SetPoint Medical has begun enrolling patients in a first-of-its-kind clinical pilot study testing whether its implanted neurostimulation device can help repair nerve damage in people living with relapsing-remitting multiple sclerosis (RRMS).

 

The study will evaluate the SetPoint System as a potential therapy to promote remyelination—repair of the protective coating around nerve fibers that is damaged in MS. The company says the trial marks an early but significant step in expanding its vagus-nerve–based platform beyond rheumatoid arthritis.

 

The US Food and Drug Administration has cleared the study under an Investigational Device Exemption (IDE), and the device has also received Breakthrough Device Designation and entry into the FDA’s Total Product Life Cycle Advisory Program.

 

The randomized, double-blind, sham-controlled pilot study will enroll up to 60 participants across multiple U.S. centers. Patients will continue standard disease-modifying therapies while receiving either the active device or a sham procedure, with outcomes measured over one year.

 

The device itself involves a miniaturized neurostimulator implanted on the left vagus nerve, delivering a one-minute electrical pulse once daily to modulate immune activity.

 

"Remyelination is one of the most critical yet unmet clinical needs in the treatment of multiple sclerosis,” said Jacqueline Rosenthal, principal investigator 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.”