Overview
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- TickerPFSA on Nasdaq1
- IndustrySurgical & Medical Instruments & Apparatus1
- HeadquartersNew York, New York1
- Incorporated inDE2
- Business address207 West 25Th St, 9Th Floor, New York, Ny 100012
- Filer category, Emerging growth company2
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“decoupling the sensor and the reading elements,” we believe that our approach has a few major advantages:4 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 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Research and development95¢$1.6M
- Income tax5¢$80.5K
Out of $100.0K in revenue.56 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Government grant revenue | $100.0K | |
| Research and development | $2.8M | $1.6M |
| General and administrative | $24.9M | $3.0M |
| Total operating expenses | $27.7M | $4.6M |
| Loss from operations | -$27.7M | -$4.5M |
| Loss on change in the fair value of convertible notes | -$3.4M | -$311.0K |
| Gain on the change in fair value of warrant liabilities | $895.0K | |
| Loss on the change in fair value of digital assets | -$555.0K | |
| Interest expense (including related parties amounts of $1,330 and $2,400 for the years ended December 31, 2025 and 2024, respectively) | -$2.5M | -$4.4M |
| Financing costs | -$2.6M | |
| Other income | $16.0K | $5.0K |
| Total other expense, net | -$8.1M | -$4.7M |
| Net loss | -$35.8M | -$9.2M |
| Net loss per share, basic (in Dollars per share) | -$107.01 | -$357.14 |
| Net loss per share, diluted (in Dollars per share) | -$107.01 | -$357.14 |
| Weighted-average common shares outstanding, basic (in Shares) | 334.8K shares | 25.8K shares |
| Weighted-average common shares outstanding, diluted (in Shares) | 334.8K shares | 25.8K shares |
| Interest expense, related parties | $1.3M | $2.4M |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 5 fiscal years (annual) or 5 quarters (quarterly), latest first.5
| Period ending | 2025-12-31 | 2025-10-31 | 2025-08-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|---|
| Cash | $1.8M | $191.0K | |||
| Prepaid expenses and other current assets | $541.0K | $69.0K | |||
| Digital assets | $1.4M | ||||
| Total current assets | $3.8M | $260.0K | |||
| Deferred offering costs | $2.8M | $1.5M | |||
| Property and equipment, net | $8.0K | ||||
| Other non-current assets | $3.0K | $56.0K | |||
| Total assets | $3.8M | $3.1M | |||
| Accounts payable | $7.3M | $5.0M | |||
| Excise tax payable | $2.0M | ||||
| Accrued expenses and other current liabilities | $6.0M | $4.0M | |||
| Convertible notes payable (including notes payable to related parties of $4,160 and $25,056 as of December 31, 2025 and 2024, respectively) | $4.2M | $45.9M | |||
| Promissory notes and other (including notes payable to related parties of $400 and $850 as of December 31, 2025 and 2024, respectively) | $1.3M | $910.0K | |||
| PPP loan | $1.4M | $1.4M | |||
| Total current liabilities | $22.3M | $57.1M | |||
| Warrant liabilities at fair value | $298.0K | ||||
| Loans payable at fair value | $7.9M | ||||
| Total liabilities | $30.4M | $57.1M | |||
| Total convertible preferred stock | $65.1M | ||||
| Additional paid-in capital | $134.1M | $5.8M | |||
| Accumulated deficit | -$160.8M | -$125.0M | |||
| Total stockholders deficit | -$26.7M | -$119.2M | -$110.0M | ||
| Total liabilities and stockholders deficit | $3.8M | $3.1M | |||
| Undesignated preferred stock, par value (in Dollars per share) | $0.00 | ||||
| Undesignated preferred stock, shares authorized (in Shares) | 1.0M shares | ||||
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | $1.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 600.0M shares | 600.0M shares | 600.0M shares | ||
| Common stock, shares issued (in Shares) | 1.2M shares | 25.8K shares | |||
| Common stock, shares outstanding (in Shares) | 1.2M shares | 25.8K shares |
| Period ending | 2025-12-31 | 2025-10-31 | 2025-08-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|---|
