Liberate Medical’s VentFree™ Muscle Stimulator Receives Breakthrough Device Designation from the FDA to Reduce Mechanical Ventilation Duration

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.

“Breakthrough Device Designation is important recognition of the potential for the VentFree muscle stimulator to address a serious unmet medical need and will help us bring the device to patients as efficiently as possible.” said Angus McLachlan, PhD, CEO and co-Founder of Liberate Medical, “Patients requiring prolonged periods of ventilator support suffer from significant rates of mortality and clinical complications, both while in the hospital and after discharge, and cost the U.S. health care system about $20B per year. Our pilot trial, which has been selected for oral presentation at the ATS International Conference in May, provided an initial indication that the VentFree muscle stimulator may be able reduce the duration of ventilator support in these patients. In doing so, we believe that it has the potential to save lives, reduce morbidity and significantly reduce hospital costs.”

About Prolonged Mechanical Ventilation

Approximately 40% of mechanically ventilated patients require more than four days of ventilator support, and the number of these patients is increasing at 5.5% per year. Prolonged periods of 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 hospital survival decreases, and hospital mortality almost doubles in those patients who take more than 7 days to wean from ventilator support. Furthermore, patients surviving prolonged mechanical ventilation suffer from significant rates of one-year mortality and substantially reduced functional status​. In the U.S. the cost of caring for these patients is estimated to be almost $20 billion per year

About Liberate Medical and the VentFree Muscle Stimulator

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.


Liberate Medical Awarded Additional $500,000 by the National Science Foundation

Crestwood, Kentucky, 18 September 2018: The National Science Foundation awarded Liberate Medical a $498,366 Phase IIB Small Business Technology Transfer (STTR) grant to support the commercialization of company’s VentFree™ muscle stimulation technology.

Invasive mechanical ventilation commonly results in respiratory muscle dysfunction, which is a major underlying factor for patients requiring prolonged periods of ventilator support. These patients suffer from a wide range of clinical complications and represent a large cost to the health care system. The VentFree muscle stimulator is designed to prevent or reverse respiratory muscle weakness and, in turn, reduce mechanical ventilation days and hospital length of stay.

This funding is additional to the $749,408 Liberate Medical has already received and is intended to further the commercialization of the technology.

Liberate Medical’s CEO, Dr. Angus McLachlan, said, “Liberate Medical is delighted to have received this additional support from the National Science Foundation. The VentFree muscle stimulator is an exciting new treatment modality that could considerably improve patient outcomes and reduce provider cost. The development work we have completed to date has demonstrated the potential of this technology and this additional support will allow us to move the device closer to market.”

Small businesses can receive up to $1.5 million in funding from NSF. Companies must first have received a Phase I award (up to $225,000) to become eligible to apply for a Phase II grant (up to $750,000) to further develop and commercialize the technology. Small businesses with Phase II grants are eligible to apply for the Phase IIB matching grant (up to $500,000 in additional matching funds with qualifying third-party investment or sales). All proposals submitted to the NSF SBIR/STTR program undergo a rigorous merit-based review process. 

About Liberate Medical

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. Its proprietary technology uses electrical muscle stimulation to activate the expiratory muscles in synchrony with exhalation and is being developed to accelerate the process of weaning patients from mechanical ventilation (VentFree muscle stimulator), and to reduce shortness of breathing in patients with chronic obstructive pulmonary disorders (SecondBreath™ muscle stimulator). The VentFree muscle stimulator and the SecondBreath muscle stimulator are at this time investigational devices only and are not for sale in any country.

About the NSF’s Small Business Programs

America’s Seed Fund powered by NSF awards $200 million annually to startups and small businesses, transforming scientific discovery into products and services with commercial and societal impact. Startups working across almost all areas of science and technology can receive up to $1.5 million in non-dilutive funds to support research and development (R&D), helping de-risk technology for commercial success. America’s Seed Fund is congressionally mandated through the Small Business Innovation Research (SBIR) program. The NSF is an independent federal agency with a budget of about $7.8 billion that supports fundamental research and education across all fields of science and engineering. For more information, visit seedfund.nsf.gov.


Liberate Medical, LLC to present at the Digital Medicine and Medtech Showcase™ Annual Conference on January 10, 2018

Crestwood, KY, Jan. 04, 2018 – Liberate Medical, LLC, a clinical stage medical device company developing neuromuscular electrical stimulation devices to improve care for patients with pulmonary disorders, today announced that its CEO, Angus McLachlan, will present at the Digital Medicine and Medtech Showcase ™ 2018 on Wednesday, January 10, 2018 at 1.15 p.m. (PST) at the Hilton San Francisco Union Square.

The Digital Medicine and Medtech Showcase™, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

About Liberate

Liberate Medical develops neuromuscular electrical stimulation devices to improve the quality and reduce the cost of care for patients with pulmonary disorders. Its proprietary technology uses electrical muscle stimulation to activate the expiratory muscles in synchrony with exhalation, and is being developed to prevent breathing muscle atrophy in patients who are difficult to wean from mechanical ventilation (VentFree™ muscle stimulator), and to reduce shortness of breathing in patients with chronic obstructive pulmonary disorders (SecondBreath™ muscle stimulator).