BIEL, Switzerland--(BUSINESS WIRE)--STIMIT AG announced today it is enrolling patients in its FDA Investigational Device Exemption (IDE) clinical trial, “STIMIT ACTIVATOR 1 PIVOTAL STUDY,” with world renowned clinical centers. STIMIT’s initial therapy in its platform uses noninvasive diaphragm neurostimulation and is designed to preserve diaphragm thickness in patients who are on invasive mechanical ventilation (MV) and thus are at risk of diaphragmatic dysfunction/atrophy. The IDE study will evaluate the safety and effectiveness of the technology for this indication.
The diaphragm is our core breathing muscle and its fibers are lost by 50% in 3 days when patients on mechanical ventilators do not breathe on their own (Levine et al. 2008). Maintaining diaphragm activity is critically important to rapidly wean patients from mechanical ventilation (Morsy et al. 2015; Goligher et al. 2019), as patients on prolonged mechanical ventilation produce a massive cost of more than USD 16 billion in USA alone (Zilberberg et al. 2012).
STIMIT’s current trial and indication are evaluating whether the STIMIT technology preserves diaphragm thickness.
“STIMIT Activator represents the world's only early-intervention, completely noninvasive therapy undergoing an IDE study designed specifically for diaphragm stimulation which is intended to induce inspiratory efforts in critically ill patients,” said Dr. Laurent J. Brochard, MD, HDR, Principal Investigator (PI) of the study and Head of the Interdepartmental Division of Critical Care, University of Toronto. “Diaphragm activity and the physiological approach to breathing is of utmost importance for any ICU patient and for hospitals aiming to liberate their patients earlier in a better state.”
In a broader picture, diaphragm stimulation may have potential benefits at the interface to the lung (physiological pressure distribution), as well as the brain (activate and preserve cells in brain areas responsible for breathing), and the heart (venous backflow) (Morris et al. 2022), requiring further research.
“Our vision for STIMIT goes far beyond this initial therapeutic application under investigation,” explained Ronja Müller-Bruhn, CEO of STIMIT. “Our earlier feasibility trials with anesthetized, healthy, and critically ill patients showed promising data that the STIMIT technology could ventilate patients in the future… that is, to noninvasively support moving air in and out of the lungs using physiological diaphragm breathing of a patient. This, of course, has enormous potential for ventilation and critical care.”
Initial patients are being enrolled at Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard Medical School; Yale New Haven Hospital (YNHH), the primary teaching hospital for Yale School of Medicine; UVA Health University Medical Center, a teaching hospital of University of Virginia School of Medicine; and, St. Michael’s Hospital, a leading Canadian teaching and research hospital of Unity Health Toronto.
The STIMIT Activator 1 is limited by United States law to investigational use.
