Profusa U.S. Study Met Primary End Points as Presented at Late Breaking Clinical Trials at Paris Vascular Insights 2025
Rhea-AI Summary
Profusa (Nasdaq: PFSA) presented FDA-advised pilot phase results at Paris Vascular Insights on Dec 13, 2025 showing its Lumee™ implantable hydrogel sensors met primary end points for long-term tissue oxygen monitoring in peripheral artery disease (PAD) patients.
Key facts: 15 PAD patients were followed up to 12 months with visits on days 2, 10, 90, 180, 365; Lumee traces strongly correlated with transcutaneous partial pressure of oxygen (tcpO2); sensors remained functional up to one year; no sensor placement–related adverse events were reported. Results are said to support a potential U.S. FDA submission and a planned EU commercialization start in early 2Q 2026.
Positive
- Primary end points met in FDA-advised pilot study
- Study monitored 15 PAD patients over 12 months
- Lumee traces strongly correlated with tcpO2
- Sensors remained functional for up to 1 year
- No sensor placement–related adverse events reported
Negative
- Pilot cohort size was limited to 15 patients
- No U.S. FDA clearance yet; data supports potential submission but is not approval
News Market Reaction
On the day this news was published, PFSA declined 19.87%, reflecting a significant negative market reaction. Argus tracked a peak move of +23.5% during that session. Argus tracked a trough of -36.4% from its starting point during tracking. Our momentum scanner triggered 27 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $10M at that time. Trading volume was very high at 3.3x the daily average, suggesting heavy selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PFSA was down 13.35% while key medical device peers like AIMD and ALUR were up 2.25% and 1.83%, respectively, indicating stock-specific pressure rather than a sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 11 | Clinical presentation | Positive | +0.6% | US pilot study abstract accepted for LINC 2026 presentation. |
| Nov 24 | Clinical update | Positive | +8.4% | Late-breaking US clinical trial update accepted at PVI 2025. |
| Nov 19 | Quarterly results | Positive | -6.0% | Q3 2025 highlights with debt reduction, PIPE/ELOC funding and revenue outlook. |
| Oct 30 | Commercial roadmap | Positive | -9.8% | Outlined Lumee commercialization timing and long-term revenue targets. |
| Oct 28 | Manufacturing update | Positive | -2.1% | Completed manufacturing build-out with capacity above 2026 needs. |
Positive operational, roadmap, and financing updates have often seen muted or negative next-day price reactions, while clinical conference news has aligned more with modest gains.
Over the last few months, Profusa reported manufacturing readiness for Lumee, laid out a commercialization roadmap with revenue targets through 2030, and detailed third-quarter 2025 financing progress, including debt reduction and PIPE/ELOC access. It also highlighted multiple clinical data presentations for Lumee oxygen monitoring in PAD, including upcoming sessions at Paris Vascular Insights 2025 and LINC 2026. Historically, clinical communication has coincided with small positive moves, whereas strategic and financial updates have often been followed by share price weakness.
Market Pulse Summary
The stock dropped -19.9% in the session following this news. A negative reaction despite positive study results fits a pattern where Profusa’s operational and strategic announcements have previously seen follow-up declines, such as moves of -5.95% and -9.85% after recent updates. The market may have focused on broader risk factors highlighted in prior filings and earnings, including financing needs and execution risk, leading to selling pressure even as the Lumee platform advances clinically.
Key Terms
peripheral artery disease medical
transcutaneous partial pressure of oxygen medical
implantable hydrogel sensor medical
tissue oxygenation medical
critical limb ischemia medical
AI-generated analysis. Not financial advice.
Data from FDA-advised study demonstrates Lumee™ Oxygen tissue monitoring is a safe and effective long-term method in PAD patients and will support potential FDA submission; strongly correlates with transcutaneous partial pressure of oxygen
BERKELEY, Calif, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering a next-generation technology platform enabling the continuous monitoring of an individual’s biochemistry, presented pilot phase data demonstrating the study’s primary end points were successfully met at the late breaking clinical trial session at the Paris Vascular Insights (PVI) 2025, on December 13, 2025, in Paris, France. Data from the FDA-advised clinical study performed in the U.S. (University of California San Francisco, San Francisco VA Medical Center, and San Francisco General Hospital) showed Lumee oxygen tissue monitoring is a safe and effective method for long term monitoring of peripheral artery disease (PAD) patients. The data also demonstrated strong correlation with traditional transcutaneous partial pressure of oxygen (tcpO2).
The presentation, titled, “Monitoring Tissue Oxygen Dynamics with a Novel Implantable Hydrogel Sensor in Patients with Peripheral Arterial Disease,” highlighted pilot phase study results from 15 PAD patients with subcutaneous hydrogel sensors implanted in the arm and foot. Tissue oxygenation was measured using both Lumee sensors and tcpO₂. Sensors were monitored over 12 months with visits at days 2, 10, 90, 180, and 365.
Presented Data Highlights:
- Lumee oxygen traces strongly correlated with tcpO₂
- Both devices detected oxygen decreases during occlusion
- Sensors remained functional for up to one year
- No sensor placement related adverse events were reported
“Our Lumee oxygen monitoring technology was designed for use both in the clinic and at home. We are pleased by the presented data, which will support our potential U.S. FDA submission and our goal of making long term oxygen tissue monitoring easily accessible at home to improve overall patient outcomes,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO. “We are on track to begin commercialization of Lumee tissue oxygen monitoring in the European Union in the beginning of 2Q 2026 and look forward to serving the needs of the PAD market, with more than 716,000 annual critical limb ischemia procedures in Europe.”
About Profusa
Based in Berkeley, Calif., 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 (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. 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 in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and in other documents filed 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
What did Profusa (PFSA) announce on Dec 15, 2025 about Lumee in PAD patients?
How long were Lumee sensors monitored in the PFSA study and when were visits scheduled?
Does the Profusa (PFSA) data support a U.S. FDA submission and what is the timeline for EU commercialization?
How many patients were included in Profusa's Lumee pilot study (PFSA)?
What clinical measures did Lumee sensors correlate with in the PFSA study?
Were there any sensor-related adverse events reported in Profusa's PFSA study?
