SetPoint Medical has secured approval from the US Food and Drug Administration (FDA) for SetPoint System, its neuroimmune modulation device for treating rheumatoid arthritis (RA).
The SetPoint System targets adults with moderate-to-severe RA who are inadequately managed by or intolerant to existing advanced therapies.
The therapies include biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
The SetPoint System offers a novel approach to treating RA by providing an effective treatment option that mitigates immune-compromising risks.
SetPoint Medical CEO Murthy Simhambhatla said: “The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases.
“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 US cities this year, followed by expansion across the country starting in early 2026.”
SetPoint System is an implantable neurostimulation device that delivers daily electrical stimulation to the vagus nerve, activating the body’s anti-inflammatory and immune-restorative pathways.
Its efficacy and safety were validated in the RESET-RA study, involving 242 patients with moderately to severely active RA who had an incomplete response to one or more DMARDs.
The study confirmed the device’s safety, with a low rate of serious adverse events and no malignancies, major cardiac events, or serious infections linked to the therapy.
The SetPoint System also received Breakthrough Device Designation from the FDA, recognising its potential for more effective treatment of debilitating diseases.
SetPoint Medical plans to explore the application of its platform for other autoimmune conditions, including Crohn’s disease and multiple sclerosis.
RESET-RA study national rheumatology principal investigator John Tesser said: “This is a landmark study in the treatment and care of rheumatoid arthritis.
“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. 75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.”
