Inspira Technologies Reports Pivotal Results For HYLA Blood Sensor, Achieving 97.35% Accuracy In Latest Performance Testing Phase That Will Support Upcoming FDA Submission

Author: Benzinga Newsdesk | September 11, 2025 09:32am

Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ:IINN) ("Inspira," "Inspira Technologies," or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in its latest performance testing phase that will support its upcoming U.S. Food and Drug Administration ("FDA") submission. These results represent a significant advancement from the initial data obtained in a clinical study, as announced on March 4, 2025.

The clinical study from March, conducted at a medical center ranked among the world's leading hospitals, provided validation for HYLA's performance, while these latest test results confirm the device's readiness for the regulatory pathway in the U.S. and Europe.

Key features of the HYLA Blood Sensor include:

• High Accuracy: Achieves 97.35% accuracy relative to standard blood gas analyzers.
• Continuous Monitoring: Provides second-by-second data, eliminating the need for intermittent blood draws.
• Non-invasive Technology: Utilizes optical measurement, operating without drawing blood from the patient.
• Versatility: Compatible with various medical procedures, including cardiopulmonary bypass, extracorporeal membrane oxygenation, continuous renal replacement therapy, and dialysis.
• Modular Design: Engineered to complement existing medical devices, targeting the two-million annual open-heart surgery patients globally.

While primarily designed for integration with Inspira's ART device line, the HYLA sensor is also being developed as a standalone device. This positions the HYLA platform to penetrate the broader disposables market, leveraging a planned razor-and-blade recurring revenue model.

Posted In: IINN