SetPoint Medical Receives FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis
SetPoint System offers the first clinically-proven neuromodulation treatment option for rheumatoid arthritis (RA)
VALENCIA, Calif. — July 31, 2025 — SetPoint Medical, a company dedicated to developing therapies for people living with chronic autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s SetPoint System, a breakthrough innovation for people with rheumatoid arthritis (RA). The SetPoint System is a first-of-its-kind neuroimmune modulation device for the treatment of adults living with moderate-to-severe RA who are not adequately managed by—or cannot tolerate—existing advanced RA therapies, such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
“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.”
A Novel Therapy, Backed by Robust Clinical Research
More than 1.5 million Americans are living with RA, a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissue, leading to joint pain, bone erosion, deformity, reduced mobility, and long-term disability. There is no cure for RA, and current treatment options are often limited by poor patient adherence and dissatisfaction. Only 25% of RA patients are satisfied with their therapy,1 and up to 50% discontinue their prescribed therapies within two years, largely due to inadequate or diminishing outcomes or intolerance to adverse effects.2,3
The SetPoint System is an implantable, integrated neurostimulation device designed to deliver electrical stimulation to the vagus nerve, once daily, to activate the body’s innate anti-inflammatory and immune-restorative pathways. This groundbreaking therapy has the potential to transform the care for RA sufferers by offering a treatment option without immune-compromising risks.
FDA approval is supported by the results of the 242-patient randomized, double-blind, sham-controlled, RESET-RA study, that demonstrated the SetPoint System’s safety and efficacy in patients with moderately to severely active RA who had an incomplete response or intolerance to one or more biologic or targeted synthetic DMARDS.
“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 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. 75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.”
The device placement procedure and stimulation therapy were well-tolerated, with a low rate of related serious adverse events (1.7%), and no observations of malignancies, major cardiac events, or serious infections related to the SetPoint Therapy.
“The approval of the SetPoint System highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease, by harnessing the body’s neural pathways to combat inflammation,” said Mark Richardson, MD, PhD, 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. “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.”
The SetPoint System received Breakthrough Device Designation from the FDA, a program designed for technologies that offer potentially more effective treatment or diagnosis for debilitating diseases. The company is also planning to evaluate its platform for treatment of additional autoimmune indications, including multiple sclerosis and Crohn’s disease.
About Setpoint Medical
SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases. The company’s FDA-approved SetPoint System is the first neuroimmune modulation therapy available for people living with rheumatoid arthritis (RA), offering a novel, device-based alternative for those who do not respond to or cannot tolerate biologic or targeted drug therapies. SetPoint’s proprietary integrated neurostimulation platform is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint. With a vision to redefine the care of autoimmune conditions, SetPoint is also planning to evaluate its platform technology for other conditions including multiple sclerosis and Crohn’s disease. Learn more at setpointmedical.com.
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1 Radawski C, Genovese MC, Hauber B, et. al. Patient Perceptions of Unmet Medical Need in Rheumatoid Arthritis: A Cross-Sectional Survey in the USA. Rheumatol Ther. 2019 Sep;6(3):461-471.
2 Strand V, Miller P, Williams SA et al. Discontinuation of Biologic Therapy in Rheumatoid Arthritis: Analysis from the Corrona RA Registry. Rheumatol Ther 4, 489–502 (2017).
3 Pombo-Suarez M, Sanchez-Piedra C, Gómez-Reino J, et. al. After JAK inhibitor failure: to cycle or to switch, that is the question – data from the JAK-pot collaboration of registries. Ann Rheum Dis. 2023 Feb;82(2):175-181.