Sam Brusco, Associate Editor04.20.22
Stimwave yesterday began the level-1 FREEDOM (FREEDOM – 1) clinical trial series to monitor chronic knee pain patients’ response to the company’s Freedom peripheral nerve stimulation (PNS) over time.
The primary endpoint is pain reduction equal to or greater than 50% based on the visual analog scale. Secondary outcomes include changes in physical knee function while receiving PNS, 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,” Standiford Helm, MD, Lead Investigator for FREEDOM – 1 told the press. “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,” added Aure Bruneau, Stimwave’s CEO.
Upon completion, study data will be aggregated to show further broad proof of efficacy with Freedom PNS therapy.
The primary endpoint is pain reduction equal to or greater than 50% based on the visual analog scale. Secondary outcomes include changes in physical knee function while receiving PNS, 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,” Standiford Helm, MD, Lead Investigator for FREEDOM – 1 told the press. “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,” added Aure Bruneau, Stimwave’s CEO.
Upon completion, study data will be aggregated to show further broad proof of efficacy with Freedom PNS therapy.