SetPoint: The Implant That Resets Your Immune System

Rheumatoid arthritis has been treated with drugs for decades. The SetPoint System is the first FDA-approved device that treats it by stimulating a nerve instead, activating the body's own pathways to reduce inflammation.

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A Disease the Body Was Always Capable of Managing

Rheumatoid arthritis makes the immune system attack its own joints. The inflammation builds over time, damages tissue, limits movement, and gets worse without treatment. For decades, the answer has been medication. Biologics, immunosuppressants, and targeted drugs are delivered into the bloodstream. They have helped many patients and fallen short for many others. The SetPoint System takes a completely different approach. Not a drug. A nerve.

SetPoint System: The First FDA-Approved Neuroimmune Modulation Device

Inside the body runs a pathway called the vagus nerve. It connects the brain to the rest of the body and plays a central role in something scientists call the inflammatory reflex, the body's own built-in system for controlling immune response and keeping inflammation in check. In rheumatoid arthritis that system stops working properly. The SetPoint System restores it. A small wireless implant delivers a precise electrical signal to the vagus nerve, activating the body's natural pathways to reduce inflammation and rebalance the immune system. No drug. No chemical suppression. Just the body's own mechanism, switched back on. It is the first and only FDA-approved treatment for rheumatoid arthritis that works through nerve stimulation rather than medication.

One Minute a Day, for Ten Years

Once implanted and activated, the SetPoint System runs on its own. One minute of stimulation every day for up to ten years. No injections. No daily pills. No treatment schedule to manage. The only task is charging the implant battery for a few minutes each week. In the RESET-RA clinical study, patients with moderately to severely active rheumatoid arthritis who had not responded well to biologics or targeted drugs showed an average improvement of 60 percent in tender and swollen joint counts over 12 months. Nine out of ten participants said they would recommend the therapy to someone they know.

A Platform Built for More Than One Disease

The SetPoint System received FDA approval for rheumatoid arthritis in July 2025. The results of the landmark RESET-RA study were published in Nature Medicine in January 2026. SetPoint Medical has since enrolled the first patients in a pilot study evaluating the same neuroimmune modulation approach for multiple sclerosis. The same technology that resets the immune response in rheumatoid arthritis may have a role to play in other autoimmune conditions where that response has gone wrong.

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