PFSA biotech catalysts & pipeline

PROFUSA INC · Data as of 2026-09-08

Upcoming catalysts

oxygen platform — NDA/BLA submission

2026

We believe that our oxygen platform serves a critical need, and we hope to expand our reach into the U.S. market with a pivotal clinical study concurrent with our EU commercial launch, followed by a U.S. FDA submission mid-next year, and with U.S. commercialization anticipated halfway through 2027.

Source filing

Lumee — NDA/BLA submission

late 2026

Profusa anticipates beginning commercialization of Lumee Oxygen in Europe in early 2026 and continuing its U.S. study for submission for U.S. FDA marketing authorization late 2026.

Source filing

Explore the free biotech catalyst calendar