Image Credit: SetPoint Medical
SetPoint Medical is a company based in Valencia, California developing an implantable-device-based therapy for chronic autoimmune diseases. It announced in May that it has received FDA IDE approval to study its device 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 “microregulator” 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).