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Profusa To Withdraw S-1 Registration Statement to Pursue a Smaller, More Focused Offering

MWN-AI** Summary

Profusa, Inc. (Nasdaq: PFSA), a Berkeley-based digital health company, has announced its decision to withdraw its S-1 registration statement to pursue a more streamlined capital raise. Originally filed on February 13, 2026, the registration aimed for a $15 million public offering. However, the company has reassessed its immediate capital needs in light of recent commercial progress, particularly advancements related to its Lumee™ Oxygen product set to launch in Europe in Q2 2026, as well as its collaboration with the Mayo Clinic to enhance and introduce new continuous oxygen monitoring solutions in the U.S.

Profusa's CEO, Dr. Ben Hwang, stated that the decision aligns with their current operational requirements and is in the best interest of both the company and its shareholders. The shift away from a larger offering reflects a stronger operational stance and ongoing developments that could better position the company for its future objectives. The focus will now be on a smaller, more targeted offering which will aid in supporting the anticipated revenue from the European market launch and facilitating collaboration efforts in the U.S.

No securities were sold in conjunction with the previously filed registration, and Profusa emphasized that this communication does not constitute an offer to sell or solicit any offers to buy the company’s common stock. Profusa's strategy highlights its commitment to innovative biosensors that provide continuous, actionable data for medical use, enhancing the accuracy and reliability of personal biochemical monitoring.

While the announcement reflects a cautious approach to capital management, it also underscores the potential growth trajectory of the company as it aims for significant market entries later in 2026.

MWN-AI** Analysis

Profusa, Inc.'s recent decision to withdraw its S-1 Registration Statement in favor of a smaller, more focused offering exemplifies a prudent strategic pivot in response to evolving market conditions and operational insights. The company is realigning its capital strategy to better support the anticipated launch of its LumeeTM Oxygen product in Europe and its collaboration with the Mayo Clinic for U.S. market entry later in 2026.

Given the updated projections for 2026 revenue and the maturation of its partnerships, the $15 million originally sought is deemed excessive. This nuanced approach not only preserves capital but also mitigates shareholder dilution. By targeting a more tailored offering, Profusa aims to adequately fund its immediate operational needs while streamlining its path to market.

Investors should regard this maneuver as a positive development. The decision underscores management’s commitment to fiscal responsibility and operational efficacy. With the medical device and digital health sectors continually evolving, Profusa’s strategic focus could position it favorably amidst potential market shifts. Notably, the collaboration with Mayo Clinic—a respected entity in healthcare—lends credibility and may enhance product visibility and adoption.

While this decision does alleviate immediate fundraising pressures, potential investors should maintain a cautious outlook. Forward-looking statements indicate inherent risks related to market entry and product reception. Therefore, investors might consider monitoring Lumee's market performance closely as its European launch approaches.

In conclusion, Profusa is fostering a disciplined approach to growth by recalibrating its funding strategy, signaling a robust understanding of its operational landscape. Investors looking for exposure in digital health should view this as a critical juncture for the company, while being mindful of the associated risks that may impact revenue trajectories in the near term.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

After Reevaluating its Near-term Capital Needs Given the Recent Changes in its Projected 2026 Revenue and Mayo Collaboration, the Company Determined that a $15 Million Offering is Not Required to Achieve Near-term Revenue Projections

BERKELEY, CA, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering the next generation of technology platform enabling the continuous monitoring of an individual’s biochemistry, announces it has elected not to proceed with its public offering and intends to file a post-effective amendment with the U.S. Securities and Exchange Commission (the “SEC”) for the Company’s Registration Statement on Form S-1 (No. 333-293451), as amended, originally filed with the SEC on February 13, 2026 (the “Registration Statement”). The Company will pursue a smaller, more focused offering to support near-term projected Europe LumeeTM Oxygen product revenue starting in Q2 2026 and investment in its Mayo collaboration to accelerate Lumee Oxygen in the U.S. and develop and commercialize new continuous oxygen monitoring products. No securities were sold in connection with the offering described in the Registration Statement.

“We determined that due to our recently announced commercial and operational progress, a smaller, more focused offering is better aligned with our current operational requirements and in the best interest of the Company and its shareholders. Our decision reflects our continued progress in strengthening our balance sheet; having made important operational progress with commercial operations in anticipation of our projected early Q2 2026 Europe Oxygen market launch; and our targeted U.S. market entry for Lumee Oxygen in late 2026 in collaboration with the Mayo Clinic,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Company’s common stock or any securities, and there shall not be any offer, solicitation or sale of securities mentioned in the press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such any state or jurisdiction.

About Profusa

Based in Berkeley, CA, Profusa is a commercial stage digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on.

“LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa, Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.

For more information, visit https://profusa.com.

Special Note Regarding Forward-Looking Statements

Certain statements in this press release may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements including, without limitation, risks related to the Company's planned European and U.S. product launches, the risk that such product launches may not result in revenue at the levels anticipated, the risk that customer demand may be less than expected, and risks relating to the Company’s withdrawal of the Registration Statement and conducting a smaller offering of its securities. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management, are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described more fully in the Company's public filings made by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate.

Contacts

Investor and Media Contacts
email:  info@coreir.com
phone:  1 (212) 655-0924


FAQ**

How will Profusa Inc. PFSA ensure its smaller, more focused offering aligns with its operational goals and supports the launch of the LumeeTM Oxygen product in Europe?

Profusa Inc. will ensure alignment of its focused offering with operational goals by leveraging targeted strategies, incorporating market feedback, and optimizing resources to successfully support the launch of the Lumee™ Oxygen product in Europe.

What specific changes in projected 20revenue and the Mayo collaboration influenced Profusa Inc. PFSA's decision to withdraw the $15 million public offering?

Profusa Inc. withdrew the $15 million public offering due to a more conservative outlook on projected 2026 revenue and adjustments in the Mayo collaboration, which indicated reduced anticipated financial inflows.

Can Profusa Inc. PFSA provide more details on the expected timeline and strategy for entering the U.S. market with Lumee Oxygen in late 2026?

Profusa Inc. (PFSA) plans to provide detailed timelines and strategies for launching Lumee Oxygen in the U.S. market by late 2026 during their upcoming investor briefings, focusing on regulatory approvals, partnerships, and market penetration strategies.

How does Profusa Inc. PFSA plan to measure the success of its investment in the Mayo collaboration and its impact on the development of future continuous oxygen monitoring products?

Profusa Inc. PFSA plans to measure the success of its Mayo collaboration by assessing advancements in continuous oxygen monitoring technology, evaluating clinical outcomes, and analyzing market adoption and revenue growth from the resulting products.

**MWN-AI FAQ is based on asking OpenAI questions about Profusa Inc. (NASDAQ: PFSA).

Profusa Inc.

NASDAQ: PFSA

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