Synapse Biomedical Receives $2.4 Million

Supports Next Generation of NeuRx^® Platform

CLEVELAND, Dec. 18, 2013 /PRNewswire-USNewswire/ -- Synapse Biomedical Inc. (www.synapsebiomedical.com) announced today it has been awarded approximately $2.4 million in funding from Ohio Third Frontier Commission to support the next generation design and development of the NeuRx^® technology to expand its indications for use in managing critical care patients with respiratory  insufficiency.

(Logo: http://photos.prnewswire.com/prnh/20131218/DC35499LOGO)

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

"This is an important award for Synapse Biomedical which will significantly accelerate timing of our next clinical trial. We anticipate the NeuRx^® and Transloc^® technology will lead to a reduction in length of stay (LOS) and improved outcomes for critical care patients.  This support from the Ohio Third Frontier Commission is an important third component in our public, academic and private partnership to make these devices available," said Anthony Ignagni, President and Chief Executive Officer. The technology originated at Case Western Reserve University for spinal cord injured patients and was then developed further by Synapse for ALS and now critical patients.

According to US Department of Health and Human Services 2011 report, over 1.6 million people each year are intubated with mechanical ventilation which results in more than 110,000 people requiring invasive tracheostomy and extended ventilator support.

"Up to 20% of patients who receive mechanical ventilation in the Surgical Intensive Care Unit (SICU) can have difficulty weaning from a ventilator, so the impact of the results of this clinical trial will be significant.  The cumulative effect of mechanical ventilation and the link to ventilator acquired pneumonia are well documented," said Dr. Raymond Onders, co-founder of Synapse Biomedical and Margaret and Walter Remen Chair in Surgical Innovation at University Hospitals Case Medical Center.

A positive end result of the trial will impact intensive care unit management of mechanical ventilation at Acute Care Hospitals.  The NeuRx^® technology should lead to a reduction in the cost of care of these ventilated patients as they are the leading costs in the U.S. Healthcare system at $81 billion, according to the Department of Health and Human Services 2011 report.

"In our clinical trial we will collaborate with thought-leading surgeons and critical care physicians in major academic research institutions (www.synapsebiomedical.com/als/usneurx-centers.shtml).   It's very exciting news for our existing customers who have been requesting access to this application for years," said Steven Annunziato SVP Marketing and Sales.

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.

About OHIO Commercial Acceleration Loan Fund
The Commercial Acceleration Loan Fund (CALF) is an Ohio Third Frontier program providing early-stage funding to investment-validated Ohio companies to develop next generation products and services. The program seeks to support companies and technology platforms that represent a potential path to growth, market entry and/or entering the regulatory approval process within three to five years.

SOURCE Synapse Biomedical Inc.