Mainstay Medical Announces Coverage Recommendation from the International Society for the Advancement of Spine Surgery (ISASS) for ReActiv8

Mainstay Medical Holdings plc today announced that the International Society for the Advancement of Spine Surgery (ISASS) has issued recommendations and coverage criteria for the use of restorative neurostimulation for the treatment of chronic mechanical low back pain associated with multifidus muscle dysfunction. ReActiv8® restorative neurostimulation is the only therapy approved in the United States, Europe and Australia for this indication.

The Statement, which affirms ISASS’ support for coverage by payers of implantable restorative neurostimulation in appropriately selected patients, was published in the December issue of the International Journal of Spine Surgery and can be accessed here: https://www.ijssurgery.com/content/early/2025/12/10/8833.

The Statement reflects the growing body of clinical evidence supporting the use of ReActiv8, as well as recent developments in diagnostic coding and reimbursement pathways since ISASS’ 2023 Statement on Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting from Neuromuscular Instability. Key updates include: published five-year results from the pivotal randomized clinical trial; published one-year results from a second randomized clinical trial demonstrating ReActiv8’s superiority over standard of care; evidence from multiple real-world studies; the introduction of the new ICD-10 code M62.85: dysfunction of the multifidus muscles, lumbar region; and payer trends, including the recent establishment by Anthem Blue Cross Blue Shield of favorable coverage for ReActiv8.

“ISASS has a well-established history of supporting evidence-based technologies for patients with spine disease. The evidence for restorative neurostimulation - reactivating the multifidus muscle that drives mechanical low back pain - demonstrates meaningful improvements in pain, disability, and quality of life,” said Morgan P. Lorio, MD, ISASS Past President and Chair Emeritus, Coding & Reimbursement Task Force. “With new Level I data, the dedicated ICD-10 code, recent payer decisions, and the well-established clinical and economic significance of multifidus dysfunction, ISASS supports broader coverage and appropriate clinical adoption of restorative neurostimulation to improve outcomes and reduce the healthcare burden in this defined disease state.”

“We are pleased that ISASS has taken the lead by reviewing the totality of evidence, recognizing that ReActiv8 can benefit patients and payers,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical. “We look forward to discussing our robust clinical and real-world evidence with health plans, with the goal of providing access to ReActiv8 for more patients seeking durable solutions for their mechanical chronic low back pain.”

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and who 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.

Mainstay 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, payer coverage for ReActiv8, the company’s commercial efforts and performance, as well as its research studies and results, financial position, financing strategies, product design and development, intellectual property portfolio and its scope, 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 2024, 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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