Tuesday, July 12, 2022
Inspira™ Technologies OXY B.H.N. Ltd. introduces today the "Liby™" System, an advanced form of life support better known by the medical industry as extracorporeal membrane oxygenation (ECMO), used to treat patients with life-threatening heart and lung failure. The Liby™ System is intended to target the $531million global ECMO market. The Inspira Technologies Liby™ system currently under development, is expected to be submitted to the U.S. Food and Drug Administration (FDA) for approval, during the first half of 2023.
The Inspira Technologies Liby™ system is designed to be a new generation ECMO system, with potential advantages that may improve usability and patient care. The Liby™ system is also expected to be the first system designed for integration with the Company's recently revealed non-invasive HYLA™ blood sensor technology. The addition of the HYLA to patients treated with the Liby™ system, would potentially allow for the real-time and continuous monitoring of patient condition to alert physicians of immediate signs of changes in a patient's clinical condition
The Liby™ system includes several Inspira Technologies developed features and capabilities as well as a new approach to medical device designs, including a large touchscreen and novel colorful graphical representation that increases the visibility, scope and functionality of data displayed to the medical staff. With its small footprint and lightweight characteristics, the Liby™ system is being designed with a rapid style aerospace-grade aluminum structure to be both lightweight and highly durable, and will be equipped with long battery life, a contributing factor to making the Liby™ system suitable for patient mobility within hospitals and for transportation of patients to hospitals in ambulances.
The Liby™ system is expected to be submitted to the FDA for approval during the first half of 2023. Subject to FDA approval, the Liby™ system's expected regulatory pathway is intended to be designated as a Class II 510 (K), meaning it may not require human trials.