or other events by us or our competitors; ● conditions or trends in the life sciences and medical technology industries; ● changes in the economic performance or market valuations of other life sciences and medical technology companies; ● general market conditions or domestic or international macroeconomic and geopolitical factors unrelated to our performance or financial condition; ● sale of our Common Stock by stockholders, including executives and directors; ● volatility and limitations in trading volumes of our Common Stock; ● volatility in the market prices and trading volumes of the life sciences and medical technology stocks; ● our ability to finance our business; ● ability to secure resources and the necessary personnel to pursue our plans; ● failure to meet external expectations or management guidance; ● changes in our capital structure or dividend policy, future issuances of securities, sales or distributions of large blocks of Common Stock by stockholders; ● our cash position; ● announcements and events surrounding financing efforts, including debt and equity securities; ● analyst research reports, recommendations and changes in recommendations, price targets, and withdrawals of coverage; ● departures and additions of key personnel; ● disputes and litigation related to intellectual properties, proprietary rights, and contractual obligations; ● investigations by regulators into our operations or those of our competitors; ● changes in applicable laws, rules, regulations, or accounting practices and other dynamics; and ● other events or factors, many of which may be out of our control.37

InTable ~~the past, following periods~~ of ~~volatility~~Contents in the overall market and the market prices of particular companies’ securities, securities class action litigation has often been instituted against these companies. Litigation of this type, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources. Any adverse determination in any such litigation or any amounts paid to settle any such actual or threatened litigation could require us to make significant payments.

43 Successful cybersecurity attacks, data breaches, unapproved use of machine learning or AI tools, or other security incidents could result in the loss of IP and key technological advantages. Security incidents could result in, for example, unauthorized access to, disclosure, modification, misuse, loss, or destruction of company, patient, or other third party data; theft or import of sensitive, regulated, or confidential data including personal information and IP, such as key innovations in AI; the loss of access to critical data or systems through ransomware; and business delays.

~~Table~~If we infringe or violate the patents or proprietary rights of ~~Contents~~ other parties or are subject to an intellectual property infringement or misappropriation claim, our ability to grow our business may be severely limited.

WeOur ~~currently~~commercial ~~take~~success ~~advantage~~also ofdepends ~~reduced~~upon ~~disclosure~~our ability, and ~~governance~~the ~~requirements~~ability ~~applicable~~of any third party with which we may partner, to ~~smaller~~develop, ~~reporting~~manufacture, ~~companies~~market and sell our products, ~~which~~if ~~could~~approved, ~~result~~and inuse our ~~Common~~patent-protected ~~Stock~~technologies ~~being~~without ~~less~~infringing ~~attractive~~the topatents ~~investors~~of third parties. Extensive litigation over patents and other intellectual property rights is common in the medical device industry.

