FDA Approves Investigational Device Exemption for SetPoint Bioelectronic Therapy Clinical Study in Rheumatoid Arthritis

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SetPoint Medical states the multi-center study, “A Randomized Controlled Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients with Rheumatoid Arthritis,” will assess the safety and efficacy of SetPoint’s proprietary bioelectronic device in adult patients with RA who have failed multiple biologic agents. A total of 15 subjects, aged 22 to 75, will be enrolled across seven U.S. investigational centers.

David Chernoff, M.D., Chief Medical Officer of SetPoint Medical notes, “We are ready to build on the published positive data from our earlier first-in-human proof-of-concept study of bioelectronic therapy in RA, which significantly improved measures of RA disease activity in this difficult-to-treat patient population and also inhibited cytokine production.”  He added, “The new trial will evaluate SetPoint’s advanced generation proprietary miniaturized, rechargeable wireless implanted device. This novel device will be used to stimulate the vagus nerve in order to activate the efferent arm of the Inflammatory Reflex known as the Cholinergic Anti-inflammatory Pathway (CAP).”

SetPoint is developing a novel proprietary bioelectronic medicine platform that activates the body’s natural Inflammatory Reflex in order to activate systemic anti-inflammatory pathways. The emerging field of bioelectronic medicine aims to address unmet patient needs by delivering targeted digital doses to modulate physiological circuits for treatment of diseases historically treated with drugs.

Anthony Arnold, Chief Executive Officer of SetPoint Medical said, “Gaining IDE approval for the clinical trial with our propriety device is an important milestone in moving our bioelectronic medicine program towards commercialization.”  Arnold added, “This strengthens our resolve to give physicians a new therapeutic alternative designed to be safer and more cost effective for patients with not only RA but other chronic inflammatory diseases.”

Rheumatoid arthritis is a chronic inflammatory disease that affects 1.3 million people in the United States and costs tens of billions of dollars annually to treat.