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SetPoint Medical has reported positive topline results from the RESET‑RA Phase 3 study, demonstrating that its implantable vagus nerve stimulation device significantly improved ACR20 response rates in moderate-to-severe rheumatoid arthritis patients who were incomplete responders or intolerant to biologic/targeted synthetic DMARDs. The system is also being evaluated for relapsing-remitting multiple sclerosis and has received FDA Breakthrough Device Designation for this indication. Proof-of-concept data are available in Crohn’s disease; preclinical work is ongoing in other autoimmune conditions.
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