Nexstim said today that slow enrollment in pivotal trial of its Navigated Brain Therapy transcranial magnetic stimulation device in treating patients rehabilitating from stroke.
The 60-patient E-Fit study, launched in March, is designed to supplement Nexstim’s already complete Niche study. The Finnish company originally expected to conclude the E-Fit supplemental during the 1st quarter next year, but said today that “start-up issues” at some of the 5 U.S. sites “created a slight delay in the enrollment rate.”
The E-Fit trial is now slated to be completed during the 2nd quarter of 2018, the company said.
Nexstim’s NBT device is approved in the European Union for treating stroke, major depression and chronic neuropathic pain. The company plans to use the E-Fit data to back a bid for FDA approval.