Profusa U.S. Study Met Primary End Points as Presented at Late Breaking Clinical Trials at Paris Vascular Insights 2025
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.
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