NeuroSigma, Inc., a California-based medical device company, today announced that it has received a Class 2 medical device license for its Monarch™ eTNS™ (external trigeminal nerve stimulation) System from Health Canada. The license covers the use of the Monarch eTNS System for treatment of drug-resistant epilepsy (DRE), major depressive disorder (MDD), and treatment-resistant depression.
The Monarch, CE Mark approved in the European Union in 2012, but not yet approved in the United States (US), is now available to patients in Canada. Drug resistant epilepsy (DRE) is a serious medical disorder, and affects approximately 30% of all patients with epilepsy. Major depressive disorder is a prevalent condition, affecting up to 16% of the population at some point during their lives.
The Health Canada approval was supported by years of safety and efficacy data generated in Phase I and Phase II clinical trials in the US, in which the therapy was shown to substantially reduce seizure frequency and significantly improve mood. Results from a Phase II Randomized Controlled Trial of eTNS for epilepsy were published online in the January 26, 2013 issue of Neurology®, the medical journal of the American Academy of Neurology. The clinical trial enrolled 50 patients, and was conducted at the University of California Los Angeles (UCLA) and the University of Southern California (USC). After 18 weeks of eTNS therapy, 40.5% of patients in the treatment group had a reduction in seizures of at least 50%. In addition to clinical trials in epilepsy, NeuroSigma has funded clinical trials at UCLA for the treatment of major depression, PTSD and ADHD.
The Monarch eTNS System will be sold by prescription in Canada to patients under physician supervision. The system is composed of an external pulse generator and disposable external electric patches placed on the forehead that are replaced daily. The patches are worn primarily in the evening while asleep.
"We are very pleased to have received the license from Health Canada," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma. "It is another major milestone for NeuroSigma in the commercialization of trigeminal nerve stimulation and enables us to work with a new physician population and their patients. We are committed to making eTNS affordable and available worldwide."
"I am delighted as an inventor that this therapy is now available to physicians and patients in Canada," added Christopher DeGiorgio , M.D., Vice President of Neurology and Professor of Neurology at UCLA. "In the United States, we have completed our pre-IDE meeting with the FDA and are preparing our 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."
"As a psychiatrist, I'm excited to see that this new treatment paradigm will be available to physicians in Canada to address the unmet needs for their patients with depression," added Ian Cook , M.D., Director of the UCLA Depression Research & Clinic Program and Senior Medical Advisor to NeuroSigma.
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