SPR’S Smartpatch® Percutaneous PNS System Receives Australian Regulatory Approval
Cleveland, Ohio (PRWEB) November 22, 2013 -- The Smartpatch percutaneous peripheral nerve stimulation (PNS) system has received regulatory approval for the treatment of chronic shoulder pain in Australia. Regulatory approval was granted by the Therapeutic Goods Administration (TGA), the Australian Government agency responsible for regulating medical devices. NDI Medical manufactures the Smartpatch system for its portfolio company, SPR Therapeutics, who will manage commercialization.
"We are looking forward to commercializing Smartpatch in Australia as the world’s first and only approved percutaneous PNS system for the treatment of chronic shoulder pain and to implementing and refining the market entry and physician training programs we will leverage in the United States following FDA clearance,” said Maria Bennett, President and CEO of SPR Therapeutics.
SPR's PNS technology platform is being developed to address a spectrum of acute and chronic pain indications. The Smartpatch PNS System is currently being evaluated in two U.S. multi-center, randomized controlled clinical trials to support FDA market clearance for use in shoulder pain and in neuropathic pain. The Smartpatch system uses a proprietary method of percutaneous peripheral nerve stimulation that has demonstrated significant pain relief and improvement in quality of life in multiple studies. Unique to SPR’s approach is that the majority of the patients in SPR’s clinical trials have reported pain relief that extends well beyond the 30-day treatment period.
“Prior to the development of Smartpatch, patients suffering from shoulder pain who could have benefitted from Peripheral Nerve Stimulation were unlikely to undergo the invasive surgical procedure required by previously available PNS systems,” said Dr. Marc Russo, MBBS, Director of the Hunter Pain Clinic in Newcastle NSW Australia, and Secretary of the International Neuromodulation Society. “Smartpatch’s percutaneous PNS approach fills a critical gap in the pain treatment continuum by offering a minimally invasive alternative to narcotics or more invasive surgery.”
About SPR™ Therapeutics
SPR™ Therapeutics (Stimulation for Pain Relief) is a medical device company that has developed a revolutionary and proprietary peripheral nerve stimulation therapy platform to addresses the critical unmet need for less invasive, longer lasting, and cost effective treatments for acute and chronic pain. SPR Therapeutics was formed in January 2010 as a portfolio company of NDI Medical, LLC. For more information, visit http://www.sprtherapeutics.com.
About NDI Medical
Founded in 2002, NDI is a hybrid venture capital and commercialization firm, and the only one focusing exclusively on innovative neurodevice technologies that address unmet needs with potential to provide significant returns to its investors. NDI is headquartered in Cleveland, Ohio with locations in North Carolina’s Research Triangle and Minneapolis, Minnesota. For more information, visit http://www.ndimedical.com.
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Bethany Hilt, Falls Communications, http://www.fallscommunications.com, +1 (216) 696-0229, [email protected]
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