Crestwood, KY, 24th January 2019 – Liberate Medical, a clinical stage medical device company, focused on the development of novel non-invasive neuromuscular electrical stimulation devices to address pulmonary conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's VentFree muscle stimulator. The proposed indication for the device is preventing breathing muscle atrophy and reducing the number of days of ventilator support in adults who require mechanical ventilation.
The Breakthrough Device program is intended to expedite the process of bringing to market devices, for which no approved or cleared alternative exists, or that offer significant advantages over existing alternatives, and that treat life-threatening, or irreversibly debilitating, diseases or conditions. The benefits of the program include priority review for regulatory submissions and the opportunity for regular and interactive engagement with the FDA to facilitate the efficient clinical and technical development of the device. Since the program started in late 2016, only 110 devices have received the designation. Liberate Medical believes that it is the first KY company to have received the Breakthrough Device Designation.
Liberate Medical is a clinical-stage medical device company that develops neuromuscular electrical stimulation devices to improve the quality and reduce the cost of care for patients with pulmonary disorders.
Invasive mechanical ventilation commonly results in respiratory muscle weakness, which is a major underlying factor for patients requiring prolonged periods of ventilator support. Current methods of respiratory muscle training cannot be used when patients are sedated or delirious, as is common during mechanically ventilation in the ICU. The VentFree muscle stimulator uses proprietary non-invasive electrical muscle stimulation technology to activate 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 novel solution to prevent respiratory muscle atrophy. 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.
Liberate Medical was a participant in XLerlateHealth healthcare accelerator. The development of the VentFree muscle stimulator has been supported by grants from the National Science Foundation and KY Cabinet for Economic Development.