DUBLIN, July 28, 2026 -(BUSINESS WIRE)- Mainstay Medical Holdings plc today announced that Highmark Inc. has established favorable coverage for the company’s ReActiv8 Restorative NeurostimulationTM therapy, for eligible members when clinically appropriate and medically necessary, in accordance with members’ health plan benefits and applicable coverage guidelines. The policy went into effect on July 27, 2026 and specifies that ReActiv8 is the only therapy considered medically necessary by the policy when the conditions for coverage are met.
Highmark Inc., together with its Blue-branded affiliates, now collectively comprises the third largest overall Blue Cross Blue Shield-affiliated organization in the country with nearly 8 million members in Pennsylvania, Delaware, New York, West Virginia, Missouri and Kansas.
“We are committed to providing our members access to therapies that are clinically proven to improve health outcomes for patients in need,” said Matt Fickie, M.D., Senior Medical Director for Medical Policy for Highmark, Inc.“ReActiv8 has proven to be a safe and effective treatment option for patients with intractable chronic low back pain from multifidus dysfunction, with clinical trials also showing reduced opioid use.”
“With Highmark’s decision, ReActiv8 is now available to more than 50 million Blues-affiliated members across the United States,” said Jason Hannon, CEO of Mainstay Medical.“We have worked hard to generate robust clinical data demonstrating ReActiv8’s effectiveness and safety. ReActiv8 therapy is distinct from standard peripheral nerve stimulators that provide palliative (temporary) stimulation, and our clinical evidence demonstrates its durable impact across multiple clinical-study and real-world patient populations. Decisions like this one give physicians a safe and effective option for a distinct group of patients whose treatment options have been limited. We look forward to sharing our evidence with other major health plans as we work to expand access for the patients who can benefit from ReActiv8.”
Under its policy, Highmark, Inc. considers ReActiv8 to be medically necessary for the treatment of chronic low back pain when a number of clinical criteria are met. These include a diagnosis of lumbar multifidus muscle dysfunction and patient selection criteria consistent with FDA approval guidelines and Mainstay’s clinical trial protocols.
Mechanical chronic low back pain associated with multifidus muscle dysfunction is a distinct and diagnosable condition. Affected patients have typically remained symptomatic despite conservative care, including pain medication and physical therapy, and many are not candidates for spine surgery, leaving them with limited treatment options. Positive coverage decisions such as Highmark’s give treating physicians access to an evidence-based therapy for patients who might otherwise continue to cycle through approaches that do not provide durable relief.
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 NeurostimulationTM 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 payer coverage and ability to gain access to ReActiv8 for patients and physicians, and its 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 2025, 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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