A groundbreaking FDA-approved device now offers hope to Americans suffering from severe rheumatoid arthritis who have been failed by Big Pharma’s expensive drug treatments.
Story Highlights
- FDA approves first-ever vagus nerve stimulation device for rheumatoid arthritis treatment
- SetPoint System provides drug-free alternative for patients who can’t tolerate costly biologic medications
- Clinical trials show 75% of patients remained free from expensive drug therapies after one year
- Device rollout begins late 2025 with nationwide expansion planned for 2026
Revolutionary Medical Device Breaks Big Pharma’s Treatment Monopoly
The FDA approved SetPoint Medical’s revolutionary SetPoint System on July 31, 2025, marking the first time Americans with moderate-to-severe rheumatoid arthritis have a viable alternative to expensive pharmaceutical treatments. This implantable device stimulates the vagus nerve in the neck, activating the body’s natural anti-inflammatory pathways without relying on costly biologic drugs that can cost patients tens of thousands annually while suppressing their immune systems.
The device represents a paradigm shift away from pharmaceutical dependency toward bioelectronic medicine, offering particular hope for patients who cannot tolerate or afford traditional drug therapies. SetPoint Medical plans initial commercialization in select U.S. cities by late 2025, followed by nationwide expansion in early 2026, giving more Americans access to this innovative treatment option.
Watch: What is vagus nerve stimulation?
Clinical Trial Results Demonstrate Superior Patient Outcomes
The pivotal RESET-RA phase 3 trial provided compelling evidence that the SetPoint System delivers sustained results without the side effects associated with immunosuppressive drugs. Dr. John Tesser, the principal investigator, reported that 75% of study participants remained free from biologic or targeted synthetic disease-modifying drugs at the one-year mark, representing a significant victory for patient autonomy over pharmaceutical dependence.
The randomized, double-blind, sham-controlled trial demonstrated significant symptom improvement compared to placebo groups, with notably low rates of serious adverse events. This safety profile stands in stark contrast to biologic medications, which carry risks of serious infections and other complications due to their immune-suppressing effects, concerns that resonate with Americans seeking safer medical alternatives.
Innovation Offers Hope Beyond Traditional Pharmaceutical Failures
Rheumatoid arthritis affects millions of Americans, with many patients experiencing inadequate relief from standard treatments or suffering intolerable side effects from expensive biologic drugs. The SetPoint System targets the vagus nerve’s role in the “inflammatory reflex,” a natural neural circuit that regulates immune responses, representing a return to working with the body’s design rather than against it.
SetPoint Medical CEO Murthy V. Simhambhatla called the approval a “transformative milestone in the management of autoimmune diseases,” with plans already underway for trials targeting multiple sclerosis and Crohn’s disease. This innovation validates bioelectronic medicine as a legitimate field, potentially reducing healthcare costs while improving patient outcomes through American ingenuity rather than foreign pharmaceutical dependence.
Sources:
FDA Approves Vagal Nerve Stimulator for RA – RheumNow
FDA Approves Neuroimmune Modulation Device for Rheumatoid Arthritis – EMPR
SetPoint Medical Receives FDA Approval for Novel Neuroimmune Modulation Therapy
