Liberate Medical’s PREVENT Trial Enrollment is Complete

Liberate Medical has enrolled its last patient in the PREVENT pivotal trial, which is evaluating the ability of its VentFree Respiratory Muscle Stimulator in reducing mechanical ventilation duration in ICU patients.

“Completing enrollment of 250 patients in the PREVENT trial is a landmark milestone for Liberate Medical and for the field of critical care,” Liberate Medical CEO Angus McLachlan said. “The clinical and economic burden of prolonged mechanical ventilation is enormous—for patients, for families, and for health systems. We believe VentFree has the potential to transform ventilator weaning, and the PREVENT data will give us the evidence base to do that. We are grateful to the patients who participated, the clinical investigators who enrolled them, and the critical care teams at our trial sites around the world who made this possible.”

With the 250-patient, global multicenter PREVENT trial now fully enrolled, Liberate Medical plans to submit a De Novo application to the U.S. Food and Drug Administration (FDA) while building its commercial readiness—including adding senior commercial leadership—in preparation for anticipated U.S. market entry upon FDA authorization.

Mechanical ventilation is a life-sustaining intervention used in more than 800,000 ICU admissions annually in the United States. While essential, prolonged ventilation carries significant risks, including hospital-acquired infections, deteriorated quality of life, and death, imposing an estimated $45 billion annual burden on the U.S. healthcare system.

“There has long been a gap in our ability to address respiratory muscle weakness at the bedside while patients are still ventilated,” said Kimberly Rengel, assistant professor, Anesthesiology Critical Care, at Vanderbilt University Medical Center, and site principal investigator at the highest-enrolling U.S. site in the PREVENT study. “We look forward to integrating VentFree into our standard ICU weaning protocols once it receives FDA authorization. A technology that can improve respiratory muscle strength and cough has the potential to change how we approach ventilator weaning.”

“At Radboudumc, we have already incorporated VentFree into routine clinical care in our ICU under its CE mark,” added Tim Frenzel, M.D., intensivist at the Center of Expertise for Weaning of Mechanical Ventilation at Radboudumc, Nijmegen, the Netherlands, and site principal investigator at the highest-enrolling site in the PREVENT study. “The clinical rationale for respiratory muscle stimulation during mechanical ventilation is compelling, and our experience using VentFree in daily practice reinforces our confidence in this technology.”

Liberate Medical develops neuromuscular electrical stimulation technology to improve the quality and reduce care costs for patients with pulmonary disorders. The VentFree Respiratory Muscle Stimulator is reportedly the first and only non-invasive, breath-synchronized neuromuscular electrical stimulator designed to reduce mechanical ventilation duration by improving expiratory muscle strength and cough. VentFree has received FDA Breakthrough Device Designation, Emergency Use Authorization (EUA) from the FDA, and CE marking in the European Union.

This work was supported by the Assistant Secretary of Defense for Health Affairs, endorsed by the U.S. Department of Defense, for $6,480,942, through the Peer Reviewed Medical Research Program under Award No. W81XWH2211123.