S-1/A: Profusa Amends S-1, Details Capital Raises & Nasdaq Compliance

Profusa, Inc. files an S-1/A detailing ongoing capital raises through an equity line and convertible notes, recent PPP loan forgiveness, a new Mayo Clinic license, and efforts to address Nasdaq listing deficiencies following a reverse stock split.

Summary

• Profusa, Inc. filed an Amendment No. 1 to its S-1 registration statement on February 17, 2026.
• The filing relates to the issuance of up to 126,500 shares of common stock upon exercise of public warrants and the resale of up to 579,865 shares by selling stockholders.
• The company completed a business combination with Legacy Profusa on July 11, 2025, becoming Profusa, Inc., a digital health technology company developing biointegrated sensors.
• Profusa is developing the Lumee Oxygen Platform (for tissue oxygen monitoring, CE approved in EU, U.S. FDA approval targeted late 2026) and the Lumee Glucose Platform (for continuous glucose monitoring, next validation study H1 2026, U.S. PMA pathway expected).
• The company has incurred significant net losses, reporting $(27.3) million for the nine months ended September 30, 2025, and used $(11.1) million in cash from operations for the same period.
• As of September 30, 2025, Profusa had a working capital deficit of $(19.3) million and an accumulated deficit of $(152.2) million.
• Management has expressed substantial doubt about the company's ability to continue as a going concern.
• Profusa entered into a Committed Equity Facility (ELOC) with Ascent Partners Fund LLC on July 28, 2025, allowing the sale of up to $100 million in common stock over 36 months.
• The ELOC purchase price is 97% of the lowest volume-weighted average price (VWAP) during a valuation period, subject to a floor price (initially $0.111 for 182,000 shares, then $0.14).
• Profusa drew $3.5 million from the ELOC by September 30, 2025, and an additional $6.8 million between September 30, 2025, and the filing date.
• Proceeds from ELOC sales are primarily for Bitcoin purchases if the cash balance exceeds $5 million, otherwise to reach $5 million cash, then Bitcoin.
• The company also has a PIPE Subscription Agreement with Ascent, with an initial $10 million principal note issued on July 11, 2025, and a second tranche of $2,222,222 principal issued on September 30, 2025.
• Subsequent to September 30, 2025, $4.3 million of PIPE principal/interest was repaid or converted into 170,811 shares.
• Profusa received Nasdaq deficiency notices on September 11, 2025 (minimum bid price $1.00 and MVLS $50M) and October 27, 2025 (MVPHS $15M).
• A 1-for-75 reverse stock split was effected on February 9, 2026, to regain Nasdaq compliance.
• On February 11, 2026, Profusa entered an exclusive know-how license agreement with Mayo Foundation for Medical Education and Research for continuous oxygen measurement and Critical Limb-Threatening Ischemia (CLTI).
• The company received approval for forgiveness of its $1,304,996.05 Paycheck Protection Program (PPP) loan on February 11, 2026.
• As of February 13, 2026, the common stock closed at $2.01 per share, while warrants have an exercise price of $862.50 per whole share (for 1/75 share), making cash exercise highly unlikely.
• Profusa holds 16.51 Bitcoin coins as of the filing date, valued at $2.0 million, as part of its treasury strategy, which exposes it to high volatility.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this filing with a negative sentiment due to significant and increasing net losses, substantial cash burn from operations, and explicit 'going concern' doubt. While capital raises and a Mayo Clinic license offer some positive developments, the underlying financial instability, Nasdaq delisting risks, and the highly speculative Bitcoin treasury strategy outweigh these, indicating a precarious financial position.