| Cash | $1.8M | $191.0K | |||
| Prepaid expenses and other current assets | $541.0K | $69.0K | |||
| Digital assets | $1.4M | ||||
| Total current assets | $3.8M | $260.0K | |||
| Deferred offering costs | $2.8M | $1.5M | |||
| Property and equipment, net | $8.0K | ||||
| Other non-current assets | $3.0K | $56.0K | |||
| Total assets | $3.8M | $3.1M | |||
| Accounts payable | $7.3M | $5.0M | |||
| Excise tax payable | $2.0M | ||||
| Accrued expenses and other current liabilities | $6.0M | $4.0M | |||
| Convertible notes payable (including notes payable to related parties of $4,160 and $25,056 as of December 31, 2025 and 2024, respectively) | $4.2M | $45.9M | |||
| Promissory notes and other (including notes payable to related parties of $400 and $850 as of December 31, 2025 and 2024, respectively) | $1.3M | $910.0K | |||
| PPP loan | $1.4M | $1.4M | |||
| Total current liabilities | $22.3M | $57.1M | |||
| Warrant liabilities at fair value | $298.0K | ||||
| Loans payable at fair value | $7.9M | ||||
| Total liabilities | $30.4M | $57.1M | |||
| Total convertible preferred stock | $65.1M | ||||
| Additional paid-in capital | $134.1M | $5.8M | |||
| Accumulated deficit | -$160.8M | -$125.0M | |||
| Total stockholders deficit | -$26.7M | -$119.2M | -$110.0M | ||
| Total liabilities and stockholders deficit | $3.8M | $3.1M | |||
| Undesignated preferred stock, par value (in Dollars per share) | $0.00 | ||||
| Undesignated preferred stock, shares authorized (in Shares) | 1.0M shares | ||||
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | $1.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 600.0M shares | 600.0M shares | 600.0M shares | ||
| Common stock, shares issued (in Shares) | 1.2M shares | 25.8K shares | |||
| Common stock, shares outstanding (in Shares) | 1.2M shares | 25.8K 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.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$35.8M | -$9.2M |
| Noncash interest expense | $2.5M | $4.4M |
| Noncash loss on change in fair value of convertible notes | $3.1M | $311.0K |
| Noncash issuance of inducement shares and in connection with the merger | $7.3M | |
| Noncash issuance of warrants to financial advisor | $330.0K | |
| Noncash issuance of warrants associated for ELOC Warrants | $982.0K | |
| Loss on disposition of property and equipment, net | $2.0K | |
| Stock-based compensation expenses | $891.0K | $21.0K |
| Gain on change in fair value of warrant liabilities | -$895.0K | |
| Loss on change in fair value of digital assets | $555.0K | |
| Noncash merger transaction costs | $500.0K | |
| Other receivables | $45.0K | |
| Prepaid expenses and other current assets | $211.0K | $77.0K |
| Other non-current assets | $53.0K | -$25.0K |
| Accounts payable | $3.6M | $645.0K |
| Accrued expenses and other current liabilities | $522.0K | $1.7M |
| Net cash used in operating activities | -$16.2M | -$2.1M |
| Purchase of digital assets | -$2.0M | |
| Purchase of property, plant and equipment | -$8.0K | |
| Net cash used in investing activities | -$2.0M | |
| Proceeds from issuance of notes | $1.4M | $3.2M |
| Proceeds from ELOC | $10.3M | |
| Proceeds from issuance of loans payable | $11.0M | |
| Proceeds from issuance of convertible loan | $16.0K | |
| Net cash received from the reverse recapitalization | $2.0K | |
| Repayment of convertible notes, senior notes, promissory notes and other | -$2.9M | -$150.0K |
| Payment of deferred offering costs | -$961.0K | |
| Net cash provided by financing activities | $19.8M | $2.1M |
| Net increase in cash | $1.6M | $49.0K |
| Assumption of net liabilities of Northview | $8.4M | |
| Increase in unpaid deferred offering costs | $269.0K | |
| Conversion of preferred stock into common stock | $65.1M | |
| Conversion of debt to equity | $51.4M | |
| Financing of D&O insurance premium | $657.0K | |
| Cash paid for interest | $296.0K | |
| Cash paid for taxes | $1.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Profusa, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Profusa, Inc.
