Randomized controlled clinical trials are expected to verify its effectiveness ReActiv8® Restorative NeurostimulationTM value with optimal medical management
DUBLIN–(BUSINESS WIRE)–Mainstay Medical Holdings plc announced today that it has completed enrollment in the RESTORE randomized clinical study of ReActiv8 for the treatment of refractory chronic low back pain. Designed to provide a direct comparison to optimal medical management, the study aimed to test the hypothesis that adding ReActiv8 restorative neurostimulation therapy to current care paradigms could significantly improve back pain-related disability.
recover(aboutactivate 8 SStimulate timetreatment comparison oxygenBest Medical Management: A rightmasculinization SecondEvaluation) clinical study was a prospective, randomized controlled trial conducted at 25 leading centers in the United States. Eligible patients were randomized to continue optimal medical management or ReActiv8 restorative neurostimulation plus optimal medical management. Patient-reported outcomes will be collected periodically until the primary endpoint of one year, when patients in the control group will receive implantation of the ReActiv8 System. The co-principal investigator of the RESTORE study is Dr. Frank Schwab, Chief of Orthopedic Spine Surgery at Lenox Hill Hospital and Chief of Orthopedic Spine Surgery at Northwell Health System. Dr. Chris Gilligan, Director of the Spine Center at Brigham and Women’s Hospital and Assistant Professor of Anesthesiology at Harvard Medical School; and Dr. Kiran Patel, Director of Pain Medicine at Lenox Hill Hospital and Founder and CEO of the Neuromodulation Center of Excellence in New York City.
Jason Hannon, Chief Executive Officer, Mainstay Medical, pointed out: “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 initial data from the study to be read out in the second half of 2024, and we look forward to working with Our physician clients and their patients share this data and use it to further entice managed care organizations in the US to scale up commercial scale insurance for this incredible therapy. I would like to thank Dr. Frank Schwab, Dr. Chris Gilligan and Dr. Kiran Patel as co-principal investigators of this important study, along with each recruiting site and all participating patients.”
“This randomized controlled clinical trial in a hard-to-treat and underserved patient population will generate high-quality data comparing ReActiv8 to the current standard of care.” Dr. said. RESTORE study co-principal investigators Frank Schwab, Chris Gilligan and Kiran Patel. “Once the data is released, it will meaningfully add to the growing body of clinical evidence on ReActiv8 and firmly establish the therapy’s role in the treatment of patients with mechanical low back pain“.
PhD. Schwab, Gilligan and Patel continued: “The RESTORE trial provides a substantial addition to treatment options for this patient population who have extremely limited options beyond temporary palliative care and medications. Directly addressing the underlying problem of muscle dysfunction could represent a major advance in treatment options. We We would like to thank the patients who agreed to be screened in this study, the trial investigators and their hard-working staff, and the Mainstay team for their enthusiasm and commitment to the project. We look forward to the results of this trial to demonstrate the extent to which ReActiv8 can improve the lives of these patients beyond the drugs currently used to treat them. “
About RESTORE Clinical Research
The RESTORE clinical study is a multicenter, prospective, one-way crossover randomized trial. A total of 226 patients in the study were randomized at 25 leading centers in the United States. Eligible patients were randomly assigned to receive optimal medical management or ReActiv8 restorative neurostimulation plus optimal medical management. Patient-reported outcomes will be collected periodically until the primary endpoint of one year, when patients in the control group will receive implantation of the ReActiv8 System. Evaluation of patients will continue for one year.
ReActiv8 is an implantable medical device designed to treat adults with refractory chronic low back pain (CLBP) associated with multifidus dysfunction, as evidenced by imaging or physiological testing. Candidates for ReActiv8 are patients with multifidus dysfunction who have failed other forms of treatment, including pain medication and physical therapy, and who are not candidates for spinal surgery. ReActiv8 has received regulatory approval in multiple geographic regions and is marketed in the European Economic Area, Australia, the United Kingdom and the United States.
About Zhongzhu Medical
Mainstay Medical is a medical device company focused on commercializing ReActiv8, its innovative implantable restorative neurostimulation system®, for persons with mechanical CLBP disabilities. Mainstay Medical is headquartered in Dublin, Ireland, with subsidiaries in Ireland, USA, Australia, Germany and the Netherlands.
Visit www.mainstaymedical.com for more information.
All statements other than statements of historical fact in this release are or may be deemed forward-looking statements. These forward-looking statements may include, but are not limited to, statements about the company’s intentions, beliefs or current expectations, including the company’s research and results, commercial efforts and performance, financial condition, financing strategy, product design and development, regulatory applications and approvals and reimbursement arrangements.
Forward-looking statements involve risks and uncertainties and are not guarantees of future performance. Actual results may differ materially from those described or suggested in the forward-looking statements. A number of factors could cause results and developments to differ materially from those expressed or implied by the forward-looking statements herein, including, but not limited to, risks and uncertainties contained in the company’s annual report for the year ended December 31, 2022, which and uncertainties should be read in conjunction with the Company’s public disclosures, which are available on the Company’s website (www.mainstaymedical.com). The forward-looking statements herein speak only as of the date of this announcement.
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