HSCS on Nasdaq
HeartSciences Inc.
In its 2026 annual report the company says: “We are a healthcare information technology company focused on advancing electrocardiography through the integration of artificial intelligence. Our first commercial product is MyoVista Insights™, a cloud-native, vendor- and device-agnostic ECG management platform designed to modernize ECG workflows and enable scalable deployment of AI-ECG capabilities across healthcare systems.”5 It is headquartered in Southlake, Texas.1 Its shares trade on Nasdaq under the symbol HSCS.1
$3.10 up 0.07 (2.48%)Price as of Oct 15, 2026 at 17:33 UTC
Last updated Oct 20, 2026.
Overview
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- TickerHSCS on Nasdaq1
- IndustryFinance Services1
- HeadquartersSouthlake, Texas1
- Incorporated inTX4
- Business address550 Reserve St, Suite 360, Southlake, Tx 760924
- Filer category, Emerging growth company4
- Legal formCorporation
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We are a healthcare information technology company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”). Our first commercial product is MyoVista Insights™, a cloud-native, vendor- and device-agnostic ECG management platform designed to modernize ECG workflows and enable scalable deployment of AI-ECG capabilities across healthcare systems.5 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 2026
Where the money goes
Where each dollar of revenue went, fiscal 2026
- Cost of revenue0¢$1.8K
- Research and development34¢$2.8M
- Selling, general and admin66¢$5.6M
Out of $4.3K in revenue.3 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.3
| Period ending | 2026-04-30 | 2025-04-30 |
|---|---|---|
| Revenue | $4.3K | $4.3K |
| Cost of sales | $1.8K | $1.9K |
| Gross margin | $2.6K | $2.5K |
| Research and development | $2.8M | $4.4M |
| Selling, general and administrative | $5.6M | $4.0M |
| Total operating expenses | $8.4M | $8.4M |
| Loss from operations | -$8.4M | -$8.4M |
| Interest expense | -$753.0K | -$500.5K |
| Other income | $24.0K | $87.8K |
| Total other expense | -$729.0K | -$412.7K |
| Net loss | -$9.1M | -$8.8M |
| Net loss per share, basic and diluted (in dollars per share) | -$3.48 | -$9.34 |
| Weighted average common shares outstanding, basic and diluted (in shares) | 2.6M shares | 938.3K shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 5 fiscal years (annual) or 6 quarters (quarterly), latest first.3
| Period ending | 2026-06-30 | 2026-04-30 | 2025-12-31 | 2025-06-30 | 2025-04-30 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $1.7M | $1.7M | $1.1M | $1.1M | |
| Accounts receivable | $0 | $4.3K | |||
| Inventory, net | $655.6K | $655.6K | $650.3K | $650.3K | |
| Prepaid expenses | $83.0K | $87.4K | |||
| Other current assets | $40.4K | $40.4K | |||
| Deferred offering costs | $147.1K | $100.0K | $290.9K | $300.0K | |
| Total current assets | $2.6M | $2.2M | |||
| Property and equipment, net | $39.3K | $39.3K | $63.5K | $63.5K | |
| Capitalized software | $715.2K | $700.0K | $0 | ||
| Intangible assets, net | $1.7M | $1.6M | |||
| Right-of-use assets, net | $268.1K | $268.1K | $371.6K | ||
| TOTAL ASSETS | $5.3M | $4.2M | |||
| Accounts payable | $318.3K | $318.7K | |||
| Accrued expenses | $432.5K | $506.3K | |||
| Accrued interest expense | $328.0K | $177.6K | |||
| Operating lease liabilities, current portion | $139.0K | $139.0K | $119.5K | ||
| Notes payable | $3.6M | $3.6M | $2.6M | $2.6M | |
| Other current liabilities | $21.2K | $29.9K | |||
| Total current liabilities | $4.9M | $3.7M | |||
| Operating lease liabilities, long-term portion | $175.5K | $175.5K | $314.5K | ||
| Total long-term liabilities | $175.5K | $314.5K | |||
| TOTAL LIABILITIES | $5.0M | $4.0M | |||
| Common stock | $3.2K | $1.1K | |||
| Additional paid-in capital | $85.5M | $76.3M | |||
| Accumulated deficit | -$85.3M | -$85.3M | -$76.1M | ||
| TOTAL STOCKHOLDERS' EQUITY | $226.1K | $226.1K | $205.2K | $205.2K | |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $5.3M | $4.2M | |||
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | |||
| Preferred stock, authorized (in shares) | 20.0M shares | ||||
