Inspira Secures Vendor Approval from $12 Billion Revenue HMO (World’s 2nd Largest), Enabling Immediate ART100 Deployment

Core Insights - Inspira Technologies has received official approval from Clalit Health Services for the INSPIRA™ ART100 system, marking a significant commercial advancement for the company [1][4]. Commercial Activation - The approval allows the ART100 to transition from regulatory clearance to active commercial availability within Clalit, which serves approximately 4.9 million members [7]. - Clalit operates 14 major hospitals and over 1,600 clinics, providing access to one of the most sophisticated healthcare supply chains globally [7]. Validation of Clinical Value - The approval follows a rigorous technical and clinical review by the Professional Committee for Medical Equipment, confirming the ART100's safety and efficacy profile [7]. - This validation serves as a powerful reference case for Inspira Technologies as it accelerates commercialization efforts in the U.S. and other global markets [4]. Strategic Positioning - The CEO of Inspira Technologies emphasized that securing vendor status with Clalit is a definitive commercial inflection point, comparable to leading U.S. integrated systems like Kaiser Permanente [3]. - The company views this approval as a foundation for potentially long-term, high-quality revenue [4]. Product Overview - The INSPIRA™ ART100 system is FDA-cleared for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [5]. - The company is also developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake and breathing spontaneously [5].