The U.S. Food and Drug Administration has approved SetPoint Medical's SetPoint System, marking a breakthrough in rheumatoid arthritis treatment as the first implantable neuroimmune modulation device for adults with moderate-to-severe disease who are not adequately managed by or cannot tolerate existing advanced therapies. The device represents a novel therapeutic approach that harnesses the body's natural anti-inflammatory pathways through vagus nerve stimulation.
Revolutionary Approach to RA Management
The SetPoint System addresses a significant unmet medical need in rheumatoid arthritis care, where more than 1.5 million Americans live with this chronic autoimmune disease. Current treatment satisfaction remains low, with only 25% of RA patients satisfied with their therapy and up to 50% discontinuing prescribed treatments within two years due to inadequate outcomes or adverse effects.
"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 company plans to introduce the device in targeted U.S. cities this year, followed by nationwide expansion starting in early 2026.
Clinical Evidence from RESET-RA Trial
FDA approval was supported by robust clinical data from the 242-patient RESET-RA study, a randomized, double-blind, sham-controlled trial that demonstrated both safety and efficacy in patients with moderately to severely active RA who had incomplete response or intolerance to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
"This is a landmark study in the treatment and care of rheumatoid arthritis," said John Tesser, MD, FACP, FACR, MACR, the national rheumatology principal investigator of the RESET-RA study. The trial met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics sustained through 12 months of follow-up.
A particularly notable finding was that 75% of patients in the study remained free of biologic or targeted synthetic DMARDs at 12 months, suggesting the potential for reduced dependence on systemic immunosuppressive therapies.
Safety Profile and Procedure Details
The device placement procedure and stimulation therapy demonstrated a favorable safety profile, with a low rate of related serious adverse events at 1.7%. Importantly, no malignancies, major cardiac events, or serious infections related to the SetPoint Therapy were observed during the study period.
"After implantation during a minimally invasive outpatient procedure, the SetPoint device is programmed to automatically administer therapy on a predetermined schedule for up to 10 years, simplifying care for people living with RA," explained Mark Richardson, MD, PhD, Director of Functional Neurosurgery at Massachusetts General Hospital and national surgical principal investigator in the RESET-RA study.
Mechanism and Clinical Application
The SetPoint System functions as an integrated neurostimulation device that delivers electrical stimulation to the vagus nerve once daily, activating the body's innate anti-inflammatory and immune-restorative pathways. This approach offers a treatment option without the immune-compromising risks associated with traditional systemic therapies.
The device is specifically indicated for adults with moderately to severely active rheumatoid arthritis who have experienced inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic DMARDs. However, it is contraindicated in patients with a history of vagotomy or splenectomy, or when deemed unsafe by healthcare providers.
Future Development Pipeline
The SetPoint System previously received FDA Breakthrough Device Designation, recognizing its potential to offer more effective treatment for debilitating diseases. Beyond rheumatoid arthritis, SetPoint Medical is planning to evaluate its neuroimmune modulation platform for additional autoimmune indications, including multiple sclerosis and Crohn's disease, potentially expanding the therapeutic applications of this novel approach.
