Key takeaways:
- Implantable device stimulates the vagus nerve for 60 seconds daily.
- The device activates anti-inflammatory and immunomodulatory properties in the body.
The FDA has approved the SetPoint System, a vagus nerve stimulator from SetPoint Medical, for the treatment of rheumatoid arthritis.
The device is an implantable, integrated neurostimulator about the size of a vitamin tablet that stimulates the vagus nerve for 60 seconds once daily with the goal of activating natural anti-inflammatory capabilities within the body. The device has also demonstrated the capacity for immune modulation.
SetPoint Medical has announced FDA approval of its SetPoint System, a vagus nerve stimulator from for patient with rheumatoid arthritis.
“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” Murthy V. Simhambhatla, PhD, CEO of SetPoint Medical, said in a company press release. “We are committed to improving the health of people living with RA and look forward to working with providers and payers to make our innovative therapy accessible to their patients.
“We plan to introduce the SetPoint System in targeted U.S. cities this year, followed by expansion across the country starting in early 2026,” he added.
The FDA approval follows the double-blind, placebo-controlled RESET-RA study, in which patients underwent the daily vagus nerve stimulation and were assessed at 12 weeks. According to the researchers, the SetPoint System demonstrated statistically significant improvement over placebo in terms of ACR20 response at that time point (P = .0209).
Further results showed that for patients with one prior exposure to a biologic or traditional synthetic disease-modifying antirheumatic drug, 44.2% of those in the vagus nerve stimulation group achieved ACR20 response, compared with 19% of controls (P = .0054).
“This is a landmark study in the treatment and care of rheumatoid arthritis,” John Tesser, MD, FACP, FACR, MACR, of Arizona Arthritis & Rheumatology Associates and Midwestern University, who was a principal investigator of the RESET-RA study, said in the release.
“The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up,” he added. “75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.”
SetPoint is additionally planning to evaluate its device for the treatment of other autoimmune diseases, including multiple sclerosis and Crohn’s disease, according to the release.
