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NeuroSigma Announces Receipt of Notice of Allowance of U.S. Patent Application Related to External Trigeminal Nerve Stimulation (eTNS) for the Treatment of Epilepsy and other Neurological Disorders
Date:12/5/2013

LOS ANGELES, Dec. 5, 2013 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company, announced today that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 12/898,675 entitled "Systems, Devices and Methods For Treatment of Neurological Disorders and Conditions." The patent application, exclusively licensed to NeuroSigma, is owned by The Regents of the University of California (Regents) as a result of research conducted by physicians and scientists at the University of California, Los Angeles (UCLA). Morgan, Lewis & Bockius LLP has represented the Regents in the prosecution of this patent application and other related applications. Haynes & Boone LLP has represented NeuroSigma.

The method and system claims of the patent application cover the use of trigeminal nerve stimulation (TNS) with cutaneous electrodes for the treatment of neurological disorders, including but not limited to epilepsy, movement disorders, migraine, daily chronic headache, and acute brain injury. 

"We applaud Dr. Christopher DeGiorgio, Dr. Ian Cook and the other inventors for developing this non-invasive neuromodulation technology," said Leon Ekchian, Ph.D., President & CEO of NeuroSigma. "NeuroSigma has the exclusive rights to a large portfolio of pending TNS-related US patent applications and their foreign counterparts. We are delighted to have received our second Notice of Allowance related to this portfolio. Together with the issued patent covering neuropsychiatric applications of eTNS, this will further strengthen our position in the marketplace," added Dr. Ekchian.

The development of TNS for neurological indications has been spearheaded by Christopher DeGiorgio, M.D., Vice President of Neurology at NeuroSigma, and Professor of Neurology at UCLA. "As an inventor, I am very pleased to see that over 10 years of research by our team is reaching fruition, and will now be covered by a US patent," said Dr. DeGiorgio.

Background – The Monarch eTNS System from NeuroSigma

In August 2012, NeuroSigma received CE Mark approval in the European Union for NeuroSigma's first TNS product, the Monarch™ eTNS™ System, for the adjunctive treatment of drug-resistant epilepsy (DRE) and major depressive disorder (MDD) for adults and children 9 years and older. In addition, the Monarch™ eTNS™ System also received a Class II medical device license from Health Canada in April of 2013 covering the use of the system for treatment of DRE and MDD for adults and children 9 years and older.  NeuroSigma is currently marketing the Monarch™ eTNS™ System to patients in the European Union and Canada with a physician's prescription.

The Monarch™ eTNS™ System is composed of a cell-phone sized pulse generator that delivers electrical signals to the trigeminal nerve, which are transmitted through lead wires to a single-use patch that is applied to the forehead, thereby non-invasively modulating activity in targeted brain regions. Patients may conveniently self-administer the Monarch™ eTNS™ System at home and typically use the device while sleeping.

Background - TNS

The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. 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 near the surface of the forehead.  Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.

CAUTION: In the United States, eTNS™ is an investigationaldevice and is limited by Federal (or United States) law to investigational use.  The U.S. Food and Drug Administration has given NeuroSigma conditional approval to proceed with a pivotal Phase 3 clinical trial of eTNS in drug resistant epilepsy. Completion of that Phase 3 study is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.

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

About NeuroSigma, Inc.  

NeuroSigma is a Los Angeles-based life sciences company focused on developing trigeminal nerve stimulation (TNS) based products with the potential to transform the lives of patients suffering from major neurological and neuropsychiatric disorders, including epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). Please visit http://www.neurosigma.com for more corporate information and http://www.monarch-etns.com for more information on the Monarch eTNS System.

Forward-Looking Safe Harbor Statement: 
This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS™ system.  These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.


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