Data from a recent clinical study indicates that Profusa, Inc.’s LumeeTM Oxygen tissue monitoring system is a safe and effective long-term solution for patients with peripheral artery disease (PAD). The findings were presented during the late-breaking clinical trials session at the Paris Vascular Insights (PVI) 2025 conference on December 13, 2025.
Conducted in the United States, the FDA-advised study involved participants from the University of California San Francisco, San Francisco VA Medical Center, and San Francisco General Hospital. The results showed that the Lumee system demonstrated a strong correlation with traditional transcutaneous partial pressure of oxygen (tcpO2) measurements. This correlation is significant for accurately monitoring tissue oxygen levels in patients suffering from PAD.
Promising Study Results
The study included 15 PAD patients who had subcutaneous hydrogel sensors implanted in their arms and feet. Over a period of 12 months, tissue oxygenation was measured using both the Lumee sensors and tcpO2. Patients attended follow-up visits on days 2, 10, 90, 180, and 365 for monitoring.
Ben Hwang, Ph.D., Chairman and CEO of Profusa, expressed optimism about the study’s outcomes. “Our Lumee oxygen monitoring technology was designed for use both in the clinic and at home,” said Hwang. He added, “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.”
Profusa plans to begin the commercialization of the Lumee system in the European Union at the start of the second quarter of 2026. The company aims to address the needs of the PAD market, which sees over 716,000 critical limb ischemia procedures annually in Europe.
About Profusa and Future Prospects
Based in Berkeley, California, Profusa is a digital health company focused on developing next-generation tissue-integrated sensors capable of continuously transmitting actionable medical data. The company’s innovative biosensors are designed to be long-lasting, injectable, and affordable, thereby providing personalized biochemical insights that healthcare professionals can trust.
The Lumee system, along with its intelligent data platform, is a testament to Profusa’s commitment to improving patient care through technology. The company’s trademarks, including “LUMEE” and “PROFUSA,” are registered in several jurisdictions, including the United States, Canada, and the European Union.
As Profusa moves forward, it faces the challenge of navigating regulatory pathways and market competition. The company’s emphasis on evidence-based results from its studies will be crucial as it seeks to secure FDA approval and broaden its reach in the health technology landscape.
For more information on Profusa and its technology, visit https://profusa.com.
