FDA grants investigational device exemption to vagus nerve stimulation system for MS

The FDA has granted investigational device exemption to a clinical-stage health care firm for its proprietary neuroimmune modulation platform for individuals with relapsing-remitting MS, according to the manufacturer.

In a press release, SetPoint Medical said its neurostimulation device will be investigated in a multicenter, randomized, double-blind, sham-controlled pilot study expected to commence in 2025. The pending trial, which will evaluate whether the platform can promote remyelination in those with the progressive condition, is expected to enroll up to 60 patients across the United States.

“This IDE approval allows SetPoint to investigate our neuroimmune modulation platform in clinical trials in patients with [relapsing remitting MS] who have functional deficits such as visual impairment, which are not responsive to conventional immunosuppressive therapy,” David Chernoff, MD, chief medical officer of SetPoint, told Healio in an email. “The potential to reverse these functional deficits by promoting remyelination addresses a critical unmet clinical need for people living with MS.”

A device that targets the vagus nerve with electric stimulation, the SetPoint System is designed to activate anti-inflammatory and immune-restorative pathways within the central nervous system, the company said in the release.

The system, which can be implanted during an outpatient procedure, includes a rechargeable apparatus that provides once-daily stimulation of the vagus nerve.

SetPoint’s system had previously been granted breakthrough device designation by the FDA and subsequently accepted into the Total Product Life Cycle Advisory Program Pilot in March 2024.