SetPoint Medical to Present Data at ACR Convergence 2025 Demonstrating Sustained Efficacy and Safety for the SetPoint System to Treat Rheumatoid Arthritis

Four presentations highlight 12-month clinical outcomes, as well as MRI-assessed joint protection and patient perspectives supporting the SetPoint System as first-of-its-kind treatment for rheumatoid arthritis (RA)

VALENCIA, Calif.–(BUSINESS WIRE)–SetPoint Medical, a company dedicated to developing therapies for people living with chronic autoimmune diseases, today announced it will share four presentations highlighting new data about the SetPoint System at the upcoming American College of Rheumatology (ACR) Convergence 2025, the largest global gathering of rheumatologists. Presentations will include clinical data demonstrating that the first-of-its-kind SetPoint System’s neuroimmune modulation therapy provides sustained clinical efficacy over 12 months, inhibits joint erosion progression, and is of strong interest to adults living with moderate-to-severe rheumatoid arthritis (RA), particularly among those not satisfied with current biologic or Janus kinase (JAK) inhibitor treatments.

“The RESET-RA data document sustained clinical efficacy through one year of therapy indicating that neuroimmune modulation is effective for RA, including for those who have inadequate response to one or more biologic or JAK inhibitors,” said David Chernoff, M.D., Chief Medical Officer of SetPoint Medical. “Importantly, magnetic resonance imaging (MRI) data provides objective evidence that the SetPoint System inhibits progression of joint erosions as early as three months.”

The data are based on outcomes from the RESET-RA study, a pivotal, randomized, sham-controlled, double-blind trial of 242 patients with moderately to severely active RA who were incomplete responders or intolerant to at least one biologic or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs). The study met its primary efficacy endpoint and demonstrated a favorable safety profile leading to FDA approval for the SetPoint System in July 2025.

“We’re thrilled with the breadth of data being presented at ACR, further demonstrating the potential of the SetPoint System in treating people living with RA,” said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. “The patient preference findings reveal that individuals with RA—particularly those with prior biologic exposure—view this treatment approach positively, underscoring the need for more therapeutic options that are safe and effective.”

ACR 2025 Abstract Details

Abstract 2278: Neuroimmune Modulation for the Treatment of Rheumatoid Arthritis: Results at 12 Months from a Randomized, Sham-Controlled, Double-Blind Study

Twelve-month data from the RESET-RA study showed that SetPoint System achieved durable efficacy, sustained disease improvement, and a favorable safety profile in adults with rheumatoid arthritis who had an inadequate response or intolerance to biologic or targeted synthetic DMARDs, such as JAK inhibitors.

Key Findings:

• The statistically significant ACR20 response at three months (p=0.0209) improved further in the treatment group during open label to: 52.1% at six months, 51.7% at nine months, and 55.8% at 12 months. Similar ACR20 responses were observed among patients in the control group after they crossed over to active treatment at three months.
• Disease activity scores showed a similar trend, with 49.3% achieving DAS28-CRP low disease activity or remission, 47.4% achieving CDAI low disease activity or remission, and 77.3% achieving a EULAR good/moderate response among patients who received SetPoint Therapy through 12 months without the addition of biologics or JAK inhibitors.
• 97.5% remained on stimulation therapy at 12 months, and therapy augmentation with a biologic or JAK inhibitor occurred in 24.8% of patients.
• The implant procedure was well tolerated, with a 1.7% serious adverse event rate related to the device, procedure or stimulation. No related serious adverse events were observed following the three-month perioperative period through 12 months of follow up.
• No deaths or unanticipated adverse device effects occurred.

Abstract 1675: Neuroimmune Modulation in Patients With Active Rheumatoid Arthritis With an Inadequate Response to TNF Inhibitors (TNFi)

A RESET-RA subgroup analysis demonstrated that vagus nerve-mediated neuroimmune modulation achieved statistically significant improvement in efficacy at three months and sustained clinical benefit through 12 months, supporting neuroimmune modulation as a non-pharmaceutical option after TNFi inadequate response.

Key Findings:

• ACR20 response at three months showed a statistically significant difference between treatment 42.4% vs. control 18.2% (p=0.0057).
• ACR responses, joint counts and disease activity measures improved further through 12 months of treatment. For treatment patients receiving active stimulation without the addition of biologics or JAK inhibitors (i.e., non-augmented), ACR20/50/70 response rates at 12 months were 60%, 38% and 16% respectively, with 52% and 49% achieving LDA or remission per DAS28-CRP and CDAI scores, respectively.
• Therapy augmentation with a biologic or JAK inhibitor occurred in 13% of patients through 12 months.

