Publication of 12-month outcomes reinforces SetPoint Medical’s pioneering role in advancing neuroimmune modulation as a new treatment paradigm for rheumatoid arthritis (RA)

SetPoint Medical, a company dedicated to developing therapies for people living with chronic autoimmune diseases, today announced the publication of data from the RESET-RA study in Nature Medicine. The pivotal, double-blind, randomized, sham-controlled study evaluated the safety and efficacy of the SetPoint System, an implantable vagus nerve-targeted neuroimmune modulation device for adults living with moderately-to-severely active rheumatoid arthritis (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).

“Neuroimmune modulation represents a major inflection point in the treatment history of rheumatoid arthritis,” said John Tesser, M.D., FACP, FACR, MACR, national principal investigator of RESET-RA study. “Publication of the RESET-RA study in Nature Medicine provides peer-reviewed recognition that further validates the quality and rigor of the clinical data that supported SetPoint System’s FDA approval.”

“The SetPoint System is designed to activate the body’s innate anti-inflammatory pathways that may be dysfunctional in people living with RA,” said David Chernoff, M.D., Chief Medical Officer of SetPoint Medical. “The RESET-RA study, built on over two decades of research and engineering, verified that neuroimmune modulation can deliver clinically meaningful and sustained improvements to those who continue to struggle with RA despite trying traditional therapeutic options.”

RESET-RA results demonstrated clinically meaningful improvements and sustained efficacy through 12 months. Highlights from the published findings include:

Efficacy and durability outcomes:

• Statistically significant and clinically meaningful improvement in ACR20 response, a composite measure of the effectiveness of RA treatments set forth by the American College of Rheumatology, at three months (p = 0.0209), with improving response rates of 50.0% at 6 months and 52.8% at 12 months in open-label follow-up.
• Clinically relevant composite outcomes such as disease activity scores showed a similar trend with 77.3% achieving EULAR good/moderate response rates, 49.3% attaining DAS28-CRP (Disease activity score based on 28 joint count and CRP) low disease activity or remission, and 47.4% attaining CDAI (Clinical Disease Activity Index) low disease activity or remission after 12 months of treatment without the addition of biological DMARD or JAK inhibitor.
• At 12 months, 75.2% of patients remained free from having an adjunctive biological DMARD or JAK inhibitor added to their stimulation therapy.
• Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis MRI Scoring System (RAMRIS) demonstrated a 50% relative reduction in erosion progression in the treatment group compared to the control (p=0.016) from baseline to 3 months in a pre-specified subgroup of patients at higher risk for erosive damage.

Safety outcomes:

• The safety evaluation was based on all available data at the time of reporting, with a mean implant duration of >700 days. No related-deaths or unanticipated adverse device effects occurred at any point during the trial. Overall, adverse events (AEs) occurred in a similar proportion of patients in both arms during the controlled period.
• Related serious adverse events (rate=1.6%) were all perioperative within the first three months and resolved.
• No new serious adverse events or safety concerns identified through other protocolized safety monitoring assessments were related to the device, procedure, or stimulation, in the open-label period of stimulation through 12 months.

Publication of the data in Nature Medicine builds on a series of recent milestones for SetPoint Medical, including FDA approval of the SetPoint System and the nation’s first patient to receive the FDA-approved device at Northwell Health’s North Shore University Hospital. The SetPoint System is currently available in select U.S. markets, with broader national expansion planned throughout 2026.

About SetPoint System

The SetPoint System is indicated for use in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs. It should not be used if you have had a vagotomy or splenectomy, or if your healthcare provider determines that it is not safe for you to use the SetPoint System. Risks may include, but are not limited to, pain or infection after surgery, hoarseness, bruising, swelling, coughing and throat irritation. For full safety information, please see Instructions for Use and our Important Safety Information at spm.care/ISI. Individual results may vary.

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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