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | $0.00 | $0.00 | |
| Common stock, authorized (in shares) | 500.0M shares | 500.0M shares | 500.0M shares | ||
| Common stock, issued (in shares) | 3.2M shares | 3.2M shares | 1.1M shares | 1.1M shares | |
| Common stock, outstanding (in shares) | 3.2M shares | 1.1M shares |
| Period ending | 2026-06-30 | 2026-04-30 | 2025-12-31 | 2025-06-30 | 2025-04-30 | 2024-04-30 |
|---|---|---|---|---|---|---|
| Cash and cash equivalents | $1.7M | $1.7M | $1.1M | $1.1M | ||
| Accounts receivable | $0 | $4.3K | ||||
| Inventory, net | $655.6K | $655.6K | $650.3K | $650.3K | ||
| Prepaid expenses | $83.0K | $87.4K | ||||
| Other current assets | $40.4K | $40.4K | ||||
| Deferred offering costs | $147.1K | $100.0K | $290.9K | $300.0K | ||
| Total current assets | $2.6M | $2.2M | ||||
| Property and equipment, net | $39.3K | $39.3K | $63.5K | $63.5K | ||
| Capitalized software | $715.2K | $700.0K | $0 | |||
| Intangible assets, net | $1.7M | $1.6M | ||||
| Right-of-use assets, net | $268.1K | $268.1K | $371.6K | |||
| TOTAL ASSETS | $5.3M | $4.2M | ||||
| Accounts payable | $318.3K | $318.7K | ||||
| Accrued expenses | $432.5K | $506.3K | ||||
| Accrued interest expense | $328.0K | $177.6K | ||||
| Operating lease liabilities, current portion | $139.0K | $139.0K | $119.5K | |||
| Notes payable | $3.6M | $3.6M | $2.6M | $2.6M | ||
| Other current liabilities | $21.2K | $29.9K | ||||
| Total current liabilities | $4.9M | $3.7M | ||||
| Operating lease liabilities, long-term portion | $175.5K | $175.5K | $314.5K | |||
| Total long-term liabilities | $175.5K | $314.5K | ||||
| TOTAL LIABILITIES | $5.0M | $4.0M | ||||
| Common stock | $3.2K | $1.1K | ||||
| Additional paid-in capital | $85.5M | $76.3M | ||||
| Accumulated deficit | -$85.3M | -$85.3M | -$76.1M | |||
| TOTAL STOCKHOLDERS' EQUITY | $226.1K | $226.1K | $205.2K | $205.2K | $7.3M | |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $5.3M | $4.2M | ||||
| Preferred stock, par value (in dollars per share) | $0.00 | $0.00 | ||||
| Preferred stock, authorized (in shares) | 20.0M shares | |||||
| Common stock, par value (in dollars per share) | $0.00 | $0.00 | $0.00 | $0.00 | $0.00 | |
| Common stock, authorized (in shares) | 500.0M shares | 500.0M shares | 500.0M shares | |||
| Common stock, issued (in shares) | 3.2M shares | 3.2M shares | 1.1M shares | 1.1M shares | ||
| Common stock, outstanding (in shares) | 3.2M shares | 1.1M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.3
| Period ending | 2026-04-30 | 2025-04-30 |
|---|---|---|
| Net loss | -$9.1M | -$8.8M |
| Depreciation | $27.8K | $37.6K |
| Amortization of debt discounts and deferred financing costs | $495.9K | $285.9K |
| Amortization - Right-of-use assets, operating lease | $103.6K | $90.4K |
| Impairment of deferred offering costs | $748.6K | $0 |
| Stock-based compensation | $1.3M | $249.9K |
| Warrants issued to non-employees | $108.3K | $170.6K |
| Accounts receivable | $4.3K | -$4.3K |
| Inventory | -$5.4K | -$21.1K |
| Prepaid and other current assets | $237.9K | $357.5K |
| Deferred offering costs | -$604.7K | $402.1K |
| Capitalized software | -$715.2K | $0 |
| Accounts payable | -$334 | -$129.5K |
| Accrued liabilities | $121.5K | $16.8K |
| Other current liabilities | $0 | -$1.2K |
| Lease liability, operating lease | -$119.5K | -$102.3K |
| Net cash used in operating activities | -$7.4M | -$7.4M |
| Purchase of property and equipment | -$3.6K | -$3.2K |
| Acquisition of intellectual property - intangibles | -$40.9K | -$27.0K |
| Net cash used in investing activities | -$44.5K | -$30.2K |
| Issuance of Common Stock, net of fees | $172.8K | $1.1M |
| Issuance of Series D Preferred Stock and warrants, net of issuance costs | $5.5M | $0 |
| Proceeds from shareholder note, net | $0 | $0 |
| Principal repayments of financed insurance premiums | -$242.2K | -$264.2K |
| Net cash provided by investing activities | $8.0M | $2.7M |
| Net change in cash and cash equivalents during the year | $558.7K | -$4.7M |
| Financed insurance premiums | $233.5K | $261.2K |
No quarter-by-quarter statement was filed.
