Core Insights - Inspira Technologies has successfully validated its Next-Generation Standalone HYLA™ System, which is designed to operate independently of its existing respiratory support devices, allowing entry into the $50 billion heart-lung surgery market upon clearance [1][4] Group 1: Product Validation and Performance - The HYLA™ optical sensor achieved a 94.2% accuracy in tracking the Partial Pressure of Carbon Dioxide (pCO₂), aligning with clinical needs and demonstrating concordance with gold-standard blood gas analyzers within a 7 mmHg threshold [2][3] - This system provides continuous, non-invasive monitoring of a patient's metabolic status, potentially reducing complications during heart-lung machine and ECMO procedures by eliminating the need for intermittent blood draws [2][3] Group 2: Strategic Market Positioning - By decoupling the HYLA™ sensor from existing life-support hardware, Inspira Technologies is advancing a standalone system that can integrate into any operating room or ICU workflow, significantly expanding its total addressable market [3] - The company is pursuing a high-margin, recurring revenue model through the sale of disposable optical sensors and modular software upgrades, enhancing its long-term growth prospects [3][4] Group 3: Future Plans and Industry Engagement - The CEO of Inspira Technologies indicated that the validation confirms the technology operates at a clinical grade, enabling faster market entry and serving a large global installed base of perfusion systems [4] - The company is moving towards a planned FDA regulatory submission process in 2026, focusing on extracorporeal procedures as an immediate commercial opportunity [4]