- NorthView Sponsor I, LLC Filed SCHEDULE 13D on Profusa, Inc., latest Aug 19, 2026 (2 filings since Jun 2, 2022)
- Ascent Partners Fund LLC Filed SCHEDULE 13G/A on Profusa, Inc., latest Aug 4, 2026 (5 filings since Jul 24, 2025)
- Harraden Circle Investments, LLC Filed SCHEDULE 13G/A on Profusa, Inc., latest May 15, 2025 (2 filings since Mar 27, 2024)
- Shaolin Capital Management LLC Filed SC 13G/A on Profusa, Inc., latest Feb 22, 2024 (2 filings since Feb 14, 2023)
- FIR TREE CAPITAL MANAGEMENT LP Filed SC 13G/A on Profusa, Inc., latest Feb 14, 2024 (2 filings since Feb 14, 2023)
- Lighthouse Investment Partners, LLC Filed SC 13G/A on Profusa, Inc., latest Apr 10, 2023 (3 filings since Jan 10, 2022)
- Saba Capital Management, L.P. Filed SC 13G/A on Profusa, Inc., latest Feb 14, 2023 (2 filings since Dec 30, 2021)
- Lawrence Feis Filed SC 13G/A on Profusa, Inc., latest Feb 14, 2022 (2 filings since Jan 3, 2022)
- Profusa, Inc. New York, New York
- New Profusa, Inc. Subsidiary · California, United States
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Profusa, 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, net | $8.0K5 Dec 31, 2025 |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $1.8M5 Dec 31, 2025 | $191.0K5 Dec 31, 2024 | +830.9% |
| Deposits held (banks) | $34.4K6 Dec 23, 2024 |
Properties, in its own words
Our material facilities consist of leased office and laboratory space at 626 Bancroft Way, Suite A, Berkeley, CA. Our lease term over this property expires in 2027. Concurrently, we have entered into six months sublease agreements as a sublessor for a portion of the space that we lease with our landlord.
We believe that these facilities are suitable and adequate for our current needs.
Item 2 of the 10-K filed Apr 15, 2026.4
Leadership
Who has led Profusa, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerBen Chung-Bin Hwang Jul 21, 2025 to now11
- Chief executive officerJack E. Stover Dec 23, 2021 to Jul 21, 202512
- Chief financial officerFred S. Knechtel Dec 20, 2021 to now13
Board members and other officers (6)
- Board memberBen Chung-Bin Hwang Jul 21, 2025 to now11
- Board memberRajesh Asarpota Jul 22, 2025 to now14
- Board memberFred S. Knechtel Dec 20, 2021 to Dec 20, 202113
- Board memberLauren Chung Dec 20, 2021 to now15
- Board memberPeter O'Rourke Dec 20, 2021 to now16
- Board memberJack E. Stover Dec 23, 2021 to now12
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- New Profusa, Inc. California3
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
- NorthView Acquisition CorpJun 17, 2021 to Jul 15, 20252
Timeline
- Oct 15, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares17
- Oct 9, 20268-K Change of auditor18
- Oct 5, 20268-K Entered a material agreement; New debt or obligation19
- Sep 21, 20268-K Shareholder vote20
- Sep 16, 20268-K Entered a material agreement; New debt or obligation21
- Sep 15, 20268-K Other events22
- Sep 1, 20268-K Entered a material agreement; New debt or obligation23
