Business
Profusa Receives Purchase Orders for Lumee™ Tissue Oxygen Monitoring and Raises 2026 Revenue Guidance
With strong underlying market demand, European distributor and expert physician customer purchase orders are being received by the Company as its 2026 revenue
About this update from Profusa, Inc.
[{"type":"text","content":"With strong underlying market demand, European distributor and expert physician customer purchase orders are being received by the Company as its 2026 revenue guidance range increases to $1.5 million - $3 million BERKELEY, Calif, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering the next generation of technology platform enabling the continuous monitoring of an individual’s biochemistry, announces it has received several purchase orders for the Lumee™ tissue oxygen monitoring system from its growing network of European distributors and expert physician customers. With strong underlying market demand, Profusa increased its internal projections, and is subsequently increasing its revenue guidance range for 2026, to $1.5 million to $3 million compared to a previously announced range of $500 thousand to $2 million. “Our team is focused on establishing our commercial operations and building out broad European market coverage with distributors and expert physician customers. In the past two months, prominent vascular surgeons presented positive data from clinical studies conducted in the United States at the 2026 Leipzig Interventional Course in Germany and the 2025 Paris Vascular Insights in France. These positive results continue to validate the Lumee Oxygen’s clinical value for Chronic Limb Threatening Ischemia (CLTI) treatment. Momentum in the clinical community is increasing. We believe surgeons are anxious to incorporate Lumee Oxygen into their procedures. Surgeons and distributors have issued purchase orders in anticipation of regulatory approval as soon as April 2026. We previously received CE Mark approval under the prior European regulatory framework; however, our ability to fulfill these purchase orders remains contingent upon completion of its migration to comply with the European Union Medical Device Regulation, which the Company currently anticipates finalizing in the second quarter of 2026. Our operations team is already building inventory to support anticipated demand and enable revenue generation early in the second quarter of 2026. “We believe that with the rapid adoption of the Lumee Oxygen product by surgeons in Europe and our recently announced collaboration with the Mayo Clinic, we are well positioned to potentially en...