Thursday, September 20, 2012

SPR Therapeutics Receives FDA Approval For Pivotal Study Of SMARTPATCH Peripheral Nerve Stimulation System


CLEVELANDSept. 20, 2012 -- SPR Therapeutics, an innovator in the application of electrical stimulation to peripheral nerves for the relief of pain, has earned Investigational Device Exemption (IDE) approval from the Food and Drug Administration to initiate a multi-center, pivotal study of the SMARTPATCH Peripheral Nerve Stimulation (PNS) System for the treatment of post-stroke shoulder pain.  SPR Therapeutics is one of the growing number of neurotechnology firms in Cleveland, one of the regions recognized by the Neurotechnology Industry Organization (NIO) for spurring neurotech innovation.

According to the Post-Stroke Rehabilitation Outcomes Project, shoulder pain has been found to affect one third of post-stroke survivors, most describing their pain as moderate to severe.  "The SMARTPATCH PNS System has provided significant pain relief and improvement in quality of life in earlier studies, and if similar results are achieved in this pivotal trial, it will offer a much needed treatment for patients who have very limited options at present.  

Perhaps most interesting is that unlike any other neurostimulation technology I'm aware of, SMARTPATCH is designed to offer pain relief that persists even after the short-term therapy has ended.  SMARTPATCH holds the potential to alleviate debilitating shoulder pain and to provide an alternative to pain medications," said Dr. John Chae, professor of Physical Medicine and Rehabilitation at Case Western Reserve University and MetroHealth Medical Center.