NeuroSigma said Tuesday that its Monarch eTNS system has received a humanitarian use device designation, the first step towards obtaining a humanitarian device exemption. The neuromodulation therapy is used to treat the symptoms of Lennox-Gastaut Syndrome, a rare childhood brain disorder.

An estimated 2,085 children develop LGS each year, according to NeuroSigma. The disease impairs intellectual function, behavior and development and causes seizures. 

The noninvasive eTNS system uses a cell phone-sized pulse generator to transmit signals through a patch on the forehead and trigger nerve fibers, changing brain activity. If an HDE is granted, children and their families will be able to use the device at home, said Ian Cook, NeuroSigma’s chief medical officer. The company is collecting clinical data to support an HDE submission.

The Monarch eTNS is authorized in Europe and Canada for treating depression. — Kellen Owings