Corporate structure
HeartSciences 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 HeartSciences Inc.
- Digital Currency Group, Inc. Filed SCHEDULE 13D on HeartSciences Inc., latest Aug 18, 2026
- Ephraim G. Fields Filed SCHEDULE 13G on HeartSciences Inc., latest Jun 24, 2026
- Matthews Holdings Southwest, Inc. Filed SC 13G on HeartSciences Inc., latest Dec 11, 2023
- School Of Medicine At Mount Sinai Icahn Filed SC 13G on HeartSciences Inc., latest Nov 27, 2023
- Andrew Simpson Filed SC 13D on HeartSciences Inc., latest Jun 14, 2023 (2 filings since Mar 10, 2023)
- HILZ MARK T Filed SC 13D on HeartSciences Inc., latest Jun 14, 2023 (2 filings since Mar 10, 2023)
- HeartSciences Inc. Southlake, Texas
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What HeartSciences 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $604.5K3 Apr 30, 2026 | $600.9K3 Apr 30, 2025 | +0.6% |
| Accumulated depreciation | $565.1K3 Apr 30, 2026 | $537.4K3 Apr 30, 2025 | +5.2% |
| Property and equipment, net | $39.3K3 Jun 30, 2026 | $63.5K3 Apr 30, 2025 | −38.1% |
| Operating-lease assets (leased space) | $268.1K3 Jun 30, 2026 | $371.6K8 Apr 30, 2025 | −27.9% |
Investments
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Finite-lived intangibles, net | $1.7M3 Jun 30, 2026 | $1.6M8 Apr 30, 2025 | +2.5% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $655.6K3 Jun 30, 2026 | $650.3K3 Apr 30, 2025 | +0.8% |
| Raw materials | $323.0K3 Apr 30, 2026 | $323.0K3 Apr 30, 2025 | 0% |
| Work in process | $21.7K3 Apr 30, 2026 | $21.7K3 Apr 30, 2025 | 0% |
| Finished goods | $22.6K3 Apr 30, 2026 | $44.1K3 Apr 30, 2025 | −48.8% |
Properties, in its own words
The Company leases a 4,634 square foot suite located at 550 Reserve Street, Suite 360, Southlake, Texas 76092, pursuant to an Office Lease, dated May 2, 2017, by and between the Company and GPI-MT, LP. The lease was a 64-month lease and was amended on September 27, 2022, extending the lease term for an additional 64 months, commencing on February 1, 2023 and expiring on May 31, 2028. We consider our current office space sufficient to meet our anticipated needs for the foreseeable future and believe it is suitable for the conduct of our business.
Item 2 of the 10-K filed Jul 23, 2026.5
Leadership
Who has led HeartSciences Inc., and when. Pick a name to see everywhere that person has worked.
