Mainstay Medical Announces Completion of Enrollment of RESTORE Clinical Trial of ReActiv8® in the United States

Mainstay Medical Holdings plc today 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.

Jason Hannon, CEO of Mainstay Medical, stated: “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,” said 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.”

About the RESTORE Clinical Study

The RESTORE clinical study is a multi-center, prospective, randomized trial with one-way cross-over. A total of 226 patients were randomized in the study 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. Assessment of the patients will continue for an additional year.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction, which may be evidenced by imaging or physiological testing. Candidates for ReActiv8 are patients with multifidus muscle dysfunction who have failed other forms of therapy (including pain medication and physical therapy) and are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8^®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

Forward-Looking Statements

All statements in this announcement other than statements of historical fact are, or may be deemed to be, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the company’s intentions, beliefs or current expectations concerning, among other things, the company’s research studies and results, commercial efforts and performance, financial position, financing strategies, product design and development, regulatory applications and approvals, and reimbursement arrangements.

Forward-looking statements involve risk and uncertainty and are not guarantees of future performance. Actual results may differ materially from those described in, or suggested by, 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, without limitation, the risks and uncertainties included in the company’s Annual Report for the year ended 31 December 2022, which should be read in conjunction with the company’s public disclosures (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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