Noninvasive Brain Stimulation System Approved for Depression
The system is currently being assessed for its use in stroke rehabilitation in the Phase 3 supplemental study E-FIT.
The Food and Drug Administration (FDA) has cleared Nexstim's 'NBT' system, a non-invasive brain stimulation system, for the treatment of major depressive disorder (MDD).
The NBT system uses a method of transcranial magnetic stimulation (TMS) known as navigated TMS which allows for reproducible stimulation of specific areas of the brain. Previous studies have shown that TMS treatment may be an effective alternative to pharmacotherapy in patients with MDD who have failed drug therapy.
The Company expects to make the NBT system available in the first half of 2018.
"We are confident that by highlighting the NBT system's unique navigational capabilities, we will be able to clearly differentiate it from the non-navigational TMS devices currently on the market," said Nexstim CEO Martin Jamieson.
The system is currently being assessed for its use in stroke rehabilitation in the Phase 3 supplemental study 'E-FIT', involving 60 patients. The trial is expected to be complete in Q2 2018, allowing the Company to file for clearance of this indication.
Nexstim gains FDA clearance to commercialise its NBT® system in the US for the treatment of depression [press release]. New York, NY: Nexstim. November 13, 2017. Accessed November 20, 2017.