Positives

• Secured a significant Committed Equity Facility (ELOC) with Ascent Partners Fund LLC for up to $100 million, providing a potential source of capital.
• Successfully completed a business combination with NorthView Acquisition Corporation on July 11, 2025, transitioning to a public company.
• Received approval for forgiveness of the full $1,304,996.05 PPP loan on February 11, 2026, reducing debt.
• Entered into an exclusive know-how license agreement with Mayo Foundation for Medical Education and Research on February 11, 2026, for continuous oxygen measurement and CLTI, enhancing product development and commercialization potential.
• Lumee Oxygen Platform has CE Mark approval in the EU, with commercialization anticipated in early 2026.
• Lumee Glucose Platform has shown promising proof-of-concept clinical data with a mean absolute relative difference (MARD) of approximately 11% and up to nine months of functionality post-injection, with zero device-related serious adverse events.
• The company has a robust intellectual property portfolio with 25 issued U.S. patents and 32 rest-of-world patents, expiring between 2030 and 2040.

Negatives

• Incurred a significant net loss of $(27.3) million for the nine months ended September 30, 2025, a substantial increase from $(7.0) million in the prior year period.
• Experienced negative cash flow from operating activities, using $(11.1) million for the nine months ended September 30, 2025, compared to $(1.8) million in the prior year.
• Has a substantial accumulated deficit of $(152.2) million as of September 30, 2025, indicating a history of unprofitability.
• Management has expressed substantial doubt about the company's ability to continue as a going concern.
• Received Nasdaq deficiency notices for failing to meet minimum bid price ($1.00) and market value of listed securities ($50M and $15M) requirements, leading to delisting risk.
• The 1-for-75 reverse stock split, while intended to regain Nasdaq compliance, often signals underlying financial distress and can be viewed negatively by investors.
• The exercise price of outstanding warrants ($862.50 per whole share) is significantly higher than the current common stock price ($2.01), making cash exercise highly unlikely and limiting potential capital from this source.
• The Bitcoin treasury strategy exposes the company to high volatility and counterparty risks, and its accounting treatment could increase volatility in financial results.
• The company's commercialization plans for Lumee Oxygen in Europe were hampered by COVID-19 pandemic restrictions, delaying revenue generation.

