Mainstay Medical Holdings plc announced the completion of enrollment in its RESTORE randomized clinical study of ReActiv8 for the treatment of intractable chronic low back pain. The study is designed to provide a direct comparison to optimized medical management for the purpose of testing the hypothesis that the addition of ReActiv8 Restorative Neurostimulation therapy to current care paradigms results in significant improvements in back pain-related disability. The RESTORE (ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation) clinical study is a prospective, randomized controlled trial conducted at 25 leading centers in the U.S. Eligible patients were randomized to either continue with their optimal medical management or ReActiv8 Restorative Neurostimulation therapy plus optimal medical management. Patient-reported outcomes are being collected at regular intervals out to the one-year primary endpoint, at which time the patients in the control arm are offered implantation with the ReActiv8 system. The Co-Principal Investigators of the RESTORE study are Dr. Frank Schwab, Chair of Orthopedic Spine Surgery at Lenox Hill Hospital and Chief of Orthopedic Spine Surgery for Northwell Health System; Dr. Chris Gilligan, Director of the Spine Center at Brigham and Women?s Hospital and
assistant professor of Anesthesia at Harvard Medical School; and Dr. Kiran Patel, Director of Pain Medicine, Lenox Hill Hospital and Founder & CEO, NYC Neuromodulation Center of Excellence.