PR83677

OBERLIN, Ohio, April 15, 2020 /PRNewswire=KYODO JBN/ --

-- TransAeris(R) Diaphragm Pacing System (DPS) Could Cut Mechanical Ventilation

Time by More Than 25%, Freeing up Vital Equipment, ICU Beds and Clinical

Resources.

Synapse Biomedical, Inc. (www.synapsebiomedical.com) has received FDA Emergency

Use Authorization for the emergency use of its TransAeris(R) 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.

Photo -

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Learn more at www.synapsebiomedical.com/covid-19

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(R) 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. For more information please visit www.synapsebiomedical.com.

The TransAeris(R) 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.

SOURCE: Synapse Biomedical, Inc.

CONTACT: U.S. Contact: Synapse Customer Service, info@synapsebiomedical.com,

Tel: 1-888-767-3770; O.U.S. Contact: Moustapha Diop, COO & Managing Director --

Synapse Biomedical Europe. mdiop@synapsebiomedical.com, Tel: +1-888-767-3770