Risks

• Inability to predict the actual number of shares sold under the ELOC Purchase Agreement or the gross proceeds from those sales.
• Dilution to existing stockholders from the sale and issuance of common stock to Ascent under the ELOC, and potential price decline due to perceived future sales.
• Investors buying Purchase Shares from Ascent at different times may pay different prices and experience varying levels of dilution.
• Proceeds from ELOC sales will primarily be used to purchase Bitcoin, a highly volatile asset, which could negatively impact financial results and stock price.
• If common stock trades below the $0.111 floor price (or $0.14 thereafter) under the ELOC, the company will be unable to sell shares, limiting access to capital.
• Substantial doubt about the company's ability to continue as a going concern, which may hinder its ability to obtain further financing.
• Issuance of a material number of additional shares from outstanding warrants could result in significant dilution and depress the market price.
• Limited operating history and anticipated continued significant losses for several years.
• Risk of delisting from Nasdaq if compliance with listing requirements (minimum bid price, market value of publicly held shares) is not regained.
• Operating in a highly competitive market with larger, well-established companies possessing significant resources.
• Risks due to international operations, including local preferences, payment cycles, currency fluctuations, intellectual property protection, trade measures, and regulatory compliance.
• Consumer confusion about product features and technology could lead to purchasing competitive products or conflating adverse events with Profusa's products.
• High reliance on Lumee Oxygen Platform for commercial revenue until additional products receive regulatory approval.
• Vulnerability to supply disruptions, suboptimal quality, noncompliance, and price fluctuations due to dependence on third-party suppliers and outsourcing.
• No guarantee that the FDA will grant 510(k) clearance or PMA approval for products, adversely affecting business growth.
• Inability to successfully complete pre-clinical studies or clinical trials necessary for regulatory applications could impair commercialization of CGM systems.
• Products may cause or contribute to adverse medical events or be subject to failures/malfunctions requiring FDA reporting, leading to sanctions or recalls.
• Quality problems could lead to recalls, safety alerts, and reputational harm.
• Claims of infringement or misappropriation of intellectual property rights of others, potentially prohibiting product shipments, requiring licenses, or leading to monetary damages.
• Material weaknesses in internal control over financial reporting, which could adversely affect accurate and timely financial reporting and stock price.
• Environmental, social, and corporate governance (ESG) regulations and policies may complicate the supply chain and affect customer relationships.
• Cybersecurity risks and cyber incidents could compromise confidential data or critical systems, leading to harm to customers, expenses, liability, and reputational damage.
• Inadequate funding for the FDA, SEC, and other government agencies could delay product development or commercialization.
• Inability to adequately protect intellectual property could allow competitors to produce similar products, impairing competitiveness.
• Involvement in lawsuits to protect or enforce patents could be expensive, time-consuming, and unsuccessful.
• Claims that employees, consultants, or contractors wrongfully used or disclosed trade secrets of others.
• Inability to protect intellectual property rights throughout the world, especially in countries with weaker IP laws.
• Issued patents could be found invalid or unenforceable if challenged in court.
• Changes in patent laws or jurisprudence could diminish the value of patents.
• U.S. government funding for some patents grants the government an irrevocable, non-exclusive, royalty-free license, and potential 'march-in rights' to compel licensing to third parties.
• Patent terms may be inadequate to protect competitive position for an adequate amount of time.
• Inability to obtain necessary intellectual property licenses from third parties on satisfactory terms.
• Inadequate measures to protect the security of intellectual property and other proprietary rights.
• Unfavorable global economic and political conditions, including inflation and military conflicts, could adversely affect product demand and operations.
• Changes in financial accounting standards or practices or existing taxation rules may cause adverse unexpected revenue/expense fluctuations.
• Climate change may have a long-term impact on business, particularly manufacturing sites in California.
• Risk of product liability claims, potentially leading to damages, fines, penalties, and injunctions.
• Increased costs and additional regulations as a public company.
• Uncertainty if reduced disclosure requirements for emerging growth companies will make shares less attractive to investors.
• Risk of non-performance by counterparties in the Bitcoin treasury strategy, including custodians.
• Regulatory change reclassifying Bitcoin as a security could lead to classification as an investment company under the 1940 Act, adversely affecting Bitcoin price and common stock price.
• Temporary or permanent blockchain forks to Bitcoin or other crypto assets could adversely affect the business.
• Due diligence procedures to mitigate transaction risk may fail to prevent transactions with sanctioned entities.

Future Outlook

Profusa anticipates launching the Lumee Oxygen Platform in Europe in early 2026 and seeking U.S. FDA approval for it by late 2026. The Lumee Glucose Platform's next validation study is expected in the first half of 2026, with regulatory submission in early 2026 and U.S. launch targeted for late 2026 or early 2027. The company plans to leverage its platform to tackle other chronic conditions and develop data streams for high-growth healthcare sectors like telemedicine and health and wellness coaching. Profusa expects to incur additional substantial losses and will require further financing to fund operations and planned growth, potentially through equity or debt offerings. The company also expects continued volatility in its financial results due to its Bitcoin treasury strategy.

Management Comments

• Management believes the Lumee Glucose Platform's ability to provide continuous glucose monitoring with a single injection is an attractive alternative for diabetes management.
• Management believes the combination of potential advantages of its platform will enable it to generate both short-term revenue in wound care and diabetes management, and leverage core technology for other chronic conditions.
• Management believes Profusa's data stream could become a key enabler for high-growth healthcare sectors such as telemedicine and health and wellness coaching.
• Management believes that Lumees biosensor and artificial intelligence platform compares very attractively with some of the largest products in this market sector.
• Management believes its validated core technology can easily bridge the gap that exists in the current technology landscape for monitoring real time biochemistry.
• Management believes that, at scale, the data Profusa's platform generates from its initial products will be a key enabler for the productivity and business models for both telemedicine and coaching sectors to expand and reach more of their full potential.
• Management believes that, even in the event of noteholders demanding repayment, Profusa would likely have sufficient funds to continue operations for the near term, but its ability to operate at currently planned levels could be materially and adversely affected.

