Profusa Hits Major Clinical Milestone in PAD Study, Targets European Commercial Launch in 2026
FDA-advised pilot study confirms safety and efficacy of Lumee™ Oxygen platform, paving the way for regulatory advancements and market expansion.
Profusa (NASDAQ: PFSA), a commercial-stage digital health company, solidified its position in the biochemical monitoring market this week after presenting successful pilot phase data at a major European medical conference. The company revealed that its FDA-advised clinical study met all primary endpoints, demonstrating that its proprietary Lumee™ Oxygen tissue monitoring platform is both safe and effective for long-term use in patients suffering from peripheral artery disease (PAD).
The announcement comes on the heels of the company’s presentation at the Late Breaking Clinical Trials session of the Paris Vascular Insights (PVI) 2025, held on December 13 in Paris, France. For investors and industry observers, these results mark a pivotal moment as Profusa transitions from clinical validation toward commercial scalability in the European Union and a potential regulatory submission in the United States.
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Transforming Peripheral Artery Disease Management
The data presented in Paris underscores the potential of Profusa’s technology to revolutionize how clinicians monitor tissue oxygen levels. The study, conducted at prestigious U.S. institutions including the University of California, San Francisco, the San Francisco VA Medical Center, and San Francisco General Hospital, focused on 15 patients diagnosed with PAD.
Researchers implanted subcutaneous hydrogel sensors in the arms and feet of these patients and monitored them over a 12-month period. The results were robust: the Lumee sensors remained functional for up to one year, and the study reported zero adverse events related to sensor placement. Critically, the data showed a strong correlation between the Lumee oxygen traces and traditional transcutaneous partial pressure of oxygen (tcpO2) measurements. Both methods successfully detected oxygen decreases during occlusion, validating the Lumee platform’s accuracy against the current standard of care.
This continuous monitoring capability addresses a significant gap in the current treatment landscape. Traditional methods often provide only a snapshot of a patient’s condition, whereas Profusa’s injectable biosensors offer a long-term window into the body’s biochemistry. This shift could prove vital for the management of PAD, a condition that often leads to critical limb ischemia and requires vigilant monitoring to prevent severe complications.
Strategic Implications for 2026 and Beyond
Profusa is wasting no time in leveraging these positive results to drive its business strategy forward. The company confirmed it is on track to begin commercializing the Lumee tissue oxygen monitoring system in the European Union by the beginning of the second quarter of 2026. This launch targets a substantial market, with European healthcare providers performing more than 716,000 critical limb ischemia procedures annually.
Management views the successful U.S. pilot study as a cornerstone for its regulatory strategy across the Atlantic as well. Ben Hwang, Ph.D., Profusa’s Chairman and CEO, emphasized the dual utility of the technology in his comments regarding the data presentation.
Hwang commented:
“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 ability to monitor patients remotely represents a significant value proposition for payers and providers seeking to reduce hospital readmissions and improve long-term recovery rates. By validating the technology’s safety and efficacy over a full year, Profusa has de-risked a significant portion of its development path.
A Global Stage in Leipzig
Looking ahead, Profusa plans to maintain its momentum with another high-profile appearance early next year. The company announced that it will present additional insights from its U.S.-based pilot clinical study at the Leipzig Interventional Course (LINC) 2026. This event, scheduled for January 27-30 in Leipzig, Germany, attracts vascular specialists from around the globe.
The acceptance of their abstract for this conference suggests growing interest from the medical community in Profusa’s approach to tissue-integrated sensors. The presentation is slated for Wednesday, January 28, 2026, at the Trade Fair Leipzig. It will offer a deeper dive into the nuances of tissue oxygen monitoring and provide an opportunity for the company to engage directly with potential European adopters just months before the planned commercial rollout.
Management remains optimistic about the reception from the scientific community.
Hwang stated:
“With positive feedback from our U.S.-based clinical study evaluating our pioneering Lumee technology with tcpO2, we look forward to sharing additional clinical results and continued discussion with providers and researchers at this preeminent European conference.”
As Profusa moves closer to its commercial goals, the successful validation of its technology in a clinical setting provides a strong tailwind. Investors will likely watch the upcoming EU launch closely as a litmus test for the company’s ability to capture market share in the competitive digital health landscape.
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