Inspira™ Receives Israeli Regulatory Approval for the INSPIRA™ ART100 System

Core Viewpoint - Inspira Technologies OXY B.H.N. Ltd. has received approval from the Israeli Ministry of Health for its INSPIRA™ ART100 system, marking a significant milestone in the company's strategy to expand its market presence and develop innovative medical technologies [1][7]. Group 1: Product Approval and Features - The INSPIRA™ ART100 system is an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system that has received both Israeli AMAR approval and FDA 510(k) clearance [9]. - The INSPIRA™ ART (Gen 2), also known as INSPIRA™ ART500, features Adaptive Blood Oxygenation technology, designed to continuously measure blood parameters in real-time and deliver oxygen directly into the bloodstream, potentially allowing patients to remain awake during treatment [2][3]. - The approval of the INSPIRA™ ART100 is expected to facilitate hospitals' acquisition and use of this innovative technology, enhancing patient care [2][7]. Group 2: Strategic Implications - The receipt of Israeli regulatory approval is seen as a crucial step towards increasing local support and adoption of the INSPIRA™ ART100, showcasing the company's ability to secure regulatory approvals [7]. - The CEO of Inspira Technologies emphasized that the AMAR approval will help create business opportunities in new regions and emerging markets, following the earlier FDA approval [8]. - The company aims to reshape the respiratory and life-support landscape by developing novel technologies to prolong and improve the quality of life for patients [8].