Mainstay Medical Announces Exclusive Coverage of ReActiv8® by Blue Cross Blue Shield of North Dakota

Mainstay Medical Holdings plc today announced that Blue Cross Blue Shield of North Dakota has established favorable coverage for the company’s ReActiv8 Restorative Neurostimulation^TM therapy for the treatment of intractable chronic low back pain. The policy went into effect in January 2026 and specifies that ReActiv8 is the only therapy considered medically necessary by the policy when the conditions for coverage are met.

“We are pleased that another Blue Cross Blue Shield payer has joined Anthem in making ReActiv8 available to well-selected patients after reviewing the large body of clinical evidence we have built,”said Jason Hannon, CEO of Mainstay Medical. “Patients with intractable chronic low back pain are desperately seeking durable solutions, and ReActiv8 has proven to be a safe and effective solution through six clinical studies with 633 patients treated and 1,950 patient-years of follow-up, including two multi-center, randomized controlled clinical studies. We look forward to discussing our data with other major health plans with the goal of securing further coverage for ReActiv8.”

Under its policy, Blue Cross Blue Shield of North Dakota 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.

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^TM 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 patients and physicians for ReActiv8, 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260204342591/en/