Shortly after obtaining a green light from the FDA, SetPoint Medical announced $140 million in new funding to juice the commercialization of its neuromodulation implant for rheumatoid arthritis.
The company described the proceeds as $25 million coming courtesy of a second tranche through its series C financing, plus $115 million through a series D round—the latter being co-led by Elevage Medical Technologies and Ally Bridge Group.
The series D also counted investors in Northwell Health, SPRIG Equity, Norwest, New Enterprise Associates, Viking Global Investors, Action Potential Venture Capital, Euclidean Capital, Richard King Mellon Foundation, Morgenthaler Ventures, ShangBay Capital, Ascendum Capital, Catalio Capital Management, Gilmartin Capital and Midas Capital as well as backing from medtechs Abbott and Boston Scientific.
July 31, SetPoint reported the FDA’s approval of its neuroimmune modulation therapy for people with moderate to severe rheumatoid arthritis who have not seen success with targeted pharmaceutical treatments.
The former Fierce 15 winner’s small, wirelessly charged implant is placed directly on the vagus nerve and is designed to activate the body’s anti-inflammatory processes to help halt the immune system’s attacks on healthy tissue.
“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” SetPoint CEO Murthy Simhambhatla, Ph.D., said in a statement. “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.”
In a clinical study, about half of treated patients saw low disease activity or remission after 12 months of automatic once-daily stimulation among patients who did not take new medications or changed their previous disease-modifying therapy regimen.
The company also presented data last year showing that after 12 weeks, MRI scans tracking bone erosion progression markers showed a 74% drop compared to a randomized control group, at which point all participants in the study began receiving the therapy.