We Announce our Role as Regulatory Advisor to Liberate Medical on their Emergency Use Authorization of VentFree™
Alira Health’s Regulatory practice supported the authorization of the emergency use of VentFree™ by FDA under the Emergency Use Authorization.
FRAMINGHAM, MASSACHUSETTS – MAY 6, 2020 – Alira Health (www.alirahealth.com), a leading international healthcare and life sciences advisory firm, supported Liberate Medical, a clinical/commercial-stage medical device company, in their Emergency Use Authorization from the Federal Drug Administration (FDA) for the VentFree™ Respiratory Muscle Stimulator. Alira Health’s Regulatory team, led by Alira Health’s Mary McNamara-Cullinane, Senior Vice President, Regulatory Affairs, provided guidance and regulatory support to Liberate Medical, including developing a regulatory pathway and submission, and liaising with the FDA throughout the emergency use approval process.
“We are grateful to the FDA for recognizing the potential of VentFree™ and feel privileged to help patients on mechanical ventilation during the COVID-19 pandemic,” said Angus McLachlan PhD, co-founder and CEO of Liberate Medical. “We also thank the Alira Health team for their support in gaining this authorization for VentFree™.”
The VentFree™ Respiratory Muscle Stimulator is a non-invasive and breath-synchronized electrotherapy device that may reduce ventilation duration during the COVID-19 pandemic. Using proprietary, non-invasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, VentFree™ enables treatment to begin from the early phase of mechanical ventilation and continue until the patient is successfully weaned.
“We are proud to support the team at Liberate Medical in receiving this Emergency Use Authorization, and to help them more rapidly impact patient care during this challenging time,” said Mary McNamara-Cullinane. “Our Regulatory practice is currently working on several Emergency Use Authorization submissions, helping companies to quickly put lifesaving products into the hands of providers across the globe.”
About Liberate Medical:
Liberate Medical is a clinical / commercial 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.