CLEVELAND, Jan. 24, 2013 /PRNewswire-USNewswire/ -- Neurodevice firm SPR Therapeutics has received the CE mark for its Smartpatch system, a peripheral nerve stimulation (PNS) therapy for the minimally-invasive treatment of pain. The first indication to receive CE certification is for chronic shoulder pain. Additional pain indications in the orthopedic and rehabilitation markets are being pursed in clinical investigations.
"We will be using the CE mark to further develop clinical data and clinician advocacy in support of our shoulder pain indication through orthopedic, pain management, physical medicine and rehabilitation channels in Europe and to expand to other geographies in the future," said Maria Bennett, President and CEO of SPR Therapeutics. "Toward this end, we are in discussions with corporate strategic partners to commercialize Smartpatch outside the United States."
The CE Mark is the first market introduction for SPR's Smartpatch PNS platform technology, which is being developed to address a spectrum of pain indications affecting over 116 million Americans, including acute and chronic musculoskeletal pain. SPR is sponsoring FDA approved multi-center, randomized controlled clinical trials to support FDA market clearance for use of the Smartpatch system for treating post-stroke shoulder pain and post-amputation pain in the U.S.
The Smartpatch system is intended to be used for up to 30 days. SPR's clinical trials have reported that most patients have experienced longer lasting pain relief beyond the 30-day treatment period. The Smartpatch system uses a proprietary method of peripheral nerve stimulation to treat pain, with electrodes positioned in proximity to, but not directly contacting, peripheral nerves. SPR's pain therapy platform is non-narcotic, reversible, and has demonstrated significant pain relief in multiple studies."In addition to the significant body of clinical evidence using SPR's PNS therapy in the post-stroke shoulder pain population, the early data on the use of SPR's system in treating other types of chronic shoulder pain are promising," said Michael Hausman, M.D., the Robert K. Lippmann Professor of Orthopedic Surgery and Vice-Chairman of the Department of Orthopedics at Mount Sinai Hospital in New York City. "Smartpatch may fill a treatment gap for a minimally invasive alternative between pharmaceuticals or injections and major surgery." SPR's platform technology (an investigational device that is limited by U.S. law to investigational use) consists of two independent products for the treatment of pain; the Smartpatch system, now CE certified, and the fully-implantable MICROPULSE® system for long-term pain management. SPR's Micropulse investigational pain therapy device was featured in Bloomberg News as one of the top 16 recent medical devices in human augmentation.