AIFF on Nasdaq

FIREFLY NEUROSCIENCE, INC.

FIREFLY NEUROSCIENCE, INC. is an artificial intelligence company advancing precision neuroscience.1 It is headquartered in Kenmore, New York.1 Its shares trade on Nasdaq under the symbol AIFF.1

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Last updated Oct 20, 2026.

Overview

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  • TickerAIFF on Nasdaq1
  • IndustryServices-Prepackaged Software1
  • HeadquartersKenmore, New York1
  • Incorporated inDE2
  • Business address1100 Military Road, Kenmore, Ny 142172
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

Firefly Neuroscience, Inc. is an artificial intelligence company advancing precision neuroscience, applying AI and large-scale electrophysiological data to give clinicians a more complete, objective picture of how an individual patient's brain is functioning.3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

56.5%Gross margin4
-775.5%Operating margin4
-1741.0%Net margin4
957.4%Revenue growth, 20254
-260.3%Return on equity4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Service brought in 71% of the revenue FIREFLY NEUROSCIENCE, INC. broke down this way in fiscal 2025.

  1. Service$814.0K471%up 1885% from 2024
  2. Product$111.0K410%
  3. Subscription and Circulation$110.0K410%
  4. Rentals$74.0K46%up 10% from 2024
  5. Product and Service, Other$33.0K43%
Products and services by year
Products and services20242025
Service$41.0K$814.0K
Product$0$111.0K
Subscription and Circulation$0$110.0K
Rentals$67.0K$74.0K
Product and Service, Other$0$33.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue25¢$497.0K
  • Research and development75¢$1.5M
  • Income tax0¢$5.0K

Out of $1.1M in revenue.4 The company lost money this year.

Financial statements

Revenue56784$1.1M in 2025−89% since 2019
0$5.0M$10.0M$15.0M$20.0M2019: $10.2M$10.2M20192020: $13.9M$13.9M2020+37%2021: $15.0M$15.0M2021+8%2022: $12.0M$12.0M2022−20%2023: $498.0K$498.0K2023−96%2024: $108.0K$108.0K2024−78%2025: $1.1M$1.1M2025+957%
Gross profit56794$645.0K in 2025−54% since 2019
0$1.0M$2.0M$3.0M$4.0M2019: $1.4M$1.4M20192020: $2.2M$2.2M2020+58%2021: $3.6M$3.6M2021+64%2022: $2.9M$2.9M2022−21%2023: $2.6M$2.6M2023−9%2024: $108.0K$108.0K2024−96%2025: $645.0K$645.0K2025+497%
Operating income567984-$8.9M in 2025+1117% since 2019
-$15.0M-$10.0M-$5.0M0$5.0M2019: -$727.8K-$727.8K20192020: $411.8K$411.8K20202021: -$2.6M-$2.6M20212022: -$5.4M-$5.4M2022+106%2023: -$3.1M-$3.1M2023−43%2024: -$10.1M-$10.1M2024+227%2025: -$8.9M-$8.9M2025−12%
Net income567984-$19.9M in 2025+2672% since 2019
-$20.0M-$10.0M0$10.0M2019: -$717.2K-$717.2K20192020: $413.4K$413.4K20202021: -$1.1M-$1.1M20212022: -$17.8M-$17.8M2022+1469%2023: -$2.6M-$2.6M2023−85%2024: -$10.5M-$10.5M2024+302%2025: -$19.9M-$19.9M2025+90%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
REVENUE$1.1M$108.0K
COST OF GOODS SOLD$497.0K$0
GROSS PROFIT$645.0K$108.0K
Research and development expenses$1.5M$2.0M
Selling and marketing expenses$800.0K$1.2M
General and administration expenses$7.0M$6.1M
Impairment of assets$251.0K$874.0K
TOTAL OPERATING EXPENSES$9.5M$10.2M
OPERATING (LOSS)-$8.9M-$10.1M
Interest and bank fees-$159.0K-$69.0K
Interest income$89.0K$0
Foreign exchange gain (loss)-$5.0K$11.0K
Change in derivative fair value-$9.4M-$156.0K
Loss on settlement-$1.4M$0
Other (income) expenses-$224.0K-$190.0K
TOTAL OTHER INCOME (EXPENSE)-$11.0M-$404.0K
LOSS BEFORE INCOME TAX-$19.9M-$10.5M
Income tax provision (benefit)$5.0K-$2.0K
NET LOSS AND COMPREHENSIVE LOSS-$19.9M-$10.5M
Deemed dividend on warrant inducement$4.6M$0
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS-$24.5M-$10.5M
BASIC AND DILUTED LOSS PER SHARE (in dollars per share)-$1.97-$1.60
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING, BASIC AND DILUTED (in shares)12.4M shares6.5M shares

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Corporate structure

FIREFLY NEUROSCIENCE, INC. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of FIREFLY NEUROSCIENCE, INC.

