Profusa, Inc. (NASDAQ: PFSA), a digital health company, has submitted its response package to European Notified Body GMED as part of the ongoing CE Mark review process for its Lumee Oxygen Platform. The submission follows the successful completion of Stage 1 and Stage 2 quality system and technical documentation assessments conducted by GMED under the Medical Device Regulation (MDR) conformity assessment process. This milestone supports Profusa's broader strategy to commercialize the technology in Europe.

The response package included updates across multiple aspects of the MDR submission, including technical documentation, quality system evidence, clinical evaluation activities, and supporting validation information. The CE Mark review process remains ongoing, and there is no assurance regarding the timing or outcome of GMED's assessment.

Ben Hwang, Ph.D., Profusa's Chairman and Chief Executive Officer, emphasized the significance of the submission. "Submitting our responses to GMED marks another meaningful milestone in the CE Mark review process," Hwang said. "We appreciate GMED's continued engagement throughout the assessment and remain committed to working collaboratively with the agency as it completes its review."

The Lumee Oxygen Platform is designed to provide continuous, real-time monitoring of tissue oxygen levels through Profusa's proprietary tissue-integrated biosensor technology. The platform aims to provide clinicians with objective tissue perfusion data to support treatment decision-making and patient monitoring.

Profusa, based in Berkeley, CA, is a commercial-stage digital health company focused on developing tissue-integrated sensors for medical use. The company's long-lasting, injectable biosensors and intelligent data platform aim to provide personalized biochemical data for clinicians. Profusa will continue to support the review process and provide updates on material regulatory milestones as appropriate.