Industry Context

StockSavvy.ai notes that Profusa operates in the highly competitive and rapidly evolving digital health and medical technology sectors, particularly in continuous glucose monitoring (CGM) and oxygen monitoring. The company's strategy to focus on Europe first for regulatory approval is a common approach for medical device companies due to traditionally lower barriers compared to the U.S. FDA. The emphasis on biointegrated sensors that overcome the foreign body response and offer long-term functionality addresses a key limitation of current CGM devices. The pursuit of a Bitcoin treasury strategy is an unconventional and high-risk move for a medical device company, diverging significantly from typical industry treasury management practices and exposing it to unique market volatility. The company's efforts to integrate with telemedicine and health and wellness coaching align with broader industry trends towards remote patient monitoring and data-driven personalized healthcare, but its success hinges on achieving regulatory approvals and market acceptance against established players like Abbott and Medtronic.

Comparison to Industry Standards

• Profusa's Lumee Glucose platform aims for a mean absolute relative difference (MARD) of approximately 11% with up to nine months of functionality post-injection. This compares to existing CGM solutions like Dexcom G6 (10-day sensor, MARD 9.0% for adults), Abbott Freestyle Libre 2 (14-day sensor, MARD 9.3% for adults), Medtronic Guardian Connect (7-day sensor, MARD 8.7% for adults), and Senseonics Eversense E3 (180-day sensor, MARD 8.5% for adults). Profusa's longer sensor life (up to 9 months) is a potential advantage over most competitors, but its MARD is currently higher than established market leaders, indicating a need for further accuracy improvements to meet industry benchmarks.
• The Lumee Oxygen Platform competes with devices from Siemens Healthineers, Perimed AB, SenTec AG, Radiometer Medical, MESI, and ATYS Medical in oxygen monitoring. Profusa's biointegrated sensor, designed to function for more than six times longer than known best-in-class solutions, offers a distinct advantage in longevity, potentially reducing patient burden and healthcare costs compared to existing short-term solutions.
• The company's strategy to offer a single-injection, long-term CGM solution is a direct response to the inconvenience of frequent sensor replacements (e.g., weekly for needle-type CGMs) and the invasiveness of surgically implanted alternatives (e.g., Senseonics Eversense E3 requiring surgical implantation).

Corporate Governance

Legal Proceedings

• The company is currently defending one litigation with a vendor, with estimated incremental legal costs of less than $0.1 million accrued.
• No other material litigation, arbitration, or governmental proceedings are currently pending against the company or its management team.

Related Party Transactions

• Tasly Convertible Debt: In June 2023, Profusa entered into a short-term loan agreement with Tasly, a shareholder, for up to $1.6 million. The loan bears 12% annual interest (24% default) and matured on December 31, 2023 (extended to March 31, 2024). The company is in default, and the note is convertible into senior unsecured promissory notes or common stock at $144.00 per share (adjusted for reverse split). Fair value was $2.1 million as of September 30, 2025.
• Ascent PIPE Convertible Note: On February 11, 2025, NorthView (now Profusa) executed a PIPE Subscription Agreement with Ascent Partners Fund LLC, a shareholder, for up to $22,222,222 in senior secured convertible notes. An initial note of $10 million principal was issued on July 11, 2025, and a second tranche of $2,222,222 principal on September 30, 2025. The note matures on January 11, 2027, with 10% annual interest (24% default) and is convertible at the lower of $750 or 95% of lowest daily VWAP (floor $7.50, adjusted for reverse split). Fair value was $14.4 million as of September 30, 2025.
• Promissory Notes to Founders: In 2010 and 2011, two founders provided $0.2 million in promissory notes (5% annual interest, no set maturity). In 2022, $0.3 million was borrowed from founders (zero interest, $0.2 million repaid). In 2023, $0.3 million from an existing investor and $0.1 million from an unrelated party (12% annual interest, repayable on demand after December 31, 2024). The company is in default on these notes, with a carrying value of $0.9 million as of September 30, 2025.
• Convertible Working Capital Promissory Note with Sponsor: Previously held by NorthView, now by Profusa, with the Sponsor for up to $2.5 million. Non-interest bearing, convertible into warrants at $75 per warrant or common stock at $166.50 per share (adjusted for reverse split). Carrying value of $1,919,796 as of September 30, 2025, classified as a current liability due to deferred repayment.

