Profusa Expands Lumee Oxygen Monitoring Platform Through Strategic Partnerships and Commercial Launch
Key Insights
Profusa (search) has entered a collaboration with Mayo Clinic to accelerate regulatory approval and develop new clinical applications for its Lumee (search) oxygen monitoring technology, targeting cardiovascular, renal, and orthopedic indications.
The company has expanded its European commercial network by partnering with French distributor MedSell (search), now reaching approximately 200,000 annual critical limb ischemia (search) cases across the European Union.
Profusa (search) launched its Healthcare Research version of Lumee (search) tissue oxygen (search) monitoring for the contract research organization market, targeting the $47.9 billion global CRO market and generating immediate commercial revenue.
Profusa (search), a Berkeley-based digital health company, has announced three significant developments that position its Lumee (search) oxygen monitoring technology for expanded clinical applications and commercial growth. The company's tissue-integrated biosensor platform, which enables continuous real-time measurement of tissue oxygen (search), represents what the company describes as "a first-of-its-kind, disruptive biochemistry monitoring platform" following over a decade of development and more than $100 million in investment.
Mayo Clinic Partnership Targets High-Impact Clinical Applications
Profusa (search) has entered into a know-how agreement with Mayo Clinic to investigate high-impact clinical applications of its oxygen monitoring technologies for new product development and commercialization. The collaboration focuses on potential target indications including cardiovascular, renal, multi-organ, and orthopedic applications, where intra-organ postoperative perfusion monitoring has potential to improve clinical outcomes.
"Oxygen is essential for cellular metabolism and tissue repair, with lack of sufficient oxygenation impairing wound healing, increasing risk of infection, and contributing to complications common to surgery, such as leakage and anastomotic structure," said Michael Kendrick, M.D., Chair of Department of Surgery at Mayo Clinic, Rochester, Minnesota. "Our collaboration gives us the opportunity to leverage their innovative platform to potentially address unmet clinical challenges, including the ability to monitor beyond subcutaneous tissue."
The partnership also supports Profusa (search)'s potential commercialization of Lumee (search) oxygen sensing and tissue monitoring technology for critical limb ischemia (search) in the United States.
European Market Expansion Through French Distribution Partnership
Profusa (search) has strengthened its European commercial network by partnering with MedSell (search), a French medical device distribution company, to commercialize Lumee (search) Oxygen tissue monitoring in France. This agreement builds upon previously announced distributor partnerships in Spain, Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia, enabling the company to now reach more than 200,000 critical limb ischemia (search) cases annually in the European Union.
MedSell (search) will commercialize the technology in both hospital settings and outpatient care, particularly in wound care and healing clinics addressing patients with complex and chronic wounds. "The device enables the measurement of tissue oxygen (search) perfusion before revascularization, during endovascular or open surgical procedures, and throughout follow-up in hospitals or wound care clinics," said Benoit Salaün, Pharm.D., Ph.D., MedSell General Manager.
The distribution partnership complements Profusa (search)'s collaboration with Yann Gouëffic, M.D., Ph.D., professor of vascular surgery at Groupe Hospitalier Paris Saint Joseph (search), whose practice accounts for approximately 8% of all critical limb threatening ischemia (search) cases in France.
Healthcare Research Market Entry Generates Immediate Revenue
Profusa (search) has launched its Healthcare Research version of the Lumee (search) tissue oxygen (search) monitoring system into the contract research organizations market, targeting the global CRO market valued at $47.9 billion in 2025 and growing at 7% compound annual growth rate. Industry forecasts estimate this market could expand to over $91.2 billion by 2034.
The research-use-only offerings provide researchers and R&D teams access to continuous, real-time measurement of tissue oxygenation across applications including advanced in vitro and organ-on-chip models, preclinical pharmacology and toxicology studies, and translational research programs. The system supports research into complex biological processes such as tissue oxygenation dynamics in wound healing and tumor microenvironments in oncology.
Sean Givens has been appointed to lead commercialization efforts as Head of Government and Healthcare Research Business. "Our sensors are validated, ready to ship, and already generating strong interest across the industry," said Givens, who brings over 20 years of government accounting and contracting experience. "By partnering with CROs, we can help accelerate better drug development decisions while creating a meaningful, near-term revenue stream for Profusa (search)."
Financial Projections and Commercial Timeline
Ben Hwang, Ph.D., Profusa (search)'s Chairman and CEO, outlined the company's commercial strategy and financial projections. "We are focused on executing on our commercial strategies, including plans to potentially achieve $200 to $250 million in revenue by 2030; capitalize on the near-term as we begin to commercialize in Europe in 2Q 2026 with the goal of addressing the US Lumee (search) oxygen opportunity in 2027," Hwang said.
The company expects to deliver potential revenue of $0.5 to $2 million in 2026 and $9 to $13 million potential revenue in 2027. Hwang noted that the European clinical community continues to validate the Lumee (search) Oxygen tissue monitoring technology, including recent presentations of US-based clinical trial data at Paris Vascular Insights and Leipzig Interventional Course.