Profusa Receives ISO 13485:2016 Certificate from GMED

                   Providing a Foundational Quality Management System (QMS) for Commercialization

• Certificate issued by GMED, an EU MDR notified body, following the positive certification decision previously announced
• ISO 13485 certification supports ongoing MDR conformity assessment activities for the Lumee Oxygen Platform and represents an important milestone toward MDR certification and CE marking.

BERKELEY, Calif., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA) ("Profusa" or the "Company"), a digital health company pioneering next-generation biosensor technologies, today announced that it has received its ISO 13485:2016 certificate from GMED, a notified body designated under the European Union Medical Device Regulation (MDR). The certificate covers the design, development and manufacture of the Lumee Oxygen tissue-integrated biosensors and associated readers (the Lumee Oxygen Platform) at the Company's Berkeley, California facility. Its issuance follows the positive certification decision Profusa announced on September 24, 2026.

ISO 13485 is the internationally recognized standard for medical device quality management systems. Certification demonstrates, through independent audit, that Profusa's quality management system conforms to the applicable requirements of ISO 13485:2016 within the scope of certification. ISO 13485:2016 certification is a significant step supporting the Company's ongoing MDR conformity assessment activities for the Lumee Oxygen Platform. ISO 13485 certification is also commonly expected of medical device suppliers during European hospital procurement and distributor qualification processes. CE marking would indicate conformity with applicable EU MDR requirements and permits the Company to pursue commercial distribution in the European Union, subject to satisfying applicable regulatory and operational requirements.

Europe: the foundation for MDR and order fulfillment. A certified quality management system, as demonstrated by Profusa's ISO 13485:2016 certification, is a core element of conformity assessment under the MDR. With the ISO certificate in hand, Profusa continues to work with GMED to complete the remaining MDR conformity assessment activities for the Lumee Oxygen Platform, which, if successfully completed, would support issuance of the MDR certificate and CE marking. Importantly, with the ISO certificate, Profusa can now begin manufacturing the Lumee Oxygen Sensor Platform. 

United States: aligned with FDA's quality framework. FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates ISO 13485:2016 by reference. While ISO 13485 certification does not constitute FDA clearance or approval, nor replace applicable FDA regulatory requirements, it demonstrates conformity with an internationally recognized quality management system standard incorporated into FDA's updated regulatory framework.

"Obtaining ISO 13485 certification provides potential customers, partners, and interested physicians with independent confirmation that Profusa's quality management system conforms to an internationally recognized medical device standard. This certification provides an important foundation as we continue working toward completion of our remaining MDR conformity assessment activities, obtaining MDR certification and CE marking, and preparing for future commercialization in Europe," said Ben Hwang, Ph.D., President of Profusa.

There can be no assurance regarding the timing or outcome of GMED's remaining MDR conformity assessment activities, MDR certification, the timing of CE marking, or the timing of any market entry.

About 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.

Investor and Media Contacts: 

Fred Knechtel
fred.knechtel@profusa.com