Mainstay Medical Announces Publication of the First Neuromodulation Study for Low Back Pain with 5-Year Follow-Up

Groundbreaking ReActiv8-B examine helps the long-term efficacy, security and sturdiness of ReActiv8® Restorative Neurostimulation^TM for the therapy of intractable Power Low Again Ache

DUBLIN, March 19, 2024–(BUSINESS WIRE)–Mainstay Medical Holdings plc right now introduced the publication of the 5-year comply with up from the ReActiv8-B randomized, sham-controlled, double-blinded trial. There have been 126 sufferers who accomplished the 5-year comply with up, and the printed information clearly indicated that ReActiv8® Restorative Neurostimulation is a long-term, efficient, sturdy, and protected remedy. ReActiv8 is the one restorative remedy for sufferers affected by non-surgical, mechanical CLBP evidenced by multifidus dysfunction.

The publication is offered right here:
https://www.sciencedirect.com/science/article/pii/S1094715924000552

The ReActiv8-B examine noticed a number of sufferers have their implants eliminated for decision of again ache. These removals for achievement recommend a restorative mechanism, and the remedy exhibits no proof of the lack of efficacy generally noticed with palliative remedies.

Dr. Chris Gilligan, Chief Medical Officer and Chief High quality Officer at Robert Wooden Johnson College Hospital, acknowledged: “The long-term, sturdy affected person outcomes from this examine are unprecedented within the discipline of neuromodulation. That is actually a novel remedy that’s restorative in nature and doesn’t present any of the lack of efficacy seen with different remedies in our discipline. With 5 12 months printed outcomes, we’re now not restricted to offering momentary or palliative remedies to our sufferers. ReActiv8 is altering the best way we deal with correctly chosen sufferers.”

Jason Hannon, CEO of Mainstay Medical, acknowledged: “We’re proud to have the one commercially obtainable system with a powerful security profile and long-term, peer-reviewed proof supporting the rehabilitation of this severely affected affected person inhabitants. We look ahead to sharing this information with our doctor clients and their sufferers, in addition to utilizing it to additional have interaction managed care organizations in the US to develop industrial insurance coverage entry to this unimaginable remedy.”

About ReActiv8®

ReActiv8 is an implantable medical system designed to deal with adults with intractable persistent low again ache (CLBP) related to multifidus muscle dysfunction. Multifidus muscle dysfunction could also be evidenced by imaging or physiological testing in adults who’ve failed remedy together with ache medicines and bodily remedy, and who should not candidates for spine surgical procedure. ReActiv8 has acquired regulatory approval in a number of geographic areas, and is commercially obtainable within the European Financial Space, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical system firm centered on commercializing its revolutionary implantable Restorative Neurostimulation system, ReActiv8, for folks with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Eire and has subsidiaries working in Eire, the US, Australia, Germany, and the Netherlands.

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

Mainstay Ahead-Trying 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 embody, with out limitation, statements relating to the corporate’s intentions, beliefs or present expectations regarding, amongst different issues, the corporate’s scientific outcomes, industrial efforts and efficiency, analysis research and outcomes, monetary place, financing methods, product design and improvement, mental property portfolio and its scope, regulatory purposes and approvals, and reimbursement preparations.

Ahead-looking statements contain threat and uncertainty and should not ensures of future efficiency. Precise outcomes might differ materially from these described in, or recommended by, the forward-looking statements. Various elements might 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 12 months ended 31 December 2022, which must be learn along side the corporate’s public disclosures (obtainable on the corporate’s web site (www.mainstaymedical.com)). The forward-looking statements herein converse solely as of the date of this announcement.