‘’In a life and death situation,” stated a Miami Herald article just last month, “Covid patients struggle to find lifesaving ECMO machines.”

The pandemic may seem to be weakening, but too many Covid patients throughout the country are still connected to an ECMO device. Survival rates for patients on ECMO in the U.S. are estimated to be about 50%.

ECMO, extracorporeal membrane oxygenation, is an external device that provides oxygen to a patient’s blood and therefore allows a patient’s lungs to rest. 

The Covid-19 pandemic has exposed the disadvantages of invasive Mechanical Ventilation (MV) like the ECMO, which is associated with considerable medical risks and complications, further burdening the healthcare system with long hospital stays and high treatment costs. Mechanical Ventilation (MV), the standard of care since the 1950s, requires patients to be intubated, and placed in an induced coma. 

Early oxygen saturation elevation and stabilization are key in preventing the need for MV. A new and innovative direct blood oxygenation technology may provide a solution. Augmented Respiration Technology, (ART), developed by Inspira Technologies, tackles the increased global demand for long-term and short-term respiratory support and the surge in ICU admissions as a result of Covid-19. Even prior to Covid-19, approximately 20 million patients were treated annually with MV in ICUs around the world.

In the United States alone, approximately 40% of the 5.7 million patients admitted annually to ICUs are placed on MV. Respiratory insufficiency is not just Covid-related: the World Health Organization estimates that over 400 million people globally are affected.  Symptoms include shortness of breath, an inability to breathe, a bluish tint in the face, fingertips and lips, and confusion. In most cases, it may lead to death if not treated quickly.  

Determined to eliminate as many obstacles as possible as well as potential complications of the current standard of care, Inspira technology is able to elevate oxygen saturation levels while bypassing the lung; it increases gas exchange, and reduces ventilator-associated medical complications and lung injuries. Designed for use in the early stages of deteriorating respiratory failure while patients are awake and breathing spontaneously, ART’s components make it easy to use; it does not require an ICU infrastructure and reduces risks of bleeding, hemolysis, and thrombosis. From a healthcare perspective, Augmented Respiration Technology, slated for deployment in and outside of the ICU, will be affordable. 

“I believe that administering Extracorporeal Respiratory Support as early as possible will reduce the treatment time and the aggressiveness of mechanical ventilation and allow the lungs to heal a lot faster,” says Dr. Yigal Kassif, Chairman of the Israeli ECMO Society and Director of ECMO Service at Sheba Medical Center. “We now know that aggressive invasive mechanical ventilation, in addition to oxygenating the blood and removing CO2 effectively, also causes long-term damage to the lung tissue.” 

The development process involved the pre-clinical testing of several models and designs that focused on a gas exchange using low volumes of blood. Throughout 2020, more than 40 pre-clinical studies were performed by the veterinary team at LAHAV CRO in Israel to examine the feasibility of direct blood oxygenation to preempt the need for MV. 

Sheba Medical Center, ranked by Newsweek magazine as one of the top 10 hospitals in the world, announced the collaboration with Inspira back in February, and that the Intensive Care Unit (ICU) of the Department of Cardiac Surgery at Sheba Hospital would test Inspira’s Augmented Respiration Technology (ART) on Covid-19 patients.

“Within 60 seconds, patient oxygenation goes from critically low levels to normal or near-normal levels, in other words, remarkably improved oxygenation,” says Prof. Eli Gabbay, a respiratory physician, and respiratory disease specialist.“This device is a game-changer in the management of respiratory failure.”

Since 2018, the company has completed pre-clinical studies for the purpose of research and development. “We are targeting to deploy the first systems by the end of 2022.”

“ECMO is a last resort treatment for patients who are failing to respond or improve on mechanical ventilation. ART is designed to be used at an earlier stage, providing partial support and avoiding the consequences of aggressive mechanical ventilation,”Dr. Kassif adds.

The longer a patient is on a ventilator, the longer it takes to recover; patients may need assistance for weeks to months after leaving the hospital. Many of these patients have difficulty returning to work within the first year. In the age of Covid, these symptoms are even more aggravated and the consequences more dire.  In comparison to current MV methods, this new technology will potentially  reduce patients’ length of stay in ICU, their rehabilitation period in the hospital, and the chances of readmission.