Stakeholder Impact

• Shareholders: Face significant dilution from ongoing equity raises (ELOC, PIPE) and potential future warrant exercises. The reverse stock split may not fundamentally improve the stock's value, and delisting from Nasdaq remains a risk, which could further reduce liquidity and investor confidence. The Bitcoin treasury strategy introduces additional, high-volatility risk to shareholder value.
• Employees: The company's 'going concern' doubt and history of losses create uncertainty regarding job security and long-term stability. However, continued investment in R&D and commercialization efforts could lead to future growth opportunities.
• Customers: Potential for new and improved products (Lumee Oxygen, Lumee Glucose) offers advanced monitoring solutions for chronic conditions like peripheral artery disease and diabetes. However, delays in regulatory approval or commercialization could impact product availability.
• Suppliers/Creditors: The company's financial instability and default on certain promissory notes pose risks to creditors. The ELOC and PIPE financings provide some liquidity, but the overall financial health remains a concern.
• Regulatory Bodies: The company is subject to extensive FDA and international regulations. Failure to comply or obtain necessary approvals could lead to sanctions, product recalls, and harm to the business.

Next Steps

• Launch Lumee Oxygen Platform in Europe in early 2026.
• Continue U.S. study for Lumee Oxygen Platform for FDA marketing authorization, targeted late 2026.
• Start the next validation study for Lumee Glucose Platform in the first half of 2026.
• Submit for regulatory approval for Lumee Glucose Platform in early 2026.
• Seek U.S. PMA approval for Lumee Glucose Platform, requiring a pivotal study with an estimated 120-160 subjects over at least 3 months.
• Commercialize Lumee Glucose as a professional-use device first, then a fully featured real-time use CGM device.
• Continue discussions with potential partners in Asia to establish the APAC Joint Venture.
• Monitor and work to regain compliance with Nasdaq listing standards (minimum bid price and market value of publicly held shares) by March 10, 2026, and April 27, 2026, respectively.
• Potentially file additional registration statements to register more shares for resale by Ascent under the ELOC to reach the $100 million commitment.
• Continue to evaluate the risks and rewards of the Bitcoin treasury strategy and potentially implement hedging strategies.
• Develop products for other analytes such as lactate, CO2, ethanol, and pH.
• Strategically engage in commercial B2B relationships to capture portions of the coaching, telemedicine, and health and wellness segments.

Key Dates

Recommendation

Profusa faces severe financial distress, evidenced by substantial and increasing net losses, significant cash burn from operations, and an explicit 'going concern' warning from management and auditors. While recent capital raises (ELOC, PIPE) and a Mayo Clinic license provide some short-term liquidity and strategic validation, they are insufficient to offset the fundamental issues. The Nasdaq delisting risk, despite a reverse stock split, highlights severe market value erosion. The Bitcoin treasury strategy introduces an additional layer of high, uncorrelated risk. The exercise price of outstanding warrants is astronomically higher than the current stock price, rendering them effectively worthless and eliminating a significant potential capital source. For a seasoned investor, the combination of high operational risk, regulatory uncertainty, severe dilution, and precarious financial health makes Profusa a 'strong sell' due to the high probability of further capital destruction and potential insolvency.

Keywords

Biointegrated Sensors, Digital Health, Continuous Glucose Monitoring, Tissue Oxygen Measurement, Lumee Oxygen Platform, Lumee Glucose Platform, SEC Filing, S-1/A, Nasdaq Listing, Reverse Stock Split, Committed Equity Facility, ELOC, PIPE Financing, Bitcoin Treasury Strategy, Medical Devices, FDA Approval, CE Mark, Clinical Trials, Intellectual Property, Going Concern, Mayo Clinic, PPP Loan Forgiveness, Healthcare Technology, Risk Factors, Dilution, Warrants