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Tuesday, December 26, 2023

Inspira 95% Accuracy Results for HYLA™ Blood Sensor, Planning FDA Submission

 Inspira Technologies OXY BHN Ltd. (NASDAQ: IINN) (NASDAQ: IINNW) (the "Company" or "Inspira"), a pioneer in life support technology with a vision to supersede traditional mechanical ventilators, today announced a significant advancement in its sensor technology by its team of experts. This breakthrough, in achieving 95% accuracy compared to standard blood gas analyzers, brings continuous and real-time blood monitoring capabilities compared to traditional blood gas analyzer systems used in hospitals that typically require intermittent blood draws. This advancement signals Inspira's potential entry into the disposables market. 

The development of the first HYLA™ variant, key to this advancement, marks a significant step towards its submission under a 510(k) pathway with the U.S. Food & Drug Administration ("FDA"), which is expected in the second half of 2024. This sensor technology is designed to be integrated with the Company's INSPIRA ART100 and was submitted to the FDA in September 2023, with clearance anticipated in the first half of 2024. 

The HYLA™ Blood Sensor line (the "Blood Sensor") is set to transform intensive care unit (ICU) operations, offering continuous, real-time blood data collection and analysis. This enhances patient care with critical insights and alerts, with the aim to improve medical procedures and device efficiency.

https://www.prnewswire.com/news-releases/inspira-announces-95-accuracy-results-for-hyla-blood-sensor-planning-fda-submission-for-clearance-in-2024-302022344.html

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