In the world of critical care medicine, Israeli medical technology company Inspira Technologies is working to address one of healthcare's most persistent challenges: how to support patients with respiratory failure better. With approximately 20 million patients requiring intensive respiratory support annually and mortality rates exceeding 50% in severe cases using conventional mechanical ventilation, the need for innovation in this field is urgent.
Dr. Dekel Stavi, Medical Director at Inspira Technologies and Chairman of the Israeli ECMO Society, is helping lead this effort. As a senior intensive care physician who established the ECMO program at Tel Aviv Sourasky Medical Center, his expertise in respiratory support technologies is informing Inspira's development of alternatives to traditional mechanical ventilation.
"When we look at the data, we see that mechanical ventilation, while life-saving, often requires placing patients in medically-induced comas and can lead to serious complications like ventilator-associated pneumonia and lung injury," Dr. Stavi explained in our recent interview. "This has driven our team at Inspira to explore fundamentally different approaches to providing respiratory support."
Inspira Technologies, founded in 2018 and based in Israel, is developing technology that aims to deliver oxygen directly to the blood, potentially bypassing the need for conventional mechanical ventilation in certain cases. "Our approach focuses on direct blood oxygenation, which represents a significant departure from traditional ventilation methods that push air into the lungs," Dr. Stavi said. "The potential advantage is that patients might remain awake during treatment, which could reduce complications associated with sedation and intubation."
The company recently achieved a significant milestone last year with their INSPIRA ART100 system receiving FDA 510(k) clearance in 2024 for cardiopulmonary bypass procedures. Notably, this month, Inspira announced the successful system application of their first patient at Westchester Medical Center in New York.
"While the INSPIRA ART100 is currently cleared specifically for cardiopulmonary bypass, this first clinical use is an important step in validating the company's core technologies in real-world settings," Dr. Stavi noted. "It provides valuable insights that inform the ongoing development of respiratory support applications."
The company's flagship product in development is the INSPIRA ART500 system, which aims to provide respiratory support through direct blood oxygenation. In this system, which has not yet been regulatory approved or clinically tested, there are several key technologies, one of which has been designed to oxygenate blood with minimal damage.
Complementing this technology is the HYLA blood sensor, which recently showed promising results in clinical evaluation at Sheba Hospital, achieving 96% accuracy for a key parameter compared to traditional blood analyzers. "In critical care, continuous monitoring of blood parameters is essential," Dr. Stavi said. "Currently, clinicians rely on intermittent blood draws, which only provide periodic information. The HYLA sensor aims to offer continuous, real-time monitoring without repeated blood draws, potentially allowing for earlier detection of changes in patient condition."
Dr. Stavi emphasized that while these technologies show promise, they remain in various stages of development and evaluation. "The journey from concept to validated clinical application is always challenging and requires rigorous testing," he noted. "What's important, however, is that Inspira is committed to delivering on its mission, and I believe we are showing real progress, from regulatory clearance of the INSPIRA ART100, to R&D advancements of the HYLA and INSPIRA ART500."
For patients with acute respiratory failure, the stakes couldn't be higher. Current mortality rates for those requiring suffering from moderate to severe acute respiratory distress syndrome needing a ventilator are estimated at 30%–40%, according to multiple studies cited by the company. "These sobering statistics drive our work," Dr. Stavi said and concluded, "our long-term goal is to play a central role in improving outcomes for these critically ill patients, and we continue to take significant steps towards this."
