Micro Cap Profusa Navigates European Regulatory Hurdles to Advance Oxygen Monitoring Tech

Micro cap Profusa, Inc. (NASDAQ:PFSA) stock is surging on Thursday after the company received a positive decision from GMED regarding the certification of its quality management system to ISO 13485. GMED is a notified body designated under the European Union Medical Device Regulation (MDR). 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 is intended to provide clinicians with objective tissue perfusion data that may support treatment decision-making and patient monitoring. Read Also: Penny Stock Vistagen Analyst Highlights Caution after Anxiety Data Advancing Toward CE Marking The digital health company specializing in next-generation biosensor technology said it is actively working with GMED to complete the remaining MDR conformity assessment activities required for its Lumee Oxygen Platform. Completing these assessments would enable the issuance of the relevant MDR certificate, allowing Profusa to CE mark the Lumee Oxygen Platform. A CE mark indicates that a product distributed within the 27 EU member states adheres to rigorous safety, health, and environmental protection standards. Monitoring Tissue Oxygen Despite the progress made in the conformity assessment, Profusa noted that it cannot guarantee the timing or outcome of GMED’s ongoing evaluations or the exact timeline for the Lumee Oxygen Platform’s CE marking. The Lumee Oxygen Platform utilizes Profusa’s proprietary tissue-integrated biosensor technology for the continuous, real-time monitoring of tissue oxygen levels. In July, Profusa signed an Option Agreement to acquire G3 Vision Labs, Inc. and its subsidiaries, Med Screen Laboratories Inc., Dominion Diagnostics LLC, and Acutis Diagnostics Inc. G3’s 2025 sales are estimated to be approximately $111 million. If the option is exercised, the combined company will operate as a public diagnostics company with national CLIA-certified laboratories and recurring revenues from a diversified base of providers serving addiction treatment, pain management, and behavioral health. PFSA Price Action: Profusa shares were up 50.70% at $3.08 at the time of publication on Thursday. The stock is trading near its 52-week low of $1.58, according to Benzinga Pro data. Read Also: Vertiv Expands AI Data Center Cooling Push With New Acquisition Image via Shutterstock/ sbw18