The U.S. Food and Drug Administration (FDA) has granted approval to SetPoint Medical's SetPoint System, a pioneering neuroimmune modulation device designed for the treatment of moderate-to-severe rheumatoid arthritis (RA). This significant development, highlighted by Dr. Eric Topol in a recent tweet and his "Ground Truths" post, marks the "dawn of an FDA device treatment for autoimmune diseases." The approval, announced on July 31, 2025, offers a novel, device-based alternative for adult RA patients who have not responded adequately to or cannot tolerate existing advanced therapies.
The SetPoint System is an implantable device that stimulates the vagus nerve, activating the body's innate anti-inflammatory pathways to reduce inflammation and restore immunologic balance. Unlike traditional pharmacological treatments, this approach aims to modulate the immune system without the broad immunosuppressive risks associated with some drug therapies. The device placement is an outpatient procedure, and the stimulation therapy is delivered on a preset schedule.
Clinical efficacy was demonstrated in the pivotal RESET-RA study, which formed the basis for the FDA's approval. Results indicated that over 60% of participants experienced relief from joint pain and swelling by one year with the active device. The therapy was well-tolerated, with a low rate of related serious adverse events at 1.7%, and hoarseness noted as the main adverse effect in 2% of participants.
Murthy V. Simhambhatla, CEO of SetPoint Medical, stated that the approval of the SetPoint System represents a "transformative milestone in the management of autoimmune diseases." The company plans a targeted launch of the device in select U.S. cities this year, with a wider national rollout anticipated in early 2026. SetPoint Medical is also actively exploring the potential of its neuroimmune modulation platform for other chronic autoimmune conditions, including multiple sclerosis and Crohn's disease.