Profusa, Inc. has announced significant findings from its clinical study of LumeeTM, a groundbreaking oxygen tissue monitoring system, during the late-breaking clinical trials session at the Paris Vascular Insights (PVI) 2025 conference on December 13, 2025. The study’s pilot phase demonstrated that Lumee effectively meets its primary endpoints, indicating its potential as a safe and long-term solution for patients suffering from peripheral artery disease (PAD).
Conducted in collaboration with the University of California San Francisco, the San Francisco VA Medical Center, and San Francisco General Hospital, the FDA-advised study monitored 15 PAD patients. Participants had subcutaneous hydrogel sensors implanted in their arms and feet, allowing for continuous measurement of tissue oxygen levels. The results showed a strong correlation between Lumee readings and traditional transcutaneous partial pressure of oxygen (tcpO2) measurements, underscoring the technology’s reliability.
Study Highlights and Future Plans
Dr. Ben Hwang, Chairman and CEO of Profusa, expressed optimism about the study’s outcomes, stating, “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.”
The sensors were monitored over a 12-month period with follow-up visits on days 2, 10, 90, 180, and 365, providing comprehensive data on tissue oxygenation dynamics. Profusa anticipates commencing commercialization of the Lumee oxygen monitoring system in the European Union by the beginning of the second quarter of 2026. The company aims to cater to the PAD market, which sees over 716,000 annual critical limb ischemia procedures in Europe alone.
Profusa, based in Berkeley, California, is focused on developing next-generation tissue-integrated sensors that transmit actionable, medical-grade data for personal and medical use. The company’s innovative biosensors and intelligent data platform strive to offer patients a personalized biochemical signature, delivering a level of detail that clinicians can trust.
As the field of digital health evolves, Profusa’s advancements in continuous monitoring technologies may significantly impact how clinicians manage conditions like PAD, improving patient outcomes through better-informed treatment strategies.
For further details on Profusa and its offerings, visit their website at https://profusa.com.
