Synapse Biomedical

Synapse Biomedical is a medical device company based in Oberlin, Ohio, that developed the NeuRx Diaphragm Pacing System (NeuRx DPS), a device designed to help patients with spinal cord injuries breathe without relying on mechanical ventilation. The NeuRx DPS is a battery-powered device that delivers electrical stimulation via four percutaneous intramuscular electrodes implanted into the diaphragm through minimally invasive laparoscopy. It is intended for use in patients with stable spinal cord injuries with stimulatable diaphragms but who lack control of their diaphragms.

The NeuRx DPS provides negative pressure ventilation, mimicking the body's natural breath cycle, in contrast to the positive pressure (forced air) of mechanical ventilators. It allows patients aged 18 and older to breathe without the assistance of a mechanical ventilator for at least four continuous hours a day, with many patients using the device for up to 24 hours per day.

Pioneered by Raymond Onders, MD, Chair of Surgical Innovation at University Hospitals Cleveland Medical Center, and J. Thomas Mortimer, Emeritus Professor of Biomedical Engineering at Case Western Reserve University, the NeuRx DPS was first implanted in a prospective clinical investigation in 2000. It has since been proven effective in over 2,500 patients worldwide, including actor Christopher Reeve, who was one of the first recipients.

In April 2023, the NeuRx DPS received premarket approval (PMA) from the FDA, the most stringent type of device marketing application required by the agency. This approval is expected to increase access to the device, as hospitals no longer need to undergo a lengthy internal review and approval process required under the previous humanitarian device exemption. The company has stated that it is currently stimulating over 10,000,000 breaths per day for spinal cord injured patients worldwide who cannot breathe on their own.