VALENCIA, Calif. — SetPoint Medical, a medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced that it has initiated enrollment in the pilot clinical study evaluating Setpoint System® as a potential pro-remyelination therapy for adults living with relapsing-remitting multiple sclerosis (RRMS). The study received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to evaluate SetPoint Medical’s proprietary neuroimmune modulation device. Additionally, the neuroimmune modulation device has received Breakthrough Device Designation and was accepted into the Total Product Life Cycle (TPCL) Advisory Program (TAP) by the FDA.
The primary purpose of this multicenter, randomized, sham-controlled, double-blind pilot study is to assess the safety and remyelinating effects of the SetPoint System as an adjunct to standard-of-care disease-modifying therapy (DMT) in adults with RRMS. The SetPoint System contains a miniaturized neurostimulator that is surgically implanted on the left vagus nerve and delivers electric stimulation to the nerve for one minute, once per day. The study will enroll up to 60 participants across the United States, with primary outcomes assessed at one year.
The study has enrolled patients at Shepherd Center’s Andrew C. Carlos MS Institute in Atlanta, and UW Medicine Multiple Sclerosis Center in Seattle. Other centers participating in the study include Minnesota Center for Multiple Sclerosis in Plymouth, Minn.; West Virginia University in Morgantown, W.Va.; Johns Hopkins University in Baltimore; UT Medicine Multiple Sclerosis and Neuroimmunology Center in Austin, Texas; and University of Texas Health Science Center in Houston.
“Remyelination is one of the most critical yet unmet clinical needs in the treatment of multiple sclerosis,” said Jacqueline Rosenthal, MD, medical director of the MS Institute and principal investigator of the study at Shepherd Center, where the first patient was enrolled. “While current therapies focus largely on suppressing inflammation, restoring the damaged myelin sheath is essential for preserving neuronal function and preventing long-term disability. Neuroimmune modulation is hypothesized to recalibrate immune activity while supporting the conditions necessary for myelin repair, and offers an innovative avenue to evaluate whether meaningful remyelination can be achieved in patients living with MS.”
Multiple sclerosis affects nearly one million people in the United States and is an autoimmune disorder that damages the myelin sheath—the protective layer surrounding nerve fibers—disrupting signals between the brain and other parts of the body.
“Reaching this milestone of implanting the first patients in this RRMS pilot study is a meaningful step forward for us,” said David Chernoff, MD, 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.”
For more information about the RRMS pilot study, visit clinicaltrials.gov (NCT06796504).
About SetPoint System
The SetPoint System is indicated for use in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs. The use of SetPoint System for the treatment of multiple sclerosis is not approved, is considered investigational, and its safety and effectiveness for this indication have not been established. For full safety information, please see Instructions for Use and our Important Safety Information at spm.care/ISI. Individual results may vary.
About SetPoint Medical
SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases. The company’s FDA-approved SetPoint System is the first neuroimmune modulation therapy available for people living with rheumatoid arthritis (RA), offering a novel, device-based alternative for those who do not respond to or cannot tolerate biologic or targeted drug therapies. SetPoint’s proprietary integrated neurostimulation platform is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint. With a vision to redefine the care of autoimmune conditions, SetPoint is also planning to evaluate its platform technology for other conditions including multiple sclerosis and Crohn’s disease. Learn more at setpointmedical.com.
Dr. Jacqueline Rosenthal is a study investigator for SetPoint Medical and has not been compensated in connection with this press release.