SetPoint raises $80 million to advance autoimmune disease platform

SetPoint Medical announced Thursday that it raised $80 million and also secured a loan facility worth up to $65 million. The funds will be used to complete its ongoing RESET-RA pivotal trial, which is evaluating its investigational platform for the treatment of rheumatoid arthritis (RA) using vagus nerve stimulation, along with subsequent FDA submissions and early commercialisation for the RA indication.

CEO Murthy Simhambhatla said "we look forward to furthering our clinical and regulatory goals toward FDA approval of our novel approach in partnership with our investors."

SetPoint is developing its bioelectronic platform for the treatment of chronic, inflammation-mediated autoimmune diseases, initially focusing on a potentially less immunosuppressive option for RA. The SetPoint system was granted FDA breakthrough device designation in 2020 for RA patients who have incomplete response to, or are intolerant to, multiple biologic drugs. It comprises a miniaturised stimulation device that is placed on the vagus nerve through a small incision on the left side of the neck, after which it is programmed to automatically deliver therapy on a pre-set schedule.

The company recently announced the first participant enrolled in the second stage of the 250-patient RESET-RA trial. The primary efficacy endpoint is the proportion of patients achieving an American College of Rheumatology (ACR20) response in the treatment group compared with placebo at 12 weeks.

SetPoint raised $64 million in 2021 to support the pivotal trial. 

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