  • Windsor Private Capital LP Filed SCHEDULE 13D/A on FIREFLY NEUROSCIENCE, INC., latest Jan 30, 2026 (7 filings since Aug 19, 2024)
  • Arena Investors Filed SCHEDULE 13G/A on FIREFLY NEUROSCIENCE, INC., latest Nov 14, 2025 (2 filings since Feb 20, 2025)
  • Roxy Capital Corp Filed SCHEDULE 13G/A on FIREFLY NEUROSCIENCE, INC., latest Apr 17, 2025 (2 filings since Aug 21, 2024)
  • Christopher Connor Finn Filed SCHEDULE 13G/A on FIREFLY NEUROSCIENCE, INC., latest Jan 8, 2025 (2 filings since Sep 19, 2024)
  • RJL 18 CAPITAL CANADA LP Filed SC 13G on FIREFLY NEUROSCIENCE, INC., latest Aug 21, 2024
  • Joseph Patrick Daly Filed SC 13D/A on FIREFLY NEUROSCIENCE, INC., latest Aug 7, 2023 (3 filings since Jan 14, 2022)
  • Gerald James Benoit Jr. Filed SC 13D/A on FIREFLY NEUROSCIENCE, INC., latest Aug 17, 2022 (2 filings since Jan 13, 2022)
  • Palm Management (US) LLC Filed SC 13G/A on FIREFLY NEUROSCIENCE, INC., latest Feb 14, 2022
  • GELBAND ALAN Filed SC 13G on FIREFLY NEUROSCIENCE, INC., latest Feb 11, 2022
  • FIREFLY NEUROSCIENCE, INC. Kenmore, New York

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What FIREFLY NEUROSCIENCE, INC. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Accumulated depreciation$58.0K4 Dec 31, 2025$12.0K4 Dec 31, 2024+383.3%
Property and equipment, net$146.0K4 Dec 31, 2025$136.0K4 Dec 31, 2024+7.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$5.2M4 Dec 31, 2025$04 Dec 31, 2024
Intangible assets, net (excluding goodwill)$861.0K4 Dec 31, 2025$180.0K4 Dec 31, 2024+378.3%
Accumulated amortization$183.0K4 Dec 31, 2025$55.0K4 Dec 31, 2024+232.7%
Finite-lived intangibles, net$861.0K4 Dec 31, 2025$180.0K8 Dec 31, 2024+378.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$108.0K4 Dec 31, 2025$04 Dec 31, 2024
Raw materials$108.0K4 Dec 31, 2025$04 Dec 31, 2024
Work in process$04 Dec 31, 2025$04 Dec 31, 2024
Finished goods$04 Dec 31, 2025$04 Dec 31, 2024

Properties, in its own words

We do not own any real property or facilities. In connection with the Merger, we assumed the lease of WaveDancer’s principal executive offices, which expired in November 2024. If we advance our business operations, we may seek to lease facilities of our own in order to support our operational and administrative needs. There can be no assurance that such facilities will be available, or that they will be available on suitable terms. Our inability to obtain such facilities could have a material adverse effect on our future plans and operations.

Item 2 of the 10-K filed Mar 31, 2026.3

Leadership

Who has led FIREFLY NEUROSCIENCE, INC., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (22)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorGreg Lipshitz named Apr 16, 202643
  • DirectorJACK L JOHNSON, JR named Dec 20, 2021 to Aug 22, 202244

Former names

  • WAVEDANCER, INC.Dec 16, 2021 to Aug 12, 20242
  • INFORMATION ANALYSIS INCNov 15, 1995 to Dec 14, 20212

