Mainstay Medical

Country:
Ireland
Founding year:
2006

Mainstay Medical is a Dublin-based medical device company developing the ReActiv8 Restorative Neurostimulation system for the treatment of mechanical chronic low back pain (CLBP) caused by multifidus muscle dysfunction. The company is publicly listed and has accumulated the largest evidence base of any implantable neurostimulation system specifically indicated for mechanical CLBP.

ReActiv8 consists of an implantable pulse generator connected to two leads placed bilaterally along the nerves innervating the lumbar multifidus muscle. Patients self-administer twice-daily 30-minute stimulation sessions, which elicit controlled muscle contractions designed to restore neuromuscular control and functional stability of the lumbar spine. Unlike conventional spinal cord stimulation, which masks pain signals, ReActiv8 targets the underlying biomechanical dysfunction. The pivotal ReActiv8-B randomised controlled trial demonstrated 71% pain responder rates and 65% CLBP resolution at two years, with 60% of opioid users voluntarily reducing or eliminating opioid intake.

The system received FDA approval and is commercially available in the United States, Europe, and Australia. Mainstay's clinical programme distinguishes CLBP secondary to multifidus dysfunction from neuropathic pain, establishing a distinct therapeutic category and patient selection pathway separate from conventional SCS.

Neuromodulation
Therapeutics
Clinical Workflows

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Modality:
Nerve stimulator
Form Factor:
Implant
Interface Depth:
Implantable
Indication:
Pain/migraine
Target user:
Patients
Regulatory stage:
FDA approved (PMA)

Public

Mainstay Medical is the most commercially advanced company in restorative neurostimulation for mechanical low back pain, a mechanistically distinct category from conventional SCS that targets the underlying multifidus dysfunction rather than pain signal masking. Its public status, two-year RCT data, and FDA approval give it a significant head start, though reimbursement access remains a key adoption constraint in the US market.

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Mainstay Medical is the most commercially advanced company in restorative neurostimulation for mechanical low back pain, a mechanistically distinct category from conventional SCS that targets the underlying multifidus dysfunction rather than pain signal masking. Its public status, two-year RCT data, and FDA approval give it a significant head start, though reimbursement access remains a key adoption constraint in the US market.

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