Profusa Presents Positive US-Study Clinical Results at Leipzig Interventional Course (LINC) 2026
Rhea-AI Summary
Profusa (NASDAQ: PFSA) presented positive US pilot study results for the Lumee implantable hydrogel oxygen sensor at LINC 2026 on Jan 28, 2026.
The 15-patient study at UCSF sites showed strong correlation with tcpO2, sensors functional up to one year, no placement-related adverse events, and detected reactive hyperemia in 19% (arm) and 5% (foot) of tests. The company expects EU Lumee revenue to begin 2Q 2026 and projects 2026 revenue of $0.5–$2M and 2027 revenue of $9–$13M.
Positive
- Pilot study in 15 PAD patients showed strong correlation with tcpO2
- Sensors remained functional for up to 12 months
- No sensor placement-related adverse events reported
- Company projects $0.5–$2M revenue in 2026 and $9–$13M in 2027
- EU Lumee oxygen revenue slated to commence in 2Q 2026
Negative
- Pilot study size was small at 15 patients, limiting statistical power
- Reactive hyperemia detected in only 19% (arm) and 5% (foot) of tests
News Market Reaction
On the day this news was published, PFSA declined 3.43%, reflecting a moderate negative market reaction. Argus tracked a trough of -22.7% from its starting point during tracking. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $295K from the company's valuation, bringing the market cap to $8M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PFSA was down 7.95% while only one momentum peer, AIMD, was also down (-8.92%), suggesting a stock-specific move rather than a broad medical devices rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 11 | LINC 2026 abstract | Positive | +0.6% | Acceptance of U.S. pilot Lumee PAD abstract for LINC 2026 presentation. |
| Nov 24 | Paris trial update | Positive | +8.4% | Late Breaking U.S.-based Lumee PAD clinical trial update at Paris meeting. |
Clinical trial conference updates have historically led to modest positive moves for PFSA, unlike the pre-news decline seen here.
This announcement extends Profusa’s pattern of showcasing Lumee™ clinical data at major vascular conferences. Prior clinical-trial tagged news included acceptance of a U.S. pilot study abstract for LINC 2026 on Dec 11, 2025 and a Late Breaking Clinical Trial update at Paris Vascular Insights 2025 on Nov 24, 2025, both focused on peripheral artery disease and tcpO2 comparisons. Around these, the company expanded its European commercial network and launched Lumee Healthcare Research offerings, reinforcing a dual track of clinical validation and commercialization planning.
Historical Comparison
Past clinical-trial headlines for PFSA saw an average move of 4.48%. Today’s pre-news -7.95% decline contrasts with that generally positive reaction pattern.
Clinical communications have progressed from announcing acceptance of PAD Lumee data at major conferences to repeated detailed updates, reinforcing a consistent focus on peripheral artery disease outcomes and tcpO2 comparisons.
Market Pulse Summary
This announcement presents positive U.S. clinical data for the Lumee™ oxygen tissue monitoring platform in 15 peripheral artery disease patients, showing year-long sensor functionality, safety, and strong correlation with tcpO2 over 12 months. It builds on prior conference-focused clinical communications and ties directly to management’s commercial plans, including EU Lumee oxygen revenue expected from 2Q 2026 and potential revenue of $0.5–2M in 2026 and $9–13M in 2027. Investors may monitor further trial updates and commercialization milestones.
Key Terms
peripheral artery disease medical
tcpO2 medical
implantable hydrogel sensor medical
subcutaneous medical
AI-generated analysis. Not financial advice.
Study conducted at US sites evaluates LumeeTM in peripheral artery disease (PAD) patients
BERKELEY, Calif, Jan. 29, 2026 (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, announces the presentation of positive US-study clinical trial results at Leipzig Interventional Course in Leipgzig, Germany on Wednesday, January 28, 2026. The study, conducted at the 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 during occlusion-induced oxygen decreases on the arm and foot and during Buerger’s positional maneuver test on the foot.
- Lumee detected post-occlusion reactive hyperemia in
19% (arm) and5% (foot) of tests, whereas tcpO₂ showed no hyperemic response - Sensors remained functional for up to one year
- No sensor placement related adverse events were reported
“Results of our US-clinical study on PAD continues to be well received by the clinical community, with positive reception at LINC 2026,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO. “We believe this data presented at a preeminent European clinical conference, in addition to support from a growing network of European KOL and physician customers, bode well for our planned commercial activities in the European Union. We are focused on executing on our commercial strategies and expect to deliver 2026 potential revenue of
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.
Contacts
Investor and Media Contacts
email: info@coreir.com
phone: 1 (212) 655-0924
FAQ
What did Profusa (PFSA) report about the 2026 US pilot study for Lumee in PAD patients?
How did Lumee sensors perform versus tcpO2 in the Profusa PFSA study presented at LINC 2026?
What safety results did Profusa (PFSA) present for the Lumee implantable sensor?
When will Profusa (PFSA) begin EU Lumee oxygen revenue and what are the 2026–2027 projections?
What are the limitations of the Profusa PFSA pilot PAD study investors should note?
