SetPoint Medical is planning to launch a clinical trial next year to investigate its nerve stimulator device, intending to support myelin repair, in people with relapsing-remitting multiple sclerosis (RRMS).
The announcement comes after U.S. Food and Drug Administration (FDA) approval of an investigational device exemption, allowing the company to initiate clinical studies to collect safety and efficacy data on the device and its use, SetPoint reported in a company press release.
It also follows a Phase 3 trial of the device in people with rheumatoid arthritis, another autoimmune disease marked by damaging inflammation, that found clinical benefit with reasonable safety.
Aiming to enroll up to 60 RRMS patients at multiple sites in the U.S., the upcoming trial will randomly assign participants to treatment with the device or to a sham procedure. Assignment will be blinded, meaning neither patients nor their treating physicians will know who is receiving which procedure….read full story HERE