Beyond Drugs: Vagus Nerve Implant Redefines Rheumatoid Arthritis Care

VALENCIA, CA – January 05, 2026 – For the more than 1.5 million Americans battling rheumatoid arthritis (RA), the treatment journey is often a grueling cycle of powerful drugs with diminishing returns and significant side effects. But a groundbreaking development, blending neuroscience with immunology, is poised to redefine this landscape. SetPoint Medical has announced that its pivotal RESET-RA study results have been published in the prestigious journal Nature Medicine, providing robust scientific validation for its innovative SetPoint System—a first-of-its-kind implantable device that treats RA not with drugs, but with electricity.

The publication marks a critical milestone for a therapy that offers hope to patients with moderately-to-severely active RA who have found little relief from existing advanced treatments, such as biologics and targeted synthetic drugs. The device, which received FDA approval last year, represents a new frontier in medicine known as neuroimmune modulation, which harnesses the body's own neural circuits to control inflammation.

A New Paradigm in Autoimmune Treatment

Instead of introducing chemicals to block inflammatory pathways, the SetPoint System works by activating the body's innate anti-inflammatory mechanisms. The therapy involves a small, rechargeable neurostimulator, about the size of a pill, which is implanted on the vagus nerve in the neck during a roughly 60-minute outpatient procedure. Once implanted, the device is programmed to deliver a gentle electrical pulse for just one minute each day.

This stimulation targets the body's "inflammatory reflex," a natural neural pathway that regulates the immune system. By activating this reflex, the device helps reduce the production of pro-inflammatory cytokines—the proteins that drive the painful inflammation and joint damage characteristic of RA. This approach aims to restore the body's natural immunologic balance, or "setpoint," rather than broadly suppressing the immune system, which is a common risk associated with many traditional RA medications.

"Neuroimmune modulation represents a major inflection point in the treatment history of rheumatoid arthritis,” said Dr. John Tesser, the national principal investigator of the RESET-RA study. He emphasized that the publication in a top-tier, peer-reviewed journal validates the quality and rigor of the clinical data that led to the device's FDA approval.

Landmark Study Confirms Efficacy and Safety

The RESET-RA study was a rigorous, double-blind, randomized, sham-controlled trial designed to definitively assess the SetPoint System's performance. The results published in Nature Medicine demonstrated both statistically significant and clinically meaningful benefits for patients.

Key findings from the study revealed impressive efficacy and durability over 12 months of treatment:

• Sustained Improvement: Patients showed a significant improvement in symptoms at three months, as measured by the American College of Rheumatology's ACR20 response criteria. This improvement was not only maintained but enhanced over time, with 52.8% of patients achieving this response at the 12-month mark.

• Reduced Disease Activity: Nearly half of the patients (49.3%) achieved low disease activity or even remission after a year of therapy, as measured by the comprehensive DAS28-CRP score, without the need for additional biologic or JAK inhibitor drugs.

• Less Reliance on Drugs: A remarkable 75.2% of patients treated with the SetPoint System remained free from needing to add powerful adjunctive drug therapies to their treatment regimen throughout the first year.

• Protection Against Joint Damage: In a pre-specified subgroup of patients at high risk for erosive damage, MRI scans showed a 50% relative reduction in bone erosion progression in the treatment group compared to the control group within the first three months.

The safety profile was equally compelling. With a mean implant duration of over 700 days, there were no related deaths or unanticipated adverse effects from the device. The few related serious adverse events (1.6%) were all associated with the initial surgical procedure and resolved completely. The most common side effect was temporary hoarseness, a known risk of surgery near the vagus nerve.

"The SetPoint System is designed to activate the body’s innate anti-inflammatory pathways that may be dysfunctional in people living with RA,” noted Dr. David Chernoff, Chief Medical Officer of SetPoint Medical. He explained that the RESET-RA study was the culmination of over two decades of research, verifying that this approach can deliver sustained improvements for those who have exhausted traditional options.

Addressing a Critical Unmet Need

For a significant portion of RA patients, the current arsenal of advanced drugs fails to provide adequate relief or comes with intolerable side effects. These individuals are often left to manage chronic pain, stiffness, and progressive joint damage with few viable alternatives. The SetPoint System directly targets this unmet need, offering a non-pharmacological solution that works in harmony with the body's own systems.

Patient satisfaction data from the clinical trial underscores its real-world impact. An overwhelming 94% of participants said they would recommend the therapy to a friend or family member. This high level of satisfaction points to the life-changing potential for those who have felt left behind by conventional medicine, offering them a chance to regain function and quality of life.

From Lab to Market: The Path to Patient Access

With FDA approval secured through the agency's Breakthrough Device Designation program, SetPoint Medical has already begun a phased commercial launch in select U.S. markets. The company's strategy is bolstered by a crucial milestone achieved late last year: approval for a Transitional Pass-Through Payment from the Centers for Medicare & Medicaid Services (CMS). This designation helps ensure hospitals are adequately reimbursed for using the new technology, a critical step in removing financial barriers and facilitating broader patient access.

A full national expansion is planned throughout 2026, bringing this novel therapy within reach of more patients across the country. As the first and only FDA-approved neuroimmune modulation therapy for RA, the SetPoint System has established a significant first-mover advantage in a market long dominated by pharmaceuticals.

Looking ahead, the company is already planning to explore the potential of its platform technology for other chronic autoimmune conditions, including multiple sclerosis and Crohn's disease. This suggests that the bioelectric treatment of RA may be just the first chapter in a much larger story about the future of medicine, where harnessing the body's own neural wiring could become a primary tool in managing chronic disease.