BERKELEY, Calif. — February 19, 2026 — Leads & Copy — Profusa, Inc. (Nasdaq: PFSA) has received several purchase orders for its Lumee™ tissue oxygen monitoring system from European distributors and expert physician customers.
The digital health company, which specializes in technology for continuous monitoring of an individual’s biochemistry, anticipates revenue to be in the range of $1.5 million to $3 million for 2026.
Profusa increased its internal projections due to strong market demand, raising its revenue guidance range for 2026 from a previously announced $500,000 to $2 million.
Ben Hwang, Ph.D., Profusa’s Chairman and CEO, said the team is focused on establishing commercial operations and building broad European market coverage with distributors and expert physician customers. He added that momentum in the clinical community is increasing, and 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.
In the past two months, vascular surgeons presented positive data from U.S.-based clinical studies at the 2026 Leipzig Interventional Course in Germany and the 2025 Paris Vascular Insights in France. Profusa said the results validate the Lumee Oxygen’s clinical value for Chronic Limb Threatening Ischemia (CLTI) treatment.
The company previously received CE Mark approval under the prior European regulatory framework; however, fulfilling the purchase orders is contingent upon completing its migration to comply with the European Union Medical Device Regulation. Profusa anticipates finalizing this in the second quarter of 2026 and is building inventory to support anticipated demand and enable revenue generation early in the second quarter of 2026.
Profusa said it believes that with the rapid adoption of the Lumee Oxygen product by surgeons in Europe and its recently announced collaboration with the Mayo Clinic, it is well positioned to potentially enter the U.S. market as soon as late 2026. The company expects revenue to build throughout 2026 with additional focus on its Healthcare Research business.
Profusa intends to provide an update on its European CE Mark approval via GMED under EU Medical Device Regulation (MDR) in 1Q2026, which will catalyze product shipments beginning 2Q2026.
Profusa is based in Berkeley, Calif.
Source: Profusa
