- Study projects SetPoint System® could save the U.S. health system more than $350,000 per patient over a lifetime compared to standard-of-care, pharmacologic treatments
- The cost of device and procedure cost were projected to be fully recouped within 16 months
VALENCIA, Calif., May 14, 2026 /PRNewswire/ -- SetPoint Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced the publication of a landmark, peer-reviewed cost-effectiveness study in the Journal of Medical Economics demonstrating that its SetPoint System®, a U.S. Food and Drug Administration (FDA) approved neuroimmune modulation device, is associated with substantial cost savings and improved quality of life compared to standard pharmacologic treatment for adults with moderate-to-severe rheumatoid arthritis (RA) in the United States.
"This analysis provides compelling evidence that the SetPoint System delivers both clinical benefit to those with RA and meaningful economic value to the healthcare system," said Murthy Simhambhatla, CEO of SetPoint Medical. "The fact that the device is projected to pay for itself within 16 months – and continues to generate savings throughout a patient's lifetime – reinforces our conviction that neuroimmune modulation represents a transformative shift in the standard of care for RA."
The decision-analytic Markov model evaluated the cost-effectiveness of neuroimmune modulation therapy at the two-year, 10-year, and lifetime horizons, with clinical inputs drawn from the RESET-RA pivotal trial that supported the FDA approval of the SetPoint System. Key findings in this study include:
- Cost recovery projected in under 16 months: The upfront cost of the SetPoint System, as well as its implant procedure, was fully amortized within 16 months of therapy initiation.
- Highly cost-effective, "dominant" treatment strategy: Neuroimmune modulation therapy was associated with cost savings of $25,397, $197,062 and $350,052, at two years, 10 years and over lifetime, respectively, while generating incremental quality-adjusted life-years (QALYs), rendering the therapy economically dominant.
- Consistent effectiveness across varied scenarios: Neuroimmune modulation therapy remained highly cost-effective or dominant across the full range of sensitivity analyses, including scenarios with significantly lower drug cost inputs, increased uptake of drugs in combination with SetPoint Therapy, and alternative device service life assumptions.
"These findings demonstrate the substantial health-economic value of neuroimmune modulation therapy as a treatment alternative for rheumatoid arthritis," said senior author Jan B. Pietzsch, Ph.D., of Wing Tech Inc. and director of Health Economics and Value at the Stanford University's Mussallem Center for Biodesign. "Achieving the projected level of health-economic dominance – sizable cost savings at concurrent outcome improvement – is unique among implantable medical devices."
More than 1.5 million Americans are living with RA, a chronic autoimmune disease with no cure that causes the immune system to attack healthy tissue, leading to joint pain, bone erosion, deformity, and long-term disability. Standard RA treatment with biological and targeted synthetic antirheumatic drugs (b/tsDMARDs) accounted for nearly $30 billion in drug spending, including $13.6 billion in Medicare Part D spend, in 2023.
The SetPoint System offers a non-pharmacologic, device-based treatment alternative for adults with moderate-to-severe RA who have had an inadequate response, loss of response, or intolerance to one or more b/tsDMARDs. The fully integrated neurostimulator delivers one-minute stimulation daily to the vagus nerve to activate innate anti-inflammatory pathways, with an FDA-labeled service life of up to 10 years. The SetPoint System was U.S. FDA approved in July 2025 and is currently available in select U.S. markets, with broader national expansion planned throughout 2026.
To read the full study, "Cost-effectiveness of Vagus Nerve-Mediated Neuroimmune Modulation for the Treatment of Moderate-to-Severe Rheumatoid Arthritis," visit the Journal of Medical Economics. The Journal of Medical Economics holds a Q1 ranking in Health Policy and publishes rigorously peer-reviewed research in the pharmacoeconomics, with a focus on high-quality economic assessments of novel therapeutic and device interventions.
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 biological 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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SOURCE SetPoint Medical
