Core Insights - Inspira Technologies announced positive results from its clinical study of the AI-powered HYLA blood sensor, achieving 96% accuracy for a key parameter compared to traditional blood test analyzers [2][3] - The HYLA technology aims to provide continuous, real-time blood monitoring without the need for blood draws, targeting multiple multi-billion-dollar market segments [1][5] - The company plans to submit for FDA approval in the second half of 2025, with the goal of deploying the technology in U.S. hospitals for data collection and post-market validation [4][6] Clinical Study Details - The clinical study involved 6 patients undergoing open-heart surgery, where the HYLA sensor was attached to monitor blood flow during the procedure [2][3] - The HYLA sensor demonstrated 92.3% accuracy in identifying oxygen deficiencies, showcasing its potential for early detection and personalized care [2][3] - Data from the clinical study will be used to enhance the AI algorithms and improve the accuracy of the monitoring system [2][3] Market Potential - The HYLA blood sensor targets the blood gas analyzer market, projected to reach $5.7 billion by 2030, and could strengthen Inspira's position in the $19 billion mechanical ventilation market [5] - The technology is designed for versatility across various clinical settings, including intensive care units and operating rooms, with applications in critical care monitoring and emergency medicine [5][6] Company Overview - Inspira Technologies focuses on developing innovative respiratory support and diagnostic technologies, with its flagship INSPIRA ART system aimed at revolutionizing critical care [6][7] - The company has received regulatory approvals for its INSPIRA ART100 system for cardiopulmonary bypass procedures in the U.S. and Israel [7]
Inspira Technologies Announces Positive Results from Clinical Study of HYLA Blood Sensor, Achieving 96% Accuracy