Novel Extracorporeal Oxygenation System Could Become First Respiratory Device to Substitute Mechanical Ventilation

A novel low-flow early extracorporeal blood oxygenation system intends to offer acute respiratory patients, who continue to deteriorate following non-invasive ventilation treatment, creating a new alternative to invasive mechanical ventilation.

Inspira Technologies (Ra'anana, Israel) has filed a Patent Cooperation Treaty (PCT) patent application for its novel ART device and its proprietary methods of use to minimize the need for invasive mechanical ventilation which requires intubation and induced coma. Despite the fact that, at the non-invasive ventilation treatment stage, these patients are still breathing spontaneously, the only alternative treatment available to them after non-invasive ventilation has failed is invasive mechanical ventilation.

The ART is designed to enrich approximately 1-1.5 liters of blood in a minute to rebalance oxygen saturation levels in minutes. The ART device utilizes a hemo-protective flow approach intended to increase blood oxygenation levels and remove CO2 to potentially prevent invasive mechanical ventilation and minimize the risks and complications associated with this type of treatment. The ART device, a novel extracorporeal oxygenation system, is being developed for treatment of patients in order to maintain spontaneous breathing. This initiates a circulation rate of 30 ml/Kg per minute that is significantly lower than the circulation rate used in extracorporeal membrane oxygenation (ECMO) that ranges between 60-80 ml/kg/min for veno-venous ECMO and 50-60 ml/kg/min for veno-arterial ECMO.

ART is being mechanically engineered and designed to optimize the safety profile of low flow extracorporeal treatment due to the reduction of shear forces on the blood, therefore contributing to reducing hemolysis and blood clotting. These methods of use and mechanical design are intended to provide a safe profile of treatment potentially resulting in the prevention or minimization of mechanical ventilation and all its associated damages to the patient lung and his/her overall survival; and reduction of bleeding and occurrences of infection due to a single cannula insertion point.

In addition, the ART is designed to allow deployment and utilization in hospitals without prior extracorporeal membrane oxygenation (ECMO) experience. A novel design minimizes the need for a perfusionist because a "plug and play" disposable cartridge minimizes the need for a perfusionist to assemble disposable parts prior to utilization; and an auto-priming system eliminates the need for a perfusionist required today for priming ECMO systems. Additional potential advantage of ARTs' auto priming system includes the prevention of human errors and ensures a safe, emboli-free connection to the patient's vascular system.

"The PCT patent application for our ART device - the first respiratory device to potentially substitute mechanical ventilation, designed for deployment and use both in and outside of the ICU," said Dagi Ben-Noon, Inspira Technologies' Chief Executive Officer. "ART's safety profile design is targeted to allow for an early extracorporeal intervention aimed to prevent mechanical ventilation while also offering a cost-benefit solution from a payor perspective."

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