Mainstay Medical Limited

Mainstay Medical Limited manufactures the ReActiv8 Restorative Neurostimulation system, a minimally invasive medical device designed to treat mechanical chronic low back pain (CLBP). ReActiv8 is the first and only restorative neurostimulation therapy that directly stimulates the nerves of the multifidus muscle, which is responsible for stabilizing the lumbar spine. The device addresses the underlying anatomical cause of mechanical low back pain rather than merely managing symptoms through pain medication or conservative approaches. The system is minimally invasive and employs the body's natural mechanisms to interrupt the cycle of pain, degeneration, and loss of function. Clinical trial data (ReActiv8-B) demonstrates significant outcomes including ≥50% VAS pain reduction, ≥20-point ODI improvement, and voluntary opioid reduction or elimination in eligible patients. The ReActiv8 system is full-body MRI conditional, permitting patients to undergo diagnostic MRI scans post-implantation. The company markets the device to both patients experiencing chronic low back pain unresponsive to conventional therapies and physicians seeking a restorative alternative to pharmacological, physical therapy, and surgical interventions. Mainstay Medical serves the orthopedic and spine specialty markets and provides patient information, clinical data, and physician resources to support adoption and treatment planning.