NeuroSigma Announces Debut of Its Monarch eTNS System in Canada

LOS ANGELES, June 21, 2013 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles based medical device company, today announced that its Monarch™ eTNS™ System for the adjunctive treatment of epilepsy and depression will make its Canadian debut at the 30^th International Epilepsy Congress, taking place in Montreal, Canada from June 23 to June 27, 2013. The Monarch eTNS System will be on display at the NeuroSigma Booth #413 throughout the conference.

"This conference represents the first opportunity for Canadian physicians, epilepsy specialists, and healthcare professionals to see the Monarch eTNS system up close, and to learn about the latest results from recent clinical trials. Our team looks forward to forging new relationships with physicians that desire a non-invasive, safe, and affordable neurostimulation therapy for the management of epilepsy and depression," said Leon Ekchian, Ph.D., NeuroSigma's President & CEO.

NeuroSigma will host a Satellite Symposium on the safety and efficacy of eTNS for epilepsy and psychiatric disorders on Tuesday June 25, from 4:30 pm to 6:00 pm in Hall 4, Palais des Congres de Montreal. New results from acute and long-term trials in epilepsy will be presented by Christopher DeGiorgio, M.D., NeuroSigma's Vice President of Neurology and Professor of Neurology at UCLA.  These findings will be used to guide NeuroSigma's planned Phase III trial of eTNS for epilepsy. In addition, results from clinical trials of eTNS for major depressive disorder (MDD), attention deficit hyperactivity disorder (ADHD), and post-traumatic stress disorder (PTSD) will be presented by Ian Cook, M.D., NeuroSigma's Chief Medical Advisor and Director of the UCLA Depression Research and Clinic Program.

About TNS and The Monarch System

The Monarch eTNS system is composed of an external electric patch, which is attached to a patient's forehead to safely stimulate branches of the trigeminal nerve through the skin, and a very low current external electric pulse generator.  The electric patches are replaced daily for effective therapy and can be worn primarily in the evening while asleep.  In clinical trials, eTNS has been both well tolerated and found to substantially reduce seizures in patients with epilepsy and reduce symptom severity in patients with depression, PTSD and ADHD.

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.

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 TNS therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). Please visit www.neurosigma.com for more corporate information and 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™ 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.

SOURCE NeuroSigma, Inc.