Profusa Clears Key Hurdle Toward CE Mark for Lumee Oxygen Platform
PFSA sits 78% above its 52-week low of $1.58.
Summary
Profusa received a positive decision from GMED on its ISO 13485 quality management system certification, a required step toward CE marking for its Lumee Oxygen Platform in the EU. The company expects formal certification in early October, with remaining MDR conformity assessment activities still pending. This is a meaningful regulatory milestone for a company with a $1.2M market cap and going concern doubts, as CE mark would open the 27-country EU market for its tissue oxygen biosensor. The news follows a series of financing and restructuring moves, including a recent convertible note and a pending G3 Vision Labs acquisition. No specific date is given for final CE mark issuance, and the company cautions that timing and outcome remain uncertain.
At the time of this announcement, PFSA was trading at $2.81 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.2M. The 52-week trading range was $1.58 to $3,000.01. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.