SetPoint Medical, a clinical-stage bioelectronic medicine company developing therapy for chronic autoimmune diseases, today announced that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to study its proprietary bioelectronic platform in patients with rheumatoid arthritis (RA).
The multicenter, double-blind, randomized, sham controlled pivotal trial will enroll up to 250 patients at 40 sites across the U.S. The trial will evaluate the safety and effectiveness of the SetPoint bioelectronic platform in patients with moderate-to-severe RA who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).
“RA is a debilitating condition for patients, which without effective treatment, can result in long-term loss of physical function and irreversible joint damage,” said Jeff Curtis, MD, Professor of Medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham, and National Co-Principal Investigator. “The results of prior studies suggest that the SetPoint platform is well tolerated and reduces RA signs and symptoms in patients who have had inadequate response to biologic drugs. We look forward to evaluating this promising therapy in a larger blinded study.”
“We are pleased to have received IDE approval and look forward to initiating our pivotal study with our novel platform,” said Murthy V. Simhambhatla, PhD, President and CEO of SetPoint Medical. “This is a significant milestone for our company as we work to advance our therapy in patients with RA and other autoimmune diseases, as a potentially efficacious, yet less immunosuppressive option.”
About SetPoint Medical
SetPoint Medical is a privately held clinical-stage bioelectronic medicine company dedicated to treating patients with chronic autoimmune diseases. SetPoint Medical’s bioelectronic medicine platform is intended to offer patients and providers a treatment alternative for rheumatoid arthritis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. The company is developing a novel bioelectronic medicine platform that stimulates the vagus nerve to activate the inflammatory reflex to produce a systemic immune-restorative effect. Current investors in the company include New Enterprise Associates (NEA), Morgenthaler Ventures, Topspin Partners, SightLine Partners, GlaxoSmithKline’s Action Potential Venture Capital and Boston Scientific as well as an additional undisclosed strategic investor (leading medical device company). For more information, visit www.setpointmedical.com.
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The Ruth Group
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The Ruth Group
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