SetPoint Medical

SetPoint Medical develops and commercializes the SetPoint System, an FDA-approved, implantable neuroimmune modulation device for treatment of rheumatoid arthritis (RA). The company's proprietary technology stimulates the vagus nerve to activate the body's natural anti-inflammatory pathways and restore immune balance, offering a device-based therapeutic alternative to conventional biologics and targeted synthetic drugs. The SetPoint System is a small, wireless implant designed for adults with moderately to severely active RA who have demonstrated inadequate response or intolerance to one or more biologic or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs). Clinical evidence from the RESET-RA pivotal trial demonstrates 60% average improvement in tender and swollen joint counts over 12 months, with 9 of 10 study participants reporting willingness to recommend the therapy. The implant delivers one minute of daily stimulation for up to ten years, requiring only weekly battery charging. SetPoint has secured FDA approval (July 2025), CMS Transitional Pass-Through Payment approval (November 2025), and raised $140 million in private financing to support US commercialization beginning in limited areas in 2025. The company is also exploring the neuroimmune modulation platform for other autoimmune indications, including relapsing-remitting multiple sclerosis. Landmark clinical results were published in Nature Medicine (January 2026). SetPoint Medical represents a novel intersection of immunology, neuroscience, and biomedical engineering, positioning neuroimmune modulation as a transformative approach in autoimmune disease management.