Valencia, California-based SetPoint’s study evaluates the implant as a potential pro-remyelination therapy for adults living with relapsing-remitting multiple sclerosis (RRMS). It received FDA investigational device exemption (IDE) to evaluate the neuroimmune modulation device. The device also received FDA breakthrough device designation.
SetPoint Medical CEO Murthy Simhambhatla will be speaking at DeviceTalks Minnesota on May 4 at the McNamara Alumni Center at the University of Minnesota. Learn more about the event and register here.
SetPoint received FDA approval for its SetPoint neuroimmune modulation system for treating rheumatoid arthritis (RA) in July 2025. It reported the first commercial cases a month later. The company designed the implantable, integrated neurostimulation system to deliver electrical stimulation. It stimulates the vagus nerve for one minute, once per day.
The company said it aims for its RRMS study to assess the safety and remyelinating effects of its implant as an adjunct to standard-of-care disease-modifying therapy in adults with the condition. It plans to enroll up to 60 participants across the U.S., assessing primary outcomes at one year.
“Reaching this milestone of implanting the first patients in this RRMS pilot study is a meaningful step forward for us,” said Dr. David Chernoff, chief medical officer of SetPoint Medical. “Our approach to activating the body’s innate neuroimmune pathways offers a compelling and novel mechanism that could complement current standards of care of multiple sclerosis. We are deeply grateful to the investigators and patients participating in this study.”
Go here to listen to SetPoint Medical CEO Murthy Simhambhatla on the DeviceTalks Weekly Podcast, or listen below:
