SetPoint Medical announced today that the FDA approved its SetPoint neuroimmune modulation system for treating rheumatoid arthritis (RA).
The first-of-its-kind device treats adults with moderate-to-severe RA not adequately managed by (or failing to tolerate) existing therapies. Those therapies include biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
Valencia, California-based SetPoint Medical designed the implantable, integrated neurostimulation system to deliver electrical stimulation to the vagus nerve once per day. It activates the body’s innate anti-inflammatory and immune-restorative pathways to treat RA.
The company says it could potentially treat autoimmune conditions without the immunosuppressive risks associated with pharmacological therapies. After placement during an outpatient procedure, the system automatically delivers therapy on a preset schedule to improve compliance. Future applications could include multiple sclerosis and Crohn’s disease.
SetPoint Medical already has FDA breakthrough device designation for its system. Last year, the FDA accepted the technology into its Total Product Life Cycle Advisory Program (TAP) pilot. The company used data from its RESET-RA study to support its FDA PMA submission entered last fall.
The company expects to introduce the SetPoint system in certain U.S. cities through a targeted launch this year. It anticipates a wider launch across the country in early 2026.
“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” said Murthy V. Simhambhatla, CEO of SetPoint Medical. “We are committed to improving the health of people living with RA, and look forward to working with providers and payers to make our innovative therapy accessible to their patients.”
