SPR Therapeutics, LLC Receives FDA Approval for Pivotal Study of SMARTPATCH™ Peripheral Nerve Stimulation System
9/20/2012 11:07:01 AM
CLEVELAND, Sept. 20, 2012 /PRNewswire-USNewswire/ -- 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.
The SMARTPATCH PNS System utilizes a single percutaneous lead wire connected to a small skin-mounted stimulator to provide peripheral nerve stimulation for up to 30 days. The lead wire is withdrawn and the stimulator removed at the end of the treatment. SMARTPATCH has shown promising results in multiple clinical studies to date, including a recent publication in Pain Practice, a journal of the World Institute of Pain. In this study, all participants tolerated the treatment well, experienced significant pain relief and improvement in quality of life and averaged a 63 percent reduction in pain at twelve weeks following the end of treatment. The potential for pain relief benefits that extend past the course of treatment distinguish the SMARTPATCH PNS System from other neurostimulation therapies.
"Our studies thus far suggest that significant pain relief may be achieved and that it may continue after the short-term therapy has ended," said Maria Bennett, president and CEO of SPR Therapeutics. "The FDA approval to proceed with the pivotal trial gives us the opportunity to gather additional data from this randomized, double-blinded, placebo-controlled study to evaluate pain relief and other potential benefits of the SMARTPATCH PNS System and to seek FDA clearance. We are excited to get this study underway and to make the therapy available to patients."
The SMARTPATCH PNS System offers a medical device pain relief therapy that has the potential to be an alternative to pain medications, and their accompanying side-effects. The pivotal study will evaluate the safety and effectiveness of this promising therapy for those suffering from chronic pain.
SPR Therapeutics will soon initiate a recruitment campaign to enroll study participants in the following cities:
- Charlotte, North Carolina
- Chicago, Illinois
- Cleveland, Ohio
- Columbus, Ohio
- New York, New York
- Philadelphia, Pennsylvania
- West Orange, New Jersey
Individuals interested in being considered as candidates for the study are encouraged to call 888-755-7090 or to visit www.painafterstroke.com.
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 address critical unmet needs for less invasive, longer lasting and cost effective treatments for acute and chronic pain. The SMARTPATCH PNS is also currently being investigated in clinical studies for additional pain indications. SPR Therapeutics was formed in January 2010 as a portfolio company of NDI Medical, LLC, a leading commercialization firm that focuses on innovative neurodevice technologies to address significant unmet health conditions. For more information, visit www.sprtherapeutics.com.
SOURCE SPR Therapeutics