NeuroSigma's Monarch eTNS System to be Unveiled in London Newly CE Mark Approved Treatment for Epilepsy and Depression

LOS ANGELES, Sept. 25, 2012 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that its Monarch™ eTNS™ system for the adjunctive treatment of epilepsy and depression will make its debut at the 10th European Congress on Epileptology, which takes place in London, England from September 30 to October 4, 2012. 

"This conference represents an outstanding opportunity to put the Monarch in the hands of many healthcare professionals who will be future advocates of the system in the European Union.  Our team looks forward to forming alliances and introducing a new paradigm for the management of epilepsy," said Leon Ekchian, Ph.D., NeuroSigma's President & CEO.

NeuroSigma was invited by the conference organizers to lead a Satellite Symposium on September 30th, focused on trigeminal nerve stimulation (TNS) for the treatment of epilepsy and neuropsychiatric disorders.  The presentations on eTNS will cover the following topics:

  • TNS Background Science
  • Clinical Trials of eTNS for Drug Resistant Epilepsy
  • Clinical Trials of eTNS for Depression and PTSD
  • Monarch eTNS Product Launch in the European Union

The presenters will be Christopher DeGiorgio, M.D., NeuroSigma's Vice-President, Neurology, and Professor of Neurology at UCLA, Ian Cook, M.D., NeuroSigma Senior Medical Advisor and Professor of Psychiatry at UCLA and Colin Kealey, M.D., NeuroSigma's Manager of Business Development.  The symposium will include the first public presentation of long-term data on the efficacy of eTNS for the treatment of epilepsy.  Dr. DeGiorgio will also participate in an additional panel discussion, Devices and Epilepsy: the Future, on Wednesday, October 3rd.

NeuroSigma is preparing for a fourth quarter 2012 commercial launch of the Monarch in the European Union.

Background – The Monarch System

The Monarch eTNS system, which is CE-marked in the European Union, will be sold under prescription from a physician.  It is composed of an external pulse generator and electric patches placed on the forehead, which are replaced daily.  The patches can be worn primarily in the evening while asleep.  In clinical trials, eTNS has been both well-tolerated and shown to substantially reduce seizures in patients with epilepsy and improve mood in patients with depression.

Background - TNS

There are two embodiments of trigeminal nerve stimulation: eTNS™ (the Monarch system) and sTNS™ (subcutaneous electrodes and implantable pulse generator, currently being developed).  TNS stimulates 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.

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.  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.  Many patients may elect to be treated with the external eTNS system, but once approved by regulatory agencies, patients who respond well to eTNS may opt for the implantable sTNS system.

Trigeminal nerve stimulation was invented at UCLA and is exclusively licensed to NeuroSigma.

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, Monarch,  Monarch eTNS, and USB Port to the Brain 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.  Currently, NeuroSigma is focused on a number of neuromodulation therapies and through its majority-owned subsidiary, NSVascular, Inc., on Thin-Film Nitinol covered stents for endovascular applications.  NeuroSigma employs two neuromodulation therapy platforms: Trigeminal Nerve Stimulation (TNS) and Deep Brain Stimulation (DBS).  NeuroSigma has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including potential therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD) via TNS, and for PTSD and obesity via DBS.  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.

SOURCE NeuroSigma, Inc.



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