SetPoint Medical Presents 24-Month Data Demonstrating Sustained Clinical Benefit and Favorable Long-Term Safety of the SetPoint System for Rheumatoid Arthritis

Findings presented at ACR Convergence 2026 reinforce the long-term potential of neuroimmune modulation as a durable treatment approach for people living with rheumatoid arthritis

VALENCIA, Calif. - November 9, 2026 - SetPoint Medical, a company dedicated to developing therapies for people living with chronic autoimmune diseases, announced presentation of new 24-month data from its RESET-RA pivotal trial demonstrating sustained clinical responses and favorable long-term safety with the SetPoint^® System, the first U.S. Food and Drug Administration (FDA)-approved neuroimmune modulation therapy for rheumatoid arthritis (RA).

The long-term data showed that for RA patients treated with SetPoint Therapy, clinical responses were sustained and, in many cases, continued to improve through 24 months. Overall, 71% of study participants reached 24-month follow-up without the addition of a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD).

"Patients with rheumatoid arthritis need novel treatment options that can provide durable disease control over the long term," said David Chernoff, M.D., chief medical officer of SetPoint Medical. "These 24-month data show that a large majority of patients maintained meaningful clinical responses without having to add biologics or JAK inhibitors, while continuing to demonstrate a favorable safety profile. The findings further validate SetPoint neuroimmune modulation therapy as a differentiated treatment approach for those living with rheumatoid arthritis."

The RESET-RA study, which supported FDA approval of the SetPoint System in July 2025, evaluated the safety and efficacy of the neuroimmune modulation therapy in 242 adults with moderately to severely active RA who had an inadequate response, loss of response or intolerance to one or more b/tsDMARDs. The randomized, sham-controlled, double-blind trial met its primary efficacy endpoint at three months, after which participants in the sham-control group crossed over to active stimulation for long-term follow-up through 24 months.

At ACR Convergence 2026, John R.P. Tesser, M.D., FACP, MACR, Arizona Arthritis & Rheumatology Associates, presented "Vagus-Mediated Neuroimmune Modulation for the Treatment of Rheumatoid Arthritis: Long-Term Results at 24 Months from a Randomized, Sham-Controlled, Double-Blind Trial." Key findings from this latest research included:

• Sustained clinical efficacy: Among study participants receiving SetPoint Therapy without the addition of b/tsDMARDs, ACR response rates continued to improve through 24 months, with 62.7%, 38.7% and 18.7% achieving an ACR20, ACR50 and ACR70 response, respectively.
• Lower disease activity: Approximately half of participants achieved low disease activity or remission based on both Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) as well as Clinical Disease Activity Index (CDAI) with 24 months of therapy. Additionally, 77.7% achieved a DAS28-CRP good or moderate EULAR response at 24 months.
• Therapy persistence: At 24 months, 91.7% of participants continued stimulation therapy, and only 29.3% were using a b/tsDMARD in combination with SetPoint Therapy at the time of the 24-month assessment. Fourteen patients (5.8%) underwent elective device removal; all explantations were performed as elective outpatient procedures, the primary reason being perceived lack of efficacy.
• Favorable long-term safety profile: No serious adverse events, including no malignancies, major adverse cardiac events or serious infections, related to the device or stimulation therapy were reported after three-month crossover through 24 months. The most common adverse event related to the device or stimulation therapy was mild to moderate pain occurring at the implant site in <5% of patients, that resolved on its own, with adjustment to stimulation, or medication.

"These 24-month results strengthen the clinical foundation for neuroimmune modulation in rheumatoid arthritis," said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. "Durable responses at two years, alongside a consistent safety profile and high rates of patients remaining on therapy, reinforce the role of the SetPoint System for people living with RA who are inadequately managed by, or cannot tolerate, existing RA therapies. We look forward to building on this evidence as we continue expanding patient access across the United States in 2027."

The full poster presented at ACR Convergence 2026 is available here.

About the 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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