VALENCIA, Calif., June 29, 2026
SetPoint Medical has announced a significant milestone in the expansion of its FDA-approved SetPoint System®, with the first patient in North Carolina successfully treated using the innovative device-based therapy for rheumatoid arthritis (RA). The procedure was performed in collaboration with Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), the largest independent rheumatology practice in the Southeastern United States, following a referral from rheumatologist Dr. Ashley Toci. The milestone marks another step in SetPoint Medical’s nationwide commercialization strategy, bringing the first-and-only FDA-approved vagus nerve-mediated neuroimmune modulation therapy to patients in the region. Designed for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to or cannot tolerate biologic or targeted synthetic disease-modifying therapies, the SetPoint System introduces a non-pharmacological treatment approach that leverages the body’s own neurological pathways to regulate chronic inflammation. The expansion reflects growing physician confidence in neuroimmune modulation technology and reinforces the increasing role of advanced medical devices in the management of chronic autoimmune diseases.
FDA-Approved Neuroimmune Modulation Offers a New Treatment Option
Unlike traditional drug therapies, the SetPoint System® utilizes an implantable neurostimulation device that delivers one-minute daily electrical stimulation to the vagus nerve, activating the body’s natural anti-inflammatory reflex to help regulate immune system activity. This innovative approach is designed to reduce inflammation without relying solely on systemic medications, providing an alternative for patients who continue to experience persistent disease activity despite multiple treatment attempts. Rheumatologists at AOCC highlighted that although biologic therapies have transformed rheumatoid arthritis management over recent decades, many patients continue to cycle through different medications without achieving adequate disease control.
Neuroimmune modulation introduces an entirely new therapeutic category, targeting communication between the nervous and immune systems rather than directly suppressing immune responses. By stimulating the vagus nerve, the SetPoint System seeks to restore the body’s natural immune balance while minimizing the long-term treatment burden associated with continuous pharmacological therapy, offering hope to patients seeking additional options for controlling chronic inflammation and preserving joint function.
Clinical Evidence Supports National Expansion of SetPoint Therapy
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The SetPoint System received U.S. FDA approval in 2025 following results from the pivotal RESET-RA clinical study, which demonstrated meaningful improvements in rheumatoid arthritis disease activity among eligible patients. Clinical findings supported the therapy’s ability to activate innate anti-inflammatory pathways through targeted neurostimulation, addressing a significant unmet need within the rheumatoid arthritis treatment landscape. Building on this evidence, SetPoint Medical continues expanding access through collaborations with leading rheumatology centers across the United States, including the latest introduction at AOCC’s Charlotte-area clinics. Company leadership emphasized that partnerships between rheumatologists and specialists are essential for integrating innovative medical technologies into routine clinical practice while ensuring patients have access to evidence-based treatment alternatives. Looking beyond rheumatoid arthritis, SetPoint Medical is also evaluating its proprietary neuroimmune modulation platform for additional autoimmune disorders, including multiple sclerosis and Crohn’s disease, highlighting the broader potential of vagus nerve stimulation in treating chronic inflammatory conditions.
The successful first procedure in North Carolina represents another important milestone in the evolution of bioelectronic medicine, demonstrating how implantable neurostimulation technologies can complement existing standards of care and potentially reshape the future management of autoimmune diseases. As healthcare increasingly embraces precision medical technologies, SetPoint Medical continues to position neuroimmune modulation as a transformative therapeutic platform capable of delivering durable clinical benefits while reducing reliance on long-term drug therapy, advancing a new era of device-based treatment for patients living with chronic inflammatory diseases.
Source: SetPoint Medical press release
