Results Presented as an Oral Presentation
Crestwood, KY, May 21, 2019 – Liberate Medical, a clinical-stage medical device company, developing novel electrical muscle stimulation devices that non-invasively address pulmonary conditions, today announced the results from its recently completed pilot trial of the VentFree Muscle Stimulator during an oral presentation at the American Thoracic Society International Conference (“ATS”) in Dallas, TX.
The VentFree Muscle Stimulator, which received Breakthrough Device Designation from the FDA in January, is an electrotherapy device that applies stimulation to the abdominal wall muscles in synchrony with mechanical ventilation. It’s designed to prevent abdominal muscle atrophy and reduce the time to wean patients from mechanical ventilation.
The pilot trial, conducted in collaboration with Neuroscience Research Australia at the Prince of Wales Hospital, Sydney Australia was assessor blinded, randomized, sham-controlled and included twenty participants. The study demonstrated the feasibility of using the VentFree Muscle Stimulator with mechanically ventilated critically ill patients. No device related serious adverse events were reported and the results indicated that that the device may be able to reduce the duration of ventilator support in critically ill patients requiring prolonged mechanical ventilation. The abstract is available online at the American Thoracic Society website (https://www.abstractsonline.com/pp8/#!/5789/presentation/25886).
The study principal investigator, Dr. Euan McCaughey, Ph.D. commented: “We believe the results of this trial are highly encouraging and that the VentFree muscle stimulator by Liberate Medical has the potential to meaningfully improve clinical outcomes in these patients. We greatly look forward to the next phase of clinical studies.”
“Patients requiring prolonged mechanical ventilation have significant rates of illness and death, both while in the hospital and after discharge, and cost the U.S. health care system about $20B per year,” said Angus McLachlan, PhD, CEO and co-Founder of Liberate Medical. “The results from this successful pilot study support our belief that VentFree has the potential to save lives, reduce morbidity and significantly decrease hospital costs for these patients.”
About Prolonged Mechanical Ventilation
Approximately 40% of patients who need mechanical ventilation need it for more than four days, and the number of these patients is increasing at 5.5% per year. Prolonged mechanical ventilation can cause life-threatening complications including barotrauma, ventilator associated pneumonia, muscle atrophy and psychological conditions. With each day of ventilator support, the probability of dying in hospital increases, with the risk doubling in those patients who require mechanical ventilation for than 7 days. Furthermore, patients who survive prolonged mechanical ventilation are at a high risk of dying within one year after discharge and a suffer from a greatly reduced ability to perform normal daily activities. In the U.S. the cost of caring for these patients is estimated to be more than $20 billion per year.
About Liberate Medical
Liberate Medical is a clinical-stage 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.
About the VentFree Muscle Stimulator
Invasive mechanical ventilation commonly weakens the breathing muscles, increasing the need for further ventilator support. Current methods of respiratory muscle training cannot be used when patients are sedated or delirious, a common occurrence for critically ill patients. The VentFreeÔ Muscle Stimulator, which recently received Breakthrough Designation from the FDA, uses proprietary non-invasive electrical muscle stimulation technology to stimulate the expiratory muscles in synchrony with exhalation. This non-invasive approach, which does not rely on patient interaction and can be used throughout the process of mechanical ventilation, may provide a new way to prevent the atrophy of the breathing muscles that frequently occurs. In turn, this may allow patients to be weaned from mechanical ventilation sooner than would otherwise be possible. At this time, the VentFree muscle stimulator is an investigational device only and is not for sale in any country.