We may not have aidentified ~~public~~all ~~float~~patents, ofpublished ~~less~~applications ~~than~~or ~~$250~~published ~~million~~literature ~~and~~that ~~therefore~~affect ~~qualify~~our asbusiness aeither ~~smaller~~by ~~reporting~~blocking ~~company~~our ~~under~~ability to commercialize our products, by preventing the ~~rules~~patentability of ~~the~~one ~~SEC.~~or Asmore aaspects ~~smaller~~of ~~reporting~~our ~~company~~products, weor ~~are~~by ~~able~~covering tothe ~~take~~same ~~advantage~~or ofsimilar ~~reduced~~technologies ~~disclosure~~that ~~requirements,~~may ~~such~~affect asour ~~simplified~~ability ~~executive~~to ~~compensation~~market ~~disclosures~~our ~~and~~products. ~~reduced~~For ~~financial~~example, ~~statement~~we ~~disclosure~~may ~~requirements~~not inhave ~~our~~conducted ~~SEC~~a ~~filings.~~patent ~~Decreased~~clearance ~~disclosures~~search insufficient ~~our~~to ~~SEC~~identify ~~filings~~potentially ~~due~~obstructing tothird ~~our~~party ~~status~~patent asrights. aMoreover, ~~smaller~~patent ~~reporting~~applications ~~company~~in ~~may~~the ~~make~~United itStates ~~harder~~are maintained in confidence for ~~investors~~up to ~~analyze~~18 ~~our~~months ~~results~~after oftheir ~~operations~~filing. ~~and~~In ~~financial~~some ~~prospects~~cases, however, patent applications remain confidential in the U.S. WePatent ~~cannot~~and ~~predict~~Trademark ifOffice, ~~investors~~or ~~will~~the ~~find~~USPTO, ~~our~~for ~~Common~~the ~~Stock~~entire ~~less~~time ~~attractive~~prior ifto weissuance ~~rely~~as ona ~~these~~U.S. ~~exemptions~~patent. IfPatent ~~some~~applications ~~investors~~filed ~~find~~in ~~our~~countries ~~Common~~outside ~~Stock~~of ~~less~~the ~~attractive~~United asStates aare ~~result,~~not ~~there~~typically ~~may~~published beuntil aat ~~less~~least ~~active~~18 ~~trading~~months ~~market~~from ~~for~~their ~~our~~first ~~Common~~filing ~~Stock~~date. ~~and~~Similarly, ~~our~~publication ~~stock~~of ~~price~~discoveries ~~may~~in bethe ~~more~~scientific ~~volatile~~or patent literature often lags behind actual discoveries. We ~~may~~cannot ~~take~~be ~~advantage~~certain ofthat ~~the~~we ~~reporting~~were ~~exemptions~~the ~~applicable~~first to ainvent, ~~smaller~~or ~~reporting~~the ~~company~~first ~~until~~to wefile, ~~are~~patent noapplications ~~longer~~covering aour ~~smaller~~products. ~~reporting~~We ~~company,~~also ~~which~~may ~~status~~not ~~would~~know ~~end~~if ~~once~~our wecompetitors ~~have~~filed apatent ~~public~~applications ~~float~~for ~~greater~~technology ~~than~~covered ~~$250~~by ~~million.~~our Inpending ~~that~~applications ~~event,~~or if we ~~could~~were ~~still~~the befirst ato ~~smaller~~invent ~~reporting~~the ~~company~~technology ifthat is the subject of our ~~annual~~patent ~~revenues~~applications. ~~were~~Competitors ~~below~~may ~~$100~~have ~~million~~filed patent applications or received patents and wemay ~~have~~obtain aadditional ~~public~~patents ~~float~~and ofproprietary ~~less~~rights ~~than~~that ~~$700~~block ~~million~~or compete with our patents.

~~Our~~We ~~Charter~~may ~~provides~~therefore ~~that~~in the ~~Court~~future ofbe ~~Chancery~~the subject of patent or other litigation. From time to time, we may in the ~~State~~future receive letters from third parties drawing our attention to their patent rights. While we do not believe that we infringe upon any valid and enforceable rights that have been brought to our attention, and we take necessary steps to ensure that we do not infringe on the rights of ~~Delaware~~others, ~~will~~there may be ~~the~~other ~~sole~~more pertinent rights of which we are presently unaware. The defense and ~~exclusive~~prosecution ~~forum~~of ~~for~~intellectual ~~substantially~~property ~~all~~suits, ~~disputes~~interference ~~between~~proceedings, and related legal and administrative proceedings could result in substantial expense to us and significant diversion of effort by our ~~stockholders,~~technical and management personnel. An adverse determination of any litigation or interference proceeding to which we may become a party could ~~limit~~subject us to significant liabilities. An adverse determination of this nature could also put our ~~stockholders’~~patents ~~ability~~at risk of being invalidated or interpreted narrowly or require us to ~~obtain~~seek alicenses ~~favorable~~from ~~judicial~~third ~~forum~~parties. ~~for~~Licenses ~~disputes~~may ~~with~~not be available on commercially reasonable terms or at all, in which event, our business would be materially adversely affected. Intellectual property litigation or claims could force us to cease developing, selling or otherwise commercializing one or more of our ~~directors~~products; to pay substantial damages for past use of the asserted intellectual property; and redesign, ~~officers~~or rename in the case of trademark claims, our product(s) to avoid such third party rights, which may not be possible or ~~employees~~which could be costly and time-consuming. Any of these risks coming to fruition could have a material adverse effect on our business, results of operations, financial condition and prospects.

Our ~~Charter~~failure ~~provides that, unless we consent in writing~~ to ~~the~~secure ~~selection~~trademark ofregistrations ancould ~~alternative~~adversely ~~forum,~~affect the Court of Chancery of the State of Delaware is the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of the Company, (ii) any action asserting a claim of breach of a fiduciary duty owed by any current or former director, officer or stockholder to us or our ~~stockholders,~~ability ~~(iii) any action asserting a claim against the Company, its current or former directors, officers or employees arising pursuant~~ to ~~any~~market provision of the DGCL or the Charter or the Bylaws, (iv) any action as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware, or (v) any action asserting a claim against us, our ~~directors,~~products officers or employees governed by the internal affairs doctrine. This exclusive forum provision would not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction. To the extent that any such claims may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and ~~regulations~~operate ~~thereunder.~~our Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunderbusiness.

