Mainstay Medical International plc has received approval from the US Food and Drug Administration (FDA) to begin a clinical trial of ReActiv8 under an Investigational Device Exemption (IDE). ReActiv8 is an innovative implantable neurostimulation system designed to reduce the pain and disability of chronic low back pain by helping to restore control to the muscles that dynamically stabilise the lumbar spine.
“The FDA approval to start a US clinical trial of ReActiv8 is a major step towards our goal of bringing ReActiv8 to the US market,” said Peter Crosby, the chief executive officer of Mainstay Medical. “We are impressed with the FDA’s responsiveness during the development and review of this trial. It helped us to develop a clinical trial to meet the needs of the company, the FDA, and the millions of people who could potentially benefit from ReActiv8.”
The FDA approval is for the planned ReActiv8-B trial, an international, multicentre, prospective randomised sham-controlled trial designed to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with chronic low back pain and no prior back surgery.
The approval is to conduct the ReActiv8-B trial at up to 40 clinical trial sites and for 128 randomised patients to be implanted with ReActiv8 in the pivotal cohort. The IDE approval allows Mainstay Medical to engage with investigators, clinical trial sites, and Institutional Review Boards (IRBs or Ethics Committees) leading towards the first subject recruitment and implant. Upon successful completion of the ReActiv8-B trial and if the results support it, the company plans to submit an application for a Pre-Market Approval (PMA) which is required to allow the start of commercialisation in the United States.
In the approval letter, the FDA provided some helpful study design recommendations which the company is considering, and it is possible that one or more IDE supplements may be submitted in the coming months.
The principal investigator for the trial is Christopher Gilligan, chief, Division of Pain Medicine at Beth Israel Deaconess Medical Center in Boston, USA, and assistant professor of Anaesthesiology at Harvard Medical School. Gilligan is head of the Data Monitoring Committee of the ongoing ReActiv8-A trial.