Timeline

  1. Sep 14, 20268-K Executive or director change45
  2. Aug 7, 20268-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote46
  3. Jun 26, 20268-K Ended a material agreement47
  4. Jun 22, 20268-K Executive or director change48
  5. May 12, 20268-K Entered a material agreement; Unregistered sale of shares49
  6. Apr 22, 20268-K Entered a material agreement; Unregistered sale of shares50
  7. Mar 12, 20268-K Entered a material agreement; Unregistered sale of shares51
  8. Feb 4, 20268-K Entered a material agreement; Executive or director change52
  9. Dec 19, 20258-K Entered a material agreement; Unregistered sale of shares53
  10. Oct 31, 20258-K Shareholder vote54
  11. Sep 5, 20258-K Ended a material agreement; Executive or director change55
  12. Jun 16, 20258-K Entered a material agreement; Unregistered sale of shares56
  13. Mar 12, 2025New chief executive Gregory Lipschitz becomes CEO12
  14. Aug 30, 2021New chief executive Gerald James Benoit Jr. becomes CEO14
  15. Mar 30, 2021New chief executive Stanley Arthur Reese becomes CEO13

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/202657

When it reported results

  1. Dec 4, 2024Reported quarterly or annual results58
  2. Nov 15, 2024Reported quarterly or annual results59
  3. Nov 21, 2022Reported quarterly or annual results60
  4. Aug 15, 2022Reported quarterly or annual results61
  5. May 23, 2022Reported quarterly or annual results62
  6. Apr 18, 2022Reported quarterly or annual results63
  7. Nov 3, 2021Reported quarterly or annual results64

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

296 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 67 major events, 98 insider forms, 21 large holders, 5 private raises, 83 other. The latest 20:

  1. Sep 29, 20264 OWNERSHIP DOCUMENT EDGAR
  2. Sep 29, 20264 OWNERSHIP DOCUMENT EDGAR
  3. Sep 29, 20264 OWNERSHIP DOCUMENT EDGAR
  4. Sep 14, 20263 EDGAR
  5. Sep 14, 20268-K CURRENT REPORT EDGAR
  6. Aug 11, 202610-Q EDGAR
  7. Aug 7, 20268-K CURRENT REPORT EDGAR
  8. Jul 9, 2026DEF 14A EDGAR
  9. Jul 2, 2026424B3 PROSPECTUS EDGAR
  10. Jun 30, 2026EFFECT EDGAR
  11. Jun 29, 2026PRE 14A EDGAR
  12. Jun 26, 20268-K CURRENT REPORT EDGAR
  13. Jun 23, 2026S-3/A AMENDMENT NO. 1 TO FORM S-3 EDGAR
  14. Jun 22, 20268-K CURRENT REPORT EDGAR
  15. May 20, 2026S-8 REGISTRATION STATEMENT EDGAR
  16. May 20, 2026S-3 REGISTRATION STATEMENT EDGAR
  17. May 13, 202610-Q EDGAR
  18. May 12, 20268-K CURRENT REPORT EDGAR
  19. Apr 22, 20268-K CURRENT REPORT EDGAR
  20. Apr 16, 2026D EDGAR

The 296 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

36 open-market trades by officers, directors and large owners since October 2021: 26 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Oct 22, 2025Windsor Private Capital LP10% ownerSale78,031$2.07$161.5KForm 4
Oct 21, 2025Windsor Private Capital LP10% ownerSale19,222$2.40$46.1KForm 4
Oct 20, 2025Windsor Private Capital LP10% ownerSale33,500$2.46$82.4KForm 4
Oct 17, 2025Windsor Private Capital LP10% ownerSale45,036$2.55$114.8KForm 4
Oct 16, 2025Windsor Private Capital LP10% ownerSale40,139$2.65$106.4KForm 4
Oct 15, 2025Windsor Private Capital LP10% ownerSale17,500$2.74$48.0KForm 4
Oct 14, 2025HJRK Holdings Inc.10% ownerSale29,500$2.74$80.8KForm 4
Oct 13, 2025HJRK Holdings Inc.10% ownerSale32,136$2.65$85.2KForm 4
Oct 10, 2025HJRK Holdings Inc.10% ownerSale74,810$2.70$202.0KForm 4
Oct 9, 2025HJRK Holdings Inc.10% ownerSale30,126$2.94$88.6KForm 4
Sep 29, 2023BENOIT GERALD JAMES JRCEOBuy350,000$0.50$175.0KForm 4
Dec 13, 2022BENOIT GERALD JAMES JRCEOBuy3,996$0.64$2.6KForm 4
Dec 12, 2022BENOIT GERALD JAMES JRCEOBuy21,004$0.64$13.4KForm 4
Dec 6, 2022BENOIT GERALD JAMES JRCEOBuy1,798$0.69$1.2KForm 4
Dec 5, 2022BENOIT GERALD JAMES JRCEOBuy25,214$0.64$16.1KForm 4
Dec 2, 2022BENOIT GERALD JAMES JRCEOBuy17,453$0.65$11.3KForm 4
Dec 1, 2022BENOIT GERALD JAMES JRCEOBuy506$0.59$298Form 4
Nov 29, 2022BENOIT GERALD JAMES JRCEOBuy5,029$0.54$2.7KForm 4
Oct 18, 2022BENOIT GERALD JAMES JRCEOBuy19,607$1.23$24.1KForm 4
Oct 17, 2022BENOIT GERALD JAMES JRCEOBuy5,393$1.17$6.3KForm 4

