Profusa secured multiple purchase orders from European distributors and expert vascular surgeons for its Lumee tissue oxygen monitoring system, reflecting increasing clinical interest. These orders are positioned for shipment following EU regulatory clearance, underscoring growing market demand for continuous biochemistry monitoring in chronic limb threating ischemia treatment.

In response to strong order momentum, Profusa raised its 2026 revenue guidance range to $1.5 million–$3 million, up from the prior range of $500,000–$2 million. This adjustment represents a threefold increase at the low end and highlights confidence in the company's commercial ramp.

The company is migrating its CE Mark approval to comply with the European Union Medical Device Regulation, with completion expected in the second quarter of 2026. Profusa is building inventory now to support anticipated order fulfillment and initiate product shipments early in 2Q26.

With a recently announced collaboration with Mayo Clinic, Profusa aims to leverage clinical validation data to pursue US market entry as soon as late 2026. The US launch could broaden revenue streams and accelerate adoption of the Lumee platform in critical care settings.