SPR Therapeutics, a neurodevice manufacturer based in Cleveland, Ohio, announced that it received CE Mark clearance from the European Union for its Smartpatch system. According to a press release by the company, the Smartpatch system provides peripheral nerve stimulation therapy in patients suffering from chronic shoulder pain.
While the Smartpatch system is currently approved in the E.U. for the treatment of chronic shoulder pain through a minimally-invasive operation, the company is also pursuing CE Mark clearance for orthopedic pain. In addition, the company is currently pursuing clinical trials to test the efficacy of the system in rehabilitation-related pain treatment.
According to information from SPR Therapeutics, an estimated 116 million people in the United States suffer from chronic and acute musculoskeletal pain. The company is currently sponsoring an FDA-approved clinical trial in pursuit of clearance in the United States. The company is pursuing FDA approval of the smartpatch system for post-amputation pain and post-stroke shoulder pain.
Maria Bennett is the CEO and president of SPR Therapeutics. In prepared remarks, she said, "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.” She continued, "Toward this end, we are in discussions with corporate strategic partners to commercialize Smartpatch outside the United States.”