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 NeurostimulationTM 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 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.
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