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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

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 NeuroSigm
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SOURCE NeuroSigma, Inc.
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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
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