Mainstay Medical Finishes Enrollment in RESTORE Trial for Low Back Pain

Mainstay Medical has completed enrollment for its RESTORE clinical study of ReActiv8 to treat chronic, intractable low back pain. The study aims for direct comparison to optimized medical management to evaluate that adding ReActiv8 restorative neurostimulation therapy to current care paradigms brings about significant back pain-related disability improvements.
 
RESTORE was conducted at 25 U.S. centers. Patients either continued with their optimal medical management or ReActiv8 therapy plus optimal medical management. Patient-reported outcomes are being gathered at regular intervals out to one year, when patients in the control arm are offered ReActiv8 implantation.
 
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.
 
Jason Hannon, CEO of Mainstay Medical, told the press, “We are proud to have reached this important milestone in the RESTORE clinical trial as we continue to demonstrate the clinical efficacy and positive economic impact of ReActiv8. We expect the initial data readout from the study in the second half of 2024, and we look forward to sharing the data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy. I would like to thank Dr. Frank Schwab, Dr. Chris Gilligan, and Dr. Kiran Patel for acting as Co-Principal Investigators of this important study, as well as each of the enrolling sites and all of the participating patients.”
 
“This type of randomized, controlled clinical trial in this difficult-to-treat and underserved patient population will produce high-quality data comparing ReActiv8 to the current standard of care,” added Drs. Frank Schwab, Chris Gilligan, and Kiran Patel, co-principal investigators of the RESTORE study. “Once the data is published, it will meaningfully add to the growing body of clinical evidence regarding ReActiv8 and firmly establish the role of this therapy in treating mechanical low back pain patients.”
 
Drs. Schwab, Gilligan, and Patel continued: ”The RESTORE trial represents a substantial addition to the clinical evidence behind treatment options for this patient population who have extremely limited options beyond temporary palliative treatments and drugs. Directly addressing the underlying issue of muscular dysfunction can represent a substantial advancement in treatment options. We would like to express sincere thanks to the patients who agreed to be screened for this study, the trial investigators and their hard-working staff, and the Mainstay team for their passion and commitment to the program. We look forward to the results of this trial to prove the degree to which ReActiv8 can improve the lives of these patients above and beyond what is currently used to treat them.”