Profusa Announces Significant Progress Towards Lumee® Oxygen Platform CE Mark with ISO 13485 Certification Expected in Early October

BERKELEY, CA, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA), a digital health company pioneering next-generation biosensor technologies today announced that the Company has received a positive decision from GMED regarding certification of its quality management system to ISO 13485. GMED is a notified body designated under the European Union Medical Device Regulation (MDR). The Company continues to work with GMED toward completion of the remaining applicable MDR conformity assessment activities for the Lumee® Oxygen Platform. Successful completion of these activities would support issuance of the applicable MDR certificate and the Company's subsequent CE marking of the Lumee Oxygen Platform. The CE mark signifies that a product sold within the 27 EU member states meets high safety, health and environmental protection standards.

“We are pleased with the progress we have made in strengthening our quality management system, responding to GMED’s requirements and, importantly, receiving a positive decision regarding ISO 13485 certification,” said Ben Hwang, Ph.D., President of Profusa. “This represents a significant milestone for Profusa and reflects the outstanding work our team has undertaken to address GMED’s observations and advance our path toward completion of MDR conformity assessment for the Lumee Oxygen Platform.”