Monday, December 11, 2017

SetPoint Medical Gets FDA Nod On Pilot Study

Valencia-based SetPoint Medical, which develops medical devices for treating chronic inflammatory disease, said it has received Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) for a human trial. The company said the trial will cover safety and efficacy of its devices to treat Rheumatoid Arthritis. The company said the human trial will include a total of 15 subjects, aged 22 to 75. SetPoint's devices are implanted in the vagus nerve. SetPoint is venture backed by NEA, Morgenthaler, Medtronic, Boston Scientific, Topspin, Action Potential Venture Capital and others, and raised $30M in August.