Liberate Medical Announces PREVENT Study with $6.5M Grant Funding from the US DoD – Enrolls First Patients Globally

The PREVENT study is the pivotal clinical trial of the VentFree® Respiratory Muscle Stimulator and will support FDA regulatory clearance of VentFree

CRESTWOOD, KY 9 April 2024 – Liberate Medical is proud to announce the successful commencement of patient enrollment in the PREVENT trial, a pivotal clinical trial examining the VentFree Respiratory Muscle Stimulator. PREVENT is a randomized, sham-controlled, blinded trial that aims to demonstrate that VentFree reduces the duration of invasive mechanical ventilation in acute respiratory failure patients at risk of being difficult to wean.

The VentFree Respiratory Muscle Stimulator is the first and only non-invasive, breath-synchronized, neuromuscular electrical stimulator intended to reduce mechanical ventilation duration by improving expiratory muscle strength and cough. Reducing the time patients spend on mechanical ventilation should reduce the risks of prolonged mechanical ventilation, including hospital-acquired infections, deteriorated quality of life and death. The PREVENT trial follows two successful pilot randomized controlled trials that were completed in Europe and Australia. VentFree has FDA Breakthrough Device Designation, FDA Emergency Use Authorization in the US and CE marking in the European Union.

PREVENT is a global collaborative effort that plans to enroll 272 patients from 25 centers across the US, EU and Australia. The first patient enrolled globally was proudly achieved at the Prince of Wales Hospital in Sydney, Australia (PI – Dr. David Collins), with the Baylor College of Medicine in Houston, Texas (PI – Dr. Chris Howard), and Providence Regional Medical Center in Everett, Washington (PI – Dr. Jacob Glaser) leading the way as the first sites to enroll a patient in the United States. Liberate Medical extends its deepest gratitude and congratulations to these institutions for their commitment and swift implementation of the PREVENT study.

"The initiation of patient enrollment in the PREVENT trial is a landmark event for Liberate Medical and innovation in critical care medicine. We are immensely grateful for the support of the US Department of Defense, our team and our clinical partners across the world for their outstanding contributions to the successful initiation of this important trial" says Angus McLachlan, CEO Liberate Medical. “We especially want to thank the patients and their families for their participation in this trial.” 

“With the PREVENT trial, we are on the brink of improving the way we support critically ill patients. The expiratory muscles are a critical yet underappreciated component of respiratory health, and this trial will highlight their significance," says Dr. Leo Heunks, Professor of Intensive Care Medicine at Radboudumc and Co-Global Principal Investigator "As a long-standing collaborator with Liberate Medical, I am proud to be part of a trial that has the potential to change clinical care." 

Dr. Timothy Girard, Professor of Critical Care Medicine at the University of Pittsburgh and Co-Global Principal Investigator of the study, remarked, "The PREVENT trial is poised to provide invaluable insights into prevention of ventilator-induced complications. Our collaborative efforts, supported by the dedication of our participating sites, will potentially improve outcomes for mechanically ventilated ICU patients."

Funding

The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.

This work was supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $6,480,942, through the Peer Reviewed Medical Research Program under Award Number W81XWH2211123. Opinions, interpretations, conclusions, and recommendations contained herein are those of the author(s) and are not necessarily endorsed by the Department of Defense.

About Liberate Medical

Liberate Medical is a medical device company that develops neuromuscular electrical stimulation technology to improve the quality and reduce the cost of care for patients with pulmonary disorders. For more information, please visit https://liberatemedical.com.