All 36 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Greg LipschitzChief Executive Officer38$302.0K$1.1M74
2025David DeCaprioPresident and Chief Operating Officer53$179.7K$748.3K74
2025Gil IssacharFormer Chief Technology Officer$201.8K$259.0K74
2025Paul KrzywickiChief Financial Officer41$130.1K$225.2K74
2025Jon OlsenFormer Chief Executive Officer$44.9K74
2024Gil IssacharFormer Chief Technology Officer$179.5K$804.0K74
2024Jon OlsenFormer Chief Executive Officer$743.0K74
2024Paul KrzywickiChief Financial Officer41$155.0K74
2024Samer KabaFormer Chief Medical Officer$139.5K74
2024Dave JohnsonFormer Executive Chairman$72.5K74
2024Stephen PurcellFormer Chief Financial Officer$16.5K74

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Mar 8, 2026Raised $2.2 million in a private offering of equity Form D: $20.2 million offered in all Form D
  2. Jun 16, 2025Raised $1.2 million in a private offering of equity Form D: $2 million offered in all Form D
  3. Aug 11, 2022Raised $1.9 million in a private offering of equity Form D: named in the filing: TIMOTHY G HANNON, MARK T KRIAL, PAUL B BECKER, DONALD J TRINGALI, GERALD JAMES BENOIT, JR, LINDA L SINGH Form D
  4. Jul 19, 2022Filed a private offering of equity Form D: $15 million offered in all Form D
  5. Dec 10, 2021Raised $10 million in a private offering of equity Form D: 105 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Murchinson Ltd.650,000$786.5K0.4%New
BlackRock, Inc.187,168$226.5K0.0%+17,806
Boothbay Fund Management, LLC178,750$216.3K0.0%New
Geode Capital Management, LLC121,522$147.1K0.0%−34,786
Vanguard Capital Management LLC111,910$135.4K0.0%No change
Jane Street Group, LLC67,829$82.1K0.0%−112,392
UBS Group AG59,119$71.5K0.0%−73,076
Vanguard Fiduciary Trust Co50,993$61.7K0.0%No change
State Street Corp46,299$56.0K0.0%No change
Northern Trust Corp33,494$40.5K0.0%+17,730
Squarepoint Ops LLC14,290$17.3K0.0%New
Waldron Private Wealth LLC12,000$14.5K0.0%No change
Tower Research Capital LLC (TRC)5,926$7.2K0.0%+3,194
Vanguard Global Advisers, LLC2,768$3.3K0.0%No change
Citigroup Inc2,091$2.5K0.0%−26,572
Osaic Holdings, Inc.1,458$1.8K0.0%No change
Barclays PLC312$3780.0%New
Tradewinds Capital Management, LLC40$490.0%No change
SBI Securities Co., Ltd.32$390.0%−1,267
Virtu Financial LLC26,557$320.0%New
Continuum Advisory, LLC1$10.0%New
Royal Bank Of Canada1$00.0%−40

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How FIREFLY NEUROSCIENCE, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARFIREFLY NEUROSCIENCE, INC.1
  • CIK0000803578
  • Employer ID (EIN)54-11673643
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)7372 Services-Prepackaged Software1
  • SEC reviewing officeOffice of Technology, Division of Corporation Finance1
  • Business address1100 Military Road, Kenmore, NY 142171
  • Phone888-237-64121
  • Shares outstanding15,690,316 as of Aug 4, 202611
  • Public float$31.3M as of Jun 30, 20253
  • AuditorCBIZ Canada LLP, Toronto, ON, Canada PCAOB ID 7192; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceNov 15, 19951
  • Filings641 in all: 4 (160), 8-K (133), 10-Q (57), 10QSB (36), DEF 14A (25), 3 (22), 10-K (18), 10KSB (13)1
    All 51 form types

