The US Food and Drug Administration (FDA) has approved SetPoint Medical’s implantable neuroimmune modulation device, SetPoint System, to treat moderate-to-severe rheumatoid arthritis (RA) in adults.
The system is designed for individuals who are inadequately managed by or intolerant to current RA therapies such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
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The system is said to activate the body’s natural anti-inflammatory and immune-restorative pathways by delivering electrical stimulation to the vagus nerve once a day.
The neurostimulation therapy can potentially provide an alternative treatment without immune-compromising risks.
The FDA approval was based on the outcomes of the RESET-RA study, a 242-patient double-blind, randomised, sham-controlled trial, which showed the system’s efficacy and safety in this patient group.
Patients tolerated the device placement procedure and the stimulation therapy well, with a low incidence of related serious adverse events at 1.7%.
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By GlobalDataSetPoint 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 Medical is also exploring the use of its neuroimmune modulation platform for other autoimmune diseases such as multiple sclerosis (MS) and Crohn’s disease.
In March 2024, the company’s neuroimmune modulation device secured a breakthrough device designation to treat relapsing-remitting MS.