Chief operating officer
- Chief operating officerMark T. Hilz Jul 30, 2025 to now12
Board members and other officers (6)
- OfficerMark T. Hilz Jul 6, 2022 to now13
- Board memberDavid R. Wells Jan 6, 2023 to now14
- Board memberBrian Szymczak Jul 6, 2022 to now15
- Board memberMark T. Hilz Jul 6, 2022 to now13
- Board memberPatrick Kanouff Jul 6, 2022 to Jul 6, 202216
- Board memberBruce Bent Jul 7, 2022 to now17
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- Heart Test Laboratories, Inc.Jul 30, 2009 to Oct 18, 20244
Timeline
- Oct 6, 20268-K Regulation FD disclosure19
- Oct 2, 20268-K Entered a material agreement; New debt or obligation20
- Sep 17, 20268-K Regulation FD disclosure; Other events21
- Sep 15, 20268-K Results of operations22
- Aug 20, 20268-K Regulation FD disclosure23
- Aug 19, 20268-K Regulation FD disclosure24
- Aug 19, 20268-K Financial statements and exhibits25
- Aug 18, 20268-K Entered a material agreement; Unregistered sale of shares26
- Aug 7, 20268-K Listing notice or transfer27
- Jul 29, 20268-K Results of operations28
- Jul 27, 20268-K Entered a material agreement29
- Jul 27, 20268-K Financial statements and exhibits30
Calendar
When it reported results
- Sep 15, 2026Reported quarterly or annual results22
- Jul 29, 2026Reported quarterly or annual results28
- Mar 16, 2026Reported quarterly or annual results31
- Dec 15, 2025Reported quarterly or annual results32
- Sep 11, 2025Reported quarterly or annual results33
- Jul 24, 2025Reported quarterly or annual results34
- Mar 13, 2025Reported quarterly or annual results35
- Dec 16, 2024Reported quarterly or annual results36
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
322 filings to the SEC since October 2021: 5 annual reports, 13 quarterly reports, 100 major events, 35 insider forms, 8 large holders, 6 private raises, 155 other. The latest 20:
- Oct 15, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Oct 9, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
- Oct 6, 2026DEFA14A CURRENT REPORT EDGAR
- Oct 6, 20268-K CURRENT REPORT EDGAR
- Oct 6, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Oct 6, 2026PRER14A PROXY SATEMENT EDGAR
- Oct 2, 2026DEFA14A CURRENT REPORT EDGAR
- Oct 2, 20268-K CURRENT REPORT EDGAR
- Sep 30, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Sep 25, 2026S-3 REGISTRATION STATEMENT EDGAR
- Sep 24, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Sep 21, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Sep 18, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Sep 18, 2026PRER14A PROXY STATEMENT EDGAR
- Sep 17, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Sep 17, 2026DEFA14A CURRENT REPORT EDGAR
- Sep 17, 20268-K CURRENT REPORT EDGAR
- Sep 16, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
- Sep 15, 2026DEFA14A CURRENT REPORT EDGAR
- Sep 15, 20268-K CURRENT REPORT EDGAR
The 322 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
1 open-market trades by officers, directors and large owners since October 2021: 0 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jul 29, 2025 | HILZ MARK TSee Remarks | Sale | 4,416 | $3.54 | $15.6K | Form 4 |
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.
- Digital Currency Group, Inc.SCHEDULE 13D, 1 filing Aug 18, 202637
- Ephraim G. FieldsSCHEDULE 13G, 1 filing Jun 24, 202638
- Matthews Holdings Southwest, Inc.SC 13G, 1 filing Dec 11, 202339
- School Of Medicine At Mount Sinai IcahnSC 13G, 1 filing Nov 27, 202340
- Andrew SimpsonSC 13D, 2 filings Mar 10, 2023 to Jun 14, 202341
- HILZ MARK TSC 13D, 2 filings Mar 10, 2023 to Jun 14, 202342
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.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Andrew Simpson | 57 | $345.8K | $527.2K43 |
| 2025 | Mark Hilz | 67 | $337.9K | $519.2K43 |
| 2025 | Danielle Watson | 43 | $203.7K | $256.9K43 |
| 2024 | Chief Operating Officer and Secretary | $300.0K43 | ||
| 2024 | PresidentChief Executive Officer and Chairman of the Board of Directors | $300.0K43 | ||
| 2024 | Chief Financial Officer and Treasurer | $179.3K43 |
Money raised
Private offerings the company reported to the SEC on Form D.
