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HYLA™ Blood Sensor by Inspira™ Achieves 95% Accuracy; Plans FDA Clearance Submission in 2024

Wednesday, December 27, 2023

Inspira Technologies, a leader in life support technology striving to surpass conventional mechanical ventilators, has revealed a significant breakthrough in sensor technology. This latest achievement, driven by the company's team of experts, showcases an impressive 95% accuracy when compared to standard blood gas analyzers. This advancement enables continuous and real-time blood monitoring, distinguishing it from traditional hospital blood gas analyzer systems that rely on intermittent blood draws. This notable progress positions Inspira for potential entry into the disposables market.

The introduction of the inaugural HYLA™ variant, pivotal to this technological leap, represents a major step toward its anticipated submission under a 510(k) pathway with the U.S. Food & Drug Administration (FDA) in the latter part of 2024. The HYLA™ Blood Sensor line, designed to transform intensive care unit (ICU) operations, provides continuous, real-time blood data collection and analysis. This innovative approach aims to improve patient care by delivering critical insights and alerts, ultimately enhancing the efficiency of medical procedures and devices.

Key features of the Blood Sensor include its impressive 95% accuracy relative to standard blood gas analyzers, non-invasiveness eliminating the need for blood draws, durability suitable for ICU and operating room environments, versatility in compatibility with various medical procedures, and a modular design crafted to complement existing medical devices. The Blood Sensor specifically targets the two million annual open-heart surgery patients globally, offering a solution to enhance medical procedures and device efficiency.

In developing the HYLA™ Blood Sensor line, Inspira adopts a comprehensive approach, utilizing in-house lab testing and collaborations with hospitals for clinical research and development. This strategy has facilitated the definition of the Blood Sensor's disposable materials and methods, aligning with HYLA's planned razor blade business model. Although initially designed for INSPIRA ART devices, there are plans to introduce a variant of the Blood Sensor as a standalone device.