Boston, Massachusetts, United States, October 28, 2026
SetPoint Medical has announced the successful treatment of the first patient with its FDA-approved SetPoint® System at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts, marking an important milestone in expanding access to neuroimmune modulation therapy for people living with rheumatoid arthritis (RA). The procedure was performed by Joshua P. Aronson, M.D., a functional neurosurgeon at BIDMC, on October 28, 2026. The development introduces an additional treatment approach for adults with moderately to severely active rheumatoid arthritis who have not achieved adequate disease control, experienced a loss of response or cannot tolerate one or more biological or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). The SetPoint System uses an implantable neurostimulator to activate the body’s natural anti-inflammatory pathways through targeted vagus nerve stimulation, offering a device-based alternative to conventional pharmacological treatment approaches. The Boston procedure also represents an expansion of the technology’s availability across New England, allowing more eligible patients to access this innovative treatment option.
SetPoint System Introduces a New Approach to Rheumatoid Arthritis
Rheumatoid arthritis is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues, particularly the joints, resulting in inflammation, pain, swelling, stiffness and progressive joint damage. In advanced cases, the condition can cause bone erosion, deformity, reduced mobility and long-term disability. More than 1.5 million people in the United States are estimated to live with rheumatoid arthritis. Although biological therapies and targeted synthetic medicines have improved treatment options, some patients continue to experience inadequate disease control or difficulties tolerating available medications. The SetPoint System introduces a different therapeutic approach through neuroimmune modulation, which aims to influence the communication pathways connecting the nervous and immune systems. The system consists of a small implantable neurostimulator designed to deliver controlled electrical stimulation to the left vagus nerve. This nerve plays an important role in regulating several physiological processes, including the body’s inflammatory response. By activating neural pathways associated with the body’s natural anti-inflammatory mechanisms, the technology is designed to help regulate immune activity associated with rheumatoid arthritis. Unlike conventional systemic immunosuppressive treatments, this approach uses targeted electrical stimulation rather than administering another drug to modify immune activity.
FDA-Approved Vagus Nerve Stimulation Technology Expands Access
The SetPoint System received U.S. FDA approval in July 2025, becoming the first FDA-approved neuroimmune modulation therapy for eligible adults with moderately to severely active rheumatoid arthritis. Its approval followed clinical evaluation of the technology, including the pivotal RESET-RA clinical study. The system is indicated for adults who have experienced an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic DMARDs. The implant procedure involves placing the miniature neurostimulator near the left vagus nerve through a surgical approach. Following implantation, the device delivers controlled electrical stimulation according to its prescribed treatment settings. At BIDMC, the first Boston procedure was performed by Dr. Joshua P. Aronson, expanding the availability of this treatment through the hospital’s neurosurgical and rheumatology teams. Brian J. Stout, M.D., a rheumatologist at BIDMC, highlighted the potential importance of neuroimmune modulation for patients whose rheumatoid arthritis remains inadequately managed with existing biological therapies. The introduction of SetPoint Therapy in Boston represents another step towards expanding access to device-based treatment options for autoimmune diseases. As more healthcare institutions begin offering the technology, eligible patients may have additional opportunities to discuss alternative treatment approaches with their specialists.
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Boston Procedure Marks Progress in Neuroimmune Modulation
The first treatment at Beth Israel Deaconess Medical Center represents a significant commercial and clinical milestone for SetPoint Medical, a medical technology company focused on developing therapies for chronic autoimmune diseases. The company is expanding the availability of its neurostimulation platform through collaborations with rheumatologists, neurosurgeons and healthcare institutions across the United States. Boston now joins several other markets where patients can access SetPoint Therapy, reflecting the growing adoption of neuroimmune modulation as an emerging area of medical technology. Murthy V. Simhambhatla, Ph.D., President and Chief Executive Officer of SetPoint Medical, highlighted the importance of working with leading academic medical centres to expand treatment access throughout New England. The company is also exploring the potential application of its proprietary neurostimulation platform in other immune-mediated conditions, including multiple sclerosis and Crohn’s disease. However, these remain areas of planned investigation rather than approved indications. Like other implantable medical technologies, the SetPoint System carries potential risks, including surgical pain, infection, hoarseness, bruising, swelling, coughing and throat irritation. It is not suitable for everyone, and patients require specialist assessment before treatment. The first Boston procedure highlights the growing role of bioelectronic medicine in autoimmune disease management, bringing together neuroscience, medical device innovation and rheumatology to expand treatment possibilities for patients with difficult-to-manage rheumatoid arthritis.
Source: SetPoint Medical press release