- Nov 16, 2023Raised $934,997 in a private offering of equity Form D: 1 investor so far Form D
- Nov 15, 2023Raised $1.1 million in a private offering of securities Form D: 2 investors so far Form D
- Sep 7, 2023Raised $1 million in a private offering of debt Form D: 1 investor so far Form D
- Oct 12, 2021Raised $640,000 in a private offering of debt Form D: 14 investors so far Form D
- Oct 12, 2021Raised $2 million in a private offering of debt Form D: $4.4 million offered in all 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.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| TFB Advisors LLC | 29,740 | $74.6K | 0.0% | No change |
| Geode Capital Management, LLC | 23,049 | $57.9K | 0.0% | −5,889 |
| Astoria Strategic Wealth, Inc. | 18,927 | $47.5K | 0.0% | No change |
| Vanguard Capital Management LLC | 17,968 | $45.1K | 0.0% | No change |
| Vanguard Fiduciary Trust Co | 17,239 | $43.3K | 0.0% | No change |
| Tradition Wealth Management, LLC | 16,819 | $42.2K | 0.0% | No change |
| Citadel Advisors LLC | 14,488 | $36.4K | 0.0% | New |
| Citigroup Inc | 5,859 | $14.7K | 0.0% | New |
| UBS Group AG | 5,812 | $14.6K | 0.0% | −664 |
| Tower Research Capital LLC (TRC) | 1,568 | $3.9K | 0.0% | −483 |
| BlackRock, Inc. | 750 | $1.9K | 0.0% | New |
| Federation des caisses Desjardins du Quebec | 700 | $1.8K | 0.0% | No change |
| Osaic Holdings, Inc. | 650 | $1.6K | 0.0% | +600 |
| Allied Private Wealth LLC | 120 | $327 | 0.0% | New |
| Caitong International Asset Management Co., Ltd | 8 | $20 | 0.0% | New |
| Financial Management Professionals, Inc. | 2 | $5 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How HeartSciences Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARHeartSciences Inc.1
- CIK0001468492
- Employer ID (EIN)26-13444665
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
- Incorporated inTexas5
- Fiscal year endsApril 301
- Industry code (SIC)6199 Finance Services1
- SEC reviewing officeOffice of Crypto Assets, Division of Corporation Finance1
- Business address550 Reserve St, Suite 360, Southlake, TX 760921
- Phone682-237-77811
- Shares outstanding4,800,172 as of Sep 11, 202611
- Public float$10.4M as of Oct 31, 20255
- AuditorHASKELL & WHITE LLP, Irvine, California PCAOB ID 200; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceJul 30, 20091
- Filings330 in all: 8-K (93), DEFA14A (62), 4 (28), 424B3 (18), 10-Q (13), D (13), CORRESP (11), UPLOAD (9)1
All 41 form types
3 (7), 8-K/A (7), S-1/A (6), 10-K (5), 424B5 (5), EFFECT (5), S-1 (5), 253G2 (4), SC 13G (4), DEF 14A (3), S-8 (3), DRS (2), PRE 14A (2), PRER14A (2), QUALIF (2), RW (2), S-3 (2), SC 13D (2), 1-A (1), 1-A POS (1), 1-A/A (1), 144 (1), 424B4 (1), 8-A12B (1), CERT (1), D/A (1), DRS/A (1), DRSLTR (1), FWP (1), POS EX (1), PREM14A (1), SCHEDULE 13D (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Jul 23, 2026
Quarterly report (10-Q) Sep 14, 2026
Proxy statement (DEF 14A) Mar 17, 2026
Latest 8-K (8-K) Oct 6, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock | HSCS | Nasdaq |
| Warrants | HSCSW | Nasdaq |
From the cover page of the 10-K filed Jul 23, 2026 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks HeartSciences Inc. names in Item 1A of its 10-K filed Jul 23, 2026: 72 risks under these headings, as written.5
- Risks Related to Our Financial Condition and Capital Requirements
- There is substantial doubt about our ability to continue as a going concern, which could prevent us from obtaining new financing either on reasonable terms or at all.
- We have a limited operating history and we have incurred significant operating losses since our inception, and anticipate that we will incur continued losses for the foreseeable future.
- If we are unable to maintain compliance with all applicable continued listing requirements and standards of Nasdaq, our Common Stock could be delisted from Nasdaq.
- We may in the future be required to effect additional reverse stock splits or other corporate actions to maintain compliance with Nasdaq continued listing requirements.
- Our future operating results are dependent on receiving regulatory approval for the MyoVista wavECG and associated AI-ECG algorithms and/or regulatory clearances for the MyoVista wavECG and associated AI-ECG algorithms or the MyoVista Insights™ from state regulators, which we have not received as of the date of filing of this Annual Report on Form 10-K.
- We will need to raise substantial additional funding, which may not be available on acceptable terms, or at all. Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail, delay or discontinue our development efforts and other operations.
- All of our assets are subject to security interests.
- We have identified weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in the future.
- Risks Related to Our Business and Industry
- Our future success depends on our ability to develop, receive regulatory clearance or approval for, and introduce the MyoVista wavECG device to the market in a timely manner. If we do not obtain and maintain the regulatory registrations and clearances for our products, we will be unable to market and sell our products in the United States, Europe or other regions.