- Aug 31, 20268-K Listing notice or transfer24
- Aug 21, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares25
- Aug 20, 20268-K Results of operations26
- Aug 14, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events27
- Jul 31, 20268-K Entered a material agreement; Unregistered sale of shares; Bylaws or fiscal year changed28
- Jul 21, 2025New chief executive Ben Chung-Bin Hwang becomes CEO11
- Dec 23, 2021New chief executive Jack E. Stover becomes CEO12
Calendar
Coming up
- Nov 18, 2026Reports results for the quarter ending Sep/202629
When it reported results
- Aug 20, 2026Reported quarterly or annual results26
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
317 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 76 major events, 32 insider forms, 20 large holders, 170 other. The latest 20:
- Oct 15, 20268-K CURRENT REPORT EDGAR
- Oct 9, 20268-K CURRENT REPORT EDGAR
- Oct 5, 20268-K CURRENT REPORT EDGAR
- Sep 21, 20268-K CURRENT REPORT EDGAR
- Sep 16, 20268-K CURRENT REPORT EDGAR
- Sep 15, 20268-K CURRENT REPORT EDGAR
- Sep 4, 20264 EDGAR
- Sep 4, 20264 EDGAR
- Sep 1, 20268-K CURRENT REPORT EDGAR
- Aug 31, 20268-K CURRENT REPORT EDGAR
- Aug 28, 2026DEF 14A PROXY STATEMENT EDGAR
- Aug 21, 20268-K CURRENT REPORT EDGAR
- Aug 20, 20268-K CURRENT REPORT EDGAR
- Aug 19, 20264 PRIMARY DOCUMENT EDGAR
- Aug 19, 20264 EDGAR
- Aug 19, 2026SCHEDULE 13D EDGAR
- Aug 19, 20264 EDGAR
- Aug 19, 202610-Q QUARTERLY REPORT EDGAR
- Aug 18, 20264 PRIMARY DOCUMENT EDGAR
- Aug 18, 2026PRE 14A PROXY STATEMENT EDGAR
The 317 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
14 open-market trades by officers, directors and large owners since October 2021: 8 buys and 6 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 17, 2026 | HRT FINANCIAL LP10% owner | Sale | 18,395 | $5.94 | $109.3K | Form 4 |
| Aug 14, 2026 | HRT FINANCIAL LP10% owner | Sale | 3,163 | $0.90 | $2.8K | Form 4 |
| Aug 13, 2026 | HRT FINANCIAL LP10% owner | Sale | 42,411 | $0.89 | $37.7K | Form 4 |
| Aug 12, 2026 | HRT FINANCIAL LP10% owner | Buy | 5,585 | $0.96 | $5.4K | Form 4 |
| Aug 11, 2026 | HRT FINANCIAL LP10% owner | Sale | 2,280 | $0.97 | $2.2K | Form 4 |
| Aug 10, 2026 | HRT FINANCIAL LP10% owner | Buy | 4,016 | $0.94 | $3.8K | Form 4 |
| Aug 7, 2026 | HRT FINANCIAL LP10% owner | Sale | 924 | $0.95 | $878 | Form 4 |
| Aug 6, 2026 | HRT FINANCIAL LP10% owner | Buy | 926 | $0.94 | $870 | Form 4 |
| Aug 5, 2026 | HRT FINANCIAL LP10% owner | Sale | 383 | $0.94 | $360 | Form 4 |
| Aug 4, 2026 | HRT FINANCIAL LP10% owner | Buy | 1,368 | $0.95 | $1.3K | Form 4 |
| Aug 3, 2026 | HRT FINANCIAL LP10% owner | Buy | 14,556 | $0.96 | $14.0K | Form 4 |
| Jul 31, 2026 | HRT FINANCIAL LP10% owner | Buy | 8,811 | $1.05 | $9.3K | Form 4 |
| Jul 30, 2026 | HRT FINANCIAL LP10% owner | Buy | 1,063 | $1.01 | $1.1K | Form 4 |
| Jul 29, 2026 | HRT FINANCIAL LP10% owner | Buy | 1,310 | $1.01 | $1.3K | 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.
