BERKELEY, CA, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA), a digital health company pioneering next-generation biosensor technologies today announced that the Company has received a positive decision from GMED regarding certification of its quality management system to ISO 13485. GMED is a notified body designated under the European Union Medical Device Regulation (MDR). The Company continues to work with GMED toward completion of the remaining applicable MDR conformity assessment activities for the Lumee® Oxygen Platform. Successful completion of these activities would support issuance of the applicable MDR certificate and the Company's subsequent CE marking of the Lumee Oxygen Platform. The CE mark signifies that a product sold within the 27 EU member states meets high safety, health and environmental protection standards.
“We are pleased with the progress we have made in strengthening our quality management system, responding to GMED’s requirements and, importantly, receiving a positive decision regarding ISO 13485 certification,” said Ben Hwang, Ph.D., President of Profusa. “This represents a significant milestone for Profusa and reflects the outstanding work our team has undertaken to address GMED’s observations and advance our path toward completion of MDR conformity assessment for the Lumee Oxygen Platform.”
While the Company has made progress in its conformity assessment activities, there can be no assurance regarding the timing or outcome of GMED's remaining assessment activities or the timing of CE marking for the Lumee Oxygen Platform.
The Lumee Oxygen Platform is designed to provide continuous, real-time monitoring of tissue oxygen levels through Profusa's proprietary tissue-integrated biosensor technology. The platform is intended to provide clinicians with objective tissue perfusion data that may support treatment decision-making and patient monitoring.
About Profusa
Based in Berkeley, California, Profusa is a digital health company developing 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 pioneering next-generation biosensor technologies. Profusa previously announced the signing of an Option Agreement (the “Agreement”) which provides Profusa the right and option, but not the obligation, subject to satisfaction of certain conditions, to acquire G3 Vision Labs, Inc. and its subsidiaries (“G3"). Upon option exercising, the combined company is expected to operate as a public diagnostics company.
“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, including statements regarding the proposed acquisition of G3, and Profusa’s strategic plans. 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.
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