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Synapse Biomedical Receives FDA Approval of NeuRx Diaphragm Pacing System (DPS)(TM) For Spinal Cord Injury Breathing Applications
Date:6/18/2008

NeuRx DPS(TM) Allows Patients To Breathe Without Ventilator

Clinical Trials Also Underway For ALS Patients

CLEVELAND, June 18 /PRNewswire/ -- Synapse Biomedical Inc. (http://www.synapsebiomedical.com) announced today it has received approval from the U.S. Food and Drug Administration (FDA) for its NeuRx DPS(TM) for ventilator-dependent Spinal Cord Injury (SCI) patients who lack voluntary control of their diaphragms. With the FDA's approval, SCI patients and their caregivers throughout the U.S. can now access this technology that was previously only available to clinical trial participants.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080618/CLW020 )

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

The device implanted through minimally invasive laparoscopic surgery, provides electrical stimulation to muscle and nerves that run through the diaphragm. When stimulated by the NeuRx DPS(TM), the diaphragm contracts, mimicking natural breathing, and allows air to fill the upper and lower parts of the lungs rather than forcing air in with a mechanical ventilator.

The NeuRx DPS(TM) received the CE Mark (CE Registration #518356) on November 20, 2007 and is approved for treating patients with diaphragm dysfunction in the European Union. Seven successful implants have occurred at leading European hospitals including: Charite - Univeritatsmedizin (Berlin); Groupe Hospitalier Pitie-Salpetrier (Paris) and Institut GUTTMANN - Hospital De Neuro Rehabilitacio (Barcelona) since that date.

The FDA decision was completed after clinical testing, which began with clinical trials starting in 2000 under Investigational Device Exemption #G920162.

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SOURCE Synapse Biomedical Inc.
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