Profusa Adds a Leading French Critical Limb Ischemia Surgeon to Customer Base

Rhea-AI Summary

Profusa (NASDAQ:PFSA), a digital health company, has announced a significant collaboration with Dr. Yann Gouëffic, a leading French surgeon specializing in critical limb threatening ischemia (CLTI). Dr. Gouëffic, along with his FRANCE-PAD network, will adopt Profusa's Lumee™ oxygen monitoring technology for both clinical practice and home monitoring studies.

The collaboration is notable as Dr. Gouëffic and his affiliated practices handle approximately 8% of all CLTI cases in France. Dr. Gouëffic brings over 20 years of experience in endovascular procedures and has authored more than 140 peer-reviewed articles. The partnership aims to advance vascular disease management in Europe, where the endovascular market includes over 300,000 procedures annually.

Positive

• Partnership covers approximately 8% of CLTI cases in France through FRANCE-PAD network
• Expansion into European market with leading vascular surgeon adoption
• Technology enables both clinical and home monitoring capabilities
• Large market opportunity with over 300,000 procedures annually in Europe

Negative

• None.

Insights

Medical Technology Analyst

Profusa expands in Europe as leading French CLTI surgeon adopts their oxygen monitoring technology, capturing ~8% of France's CLTI market.

Profusa's announcement of adding Professor Yann Gouëffic to their customer base represents a meaningful commercial expansion in the European market for their Lumee oxygen monitoring platform. With Prof. Gouëffic and his FRANCE-PAD network accounting for approximately 8% of critical limb threatening ischemia (CLTI) cases in France, this collaboration provides Profusa with significant market penetration in a key European territory.

The endorsement from a high-profile vascular surgeon with over 20 years of experience and 140+ peer-reviewed publications adds substantial credibility to Profusa's technology. Prof. Gouëffic's description of Lumee as a "game changer" in patient care particularly highlights its value proposition in both clinical settings and home monitoring applications, suggesting potential for expanded use cases beyond the initial surgical application.

This deal targets the endovascular market which Profusa estimates at over 300,000 procedures annually in Europe, indicating substantial revenue potential if they can continue expanding their customer base. The company's focus on biochemistry monitoring represents an emerging segment in digital health that bridges hospital-based care with remote monitoring—potentially addressing the critical recovery period where complications often occur.

For investors, this represents concrete evidence of commercial traction in Europe and validation from key opinion leaders in vascular surgery, suggesting Profusa's technology platform is gaining acceptance in clinical practice.

Pr. Yann Gouëffic and affiliates (FRANCE-PAD) cover ~8% of all CLTI cases in France

BERKELEY, Calif, Oct. 01, 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, announces additional growth in its customer base in Europe, with a collaboration with Yann Gouëffic, M.D., Ph.D., professor of vascular surgery in the Vascular Center at Groupe Hospitalier Paris Saint Joseph, Paris, France and a leading surgeon in the field of critical limb threatening ischemia (CLTI). Under the agreement, Pr. Gouëffic will adopt Lumee™ oxygen monitoring technology in his practice and in clinical studies that advance application of Lumee for home monitoring. Pr. Gouëffic and his associated practices account for approximately 8% of all CLTI cases in France.

“My practice, in addition to those of my affiliates, treats a meaningful number of CLTI cases in France and I believe Profusa’s Lumee technology to be a game changer in our patient care program and a true advancement clinical disease governance,” said Pr. Gouëffic. “Real-time oxygen monitoring data for patients suffering from CLTI, while critical during surgery, is equally as important during recovery at home. Given the large clinical need, I believe offering Lumee to our patients will result in improved outcomes.”

Pr. Gouëffic has more than 20 years of experience in endovascular and open procedures for peripheral arterial diseases, specializing in lower limb arterial disease, endovascular revascularization, wound healing, and amputation prevention. In addition, Pr. Gouëffic has served as principal investigator for numerous clinical trials that advanced the management of lower limb peripheral artery disease and has authored more than 140 articles in peer-reviewed journals.   Pr. Gouëffic is the current president of the French academic association for clinical research and the coordinator of the FRANCE-PAD network of 6 high volume hospitals that account for approximately 8% of lower limb peripheral artery disease treatment volumes in France.

"Our Lumee oxygen monitoring system continues to be validated with the steady addition of new surgeon customers to our network. We warmly welcome Pr. Gouëffic and look forward to advancing vascular disease management with our commercial and clinical collaboration,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO. “We are also excited to serve Pr. Gouëffic’s affiliates, which all combined, account for approximately 8% of CLTI cases in France. We believe we provide a differentiated, real time biochemistry monitoring platform technology for use at the clinic and at home, and are focused on serving a large endovascular market need, estimated at over 300,000 procedures a year 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.

For more information, visit https://profusa.com.

Special Note Regarding Forward-Looking Statements

Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and in other documents filed by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate.

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FAQ

What is the significance of Profusa's collaboration with Dr. Gouëffic for PFSA stock?

The collaboration gives Profusa access to approximately 8% of France's CLTI cases through Dr. Gouëffic and the FRANCE-PAD network, representing significant market penetration in Europe.

How many procedures could Profusa's Lumee technology potentially serve in Europe?

The endovascular market in Europe includes over 300,000 procedures annually, representing the potential market for Profusa's Lumee oxygen monitoring technology.

What is Dr. Gouëffic's experience in vascular surgery?

Dr. Gouëffic has over 20 years of experience in endovascular procedures, has authored 140+ peer-reviewed articles, and is the current president of the French academic association for clinical research.

What is the main benefit of Profusa's Lumee technology for CLTI patients?

Lumee provides real-time oxygen monitoring for CLTI patients both during surgery and during recovery at home, potentially improving patient outcomes through continuous biochemistry monitoring.

How will the FRANCE-PAD network utilize Profusa's technology?

The FRANCE-PAD network, comprising 6 high-volume hospitals, will implement Lumee oxygen monitoring technology in both clinical practice and research studies focused on home monitoring applications.