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Bioness Initiates Study of Neuromodulation System for Chronic Peripheral Nerve Pain
Date:4/9/2012

VALENCIA, Calif., April 9, 2012 /PRNewswire/ -- Bioness Inc. today announced the initiation of a study to evaluate the safety and effectiveness of the company's StimRouter™ Neuromodulation System for those suffering from chronic peripheral nerve pain. This prospective, multi-center, randomized, double-blinded, partial crossover study will enroll 126 patients at up to 10 study sites throughout the United States. About 20 million individuals in the United States suffer from chronic peripheral nerve pain, and current treatments include non-localized therapies such as spinal cord stimulation and the use of systemic pain medication.

"Chronic peripheral nerve pain can have a dramatic impact on a patient's quality of life, and historically we have had few treatment options other than the use of pharmaceutical therapy – most often narcotics, which affect the whole body and have many undesirable side-effects," said Timothy Deer, MD, the study's medical monitor and pain management specialist at The Center for Pain Relief at Saint Francis Hospital in Charleston, West Virginia. "The StimRouter could potentially provide - for the first time - a non-pharmaceutical treatment option that can be targeted directly to the pain site for more focused pain relief. The results of this study could have a significant impact on the way we treat patients with peripheral nerve pain."

The StimRouter System is designed to relieve chronic neuropathic pain of peripheral origin. The device consists of an implanted lead that delivers low-level electrical impulses directly to the nerve that carries the pain signal. The External Pulse Transmitter (EPT), worn outside the body, sends electrical signals through the skin to the implanted lead. The EPT has the capability of storing stimulation programs to provide patients with a variety of treatment options depending on their activity or level of pain.

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SOURCE Bioness Inc.
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