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.

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