SetPoint Medical gets FDA IDE to study neurostimulation for MS

SetPoint Medical today announced FDA Investigational Device Exemption approval to study its proprietary neuroimmune modulation platform for people with relapsing-remitting multiple sclerosis.

Valencia, California–based SetPoint plans to initiate a multicenter, randomized, double-blind, sham-controlled pilot study in 2025. The plan is to enroll 60 people across the United States.

“We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area,” Dr. David Chernoff, SetPoint Medical’s chief medical officer, said in a news release. “The results from our studies in validated preclinical models of MS suggest that the SetPoint System has the potential to address the urgent unmet medical need for novel therapies that reduce demyelination and promote remyelination — providing new hope for people living with MS.”

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