~~This~~Any ~~choice~~future oftrademark ~~forum~~applications ~~provision~~in ~~may~~the ~~limit~~United aStates ~~stockholder’s~~and ~~ability~~any toother ~~bring~~jurisdictions awhere ~~claim~~we inmay afile ~~judicial~~may ~~forum~~not ~~that~~be itallowed ~~finds~~registration, ~~favorable~~and ~~for~~we ~~disputes~~may ~~with~~not usbe able to maintain or enforce our ~~directors~~registered trademarks. During trademark registration proceedings, ~~officers~~we ormay ~~employees~~receive rejections. Although we are given an opportunity to respond to those rejections, ~~which~~we may ~~discourage~~be unable to overcome such ~~lawsuits~~rejections. ~~against~~In usaddition, in the USPTO and ~~our~~in ~~directors,~~corresponding ~~officers~~foreign oragencies, ~~employees.~~third Ifparties aare ~~court~~given ~~were~~an opportunity to ~~find~~oppose ~~the~~pending ~~choice~~trademark ofapplications ~~forum~~and ~~provision~~to ~~contained~~seek into ~~our~~cancel ~~certificate~~registered oftrademarks. ~~incorporation~~Opposition toor cancellation proceedings may be ~~inapplicable~~filed oragainst ~~unenforceable~~our inapplications anand/or ~~action~~registrations, weand our applications and/or registrations may ~~incur~~not ~~additional~~survive ~~costs~~such ~~associated~~proceedings. ~~with~~Failure ~~resolving~~to secure such ~~action~~trademark registrations in ~~other~~the ~~jurisdictions,~~United ~~which~~States ~~could~~and ~~have~~in aforeign ~~material~~jurisdictions ~~adverse~~could ~~effect~~adversely onaffect our ~~business,~~ability ~~financial~~to ~~condition,~~market ~~results~~our ofproducts ~~operations~~ and ~~prospects~~our business.

~~We will issue additional equity securities in the future, which may result in dilution to existing investors.~~38

ToTable the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We will, from time to time, sell additional equity securities in one or more transactions at prices and in a manner it determines. If we sell additional equity securities, existing stockholders may be materially diluted. In addition, new investors could gain rights superior to existing stockholders, such as liquidation and other preferences. In addition, the number of ~~shares~~Contents available for future grant under our equity compensation plans may be increased in the future. In addition, the exercise or conversion of outstanding options or warrants to purchase shares of capital stock may result in dilution to our stockholders upon any such exercise or conversion.

~~All~~We ofmay ~~WaveDancer’s~~be ~~outstanding~~subject ~~shares~~to ofclaims ~~common stock, and any shares of WaveDancer Common Stock~~ that ~~were issued in the Merger are, freely tradable without restrictions or further registration under the Securities Act, except for any shares held by~~ our ~~affiliates,~~employees ashave ~~defined~~wrongfully inused ~~Rule 144 under the Securities Act. Rule 144 defines an affiliate as a person who directly,~~ or ~~indirectly~~disclosed ~~through~~alleged ~~one~~trade orsecrets more intermediaries, controls, or is controlled by, or is under common control with, us and would include persons such as our directors and executive officers and large stockholders. In turn, resales, or the perception by the market that a substantial number of ~~resales~~their ~~could~~former ~~occur, could have the effect of depressing the market price of our Common Stock~~employers.

44 As is common in the medical device industry, we may employ individuals who were previously employed at other companies similar to ours, including our competitors or potential competitors. We may become subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

~~Table~~Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of ~~Contents~~ non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the relevant patent agencies in several stages over the lifetime of the patents and /or applications. The ~~concentration~~relevant patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the ~~capital~~patent ~~stock~~application ~~ownership~~process. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with ~~our~~the ~~insiders~~applicable ~~will~~rules. ~~likely~~However, ~~limit~~there are situations in which the ~~ability~~failure to comply with the relevant requirements can result in the abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our ~~stockholders~~competitors might be able to ~~influence~~use ~~corporate~~our ~~matters~~technologies and know-how which could have a material adverse effect on our business, prospects, financial condition and results of operation.