Abstract 2614: Impact of Vagus Nerve-Mediated Neuroimmune Modulation on Structural Joint Damage Using Gd-MRI RAMRIS Imaging in Biologic-Experienced Patients With Rheumatoid Arthritis

MRI imaging analysis from the RESET-RA study demonstrated that the SetPoint System inhibited joint erosion progression in RA patients.

Key Findings:

• In the pre-specified “erosive phenotype” subgroup of patients with active synovitis or osteitis at baseline, the proportion of patients with erosion progression at three months was significantly lower for treatment (18.9%) compared to control (37.8%, p=0.0156).
• The non-enriched, intention-to-treat (ITT) population showed that at three months, treatment had fewer patients with erosion progression compared to control, but the difference was not statistically significant.
• In the control group, after crossover to active treatment and stimulation for three months, the proportion of patients with erosion progression reduced to levels comparable to the treatment group.

Abstract 0370: Patient Preferences for Treatments of Rheumatoid Arthritis: A Discrete Choice Experiment Evaluating Preference for Advanced Drug Therapies and Neuroimmune Modulation Device

A national patient preference study showed that RA patients expressed strong interest in neuroimmune modulation therapy, particularly among those not satisfied with current biologic or JAK inhibitor treatments. The results highlight significant unmet needs in treatment satisfaction and demonstrate that patients value outcomes, such as symptom improvement, physical function, fatigue reduction, and joint protection, when considering future therapy options.

Key Findings:

• Only 32% of respondents were satisfied with their current RA therapy.
• Initial impression of SetPoint Therapy was regarded as “positive” or “extremely positive” by 45% of respondents.
• Neuroimmune modulation was preferred over switching to another biologic or JAK therapy among biologic-experienced patients.
• Key drivers of preference:
  • Out-of-pocket treatment cost
  • Improvement in symptoms
  • Level of physical function and fatigue
  • Effectiveness in protecting against irreversible joint damage

ACR 2025 Presentation Details

Abstract 0370: Patient Preferences for Treatments of Rheumatoid Arthritis: A Discrete Choice Experiment Evaluating Preference for Advanced Drug Therapies and Neuroimmune Modulation Device

• Session: (0357–0386) Patient Outcomes, Preferences, & Attitudes Poster I
• Location: Hall F1
• Date & Time: Sunday, October 26, 2025, 10:30 AM – 12:30 PM CT
• Presented by: Jeffrey Curtis, M.D., MS, MPH, University of Alabama at Birmingham in Hoover, ALA

Abstract 1675: Neuroimmune Modulation in Patients With Active Rheumatoid Arthritis With an Inadequate Response to TNF Inhibitors (TNFi)

• Session: Abstracts: Rheumatoid Arthritis – Treatment I: Preventative and Novel Treatments (1674–1679)
• Location: S105
• Date & Time: Monday, October 27, 2025, 1:15 – 1:30 PM CT
• Presented by: Guillermo Valenzuela, MD, FACR, Medical Director of Integral Rheumatology & Immunology Specialists and IRIS Research and Development in Plantation and Miami, FL

Abstract 2278: Neuroimmune Modulation for the Treatment of Rheumatoid Arthritis: Results at 12 Months from a Randomized, Sham-Controlled, Double-Blind Study

• Session: (2265–2289) Rheumatoid Arthritis – Treatment Poster III
• Location: Hall F1
• Date & Time: Tuesday, October 28, 2025, 10:30 AM – 12:30 PM CT
• Presented by: John Tesser, MD, FACP, FACR, MACR of Arizona Arthritis & Rheumatology Associates in Phoenix, AZ, and national rheumatology principal investigator of the RESET-RA study

Abstract 2614: Impact of Vagus Nerve-Mediated Neuroimmune Modulation on Structural Joint Damage Using Gd-MRI RAMRIS Imaging in Biologic-Experienced Patients With Rheumatoid Arthritis

• Session: Abstracts: Imaging of Rheumatic Diseases (2609–2614)
• Location: S105
• Date & Time: Tuesday, October 28, 2025, 4:15 – 4:30 PM CT
• Presented by: Charles Peterfy, MD, PhD, Spire Sciences, Inc. in Boca Raton, FL

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.

Contacts

Emma Yang

Health+Commerce

media@setpointmedical.com