Synapse Biomedical Announces the Early Completion of Enrollment in the FDA Post Approval Study for ALS Patients

News provided by

Sep 30, 2014, 08:30 ET

CLEVELAND, Sept. 30, 2014 /PRNewswire/ -- Synapse Biomedical Inc. (www.synapsebiomedical.com) announced today it has completed the enrollment of the post-approval study of its NeuRx DPS® System for ALS patients. The last patient needed to meet the FDA enrollment requirement was implanted over a month and a half ahead of schedule. The NeuRx DPS®, which is the only medical device approved by the FDA specifically for ALS patients, is a humanitarian device that obtained approval at the end of 2011 with the demonstration of safety and probable benefit. This post-approval study, validating the safety, is also intended to help identify the patient population that may benefit most from this therapy.

(Fact sheets, patient testimonial, product video and images: www.synapsebiomedical.com/news/media)

"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", said Anthony Ignagni, President and Chief Executive Officer. "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 technology originated at Case Western Reserve University and University Hospitals Case Medical Center(UHCMC) for spinal cord injured patients and was developed further by Synapse for ALS patients following the many inquiries from patients.

Raymond Onders, M.D., Chair of Surgical Innovation at UHCMC and Co-founder of Synapse Biomedical, Inc, recently published the final pilot results of DPS in ALS states, "DPS has a proven safe role in maintaining respiration in ALS patients with one of our initial pilot patients using DPS for 6 years without the need for invasive ventilation."

Robert Miller, M.D., Lead Principal Investigator with the Forbes Norris ALS Clinic at California Pacific Medical Center, said, "We are proud to have helped complete enrollment ahead of schedule for the Post Approval Study of the NeuRx Diaphragm Pacing System. The DPS is a novel therapeutic option for those diagnosed with ALS and we hope the PAS trial will help clarify its benefits."

The NeuRx DPS® is available now for ALS (http://www.synapsebiomedical.com/als/neurx-als.shtml) at U.S. and International sites or more information can be obtained by contacting Synapse Biomedical, Inc.

About NeuRx® Technology
NeuRx Diaphragm Pacing System® (DPS) is a four-channel, battery-powered neurostimulator with implanted electrodes. The device provides electrical stimulation to the muscle and nerves of the diaphragm.

The NeuRx DPS® received CE Marking (CE Registration #518356) on November 20, 2007 and is approved for treating patients with diaphragm dysfunction in the European Union.

The NeuRx DPS® received FDA approval for ventilator dependency from spinal cord injury on June 17, 2008. In Spinal Cord Injury (SCI), the NeuRx DPS® provides ventilatory support in patients with diaphragm dysfunction of neuromuscular origin. Diaphragm dysfunction can result in abnormal or absent respiration in patient populations of high-level spinal cord injury and other injuries or diseases affecting the neuromuscular respiratory pathways.

The NeuRx DPS® received FDA approval for treating chronic hypoventilation from ALS on September 28, 2011. The NeuRx DPS® has demonstrated that it can help people with ALS live longer and sleep better than the current standard of care, alone.

For more information on current indications for use, please visit www.synapsebiomedical.com/products/patientInfo.shtml

About Synapse Biomedical
Founded in 2002, Synapse Biomedical's mission is to commercialize our life transforming neurostimulation platform used to treat people with respiratory insufficiency. Synapse is based in Oberlin, Ohio, approximately 30 miles west of Cleveland. For more information, including fact sheets, frequently asked questions, high resolution images and broadcast quality video, please visit www.synapsebiomedical.com/news/media.

Logo - http://photos.prnewswire.com/prnh/20131113/CL14319LOGO

SOURCE Synapse Biomedical Inc.