Overview of the Collaboration
Profusa, Inc. (Nasdaq: PFSA), a Berkeley, California-based digital health company, has entered into a formal know-how agreement with Mayo Clinic. Signed on February 12, 2026, this collaboration is designed to investigate and develop high-impact clinical applications of Profusa’s proprietary Lumee™ continuous tissue oxygen monitoring technology. The agreement marks a significant step forward in both the research and potential commercialization of next-generation oxygen sensing technology in the United States.
The partnership aims to accelerate regulatory approval pathways and drive commercialization efforts for the Lumee™ wearable platform, particularly for critical limb ischemia (CLI) in the U.S. market. It also opens the door to developing new tethered continuous oxygen monitoring products across a wide spectrum of clinical settings.
What Is the Lumee™ Technology?
A Decade of Innovation in Biosensor Development
The Lumee™ platform represents more than a decade of scientific research and over $100 million in total investment. It is designed to enable continuous, real-time measurement of tissue oxygen levels directly within the body — a capability that Profusa believes is a first-of-its-kind, disruptive biochemistry monitoring platform.
Unlike traditional pulse oximeters or intermittent monitoring tools, the Lumee™ system uses injectable, long-lasting biosensors integrated into tissue. These sensors continuously transmit actionable, medical-grade data that clinicians can use for more informed decision-making. The technology is especially valuable in surgical and postoperative settings where real-time perfusion data can mean the difference between a successful recovery and a serious complication.
How Continuous Oxygen Monitoring Works
The Lumee™ sensors detect oxygen saturation within the tissue itself — not just in the blood — offering a more granular and reliable picture of cellular health. This approach allows for earlier detection of oxygen deficiencies, potentially reducing complications such as wound infections, anastomotic leakage, and organ failure following surgery.
Target Clinical Indications
Expanding Beyond Critical Limb Ischemia
While the collaboration’s most immediate focus is U.S. commercialization for critical limb ischemia — a severe reduction of blood flow to the extremities that can lead to amputation — the agreement also targets several other high-impact areas. Potential new clinical indications include cardiovascular, renal, multi-organ, and orthopedic applications. All of these represent settings where intra-organ postoperative perfusion monitoring could significantly improve patient outcomes.
Critical limb ischemia alone affects hundreds of thousands of patients annually in the U.S., and current monitoring methods are often insufficient for detecting perfusion problems early enough to prevent amputation. The Lumee™ platform could offer clinicians a more effective real-time tool for managing these high-risk patients.
Expert Insights from Mayo Clinic
Addressing Unmet Clinical Challenges in Surgery
Dr. Michael Kendrick, M.D., Chair of the Department of Surgery at Mayo Clinic in Rochester, Minnesota, highlighted the clinical urgency behind this partnership. “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 Dr. Kendrick.
He added that the collaboration provides an opportunity to leverage the Lumee™ platform to potentially address unmet clinical challenges, including the ability to monitor oxygen levels beyond subcutaneous tissue — something current technologies struggle to do effectively.
Profusa’s Vision and Investment
Building a Disruptive Biochemistry Monitoring Platform
Ben Hwang, Ph.D., Profusa’s Chairman and CEO, emphasized the company’s long-term commitment to advancing oxygen monitoring technology. “Following more than a decade of development and over $100 million in investment, our Lumee technology enables continuous, real-time measurement of tissue oxygen directly within the body,” said Hwang. He noted that the company is committed to harnessing its platform for innovative solutions that address large unmet clinical needs and reduce costs for healthcare systems through earlier detection and improved disease management.
Profusa envisions the Lumee™ technology as a foundation for a broader biochemistry monitoring ecosystem — one that can eventually track multiple biomarkers in real time to support personalized, proactive medicine.
Mayo Clinic’s Financial Interest
It is important to note that Mayo Clinic holds a financial interest in the technology referenced in this collaboration. However, Mayo Clinic has confirmed that any revenue it receives will be directed toward supporting its not-for-profit mission — including patient care, education, and research. This structure reflects Mayo Clinic’s longstanding approach to commercializing innovation while maintaining its commitment to public benefit.
What This Means for Patients
The Profusa–Mayo Clinic collaboration represents a meaningful advance in how surgical and postoperative care could be delivered in the future. For patients undergoing complex surgeries — particularly those involving cardiovascular, renal, or orthopedic procedures — real-time, in-body oxygen monitoring could reduce complications, shorten hospital stays, and improve long-term outcomes.
As Profusa moves toward U.S. commercialization of Lumee™ for critical limb ischemia and pursues new indications, this partnership with one of the world’s leading medical institutions positions the technology for broader clinical adoption and regulatory momentum.
