May 6, 2020
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.
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.
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