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September 30, 2014

Synapse completes enrolment in FDA post-approval trial of NeuRx DPS system in ALS patients

US-based Synapse Biomedical has completed patient enrolment in its post-approval trial of its NeuRx Diaphragm Pacing System (DPS) system for the treatment of amyotrophic lateral sclerosis (ALS).

US-based Synapse Biomedical has completed patient enrolment in its post-approval trial of its NeuRx Diaphragm Pacing System (DPS) system for the treatment of amyotrophic lateral sclerosis (ALS).

The system is a four-channel, battery powered neurostimulator with implanted electrodes and it provides electrical stimulation to the muscle and nerves of the diaphragm.

NeuRx DPS is the only medical device approved by the US Food and Drug Administration (FDA) specifically for ALS patients.

This humanitarian device secured approval at the end of 2011 with the demonstration of safety and probable benefit.

"NeuRx DPS is the only medical device approved by the US FDA specifically for ALS patients."

The post-approval study, validating the safety, is also intended to help identify the patient population that may benefit most from this therapy.

Synapse Biomedical president and chief executive officer Anthony Ignagni said: "When we see the impact that this device can have for individual patients, we know that providing this supporting therapy is meaningful for ALS patients.

"Our FDA approval demonstrated the safety of the device and provided evidence of improvements in survival and sleep for these patients.

"It is our mission to make the NeuRx DPS available for the people with this devastating disease and to continue to advance the knowledge base of how and who to best use it in."

The NeuRx technology was originated at Case Western Reserve University and University Hospitals Case Medical Center (UHCMC) for spinal cord injured patients and further it was developed by Synapse for ALS patients.

UHCMC chair of Surgical Innovation and Synapse Biomedical co-founder Raymond Onders said: "DPS has a proven safe role in maintaining respiration in ALS patients with one of our initial pilot patients using DPS for six years without the need for invasive ventilation."

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