- NorthView Sponsor I, LLCSCHEDULE 13D, 2 filings Jun 2, 2022 to Aug 19, 202630
- Ascent Partners Fund LLCSCHEDULE 13G/A, 5 filings Jul 24, 2025 to Aug 4, 202631
- Harraden Circle Investments, LLCSCHEDULE 13G/A, 2 filings Mar 27, 2024 to May 15, 202532
- Shaolin Capital Management LLCSC 13G/A, 2 filings Feb 14, 2023 to Feb 22, 202433
- FIR TREE CAPITAL MANAGEMENT LPSC 13G/A, 2 filings Feb 14, 2023 to Feb 14, 202434
- Lighthouse Investment Partners, LLCSC 13G/A, 3 filings Jan 10, 2022 to Apr 10, 202335
- Saba Capital Management, L.P.SC 13G/A, 2 filings Dec 30, 2021 to Feb 14, 202336
- Lawrence FeisSC 13G/A, 2 filings Jan 3, 2022 to Feb 14, 202237
SEC filer profile
How Profusa, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARProfusa, Inc.1
- CIK0001859807
- Employer ID (EIN)86-34372714
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
- SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
- Business address207 West 25Th St, 9Th Floor, New York, NY 100011
- Phone212-494-90221
- Shares outstanding605,647 as of Aug 18, 20269
- Public float$1.3M as of Jun 30, 20254
- AuditorMarcum LLP, San Francisco, CA PCAOB ID 688; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceJun 17, 20211
- Filings322 in all: 8-K (73), CORRESP (33), UPLOAD (25), 4 (24), 424B3 (17), 10-Q (14), S-4/A (14), 425 (12)1
All 38 form types
DEF 14A (10), PRE 14A (10), S-1/A (9), 3 (8), EFFECT (8), NT 10-Q (8), S-1 (7), SC 13G (6), SC 13G/A (6), 10-K (5), SCHEDULE 13G/A (5), 8-A12B (3), 8-K/A (3), DEFA14A (3), 25-NSE (2), CERT (2), SEC STAFF LETTER (2), 424B4 (1), ARS (1), DEF 14C (1), DRS (1), NT 10-K (1), POS AM (1), PRE 14C (1), PRER14A (1), S-1MEF (1), S-4 (1), SC 13D (1), SCHEDULE 13D (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Apr 15, 2026
Quarterly report (10-Q) Aug 19, 2026
Proxy statement (DEF 14A) Aug 28, 2026
Latest 8-K (8-K) Oct 15, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value | PFSA | Nasdaq |
From the cover page of the 10-K filed Apr 15, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Profusa, Inc. names in Item 1A of its 10-K filed Apr 15, 2026: 76 risks under these headings, as written.4
- Profusa does not intend to pay cash dividends for the foreseeable future.
- We have been notified by Nasdaq of our failure to comply with certain Nasdaq Global Market continued listing requirements and if we are unable to regain compliance with all applicable continued listing requirements and standards of the Nasdaq Global Market, our Common Stock could be delisted from the Nasdaq Global Market.
- There can be no assurance that our increased stock price following the Reverse Stock Split will remain at a price that will be sufficient in order to meet any continued requirements and policies of Nasdaq or that our Common Stock will remain listed on Nasdaq.
- Risks Related to Our Business and Operations
- We have a history of net losses, and we may not achieve or maintain profitability in the future.
- We have substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain further financing.
- We have a limited operating history on which to assess the prospects for our business and we have incurred losses since inception. We anticipate that we will continue to incur significant losses for at least the next several years as we continue to commercialize our existing products and services and seek to develop and commercialize new products and services.
- We have incurred significant losses in the past and will likely incur losses in the future.
- We may need to raise additional funding to expand the commercialization of our products and services and to expand our research and development efforts. This additional financing may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product commercialization or development efforts or other operations.
- The clinical trial process is lengthy and expensive with uncertain outcomes. Results of earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such products.
- Our products may not achieve or maintain market acceptance.
- We operate in a highly competitive market and face competition from large, well-established companies with significant resources, and, as a result, we may not be able to compete effectively.
The other 65 risks
- The research and development efforts we undertake independently, and in some instances in connection with our collaborations with third parties, may not result in the development of commercially viable products, the generation of significant future revenues or adequate profitability.
