POMPANO BEACH, Fla.–(BUSINESS WIRE)–Today, Stimwave Technologies announced the level-1 FREEDOM clinical trial series launch. The FREEDOM clinical trial series consists of multi-center, prospective, randomized trials that monitor chronic pain patients’ responses to peripheral nerve stimulation (PNS) over time. Leading through the investment of level-1 evidence-based data in PNS is a central part of Stimwave’s ongoing commitment to outstanding outcomes for treating patients suffering from chronic pain. Upon completion of the FREEDOM clinical trial series, the study data will be aggregated to demonstrate further broad proof of efficacy with Stimwave’s Freedom PNS therapy.
Freedom-1 for Chronic Knee Pain
FREEDOM-1 is Stimwave’s first clinical trial (in the series) to evaluate treating patients with chronic knee pain using the Stimwave Freedom PNS system. The primary endpoint consists of a reduction in pain equal to or greater than 50% based on the visual analog scale. Secondary outcomes will be related to changes in the physical function of patients’ knees while undergoing treatment, and overall quality of life improvement.
“Knee pain is one of the most prevalent forms of chronic pain experienced by patients globally and is strongly correlated with the high volumes of surgical procedures performed each year on the joint,” said Standiford Helm, MD, Lead Investigator for Freedom – 1. “Despite the surgical interventions available today to fix functional problems, a patient’s quality of life can be severely impacted by chronic pain and subsequent reductions in mobility. The Freedom PNS system offers a unique solution by addressing chronic knee pain associated with a specific peripheral nerve, at the source.”
“A key component of Stimwave’s long-term value creation strategy is to collaborate with leading centers to generate high-quality, level-1 clinical data that supports the appropriate use of the Freedom PNS therapy through our market-leading medical education and market access initiatives. We are very excited to launch this initial FREEDOM-1 study in connection with the treatment of chronic knee pain and look forward to launching additional similarly structured chronic pain trials as part of our larger commitment,” said Aure Bruneau, Stimwave’s Chief Executive Officer.
About Stimwave Technologies Incorporated
Stimwave Technologies is a medical device company that develops, manufactures, and markets, neuromodulation products. Its Peripheral Nerve Stimulation (PNS) and Spinal Cord Stimulation (SCS) products are implanted technology that block pain signals to the brain and provide a drug-free alternative for treating patients suffering from chronic pain. Stimwave Technologies’ Freedom Systems, the SCS and PNS products, provide a unique and innovative technology with an HF-EMC wireless energy transfer from an external transmitter and antenna to the implanted electrode array and separate receiver. Stimwave Technologies’ FDA-cleared product portfolio can treat nerves from the neck down that are causing pain. Stimwave Technologies’ principal place of business is in Pompano Beach, Florida and it operates worldwide through its operating subsidiaries. For more information, please visit https://stimwavefreedom.com/.