Profusa Announces Significant Progress Towards Lumee® Oxygen Platform CE Mark with ISO 13485 Certification Expected in Early October

Further MDR assessment remains before the Lumee Oxygen Platform can receive the applicable certificate and CE mark.

Rhea-AI Summary

Profusa (PFSA) received a positive decision from GMED regarding ISO 13485 certification of its quality management system. Profusa expects certification in early October. GMED is a notified body under the European Union Medical Device Regulation (MDR). The decision concerns Profusa's quality management system, not CE marking of the Lumee Oxygen Platform.

Profusa is continuing work with GMED on the platform's remaining applicable MDR conformity assessments. Completing those activities would support issuance of an MDR certificate and subsequent CE marking. The outcome of the remaining assessments and the timing of CE marking remain uncertain. The platform is designed to monitor tissue oxygen levels continuously and in real time through a tissue-integrated biosensor. Its data is intended to support clinicians' treatment decisions and patient monitoring.

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Details

Market move: PFSA +96.59% vs previous close. medical device certification progress

+109.8% Peak in 1 min

$1.95 $4.49 Day Range

$2.44M Market Cap

On Sep 24, the day this news came out, the latest delayed price for PFSA is 96.59% above the previous close. Argus tracked a peak move of +109.8% during the session. Our momentum scanner has recorded 42 alerts for this stock so far that day. The latest delayed price is $4.03. Relative volume is exceptionally heavy at 2256.8x the average.

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Key Figures

ISO 13485 certification timing: Expected in early October

ISO 13485 certification timing

Expected in early October

Headline; certification

Key Terms

iso 13485, medical device regulation, notified body, ce marking, +1 more

5 terms

iso 13485 regulatory

"positive decision from GMED regarding certification of its quality management system to ISO 13485"

ISO 13485 is an international quality management standard for organizations that design, produce, or service medical devices. Think of it as a factory’s rulebook and checklist that helps ensure products are safe, consistently made, and meet regulatory rules worldwide. For investors, certification signals lower operational and regulatory risk, easier market access, and greater reliability of a company’s medical products and supply chain — similar to buying from a trusted, inspected supplier.

medical device regulation regulatory

"notified body designated under the European Union Medical Device Regulation (MDR)"

Rules and processes governments require for making, testing, approving, and monitoring medical devices so they are safe and work as intended. Think of it like a building code and inspection process for devices: meeting these rules can be costly and slow but opens markets and reduces the risk of recalls and legal trouble, while failure to comply can cut revenue, delay product launches, or cause fines—issues investors watch closely.

notified body regulatory

"GMED is a notified body designated under the European Union Medical Device Regulation"

An independent, government‑designated organization that inspects and certifies medical devices, diagnostic tests, and other regulated products to verify they meet safety and performance rules required for sale in certain markets. Think of it as an official inspector or stamp of approval: its approval affects whether a product can be legally marketed, the timing of launch, and the company’s costs and regulatory risk—key factors for investors assessing commercial prospects.

ce marking regulatory

"the Company's subsequent CE marking of the Lumee Oxygen Platform"

CE marking is a symbol placed on certain products showing they meet European Union safety, health and environmental rules required to sell them in the EU/EEA. For investors, it signals that a product has cleared a common regulatory hurdle—like a passport for market access—reducing legal and market-entry risk and often widening sales opportunities across European markets.

tissue perfusion medical

"provide clinicians with objective tissue perfusion data"

Tissue perfusion is the movement of blood through the smallest vessels (capillaries) that delivers oxygen and nutrients to cells and carries away waste products; it is often described as the volume of blood reaching a given tissue over time. It matters to investors because many drugs, medical devices and diagnostics aim to improve or measure perfusion — like ensuring proper irrigation to a field — so perfusion affects clinical outcomes, trial endpoints, regulatory review and the commercial value of related healthcare products.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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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FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does Profusa expect ISO 13485 certification?

Profusa expects ISO 13485 certification in early October. GMED has given a positive decision regarding certification of the company's quality management system; the announcement does not say certification has been issued.

Has Profusa's Lumee Oxygen Platform received CE marking?

No CE marking was announced for the Lumee Oxygen Platform. Profusa is still working with GMED on the remaining applicable MDR conformity assessments. Their outcome and the timing of CE marking remain uncertain.