FDA clears Nexstim’s noninvasive brain stimulator for depression

Nexstim won FDA clearance for its noninvasive brain stimulation system that treats major depressive disorder. The system is already CE-marked for the treatment of major depression, stroke and chronic neuropathic pain.

The company’s Navigated Brain Therapy (NBT) system uses navigated transcranial magnetic stimulation (nTMS), which enables reproducible stimulation of the part of the brain that plays a role in depression treatment, the company said.

Major depression is one of the most common mental health disorders in the U.S., affecting more than 16 million adults, 2015 figures show. Repetitive treatments using TMS have been shown to effectively treat patients with major depression for whom drugs have not worked.

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"This FDA 510(k) clearance for our NBT system is a critical milestone in the commercialization of the device in the U.S.,” said Nexstim CEO Martin Jamieson in a statement. “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.”

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The company plans to roll the NBT system out in the first half of 2018. Meanwhile, the device is also in a phase 3 trial investigating its use in the treatment of stroke rehabilitation. Nexstim plans for file for FDA clearance next year.

Nexstim also markets a TMS-based device for diagnostic use: its Navigated Brain Stimulation system. It is FDA-cleared and CE-marked for the noninvasive mapping of the brain’s motor cortex.