Synapse Biomedical said today it won a GSA schedule 65IIA contract which will allow it to supply its NeuRX diaphragm pacing system to Veterans Affairs hospitals.
The Oberlin, Ohio-based company said the approval will allow it to place its NeuRx device, designed to provide electrical stimulation to the muscles and nerves of the diaphragm, in to the government’s electronic ordering system.
“This schedule opens doors for our company to continue to help veterans and service VA hospitals. Our unique device, the NeuRx DPS, will allow many veterans with spinal cord injury to replace or reduce their need for mechanical ventilation and its use in ALS has been shown to provide a survival benefit,” CEO Anthony Ignagni said in prepared remarks.
The company’s NeuRX system won FDA approval in 2008, and again in 2011, specifically for treating chronic hypoventilation from amyotrophic lateral sclerosis. The device has a Humanitarian Device Exemption for use in patients with high spinal cord injuries and for ALS patients with chronic hypo-ventilation.
Last October, Synapse Biomedical said it signed a development deal with Case Western Reserve University to commercialize its neurostimulation device.
The deal is being supported by a $3 million grant from the Ohio 3rd Frontier Innovation Platform Program, according to Synapse. Through the deal, Case Western, Synapse, The University of Tokyo and Valtronic match funding as commercialization moves forward, Synapse said.
Synapse will produce and market the system once CE Mark approval in the European Union, Japanese PMDA approval and FDA clearance are obtained, the company said.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.