Mainstay Medical Holdings plc today announced that Anthem Blue Cross and Blue Shield (“Anthem”) has established favorable coverage for the company’s ReActiv8 Restorative NeurostimulationTM therapy for the treatment of intractable chronic low back pain. ReActiv8 is the only therapy considered medically necessary by the policy when the conditions for coverage are met. The coverage went into effect on April 16, 2025, and expands access to the procedure, when clinically appropriate, to Anthem’s policyholders.
“We have been on a 17-year mission to prove the value of ReActiv8 through careful and thorough research,” said Jason Hannon, CEO of Mainstay Medical. “We have made a commitment to developing a large body of robust clinical and real-world evidence proving the efficacy and safety of the therapy in an indication where patients are desperately seeking durable solutions. We are pleased to see a leading payer like Anthem recognize the evidence we have built, and we look forward to discussing our data with other major health plans with the goal of securing further coverage for ReActiv8. Our evidence has been generated by scores of clinical investigators around the world who care for chronic back pain patients. We are extremely grateful for the work these physicians continue to do.”
Under its policy, Anthem 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.
About Gilde Healthcare
Gilde Healthcare is a transatlantic specialist investment firm managing over €2.6 billion across two fund strategies: Venture&Growth and Private Equity. The Venture&Growth fund of Gilde Healthcare invests in fast growing companies active in digital health, medtech and therapeutics, based in Europe and North America. The Private Equity fund of Gilde Healthcare participates in profitable lower mid-market healthcare companies based in North-Western Europe. For more information, visit the company’s website at www.gildehealthcare.com.
