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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 Neuropsychiatric Disorders
Date:1/22/2013

LOS ANGELES, Jan. 22, 2013 /PRNewswire/ -- NeuroSigma, Inc., a California -based medical device company, announced today that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 12/898,686 entitled "Devices, Systems and Methods For Treatment of Neuropsychiatric Disorders." 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 neuropsychiatric disorders, including but not limited to mood, cognitive, behavioral and anxiety disorders. 

"We applaud Dr. Ian Cook , Dr. Chris DeGiorgio and the other inventors for developing this paradigm shift neuromodulation technology," said Lodwrick M. Cook, Chairman 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 first Notice of Allowance related to this portfolio which should further strengthen our position in the marketplace," added Leon Ekchian, Ph.D., NeuroSigma's President & CEO.  

The development of TNS for neuropsychiatric indications has been spearheaded by Ian Cook , M.D., Professor of Psychiatry at the UCLA Semel Institute and a Senior Medical Advisor to NeuroSigma. "As an inventor, I am very pleased that our novel and promising non-invasive treatment for depression and other neuropsychiatric disorders will now be covered by a US patent," said Dr. Cook.

NeuroSigma's first TNS product is the Monarch™ eTNS™ System.  It is composed of an external pulse generator and electric patches placed on the forehead, which need to be replaced daily.  The patches can be worn primarily in the evening while asleep.  In clinical trials, eTNS has been well-tolerated and shown to substantially reduce seizures in patients with epilepsy and improve mood in patients with depression.  In September 2012 NeuroSigma received CE Mark approval for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older.  NeuroSigma's approval was supported by years of compelling data generated in clinical trials conducted at UCLA and the University of Southern California (USC). The Monarch System was unveiled at the NeuroSigma booth at the 10th European Congress on Epileptology in London (September 30 – October 4, 2012) and is being sold by NeuroSigma in the European Union, with a physician's prescription.

Background - TNS

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. 

TNS is the electrical stimulation of branches of the trigeminal nerve, which are located very close to the surface of the skin in the forehead.  The low-energy stimulus is confined to the soft tissues of the forehead without direct penetration into the brain.  PET imaging studies in humans confirm that eTNS activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy.

There are two embodiments of TNS: eTNS™ (external electric patches and pulse generator) and sTNS™ (subcutaneous electrodes and implantable pulse generator). The eTNS system is currently being marketed in the European Union and the sTNS system is being developed at NeuroSigma. Together they offer an integrated and complimentary platform where eTNS could serve as a means to screen for sTNS candidates.  Once sTNS is approved by regulatory agencies, patients could first commence with the eTNS treatment. Those that respond to eTNS, and wish to transition to an implantable version, could be implanted with an sTNS system.

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 the Monarch eTNS are trademarks of NeuroSigma, Inc.

About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based medical device company established to develop early stage technologies with the potential to transform medical practice and patients' lives.  Currently, NeuroSigma is focused on neuromodulation therapies and has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including potential TNS therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). For more information about NeuroSigma, please visit www.neurosigma.com.

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™ and sTNS™ systems.  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.

NeuroSigma Contacts:

Dr. Leon Ekchian , President & CEO
Tel: +1-310-479-3100
Email: info@neurosigma.com
NeuroSigma, Inc.
Website: http://www.neurosigma.com


Mr. Mark Collinson , Partner
Tel: +1-310-954-1343
Email: mark.collinson@ccgir.com
CCG Investor Relations
Website: http://www.ccgir.com 


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SOURCE NeuroSigma
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