The FDA has approved SetPoint Medical’s SetPoint System, the first implantable neuroimmune modulation device for adults with moderate-to-severe rheumatoid arthritis who are not adequately managed by, or are intolerant to, biologic or targeted synthetic disease-modifying antirheumatic drugs. The device delivers daily electrical stimulation to the vagus nerve to activate endogenous anti-inflammatory and immune-restorative pathways, offering a novel, device-based alternative for rheumatoid arthritis management.
FDA approval was supported by the 242-patient, randomized, double-blind, sham-controlled RESET-RA trial. The study met its primary efficacy endpoint, with a statistically significant improvement in American College of Rheumatology 20% improvement criteria (ACR20) at 3 months. Efficacy was sustained through 12 months, with improvements in ACR response rates and disease activity metrics. At 12 months, 75% of patients remained free of biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD) therapy. Device placement and stimulation were well tolerated, with a 1.7% rate of serious adverse events attributed to the therapy. No malignancies, major adverse cardiac events, or serious infections related to the device were reported.
“This is a landmark study in the treatment and care of rheumatoid arthritis,” said John Tesser, MD, FACP, FACR, MACR, a leading rheumatologist and national rheumatology principal investigator of the RESET-RA study.
The SetPoint System previously received FDA Breakthrough Device Designation. The company plans a phased U.S. launch in 2025, with national expansion in early 2026. SetPoint Medical intends to evaluate the platform for additional autoimmune indications, including multiple sclerosis and Crohn’s disease.
“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, Ph.D., CEO of SetPoint Medical.
The SetPoint System is indicated for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic DMARDs. The device is contraindicated in patients with a history of vagotomy or splenectomy, or when deemed unsafe by a health care provider. Potential risks include pain or infection after surgery, hoarseness, bruising, swelling, coughing, and throat irritation.
Source: SetPoint Medical