- Medical device development is costly and involves continual technological change, which may render our current or future products obsolete.
- If we are unable to successfully develop and effectively manage the introduction of new products, our business may be adversely affected.
- If we are unable to establish and maintain adequate sales and marketing capabilities or enter into and maintain arrangements with third parties to sell and market our products, our business may be harmed.
- We have limited experience in marketing and selling our products and related services, and if we are unable to successfully commercialize our products and related services, our business and operating results will be adversely affected.
- We are subject to a variety of risks due to our international operations that could adversely affect our business, our operations or profitability and operating results.
- There are a variety of oxygen monitoring and CGM products and technologies, and consumer confusion about product features and technology could lead consumers to purchase competitive products instead of our products, or to conflate any adverse events or safety issues associated with oxygen monitoring and CGM products with our products, which could adversely affect our business, financial condition and results of operations.
- We expect the commercialization of the Lumee Oxygen Platform to generate nearly all our commercial revenue until we obtain regulatory approval for additional products.
- Our business, financial condition and results of operations could be adversely affected by disruptions in the global economy caused by the ongoing war in Ukraine and the Middle East conflict.
- We may face risks associated with acquisitions of companies, products and technologies and our business could be harmed if we are unable to address these risks.
- Our success will depend on our ability to attract and retain our personnel and manage our human capital, while controlling labor costs.
- We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations.
- Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability.
- If our manufacturing capabilities are insufficient to produce an adequate supply of product at appropriate quality levels, our growth could be limited and our business could be harmed.
- We depend upon third-party suppliers and outsource to other parties, making us vulnerable to supply disruptions, suboptimal quality, noncompliance and/or price fluctuations, which could harm our business.
- We will need to expand our organization, and we may experience difficulties in recruiting needed additional employees and consultants, which could disrupt our operations.
- The failure to comply with U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws in non-U.S. jurisdictions could materially adversely affect our business and result in civil and/or criminal sanctions.
- Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
- We may experience pricing pressures from contract suppliers or manufacturers on which we rely.
- Manufacturing difficulties and/or any disruption at our facilities may adversely affect our manufacturing operations and related product sales, and increase our expenses.
- Customer or third-party complaints or negative reviews or publicity about our company or our products could harm our reputation and brand.
- The size and expected growth of our addressable market has not been established with precision, and may be smaller than we estimate.
- We or the third parties upon whom we depend may be adversely affected by disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster. Any interruption in the operations of our or our suppliers’ manufacturing or other facilities may have a material adverse effect our business, financial condition and results of operations.
- Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
- If our financial performance fails to meet the expectations of investors and public market analysts, the market price of our Common Stock could decline.
- In the unlikely event that payment of certain outstanding promissory notes issued by Profusa to its founders and insiders is demanded at an inopportune time for Profusa, Profusa’s management believes it would still have sufficient funds to operate its business, but may need to adjust certain expenditures or raise additional funds to operate at its currently planned levels.
- Risks Related to Healthcare Industry Shifts and Changing Regulations
- There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our products, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.
- We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could become subject to penalties, be excluded from participation in government programs, and/or be required to make significant changes to our operations.
- If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating results.
- Failure to obtain any required regulatory authorization in foreign jurisdictions will prevent us from marketing our products abroad.
- Potential long-term complications from our current or future products under development may not be revealed by our clinical experience to date.
- Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
- Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material adverse effect on our business, results of operations, financial condition and cash flows.
- If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market.
- We may be subject to fines, penalties and injunctions if we are determined to be promoting the use of our products for unapproved or improper off-label uses or determined to have made claims that are untruthful or misleading or not adequately substantiated.
- Our current or future products may be subject to product recalls even after receiving FDA clearance or approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.
- Health care policy changes, including U.S. health care reform legislation, may have a material adverse effect on our business.
- We are subject to federal, state and foreign laws prohibiting “kickbacks” and false or fraudulent claims, and other fraud and abuse laws, transparency laws, and other health care laws and regulations, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
- Changes to the regulatory landscape may impact our ability to obtain marketing authorization for future product developments.
