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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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.
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.
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.
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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