- Our success will be dependent upon physician acceptance.
The other 62 risks
- If third-party payors do not provide adequate coverage and reimbursement for the use of the MyoVista wavECG, MyoVista Insights™ and associated AI-ECG algorithms our revenue will be negatively impacted.
- We will be dependent upon third-party manufacturers and suppliers, making us vulnerable to supply shortages and problems, increased costs and quality or compliance issues, any of which could harm our business.
- Interruptions in computing and data management cloud systems could impair the delivery of our cardiac cloud-based diagnostic services.
- Our proprietary data analytics engine may not operate properly, which could damage our reputation, give rise to claims against us or divert application of our resources from other purposes, any of which could harm our business and operating results.
- Our AI-ECG algorithms may exhibit performance limitations, including model drift or bias, that could harm clinical adoption and expose us to liability.
- Medical device development is costly and involves continual technological change in order to remain competitive which may render our products obsolete.
- Our marketplace strategy depends on third-party AI-ECG algorithm developers, and our business could be harmed if we are unable to enter into or maintain commercial arrangements with such developers on acceptable terms.
- We face intense competition in the market and, as a result, we may be unable to effectively compete in our industry.
- If we are not able to attract and retain highly skilled managerial, scientific, technical and marketing personnel, we may not be able to implement our business model successfully.
- We may need to expand our organization and we may experience difficulties in recruiting additional employees and consultants, which could disrupt our operations.
- Our management team has limited experience managing a public company.
- We manage our business through a small number of employees and key consultants.
- We expect to conduct business outside of the U.S. and doing so exposes us to additional business, regulatory, political, operational, financial and economic risks.
- We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We could face serious consequences for any violations of such laws and regulations.
- We could become subject to product liability, warranty or similar claims and product recalls that could be expensive, divert management’s attention and harm our business reputation and financial results.
- Our business and operations would suffer in the event of computer system failures, cyber-attacks or a deficiency in our cybersecurity.
- Our business may be impacted by changes in general economic conditions.
- Our business and operations, and the operations of our suppliers and customers, have been in the past, and may in the future be adversely affected by epidemics, pandemics or other public health crises.
- Risks Related to Product Development and Regulatory Approval
- Our products and operations are subject to extensive government regulation and oversight both in the U.S. and abroad, and our failure to comply with applicable requirements could harm our business.
- If and when our products are ready for sales launch into the U.S., modifications to our marketed products may require new 510(k) clearances or may require us to cease marketing or recall the modified products until clearances or approvals are obtained.
- Evolving FDA regulatory frameworks for AI- and machine learning-enabled medical devices, including Predetermined Change Control Plans, may impose additional requirements on our products and limit our ability to update or improve our algorithms.
- Clinical studies may be necessary to support future product submissions to the FDA. The clinical trial process is lengthy and expensive with uncertain outcomes, and often requires the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Delays or failures in our clinical studies will prevent us from launching sales of modified or new products into the U.S. and will adversely affect our business, operating results and prospects.
- Medical device development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.
- If the third parties on which we rely to conduct our clinical studies and to assist us with pre-clinical development do not perform as required or expected, we may be delayed or unable to obtain regulatory clearance or approval for sales launch of our products in the U.S.
- We may encounter substantial delays in our clinical studies, or we may fail to demonstrate specificity and sensitivity to the satisfaction of applicable regulatory authorities.
- The results of future clinical studies may not support additional or new claims for future products or may result in the discovery of adverse side effects.
- Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
- The MyoVista wavECG device must be manufactured in accordance with federal, state and foreign regulations, and we could be forced to recall our devices or terminate production if we fail to comply with these regulations.
- The misuse or off-label use of our products may harm our reputation in the marketplace, could potentially cause harm to the patient and lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
- Our devices may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our device, or a recall of our devices either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
- The MyoVista wavECG device may in the future be subject to product recalls that could harm our reputation, business and financial results.
- We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- Legislative or regulatory reforms in the United States or the European Union may make it more difficult and costly for us to obtain regulatory clearances or approvals for our devices or to manufacture, market or distribute our devices after clearance or approval is obtained.
- The EU Artificial Intelligence Act imposes additional regulatory obligations on AI-based medical devices, which could increase our compliance costs and delay or limit our ability to commercialize AI-ECG algorithms in the EU.
- Healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
- Disruptions at the FDA and other government agencies 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 launched for sale into the U.S. in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Changes in laws or regulations relating to data protection, or any actual or perceived failure by us to comply with such laws and regulations or our privacy policies, could materially and adversely affect our business or could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain effective patent rights for our products, we may not be able to compete effectively in our markets. If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.
- Intellectual property rights of third-parties could adversely affect our ability to market our products, and we might be required to litigate or obtain licenses from third parties in order to develop or market our products. Such litigation or licenses could be costly or not available on commercially reasonable terms.
- We may be subject to claims challenging the inventorship of our intellectual property.
- We may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming, and unsuccessful.
- Third-party claims of intellectual property infringement may prevent or delay our development and marketing efforts.
- Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of any issued patents.
- We may not be able to protect our intellectual property rights throughout the world.
- Risks Related to Our License Agreements with Mount Sinai
- We depend in part on the Mount Sinai Licenses for certain of our planned AI-ECG algorithm offerings.
- Our future financial performance will depend in part on the successful integration, improvement and software updates from the Mount Sinai algorithms.
- Our future success depends on our ability to develop, receive regulatory clearance or approval for, and introduce the algorithms underlying the Mount Sinai Licenses to the market in a timely manner. If we do not obtain and maintain the regulatory registrations and clearances for the algorithms, we will be unable to market and sell our products utilizing the Licenses in the United States, Europe or other regions.
- Risks Related to Our Proposed Merger with Fortitude
- Our proposed merger with Fortitude (as defined below) is subject to certain conditions, as well as other uncertainties, and there can be no assurances as to whether or when it may be completed. Failure to complete the proposed transactions contemplated by the Merger Agreement (as defined below) would likely materially adversely affect our business, financial condition, results of operations and stock price.
- The risks above do not necessarily comprise of all those associated with the proposed Merger and the other Transactions.
- Risks Related to the Ownership of our Securities
- The market price of our Common Stock may be highly volatile, and you could lose all or part of your investment.
- Future sales and issuances of our Common Stock or rights to purchase our Common Stock, including pursuant to our 2023 Equity Incentive Plan and other equity securities could result in dilution of the percentage ownership of our stockholders and could cause our stock price to fall.
- If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they publish negative reports regarding our business or our securities, our share price and trading volume could decline.
- Our Board of Directors is authorized to issue and designate shares of our preferred stock in additional series without shareholder approval.
- We have incurred and will continue to incur significant costs as a result of the listing of our securities for trading on Nasdaq. As a public company in the U.S., our management is required to devote substantial time to new compliance initiatives as well as compliance with ongoing U.S. requirements.
- We may be subject to securities litigation, which is expensive and could divert management attention.
- We have never paid cash dividends on our Common Stock, and we do not anticipate paying any cash dividends in the foreseeable future.
- We are an “emerging growth company” and we cannot be certain if the reduced disclosure requirements applicable to “emerging growth companies” will make our Common Stock or IPO Warrants less attractive to investors.
- Anti-takeover provisions could make a third party acquisition of us difficult.
- Provisions of the IPO Warrants, the Remaining Bridge Warrants and our Series C Preferred Stock could discourage an acquisition of us by a third party.
- Financial Industry Regulatory Authority, Inc. (“FINRA”) sales practice requirements may limit a stockholder’s ability to buy and sell our shares Common Stock.
- If our shares become subject to the penny stock rules, it would become more difficult to trade our shares.
- The risks above do not necessarily comprise of all those associated with an investment in our Company. This Annual Report on Form 10-K contains forward-looking statements that involve unknown risks, uncertainties and other factors that may cause our actual results, financial condition, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that might cause such a difference include, but are not limited to, those set out above.
Legal proceedings
From time to time, we may be subject to legal proceedings and claims arising in the ordinary course of business. Based on our current knowledge, other than ordinary routine litigation incidental to our business, there are no material pending legal proceedings to which we nor any of our subsidiaries are a party or of which any of our property is the subject. We currently believe that the amount or range of reasonably possible losses in any pending legal proceeding will not, either individually or in the aggregate, have a material adverse effect on our business, results of operations, or financial condition.
The results of any litigation cannot be predicted with certainty, and an unfavorable resolution in any legal proceedings could materially affect our future business, results of operations, or financial condition. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
The opening of Item 3, Legal Proceedings.5
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