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

Randomized managed scientific trial anticipated to validate effectiveness of ReActiv8® Restorative Neurostimulation^TM vs. optimum medical administration

DUBLIN, August 29, 2023–(BUSINESS WIRE)–Mainstay Medical Holdings plc right now introduced the completion of enrollment in its RESTORE randomized scientific research of ReActiv8 for the remedy of intractable continual low again ache. The research is designed to supply a direct comparability to optimized medical administration for the aim of testing the speculation that the addition of ReActiv8 Restorative Neurostimulation remedy to present care paradigms leads to vital enhancements in again pain-related incapacity.

The RESTORE (ReActiv8 Stimulation Remedy vs Optimum Medical Administration: A Randomized Analysis) scientific research is a potential, randomized managed trial carried out at 25 main facilities within the U.S. Eligible sufferers had been randomized to both proceed with their optimum medical administration or ReActiv8 Restorative Neurostimulation remedy plus optimum medical administration. Affected person-reported outcomes are being collected at common intervals out to the one-year major endpoint, at which era the sufferers within the management arm are provided implantation with the ReActiv8 system. The Co-Principal Investigators of the RESTORE research are Dr. Frank Schwab, Chair of Orthopedic Backbone Surgical procedure at Lenox Hill Hospital and Chief of Orthopedic Backbone Surgical procedure for Northwell Health System; Dr. Chris Gilligan, Director of the Backbone Heart at Brigham and Ladies’s Hospital and assistant professor of Anesthesia at Harvard Medical College; and Dr. Kiran Patel, Director of Ache Medication, Lenox Hill Hospital and Founder & CEO, NYC Neuromodulation Heart of Excellence.

Jason Hannon, CEO of Mainstay Medical, acknowledged: “We’re proud to have reached this necessary milestone within the RESTORE scientific trial as we proceed to reveal the scientific efficacy and optimistic financial influence of ReActiv8. We anticipate the preliminary information readout from the research within the second half of 2024, and we sit up for sharing the info with our doctor clients and their sufferers, in addition to utilizing it to additional have interaction managed care organizations in america to develop industrial insurance coverage entry to this unimaginable remedy. I want to thank Dr. Frank Schwab, Dr. Chris Gilligan, and Dr. Kiran Patel for performing as Co-Principal Investigators of this necessary research, in addition to every of the enrolling websites and all the collaborating sufferers.”

“Any such randomized, managed scientific trial on this difficult-to-treat and underserved affected person inhabitants will produce high-quality information evaluating ReActiv8 to the present normal of care,” stated Drs. Frank Schwab, Chris Gilligan, and Kiran Patel, Co-Principal Investigators of the RESTORE research. “As soon as the info is revealed, it’s going to meaningfully add to the rising physique of scientific proof concerning ReActiv8 and firmly set up the function of this remedy in treating mechanical low again ache sufferers.”

Drs. Schwab, Gilligan, and Patel continued: ”The RESTORE trial represents a considerable addition to the scientific proof behind remedy choices for this affected person inhabitants who’ve extraordinarily restricted choices past momentary palliative remedies and medicines. Straight addressing the underlying situation of muscular dysfunction can signify a considerable development in remedy choices. We want to specific honest due to the sufferers who agreed to be screened for this research, the trial investigators and their hard-working workers, and the Mainstay staff for his or her ardour and dedication to this system. We sit up for the outcomes of this trial to show the diploma to which ReActiv8 can enhance the lives of those sufferers above and past what’s presently used to deal with them.”

In regards to the RESTORE Medical Research

The RESTORE scientific research is a multi-center, potential, randomized trial with one-way cross-over. A complete of 226 sufferers had been randomized within the research at 25 main facilities within the U.S. Eligible sufferers had been randomized to both proceed with their optimum medical administration or ReActiv8 Restorative Neurostimulation remedy plus optimum medical administration. Affected person-reported outcomes are being collected at common intervals out to the one-year major endpoint, at which era the sufferers within the management arm are provided implantation with the ReActiv8 system. Evaluation of the sufferers will proceed for an extra yr.

About ReActiv8®

ReActiv8 is an implantable medical gadget designed to deal with adults with intractable continual low again ache (CLBP) related to multifidus muscle dysfunction, which can be evidenced by imaging or physiological testing. Candidates for ReActiv8 are sufferers with multifidus muscle dysfunction who’ve failed different types of remedy (together with ache treatment and bodily remedy) and are usually not candidates for spine surgical procedure. ReActiv8 has obtained regulatory approval in a number of geographic areas, and is commercially out there within the European Financial Space, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical gadget firm centered on commercializing its progressive implantable Restorative Neurostimulation system, ReActiv8^®, for individuals with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Eire and has subsidiaries working in Eire, america, Australia, Germany, and the Netherlands.

Additional data will be discovered at www.mainstaymedical.com.

Ahead-Wanting Statements

All statements on this announcement aside from statements of historic truth are, or could also be deemed to be, forward-looking statements. These forward-looking statements might embrace, with out limitation, statements concerning the corporate’s intentions, beliefs or present expectations regarding, amongst different issues, the corporate’s analysis research and outcomes, industrial efforts and efficiency, monetary place, financing methods, product design and improvement, regulatory purposes and approvals, and reimbursement preparations.

Ahead-looking statements contain danger and uncertainty and are usually not ensures of future efficiency. Precise outcomes might differ materially from these described in, or urged by, the forward-looking statements. A lot of components may trigger outcomes and developments to vary materially from these expressed or implied by the forward-looking statements herein, together with, with out limitation, the dangers and uncertainties included within the firm’s Annual Report for the yr ended 31 December 2022, which must be learn along side the corporate’s public disclosures (out there on the corporate’s web site (www.mainstaymedical.com)). The forward-looking statements herein communicate solely as of the date of this announcement.