~~Our~~Patent ~~executive~~terms ~~officers,~~may ~~directors,~~be ~~five~~inadequate ~~percent~~to orprotect ~~greater stockholders, and the respective affiliated entities beneficially own approximately 20% of~~ our ~~outstanding~~competitive ~~Common~~position ~~Stock.~~on ~~As a result, these stockholders, acting together, have control over matters that require approval by~~ our ~~stockholders,~~products ~~including~~for ~~the~~an ~~election~~adequate ofamount ~~directors and approval~~ of ~~significant corporate transactions~~time. Corporate actions might be taken even if other stockholders oppose them. This concentration of ownership might also have the effect of delaying or preventing a corporate transaction that other stockholders may view as beneficial.

~~Certain~~Patents ~~stockholders~~have ~~could~~a ~~attempt~~limited tolifespan. ~~influence~~In ~~changes~~the United States, ~~which~~if ~~could~~all ~~adversely~~maintenance ~~affect~~fees ~~our~~are ~~operations~~timely paid, ~~financial~~the ~~condition~~natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the ~~value~~protection it affords, is limited. Even if patents covering our products are obtained, once the patent life has expired for a product, we may be open to competition from competitive products. Given the amount of time required for the development, testing and regulatory review of new products, patents protecting such products might expire before or shortly after such products are commercialized. As a result, our ~~Common~~patent ~~Stock~~portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

~~Our~~We ~~stockholders~~ may ~~from~~be ~~time~~subject to ~~time~~claims ~~seek~~challenging to acquire a controlling stake, engage in proxy solicitations, advance stockholder proposals or otherwise attempt to effect changes. Campaigns by stockholders to effect changes at publicly traded companies are sometimes led by investors seeking to increase short-term stockholder value through actions such as financial restructuring, increased debt, special dividends, stock repurchases or sales of assets or the ~~entire~~inventorship ~~company. Responding to proxy contests and other actions by activist stockholders can be costly and time-consuming and could disrupt our operations and divert the attention~~ of ~~the Board and senior management from~~ our ~~business~~patents and ~~operations.~~other ~~These~~intellectual ~~actions could adversely affect our operations, financial condition and the value of our Common Stock~~property.

~~The~~We ~~sale~~may be subject to claims that former employees, collaborators or ~~availability~~other ~~for~~third ~~sale~~parties ofhave aan ~~substantial~~interest ~~number~~in our patents or other intellectual property as an inventor or co-inventor or an author. For example, we may have inventorship or ownership disputes arise from conflicting obligations of ~~shares~~consultants or others who are involved in developing our products. Litigation may be necessary to defend against these and other claims challenging inventorship or our ownership of ~~Common~~our ~~Stock~~patents or other intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could ~~adversely~~have ~~affect~~a ~~the~~material ~~market~~adverse ~~price~~effect ofon our business. Even if we are successful in defending against such ~~shares~~claims, litigation could result in substantial costs and be a distraction to management and other employees.

~~Sales~~We ofuse aAI ~~substantial number of shares of Common Stock~~ in ~~the~~our ~~public~~business, ~~market~~ and ~~other~~challenges ~~legal~~with ~~restrictions~~properly onmanaging ~~resale,~~its oruse ~~the perception that these sales~~ could ~~occur,~~result ~~could adversely affect the market price of such shares and could materially impair our ability to raise capital through equity offerings~~ in ~~the~~reputational ~~future. As of March 25~~harm, ~~2025~~competitive ~~we have approximately 11~~harm,~~622,952 shares~~ ofand ~~Common~~legal ~~Stock outstanding~~liability, ~~without giving effect to the Reverse Stock Split, excluding securities underlying options~~ and ~~warrants,~~adversely ~~and~~affect ~~based on the Exchange Ratio of 0.1040. This includes the shares being issued to~~ our ~~stockholders~~results ~~as merger consideration, which may be resold in the public market immediately without restriction. We are unable to predict what effect, if any, market sales~~ of ~~securities held by our significant stockholders, directors or officers or the availability of these securities for future sale will have on the market price of our Common Stock~~operations.

IfWe ~~securities~~incorporate ~~analysts~~AI dosolutions ~~not~~into ~~publish~~our ~~research~~software orplatform, ~~reports~~services, ~~about~~and features, and these applications are important in our ~~business,~~operations. Our competitors or ifother ~~they~~third ~~publish~~parties ~~negative~~may ~~evaluations~~incorporate AI into their products more quickly or more successfully than us, ~~the~~which ~~price~~could ofimpair our ~~Common~~ability ~~Stock~~to ~~could~~compete ~~decline~~effectively and adversely affect our results of operations.