- Our failure to comply with laws, regulations and contract requirements relating to reimbursement of health care goods and services may subject us to penalties and adversely impact our reputation, business, financial condition and cash flows.
- We are subject to complex and evolving U.S. and foreign laws and regulations and other requirements regarding privacy, data protection, security, and other matters. Many of these laws and regulations are subject to change and uncertain interpretation, and could result in claims, changes to our business practices, monetary penalties, increased cost of operations, or declines in user growth or engagement, or otherwise harm our business.
- Security breaches and other disruptions that compromise our information and expose us to liability, could cause our business and reputation to suffer and could subject us to substantial liabilities.
- Cybersecurity risks and cyber incidents could result in the compromise of confidential data or critical data systems and give rise to potential harm to customers, remediation and other expenses, expose us to liability under HIPAA, consumer protection laws, or other common law theories, subject us to litigation and federal and state governmental inquiries, damage our reputation, and otherwise be disruptive to our business and operations.
- Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches, service interruptions, or data corruption could significantly disrupt our operations and adversely affect our business and operating results.
- Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, thereby preventing new products and services from being developed or commercialized in a timely manner or otherwise preventing those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Risks Related to Intellectual Property Protection and Use
- We may become subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages and injunctive relief. We may also be subject to other claims or suits.
- Our inability to adequately protect our intellectual property could allow our competitors and others to produce products based on our technology, which could substantially impair our ability to compete.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of their other clients or former employers to us, which could subject us to costly litigation.
- We may not be able to protect our intellectual property rights throughout the world, which could materially, negatively affect our business.
- If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of our current or future products, and we cannot provide any assurances that we would be able to obtain such licenses.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- The measures that we use to protect the security of our intellectual property and other proprietary rights may not be adequate, which could result in the loss of legal protection for, and thereby diminish the value of, such intellectual property and other rights.
- Our issued patents could be found invalid or unenforceable if challenged in court, which could have a material adverse impact on our business.
- Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products.
- Several inventions covered by our patent portfolio were made using U.S. government funding. The U.S. government has an irrevocable, non-exclusive, royalty-free license to use such other inventions.
- Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submission, fee payment and other requirements imposed by government patent agencies and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Patent terms may be inadequate to protect our competitive position on products or product candidates for an adequate amount of time.
- If we do not obtain patent term extension and/or data exclusivity for any product candidates we decide to develop as drug product candidates, our business may be materially harmed.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- Intellectual property rights do not necessarily address all potential threats.
- General Risks of Profusa’s Business
- If we are unable to successfully remediate our existing material weaknesses and maintain effective internal control over financial reporting, investors may lose confidence in our reported financial information and our stock price and our business may be adversely impacted.
- Environmental, social and corporate governance (“ESG”) regulations, policies and provisions may make our supply chain more complex and may adversely affect our relationships with customers.
Legal proceedings
We are not currently subject to any material legal proceedings.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGARProfusa, Inc. filings on SEC EDGAR
- 2SEC EDGARProfusa, Inc. filings on SEC EDGAR
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- 5SEC EDGARProfusa, Inc. 10-K for fiscal 2024
- 6SEC EDGARProfusa, Inc. 10-K for fiscal 2024
- 7SEC EDGARProfusa, Inc. 10-K for fiscal 2022
- 8SEC EDGARProfusa, Inc. 10-Q for fiscal 2026
- 9SEC EDGARProfusa, Inc. 10-Q for fiscal 2026
- 10SEC EDGARProfusa, Inc. 10-K for fiscal 2021
- 11
- 12
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- 14SEC EDGARRajesh Asarpota, Board member
- 15SEC EDGARLauren Chung, Board member
- 16SEC EDGARPeter O'Rourke, Board member
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- 18SEC EDGARChange of auditor
- 19
- 20SEC EDGARShareholder vote
- 21
- 22SEC EDGAROther events
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- 24SEC EDGARListing notice or transfer
- 25
- 26SEC EDGARResults of operations
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- 28
- 29NasdaqNasdaq calendar
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