Profusa Submits Response Package to GMED as Part of Ongoing CE Mark Review Process for Lumee® Oxygen Platform
Rhea-AI Summary
Profusa (Nasdaq: PFSA) submitted a response package to European Notified Body GMED as part of the ongoing CE Mark review for its Lumee® Oxygen Platform. The package updates technical documentation, quality system evidence, clinical evaluation activities, and validation data under the MDR conformity process.
This follows successful completion of Stage 1 and Stage 2 assessments and aligns with Profusa’s strategy to commercialize the Lumee Oxygen Platform in Europe. The review remains in progress, with no assurance on timing or outcome.
Positive
- Completion of Stage 1 and Stage 2 MDR assessments by GMED
- Submission of updated MDR response package for Lumee Oxygen Platform
- Regulatory progress toward potential CE Mark and European commercialization
Negative
- No assurance on timing or outcome of GMED’s CE Mark assessment
- Regulatory uncertainty remains until CE Mark decision is finalized
News Market Reaction – PFSA
In the Jun 12 session, PFSA declined 17.66%, reflecting a significant negative market reaction. Argus tracked a peak move of +20.2% during that session. Argus tracked a trough of -16.3% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. Trading volume was very high at 3.5x the daily average, suggesting heavy selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 10 | Shareholder letter | Neutral | -9.7% | Company urged votes for proposals tied to listing and financing flexibility. |
| May 15 | Listing transfer | Positive | +3.7% | Transfer to Nasdaq Capital Market as part of compliance plan milestones. |
| May 08 | Nasdaq determination | Positive | +5.3% | Nasdaq Hearings Panel granted conditional continued listing on Capital Market. |
| May 05 | Strategic review | Positive | -6.6% | Board initiated strategic alternatives review and highlighted CE Mark progress. |
| Apr 06 | PanOmics LOI | Positive | +144.1% | LOI to acquire PanOmics platform for equity, expanding diagnostics footprint. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Regulatory and strategic updates have produced mixed reactions, with some positive listing decisions aligning with gains while strategic and governance communications have occasionally sold off.
Over the last few months, PFSA news centered on Nasdaq listing compliance, strategic alternatives, and an expansion into precision diagnostics. The April 6, 2026 PanOmics LOI drove a 144.06% jump, while later updates on strategic alternatives and a shareholder letter saw declines. Listing transfer and favorable Nasdaq determinations in May 2026 produced modest gains. Today’s CE Mark review milestone fits the ongoing focus on Lumee Oxygen commercialization and regulatory progress.
Key Terms
ce mark regulatory
european notified body regulatory
clinical evaluation medical
tissue oxygen monitoring medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
BERKELEY, CA, June 12, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA), a digital health company pioneering next-generation biosensing technologies, today announces that it has submitted its response package to questions received from its European Notified Body, GMED, following the successful completion of the Stage 1 and Stage 2 quality system and technical documentation assessments conducted by GMED as part of the MDR conformity assessment process for the Lumee® Oxygen Platform.
The response package included updates across multiple aspects of the MDR submission, including technical documentation, quality system evidence, clinical evaluation activities, and supporting validation information.
The submission represents an important step in the Company's ongoing efforts to obtain CE Mark certification for the Lumee Oxygen Platform and supports Profusa's broader strategy to commercialize the technology in Europe.
"Submitting our responses to GMED marks another meaningful milestone in the CE Mark review process," said Ben Hwang, Ph.D., Profusa’s Chairman and Chief Executive Officer. "We appreciate GMED's continued engagement throughout the assessment and remain committed to working collaboratively with the agency as it completes its review. We believe the Lumee Oxygen Platform has the potential to address a significant unmet need by providing clinicians with continuous, real-time tissue oxygen monitoring, and we look forward to advancing toward European commercialization."
The CE Mark review process remains ongoing, and there can be no assurance regarding the timing or outcome of GMED's assessment. Profusa will continue to support the review process and provide updates on material regulatory milestones as appropriate.
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, 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, including statements regarding the proposed acquisition, the anticipated launch of PanOmics DX™, 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.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”), or in a transaction exempt from the registration requirements of the Securities Act.
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