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

SetPoint Medical, a clinical-stage biomedical technology company developing an implantable bioelectronic medicine therapy for chronic inflammatory diseases, has received Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) to initiate a pilot trial in the U.S. for patients with drug refractory rheumatoid arthritis (RA). SetPoint’s proprietary bioelectronic device will be surgically placed on the vagus nerve and activated based on a predetermined dosage schedule to evaluate safety and efficacy.

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May 09, 2018
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FDA Approves Investigational Device Exemption for SetPoint Bioelectronic Therapy Clinical Study in Rheumatoid Arthritis

Go to the profile of SetPoint Medical

SetPoint Medical

SetPoint Medical is a privately held biomedical technology company dedicated to treating patients with debilitating inflammatory diseases using bioelectronic therapy. SetPoint’s approach is intended to offer patients and providers an alternative for the treatment of rheumatoid arthritis (RA) and other chronic inflammatory diseases with less risk and cost than drug therapy. SetPoint is developing a novel bioelectronic medicine platform that stimulates the vagus nerve to activate the body’s natural Inflammatory Reflex, which is intended to produce a potent systemic anti-inflammatory effect. The company has published positive results from a first-in-human open-label proof-of-concept trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS) and presented positive results at the American College of Rheumatology meeting. Current investors in the company include Morgenthaler Ventures, NEA, Topspin Partners, Medtronic, GlaxoSmithKline’s Action Potential Venture Capital Limited and Boston Scientific.

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