NeuroSigma has obtained Health Canada approval for its Monarch external trigeminal nerve stimulation (eTNS) system to treat drug-resistant epilepsy (DRE), major depressive disorder (MDD) and treatment-resistant depression.
The non-invasive neurostimulation system, which was awarded a CE mark in 2012, has received a Class 2 medical device license in Canada for adults and children aged nine and older.
NeuroSigma president and CEO Leon Ekchian said; "It is another major milestone for NeuroSigma in the commercialisation of trigeminal nerve stimulation, and enables us to work with a new physician population and their patients."
The Monarch eTNS System comprises an external pulse generator and daily-disposable external electric patches placed on the forehead.
Safety and efficacy data from Phase I and Phase II trials demonstrated that the therapy reduces seizure frequency and significantly improves mood.
The University of California Los Angeles (UCLA) neurology professor and neurology vice president Dr Christopher DeGiorgio said In the US, the company has completed its pre-IDE meeting with the FDA and is preparing for IDE submission to commence a multi-center pivotal trial of eTNS for epilepsy.
"Over twenty-five major epilepsy centers have expressed strong interest in being part of this trial," DeGiorgio said.
Image: The Monarch eTNS System will be sold by prescription in Canada to patients under physician supervision. Photo: Courtesy of PRNewsFoto/NeuroSigma.