The RESTORE clinical study ( Re Activ8 S timulation T herapy vs O ptimal Medical Management: A R andomized Evaluation, in French: ReActiv8 stimulation therapy c. Optimal Medical Management: A Randomized Evaluation) is a prospective, randomized, controlled trial conducted at 25 leading centers in the United States. Eligible patients were randomly assigned to continue their optimal medical treatment and ReActiv8 restorative neurostimulation therapy combined with optimal medical treatment. Patient-reported outcomes are collected at regular intervals until the primary endpoint of one year, at which point patients in the control group will be offered implantation of the ReActiv8 system. The associate principal investigators of the RESTORE study are Dr. Frank Schwab, chairman 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 anesthesia at Harvard Medical School; and Dr. Kiran Patel, director of pain medicine at Lenox Hill Hospital and founder and CEO of the New York Neuromodulation Center of Excellence.

Mainstay Medical CEO Jason Hannon said :“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 first data from the study in the second half of 2024, and we look forward to sharing this data with our physician customers and their patients, as well as using it to further engage care management organizations in the United States to 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 recruitment 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,” said Drs Frank Schwab, Chris Gilligan and Kiran Patel, associate principal investigators of the RESTORE study . "Once the data is published, it will add to the growing body of clinical evidence surrounding ReActiv8 and firmly establish the role of this therapy in the treatment of patients with mechanical low back pain ."

Drs. Schwab, Gilligan and Patel continue, "The RESTORE trial represents a substantial addition to the clinical evidence that underpins treatment options for this patient population who have extremely limited options beyond temporary palliative treatments and medications. . Directly addressing the underlying problem of muscle dysfunction can represent a substantial advance in treatment options. We would like to sincerely thank the patients who agreed to be selected for this study, the study investigators and their work team, and the Mainstay team for their passion and commitment to the program.We look forward to the results of this trial to prove how ReActiv8 can improve the lives of these patients beyond what is currently used to treat them.”

About the RESTORE Clinical Study

The RESTORE clinical study is a multicenter, prospective, randomized, one-way crossover trial. A total of 226 patients were randomly assigned to the study at 25 leading centers in the United States. Eligible patients were randomized between continuing their optimal medical treatment and ReActiv8 restorative neurostimulation therapy, combined with optimal medical treatment. Patient-reported outcomes are collected at regular intervals until the one-year primary endpoint, at which point patients in the control group will be offered implantation of the ReActiv8 system. Patient evaluation will continue for an additional year.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain associated with multifidus muscle dysfunction that can be diagnosed by imaging or physiological testing. Candidates for the use of ReActiv8 are patients with multifidus muscle dysfunction in whom other types of treatment have failed (including analgesics and physiotherapy) and for whom spinal surgery is not recommended. ReActiv8 has obtained regulatory clearances in multiple geographies and is available in the European Economic Area, Australia, United Kingdom and United States.

About Mainstay Medical

Mainstay Medical is a medical device company specializing in the commercialization of its innovative ReActiv8 ®  implantable restorative neurostimulation system for people with disabling mechanical chronic low back pain. Mainstay Medical is headquartered in Dublin, Ireland, and the company has subsidiaries in Ireland, the United States, Australia, Germany and the Netherlands.

For more details: www.mainstaymedical.com .

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contacts

PR and IR requests:

LifeSci Advisors, LLC
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Email: britchie@lifesciadvisors.com

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Jonathan Neilan or Patrick Berkery
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Email: mainstay@fticonsulting.com

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Corporate Communications
Email: Media@mainstaymedical.com

Source: businesswire.com