    CORRESP (12), SC 13G (12), SC 13D/A (10), 144 (9), UPLOAD (9), D (8), DEFA14A (8), EFFECT (7), NT 10-K (7), NT 10-Q (6), S-8 (6), SCHEDULE 13D/A (6), 4/A (5), PRE 14A (5), S-1/A (5), 424B3 (4), 5 (4), 8-K/A (4), S-1 (4), S-3 (4), SB-2/A (4), SC 13D (4), 10-K/A (3), DRS (3), SCHEDULE 13G/A (3), 10QSB/A (2), 10SB12G (2), 3/A (2), 425 (2), 5/A (2), S-3/A (2), SC 13G/A (2), 10-Q/A (1), 10KSB/A (1), 10SB12G/A (1), 424B5 (1), 8-A12B (1), ARS (1), CERT (1), DEFR14A (1), S-4 (1), S-4/A (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Jul 9, 2026
    Latest 8-K (8-K) Sep 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareAIFFNasdaq

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks FIREFLY NEUROSCIENCE, INC. names in Item 1A of its 10-K filed Mar 31, 2026: 73 risks under these headings, as written.3

  • Risks Related to the Company’s Business, Operations and Industry
  • We are facing significant liquidity risks that raise substantial doubt about our ability to continue as a going concern.
  • We have engaged, and may continue to engage, in strategic acquisitions or transactions, which could have a material adverse effect on our business, results of operations, financial condition and cash flows.
  • We may not realize the anticipated benefits of past or future acquisitions and integration of these acquisitions may disrupt our business.
  • We are subject to operating risks, including excess or constrained capacity and operational inefficiencies, which could adversely affect our results of operations.
  • Our products and information technology systems are critical to our business. Issues with product development or enhancements, IT system integration, implementation, updates and upgrades could disrupt our operations and have a material impact on our business and operating results.
  • Our operations and financial performance depend on global and regional economic conditions. Inflation, fluctuations in currency exchange rates, changes in consumer confidence and demand, tariffs and trade policy changes, and weakness in general economic conditions and threats, or actual recessions, could materially affect our business, results of operations, and financial condition.
  • Our business could be impacted by political events, trade and other international disputes, war, and terrorism, including the military conflict between Russia and Ukraine.
  • We conduct certain of our operations in Israel. Conditions in Israel, including the attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them, may affect our operations.
  • The active military conflict involving Iran, Israel and the United States poses immediate and material risks to our operations, employees, financial condition and business.
  • Any hostilities involving Israel could adversely affect our operations and results of operations. Shelter-in-place and work-from-home measures, government-imposed restrictions on movement and travel and other precautions taken to address the ongoing conflict may temporarily disrupt our employees’ ability to effectively perform their daily tasks.
  • Our operations may be impacted by natural disaster and may adversely impact our business and operating results as well as those of our potential customers and suppliers.
The other 62 risks
  • Risks Related to our Software Platform
  • Our operations depend in part on third-party software platforms and artificial intelligence services, and disruptions to those services, including interruptions resulting from government actions or policy decisions, could adversely affect our business.
  • If we are not successful in enhancing awareness of our products, driving adoption across our current target markets and expanding the population of eligible patients, our sales, business, financial condition and results of operations will be negatively affected.
  • If we fail to successfully initiate our broad commercialization program, market and sell our products cost-effectively, our sales, business, financial condition and results of operations will be negatively affected.
  • We may be unable to compete successfully with competitive technologies, which could harm our sales, business, financial condition and results of operations.
  • Patient and product variability may produce misleading report results
  • Use of our 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 expect to increase the size of our organization in the future, and we may experience difficulties in managing the operational elements or timing of this growth. If we are unable to manage or appropriately time the anticipated growth of our business, our future revenue and operating results may be harmed.
  • We may not be able to achieve or maintain satisfactory pricing and margins for our products, which could harm our business and results of operations.
  • Future sales of our products may depend on healthcare providers’ or patients’ ability to obtain reimbursement from third-party payors, such as insurance carriers.
  • Our results of operations may be harmed if we are unable to accurately forecast clinician demand for our products or any future products.
  • Adoption of our products depends on positive clinical data as well as clinician acceptance of the data and our products, and negative clinical data or perceptions among these clinicians would harm our sales, business, financial condition, and results of operations.
  • Risks Related to the Integration of the Evoke and Firefly Businesses
  • We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.
  • Risks Related to Legal, Regulatory and Compliance Matters
  • 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 any future new products, and any failure to timely do so may adversely affect our ability to grow our business.
  • Certain modifications to our products may require new 510(k) clearance or other marketing authorizations.
  • Our acquisition of Evoke increases our exposure to 510(k) regulatory risks due to the expansion of our medical device portfolio.
  • Ongoing changes in healthcare regulation could negatively affect our revenues, business and financial condition.
  • 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 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.
  • Changes in internet regulations could adversely affect our business.