~~The~~Additionally, ~~trading~~if ~~market~~the ~~for~~content, ~~our~~analyses, ~~Common~~or ~~Stock~~recommendations ~~will~~that ~~rely~~AI inapplications ~~part~~assist onin ~~the~~producing ~~availability~~are ofor ~~research~~are ~~and~~alleged ~~reports~~to ~~that~~be ~~third-party~~deficient, ~~industry~~inaccurate, or ~~financial~~biased, ~~analysts~~our ~~publish~~business, ~~about~~financial ~~us.~~condition, ~~There~~and ~~are~~results ~~many~~of ~~large,~~operations ~~publicly~~may ~~traded~~be ~~companies~~adversely ~~active~~affected. inOur ~~the~~use ~~life~~of ~~sciences~~AI and ~~medical~~machine ~~technology~~learning ~~industries,~~is ~~which~~subject ~~may~~to ~~mean~~risks itrelated ~~will~~to beflaws ~~less~~in ~~likely~~our algorithms and datasets that wemay ~~receive~~be ~~widespread~~insufficient ~~analyst~~or ~~coverage~~contain biased information. ~~Furthermore,~~The ifdevelopment ~~one~~of orAI ~~more~~technologies ofis ~~the~~complex, ~~analysts~~and ~~who~~there doare ~~cover~~several uschallenges ~~downgrades~~associated ~~our~~with ~~stock,~~achieving ~~our~~the ~~stock~~desired ~~price~~level ~~would~~of ~~likely~~accuracy, ~~decline~~efficiency, and reliability. IfThe ~~one~~algorithms orand ~~more~~models ofused ~~these~~in ~~analysts~~our ~~cease~~AI ~~coverage~~systems ofmay ushave limitations, weincluding ~~could~~biases, ~~lose~~errors, ~~visibility~~or ininability ~~the~~to ~~market,~~handle ~~which~~certain indata ~~turn~~types ~~could~~or ~~cause~~scenarios. ~~our~~There ~~stock~~is ~~price~~a torisk ~~decline.~~of ~~Additionally~~system failures, ifdisruptions, ~~securities~~or ~~analysts~~vulnerabilities ~~publish~~that ~~negative~~could ~~evaluations~~compromise the integrity, security, or privacy of ~~competitors~~our inplatform. ~~the~~These ~~life~~failures ~~sciences~~could ~~and~~result ~~medical~~in ~~technology~~reputational ~~industries~~damage, ~~the~~legal ~~comparative~~liabilities, ~~effect~~or ~~could~~loss ~~cause~~of ~~our~~user ~~stock~~confidence, ~~price~~which tocould ~~decline~~materially affect our business.

~~Our management will be required to devote substantial time to comply with public company regulations.~~39

AsTable ~~a public company, we will incur significant legal, accounting and other expenses we did not incur as a private company. The Sarbanes-Oxley Act~~ of ~~2002~~Contents (the “Sarbanes-Oxley Act”), the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”), as well as rules implemented by the SEC and Nasdaq, impose various requirements on public companies, including those related to corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these requirements. Moreover, these rules and regulations will increase our legal and financial compliance costs relative to those of we incurred as a private company, and will make some activities more time consuming and costly.

45 The use of AI applications has resulted in, and may in the future result in, cybersecurity incidents that implicate the personal data of patients and users of such applications. Any such cybersecurity incidents related to our use of AI applications could adversely affect our reputation and results of operations. AI also presents emerging ethical issues, and if our use of AI becomes controversial, we may experience brand or reputational harm, competitive harm, or legal liability. The rapid evolution of AI, including potential government regulation of AI, will require significant resources to develop, test and maintain our platform, services, and features to help us implement AI ethically in order to minimize unintended, harmful impact.

~~Table~~Legislative and governmental activity in the privacy area may result in new laws or regulations that are applicable to us and that may hinder our business, for example, by restricting use or sharing of ~~Contents~~ patient data, limiting our ability to provide certain data to our customers, limiting our ability to develop or modify our AI systems, or otherwise regulating AI and machine learning, including the use of algorithms and automated processing in ways that could materially affect our business, or which may lead to significant increases in the cost of compliance.

