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NeuroSigma Announces FDA Approval to Commence Phase III Trial
Date:7/29/2013

LOS ANGELES, July 29, 2013 /PRNewswire/ -- NeuroSigma, Inc., today announced conditional approval by the U.S. Food and Drug Administration (FDA) of its Investigational Device Exemption (IDE) application to commence a Phase III pivotal trial of the Monarch™ eTNS™ System for treatment of drug resistant epilepsy.  The Company is planning to conduct a multi-center trial at leading medical institutions in the U.S., Europe and Canada.  The objective of the study is to evaluate the safety and effectiveness of the device and provide the basis for a Pre‐Market Approval (PMA) application to the FDA.

In earlier Phase 1 and Phase 2 clinical trials of external Trigeminal Nerve Stimulation (eTNS), over 40% of patients treated showed a 50% or greater reduction in seizures.  "We are eager to take this next key step in the regulatory approval process of eTNS in the United States," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma.  "We believe a safe, non-invasive and affordable alternative to pharmaceuticals and invasive treatments is urgently needed by the 50-million people with epilepsy worldwide."

The Monarch eTNS System is currently available with a physician's prescription in the European Union and Canada as adjunctive treatment of epilepsy and depression, for adults and children 9 years and older.

About TNS and The Monarch eTNS System

The Monarch eTNS System is c
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SOURCE NeuroSigma, Inc.
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Related medicine technology :

1. NeuroSigma Subsidiary Acquires Thin-Film Nitinol Fabrication Patent Portfolio
2. NeuroSigma Receives Global Quality Control Certification
3. NeuroSigma Receives CE Certification
4. 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
5. NeuroSigma Awarded Fast Track SBIR Grant by the NIH for Development of Implantable sTNS System for Drug Resistant Epilepsy
6. NeuroSigma Invited to Present an Overview of eTNS for the Treatment of Epilepsy and Depression at The Royal Society of Medicine in London
7. NeuroSigma Receives Health Canada Approval for Its Monarch eTNS System for the Treatment of Drug-Resistant Epilepsy and Major Depressive Disorder
8. NeuroSigma Launches Dedicated Website to Introduce Its Monarch eTNS System for Epilepsy and Depression
9. NeuroSigma Announces Debut of Its Monarch eTNS System in Canada
10. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
11. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
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