- The first patient has been enrolled in a study assessing the use of Orthofix International's (OFIX +0.3%) pulsed electromagnetic field (PEMF) technology for the potential treatment of osteoarthritis (OA) of the knee. Specifically, the study will evaluate the safety and efficacy of the company's Physio-Stim system in reducing inflammation and restoring homeostasis of the extracellular matrix, with the aim of providing symptomatic relief from OA-related pain, reducing the breakdown of cartilage and stimulating the formation of new cartilage. If all goes well, this would be the first disease-modifying treatment for OA.
- The randomized, double-blind, placebo-controlled feasibility study will enroll ~150 subjects at least 40 years old at three U.S. sites. The primary endpoint is the change over time in a measure of arthritis called WOMAC score. According to ClinicalTrials.gov, the estimated completion date is July 2018.
- Physio-Stim is currently approved for the treatment of difficult-to-heal (nonunion) bone fractures. The device assists healing by delivering a non-invasive pulsed electromagnetic field signal to the targeted fracture site.
- According to a government estimate, almost half of people will develop symptomatic OA of the knee by age 85. In the U.S. there are ~700K knee replacement surgeries performed each year. The number is expected to increase to ~3.5M by 2030.