Data from a recent clinical study indicates that Profusa, Inc.’s Lumee™ oxygen tissue monitoring technology is a safe and effective long-term solution for patients suffering from peripheral artery disease (PAD). The results were presented during the late-breaking clinical trials session at the Paris Vascular Insights (PVI) 2025 conference on December 13, 2025. This research supports the potential for future submission to the U.S. Food and Drug Administration (FDA).
The study, advised by the FDA, was conducted across several prominent medical institutions, including the University of California, San Francisco, the San Francisco VA Medical Center, and San Francisco General Hospital. It focused on the effectiveness of Lumee sensors in measuring tissue oxygenation in PAD patients. The results demonstrated a strong correlation between Lumee readings and traditional transcutaneous partial pressure of oxygen (tcpO2) measurements.
Study Highlights and Future Directions
During the pilot phase, researchers monitored 15 patients with subcutaneous hydrogel sensors implanted in their arms and feet. Over a span of 12 months, data was collected at various intervals, including days 2, 10, 90, 180, and 365. The findings underscored the technology’s capability to provide reliable long-term monitoring of tissue oxygen levels, which is critical for managing PAD.
“Our Lumee oxygen monitoring technology was designed for use both in the clinic and at home,” said Ben Hwang, Ph.D., Chairman and CEO of Profusa. “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 initiate commercialization of the Lumee tissue oxygen monitoring system in the European Union by the second quarter of 2026. This move comes at a time when Europe sees over 716,000 annual critical limb ischemia procedures, highlighting a significant market opportunity for the company.
About Profusa and Its Innovations
Based in Berkeley, California, Profusa is a digital health company that focuses on developing next-generation tissue-integrated sensors. These sensors are designed to continuously transmit actionable medical data for personal and clinical use. Profusa’s innovative approach aims to provide patients and healthcare providers with a personalized biochemical signature, thereby enhancing decision-making in clinical settings.
The Lumee, Profusa’s flagship product, alongside its intelligent data platform, represents a significant advancement in patient monitoring technology. The company’s goal is to make long-lasting, injectable biosensors accessible and affordable, empowering patients to manage their health effectively.
For further details, visit Profusa’s official website at https://profusa.com.
In conclusion, the promising results from this study may pave the way for broader applications of Lumee technology, potentially improving the quality of life for PAD patients globally. As Profusa advances towards FDA submission and European commercialization, the healthcare landscape could witness a transformative change in how chronic conditions like PAD are monitored and managed.
