SetPoint Medical, a biotechnology company focused on developing therapies for chronic autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has approved its SetPoint System — a first-of-its-kind neuroimmune modulation device for adults with moderate-to-severe rheumatoid arthritis (RA) who have not responded to or cannot tolerate existing advanced therapies such as biologics and targeted synthetic DMARDs.
“This approval marks a significant milestone in autoimmune disease treatment,” said Dr. Murthy V. Simhambhatla, CEO of SetPoint Medical. “The SetPoint System offers a novel option for RA patients and underscores our commitment to improving lives. We will begin introducing the system in select U.S. cities this year, with nationwide rollout planned in early 2026.”
RA affects over 1.5 million Americans, leading to chronic joint pain, disability, and reduced quality of life. Despite available therapies, many patients experience limited benefit or discontinue treatment due to side effects or poor efficacy. Studies show that only 25% of RA patients are satisfied with their treatment, and up to 50% stop their prescribed therapies within two years.
The SetPoint System offers a non-drug, non-immunosuppressive alternative. It consists of a small implantable device that delivers daily electrical stimulation to the vagus nerve, activating the body's natural anti-inflammatory and immune-regulatory mechanisms.
FDA approval is based on results from RESET-RA, a 242-patient randomized, double-blind, sham-controlled study. Participants had moderate-to-severe RA and an inadequate response or intolerance to biologic or targeted synthetic DMARDs.
The trial met its primary endpoint of ACR20 at 3 months.
Sustained improvements in disease activity and ACR responses were observed up to 12 months.
By 12 months, 75% of participants were off biologic or targeted DMARDs.
The therapy was well-tolerated, with only 1.7% reporting serious adverse events related to the procedure or device.
No malignancies, major cardiac events, or serious infections were associated with treatment.
“This is a landmark study in RA care,” said Dr. John Tesser, national principal investigator for the RESET-RA trial. “It offers an entirely new therapeutic pathway for patients who have limited options.”
The device is implanted through a minimally invasive outpatient procedure. Once programmed, it delivers therapy automatically on a set schedule — with a device lifespan of up to 10 years — streamlining treatment and reducing the burden on patients.
“The SetPoint System demonstrates the power of neuroimmune modulation — tapping into the body’s neural networks to manage inflammation,” noted Dr. Mark Richardson, Director of Functional Neurosurgery at Massachusetts General Hospital and surgical lead for the study.
The SetPoint System was granted Breakthrough Device Designation by the FDA, reflecting its potential to address significant unmet needs. SetPoint Medical is now exploring the use of its neuroimmune modulation platform in other autoimmune diseases, including multiple sclerosis and Crohn’s disease.