Medical Device News

InspiraTM Technologies Receives Approval from Sheba Medical Center to Conduct Clinical Study of the HYLATM Blood Sensor

The clinical study is planned for Q1-2023 to be performed on patients undergoing open-heart surgery at Sheba Medical Center

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Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”), a company creating new acute respiratory care technologies, announced today that it has received approval by the Ethics Committee at Sheba Medical Center in Israel to conduct a clinical study of its HYLA blood sensor in patients undergoing open-heart surgery. The study is planned to commence in the first quarter of 2023.

The HYLA blood sensor is a non-invasive optical blood sensor being developed using machine learning based algorithms to measure blood parameters, intended to provide continuous measurements in real-time during extracorporeal procedures.

The HYLA blood sensor is being designed as a stand-alone or integrated device. Continuous and real-time measurements of key blood parameters will potentially provide alerts to physicians of sudden changes in a patient’s condition, enabling prompt medical intervention, as well as alerts relating to sudden changes in extracorporeal blood oxygenation circuit performance (i.e., blood clotting, gas supply failure, system dysfunction and blood recirculation). Early medical intervention may improve patient outcomes, reduce complications, and reduce associated costs.

The purpose of the clinical study is to assess the correlation of blood parameters measured by the HYLA blood sensor versus a standard blood gas analyzer results. As a prospective data collection clinical study, it is designed to integrate clinical research into the product development cycle.

Significance to the INSPIRA™ ART System and ALICE™ Device

The INSPIRA ART introduces a new mode of acute respiratory care by supporting a patient’s spontaneous breathing while they are awake and alert, potentially reducing the need for invasive mechanical ventilation. The ALICE is an extracorporeal blood circulation device designed to provide cardiac and pulmonary support. The HYLA blood sensor, as part of the INSPIRA ART system or ALICE Device, will allow for patient blood oxygenation while displaying continuous key blood measurements in real-time. This may empower medical teams’ patient monitoring capabilities.

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