The non-narcotic, reversible system stimulates nerves using electrodes placed in proximity of peripheral nerves and provides relief from acute and chronic musculoskeletal pain.
The company said that the device, which is intended to be used for up to 30 days, fills a treatment gap for a minimally invasive alternative between pharmaceuticals or injections and major surgery.
During the company’s clinical studies, PNS device has showed significant pain relief beyond the 30-day treatment period.
The company will use the CE mark to further develop clinical data and clinician advocacy in support of shoulder pain indication through European orthopedic, pain management, physical medicine and rehabilitation channels, and to expand to other geographies in the future.
Clinical investigations on additional pain indications in the orthopedic and rehabilitation markets are also being carried out, claims the company.
SPR Therapeutics president and CEO Maria Bennett said, "Toward this end, we are in discussions with corporate strategic partners to commercialize Smartpatch outside the United States."
To further support FDA market clearance for the use of device in the US for treating post-stroke shoulder pain and post-amputation pain, the company is sponsoring multi-center, randomized controlled clinical trials.
