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NeuroSigma Receives Health Canada Approval for Its Monarch eTNS System for the Treatment of Drug-Resistant Epilepsy and Major Depressive Disorder
Date:5/2/2013

LOS ANGELES, May 2, 2013 /PRNewswire/ -- 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.

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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
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Related medicine technology :

1. NeuroSigma Invited to Present an Overview of eTNS for the Treatment of Epilepsy and Depression at The Royal Society of Medicine in London
2. NeuroSigma Awarded Fast Track SBIR Grant by the NIH for Development of Implantable sTNS System for Drug Resistant Epilepsy
3. NeuroSigma Announces Receipt of Notice of Allowance of U.S. Patent Application Related to External Trigeminal Nerve Stimulation (eTNS) for the Treatment of Neuropsychiatric Disorders
4. NeuroSigma Receives CE Certification
5. NeuroSigma Receives Global Quality Control Certification
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