SetPoint Medical has received U.S. Food and Drug Administration (FDA) approval of its SetPoint system to treat rheumatoid arthritis (RA).

The SetPoint system is an implantable, integrated neurostimulation device that delivers electrical stimulation to the vagus nerve once a day to activate innate anti-inflammatory and immune-restorative pathways. The company believes the therapy could transform RA care by providing a treatment option without immune-compromising risks.

The FDA approval was supported by results from the 242-patient RESET-RA study that showed the SetPoint system’s safety and efficacy in patients with moderately to severely active RA who had incomplete response or intolerance to one or more biologic or targeted synthetic DMARDS.

“The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up,” said John Tesser, MD, FACP, FACR, MACR, a leading rheumatologist and national rheumatology principal investigator of the RESET-RA study. “75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.”

The device implant procedure and stimulation therapy were well-tolerated with a 1.7% of related serious adverse events. There were also no observations of malignancies, major cardiac events, or serious infections related to the therapy.

Mark Richardson, MD, Ph.D., Director of Functional Neurosurgery at Massachusetts General Hospital and Professor of Neurosciences at Harvard Medical School, and national surgical principal investigator in the RESET-RA study said the system’s approval highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease by harnessing the the body’s neural pathways to combat inflammation.

“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,” Dr. Richardson told the press.

The system earned FDA breakthrough status for RA in 2020. The company said it’s planning to evaluate the platform to treat additional autoimmune indications like 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. “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. We plan to introduce the SetPoint System in targeted U.S. cities this year, followed by expansion across the country starting in early 2026.”