Closely-held SetPoint Medical received the FDA’s investigational device exemption approval to study the company’s bioelectronic platform in a pivotal trial in patients with rheumatoid arthritis (RA).
The company’s bioelectronic platform is designed to stimulate the vagus nerve to activate the inflammatory reflex, producing a systemic immune-restorative effect.
The trial will enroll up to 250 patients at 40 sites across the U.S. to evaluate the platform in moderate-to-severe RA patients who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs.
“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,” Murthy Simhambhatla, SetPoint’s president and CEO, said in a statement.
Dr. Jeff Curtis, the study’s national co-principal investigator, added, “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.”
