In a significant advancement for autoimmune disease treatment, the U.S. Food and Drug Administration (FDA) has approved the SetPoint System, a novel implantable neuroimmune modulation device designed for adults with moderate-to-severe rheumatoid arthritis (RA).
The SetPoint System is specifically indicated for patients who have not responded to, or cannot tolerate, current advanced therapies, including biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs). The device delivers daily electrical stimulation to the vagus nerve, aiming to activate the body’s innate anti-inflammatory and immune-regulating responses.
FDA approval was based on data from the RESET-RA clinical trial, which included 242 participants randomly assigned to receive either the SetPoint device or a sham treatment.
The study met its primary efficacy endpoint, with patients achieving a 20% improvement in RA symptoms (as defined by the American College of Rheumatology) at three months.
Benefits in both symptom response and disease activity continued through 12 months, with 75% of patients remaining off biologic or targeted synthetic DMARDs at the end of the study period.
The treatment was also well tolerated. Device-related serious adverse events were reported in just 1.7% of participants, and the implantation procedure was described as minimally invasive and performed on an outpatient basis.
“This FDA approval marks a milestone in neuroimmune modulation as a therapeutic strategy for autoimmune conditions,” said Dr. Mark Richardson, M.D., Ph.D., lead investigator of the RESET-RA trial and professor at Harvard University. “The SetPoint device is programmed to deliver therapy automatically for up to 10 years, offering patients a simplified, long-term approach to managing RA.”
The device is developed and manufactured by SetPoint Medical.
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