  • Disruptions at the FDA, other agencies or notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved, or commercialized in a timely manner, or at all, which could negatively impact our business.
  • The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies, particularly if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
  • We may be subject to certain federal, state, and foreign fraud and abuse laws, health information privacy and security laws, and transparency laws, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
  • Since our software platform will utilize cloud-based information systems and the exchange of 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.
  • Our subsidiary, Firefly Neuroscience Ltd., has received Israeli governmental grants to assist in 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.
  • It may be difficult to enforce a U.S. judgment against our subsidiary, Firefly Neuroscience Ltd., and our officers and directors in Israel or otherwise outside the United States, to assert U.S. securities laws claims in Israel or to serve process on our officers and directors.
  • Cybersecurity incidents, including data security breaches or computer viruses, could harm our business by disrupting our delivery of services, damaging our reputation, or exposing us to liability.
  • 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.
  • Our business could 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.
  • 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.
  • Our business will expose us to potential liability for the quality and safety of our products and services, how we advertise and market those products and services and how and to whom we sell them, and we may incur substantial expenses or be found liable for substantial damages or penalties if we are subject to claims or litigation.
  • The ESG regulatory landscape has shifted materially under the current U.S. administration, and we face risks from both the relaxation of certain federal requirements and the continued — and potentially intensifying — pressure from state, international, and market-driven ESG expectations.
  • We are subject to consumer protection laws that regulate our marketing practices and prohibit unfair 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.
  • New FDA Quality Management System Regulation (“QMSR”) requirements could increase our compliance costs and expose us to additional regulatory risk.
  • Risks related to Our Intellectual Property
  • Our success depends in part on our proprietary technology, and if we are unable to successfully enforce our intellectual property rights, our competitive position may be harmed.
  • Economic and trade policy, including tariffs and customs regulations, could have a material and adverse effect on our business.
  • If we infringe or violate the patents or proprietary rights of other parties or are subject to an intellectual property infringement or misappropriation claim, our ability to grow our business may be severely limited.
  • Our failure to secure trademark registrations could adversely affect our ability to market our products and operate our business.
  • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • 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 non-compliance with these requirements.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • 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.
  • General Risks Related to Us
  • Our limited access to sufficient funding may hinder our ability to conduct planned operations and realize potential profits.
  • We may not continue to meet the continued listing requirements of Nasdaq, which could result in a delisting of our Common Stock.
  • The market price of our Common Stock may be subject to significant fluctuations and volatility, and the stockholders of the company may be unable to resell their shares at a profit and may incur losses.
  • We currently take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our Common Stock being less attractive to investors.
  • Our Charter provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • We will issue additional equity securities in the future, which may result in dilution to existing investors.
  • We are subject to the SEC's "baby shelf" rules, which limit the amount we may raise pursuant to our shelf registration statement, and our ability to access capital markets may be constrained as a result.
  • Certain stockholders could attempt to influence changes, which could adversely affect our operations, financial condition and the value of our Common Stock.
  • The sale or availability for sale of a substantial number of shares of Common Stock could adversely affect the market price of such shares.
  • If securities analysts do not publish research or reports about our business, or if they publish negative evaluations, the price of our Common Stock could decline.
  • Our management will be required to devote substantial time to comply with public company regulations.
  • As a non-accelerated filer, we will not be required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our Common Stock.
  • As a recently listed public company, we may not be able to timely and effectively implement controls and procedures required by Section 404 that are applicable to us as public company.
  • We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on its financial condition, results of operations and stock price, which could cause you to lose some or all of your investment.
  • Anti-takeover provisions under Delaware corporate law may make it difficult for our stockholders to replace or remove our Board, and could deter or delay third parties from acquiring us, which may be beneficial to our stockholders.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • Our management team will have broad discretion over the use of the net proceeds from the sales of our Common Stock to Konik via the ATM, if any, and investors may not agree with how we use the proceeds and the proceeds may not be invested successfully.
  • 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.

Legal proceedings

From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. We are not currently aware of any such legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition, or operating results.

The opening of Item 3, Legal Proceedings.3

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