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

omposed of an external electric pulse generator and an electric patch, which is attached to a patient's forehead to safely stimulate branches of the trigeminal nerve through the skin.  The electric patch needs to be replaced daily for effective therapy and can be worn primarily in the evening while asleep.  In clinical trials, eTNS has been well tolerated and found to substantially reduce seizures in patients with epilepsy and reduce symptom severity in patients with depression, PTSD and ADHD.  For more information on the Monarch eTNS System, please visit the Monarch website.

The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain.  The trigeminal nerve projects to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus and the cerebral cortex, which are involved in epilepsy, depression, PTSD, ADHD and other disorders. 

Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, which are located very close to the surface of the face.  The low-energy stimulus is confined to the soft tissues of the face without direct penetration into the brain.  PET imaging studies in humans confirm that eTNS alters the activity in key regions implicated in these disorders and the changes were observed within minutes of therapy.

NeuroSigma is the exclusive worldwide licensee of UCLA's entire TNS intellectual property portfolio and continues to develop additional technologies and target additional indications.

CAUTION: In the United States, both eTNS™ and sTNS™ are investigational devices and are limited by Federal (or United States) law to investigational use.

eTNS, sTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.

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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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