Mainstay Medical has submitted an application to the US Food and Drug Administration (FDA) to begin a clinical trial of ReActiv8 under an Investigational Device Exemption (IDE).
ReActiv8 is an implantable neurostimulation device designed to treat people with disabling chronic low back pain for whom conventional therapy has not been successful and for whom surgery is not indicated. The goal of ReActiv8 is to reduce pain and disability by addressing the root cause of chronic low back pain in many people by helping to restore control to the muscles that dynamically stabilise the lumbar spine.
The clinical trial protocol submitted to the FDA as part of the IDE submission is for an international, multicentre, prospective randomised controlled trial designed to show safety and efficacy of ReActiv8. The IDE submission includes details of the extensive preclinical and clinical testing conducted on ReActiv8. Upon successful completion of the trial and if the results support it, the company plans to submit an application for a pre-market approval which is the final step to allow the start of commercialisation in the USA.
“We anticipate that there may be one or more rounds of review by the FDA as we work together to develop a clinical trial that meets the needs of the company, the FDA, and the millions of people who could potentially benefit from ReActiv8,” said Peter Crosby, chief executive of Mainstay Medical.
Currently, ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world. The ReActiv8-A trial is ongoing in Europe and Australia to gather data to support an application for a CE mark which, if granted, would allow start of commercialisation in Europe.