FDA Approves SetPoint System for Hard-to-Treat Rheumatoid Arthritis

The FDA has approved SetPoint Medical’s SetPoint System, an implantable neuroimmune modulation device, for adults with moderate-to-severe rheumatoid arthritis (RA) who are unresponsive to or cannot tolerate current treatments such as biologic and targeted synthetic DMARDs.

The system works by delivering daily electrical stimulation to the vagus nerve, activating the body’s natural anti-inflammatory and immune-restoring pathways, offering a non-immunosuppressive alternative for RA management.

Approval was based on results from the RESET-RA trial, a 242-patient, double-blind, randomized, sham-controlled study, which demonstrated efficacy and safety. The procedure and therapy were well tolerated, with only 1.7% of participants experiencing serious related adverse events.

This first-in-class device marks a major advancement in autoimmune disease treatment. SetPoint Medical is also evaluating the platform for multiple sclerosis (MS) and Crohn’s disease, and the system received Breakthrough Device Designation for relapsing-remitting MS in March 2024.

01-08-2025