~~The~~General ~~Sarbanes-Oxley~~Risks ~~Act~~Related requires, among other things, that we maintain effective internal control over financial reporting and disclosure controls and procedures. In particular, we must perform system and process evaluation and testing of its internal control over financial reporting to ~~allow~~Us management and our independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act (“Section 404”). Our compliance with these requirements will require that we incur substantial accounting and related expenses and expend significant management efforts. We will likely need to hire additional accounting and financial staff to satisfy the ongoing requirements of Section 404. The costs of hiring such staff may be material and there can be no assurance that such staff will be immediately available to us. Moreover, if we are not able to comply with the requirements of Section 404, or if we or our independent registered public accounting firm identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, investors could lose confidence in the accuracy and completeness of our financial reports, the market price of our Common Stock could decline and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.

AsOur alimited ~~non-accelerated~~access ~~filer,~~to wesufficient ~~will~~funding ~~not~~may behinder ~~required~~our ability to ~~comply~~conduct ~~with~~planned ~~the~~operations ~~auditor~~and ~~attestation~~realize ~~requirements~~potential ~~of the Sarbanes-Oxley Act~~profits.

WeTo ~~are~~date, ~~not~~we anhave ~~“accelerated~~primarily ~~filer”~~funded orour aoperations ~~“large~~through ~~accelerated filer” under~~ the ~~Exchange~~sale ~~Act.~~of ~~Rule~~equity ~~12b-2~~securities ~~under~~and the ~~Exchange~~issuance ~~Act~~of ~~defines~~convertible annotes. ~~“accelerated~~These ~~filer”~~funding tosources ~~mean~~have ~~any~~been ~~company~~critical ~~that~~to ~~first~~supporting ~~meets~~our ~~the~~ongoing ~~following~~research ~~conditions~~and atdevelopment ~~the end of each fiscal year: The company had a public float of $75 million or more~~initiatives, ~~but~~maintaining ~~less~~our ~~than $700 million~~workforce, asand offinancing ~~the~~our ~~last~~early ~~business~~commercialization ~~day~~efforts. ofHowever, the ~~company’s~~capital ~~most~~we ~~recently~~have ~~completed~~raised ~~second~~to ~~fiscal~~date ~~quarter; the company~~ has not been ~~subject~~sufficient to ~~the~~cover ~~reporting~~our ~~requirements~~long-term ofoperational ~~the~~needs, ~~Exchange~~and ~~Act~~we ~~for~~continue atto ~~least~~rely ~~twelve~~on ~~calendar~~external ~~months;~~funding ~~the~~to ~~company~~sustain ~~has filed at least one annual report under the Exchange Act;~~ and ~~the~~grow ~~company~~our isbusiness. ~~not~~Although ~~eligible~~we tohave ~~use~~had ~~the~~success ~~requirements for a “smaller reporting company” under the revenue test~~ in ~~paragraph~~raising ~~(2)~~funds ~~or (3)(iii)(B)~~previously, ~~as applicable, of~~ the ~~“smaller~~availability ~~reporting company” definition in Rule 12b-2~~ of ~~the~~capital ~~Exchange~~markets ~~Act.~~is ~~Rule~~subject ~~12b-2~~to ~~under the Exchange Act defines~~ a ~~“large~~variety ~~accelerated filer” in the same way as an “accelerated filer” except that the company meeting the definition must have a public float~~ of ~~$700~~factors ~~million~~beyond orour ~~more~~control, asincluding ofmacroeconomic ~~the~~conditions, ~~last~~investor ~~business~~sentiment, ~~day~~and ofmarket ~~the company’s most recently completed second fiscal quarter~~volatility.

AThere ~~non-accelerated~~is ~~filer~~no isassurance ~~not~~that ~~required~~future tofinancing ~~file~~will anbe ~~auditor~~available ~~attestation~~to ~~report~~us on ~~internal~~acceptable ~~control~~terms. ~~over~~Market conditions or changes in our financial ~~reporting~~performance ~~that~~may islimit ~~otherwise~~our ~~required~~ability ~~under~~to ~~Section~~attract ~~404(b)~~new ofinvestment. ~~the~~If ~~Sarbanes-Oxley~~we ~~Act~~are unable to raise sufficient funds through equity or debt financing or other strategic alternatives, we may be forced to delay, scale back, or discontinue our product development and commercialization efforts, reduce our workforce, or suspend or curtail planned operations altogether.

~~Therefore~~

Filing Compare · FIREFLY NEUROSCIENCE, INC.