Synapse Biomedical Receives FDA Emergency Use Authorization for New System to Assist in Weaning Patients off of Ventilators During COVID-19 Pandemic

Synapse Biomedical, Inc. has received FDA Emergency Use Authorization for the emergency use of its TransAeris^® DPS, to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off of ventilators in healthcare settings during the COVID-19 pandemic for no more than 30 days.

The TransAeris system addresses this issue by conditioning a patient’s diaphragm to reduce/avoid VIDD. Models suggest the technology—which recently received CE Mark approval and is under clinical investigation in the U.S - could reduce ventilator burden in COVID-19 patients by 26 percent, helping to free up more ventilators in a time of great demand.

During the COVID-19 pandemic, the surge of patients requiring prolonged mechanical ventilation (PMV) has put an unprecedented demand on hospital and ICU resources. Even when their primary symptoms have stabilized, these PMV patients are still at risk for developing ventilator-induced diaphragm dysfunction (VIDD)--further prolonging their ventilation.

The TransAeris system addresses this issue by conditioning a patient's diaphragm to reduce/avoid VIDD. Models suggest the technology--which recently received CE Mark approval and is under clinical investigation in the U.S - could reduce ventilator burden in COVID-19 patients by 26 percent, helping to free up more ventilators in a time of great demand.

"More than 2,000 patients have been successfully treated world-wide with our diaphragm, pacing technologies," said Anthony Ignagni, President & CEO of Synapse Biomedical. "We welcome the FDA's leadership in providing this emergency pathway to get our latest TransAeris device into the hands of clinicians so they can help as many COVID-19 patients as possible during this pandemic."

"Trauma and high-risk surgical and cardiac patients will continue to require ICU beds and ventilators that are also needed for COVID-19 patients," said Raymond P. Onders MD, FACS, Chief of General Surgery, University Hospitals Cleveland Medical Center and Professor, Case Western Reserve University School of Medicine. "In our case, utilizing TransAeris for high risk surgical and COVID-19 patients is protecting the supply chain of ventilators, ICU beds and clinical resources by reducing the time spent on mechanical ventilators by patients at risk or experiencing prolonged mechanical ventilation."

TransAeris builds on the success of another Synapse Biomedical technology, the NeuRx® Diaphragm Pacing Stimulation (NeuRx DPS) System, which has been FDA and CE Mark approved since 2008 for people with Spinal Cord Injury (SCI) and has successfully reduced or eliminated the need for mechanical ventilation. TransAeris was created to assist patients with prolonged mechanical ventilation on a temporary basis up to 30 days, simplifying the external features of the NeuRx DPS system and distilling them into a single patient, 30-day use, disposable device. Since then, several centers in Europe, including BGU Murnau (Germany), have also used TransAeris successfully in acute spinal cord injury and polytrauma patients.

About Synapse Biomedical, Inc.: Founded in 2002, as a spinout from Case Western Reserve University and University Hospitals of Cleveland, Synapse Biomedical's mission is to provide life transforming treatments through the commercialization of neurostimulation platforms and build a sustainable enterprise on the foundation of scientific & clinical findings that will provide meaningful value to patients, employees, community, and shareholders. Synapse is headquartered in Oberlin, Ohio and has a European Office in Enghien les Bains, France.  

The TransAeris® Diaphragm Pacing System (DPS) has neither been cleared or approved for the indication to assist in weaning patients off ventilators in healthcare settings during the COVID-19 pandemic. TransAeris DPS has been authorized for the above emergency use by the FDA under an EUA. TransAeris DPS has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the TransAeris DPS under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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