Navigation Links
NeuroSigma Receives CE Certification
Date:9/5/2012

LOS ANGELES, Sept. 5, 2012 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that it received CE Certification for its external Trigeminal Nerve Stimulation (eTNS™) system, called the Monarch, 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 safety and compelling efficacy data generated in clinical trials conducted at the University of California, Los Angeles (UCLA) and the University of Southern California (USC). 

(Photo: http://photos.prnewswire.com/prnh/20120905/LA68181)

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

Planning is underway for the introduction of this treatment at major EU epilepsy and depression centers.  NeuroSigma is establishing a marketing, sales, and distribution infrastructure for a fourth quarter 2012 product launch in the EU.

Epilepsy and depression are major health concerns in the EU, with approximately 4 million people suffering epilepsy and 20 million experiencing clinical depression.

"We are proud to successfully complete the CE marking process.  It is a major milestone for NeuroSigma and will enhance our efforts to transform the way epilepsy and depression are managed.  I would like to thank all of our employees, suppliers, clinical trial sites and consultants for their hard work and all our investors for their support," said Lodwrick Cook, Chairman of NeuroSigma.

"As a company, we are committed to making eTNS affordable and widely available in the EU," added Leon Ekchian, Ph.D., President and CEO of NeuroSigma.  "We are excited to begin the rollout of our commercialization strategy for patients suffering from epilepsy and depression.  Simultaneously, we will seek to obtain approvals in other parts of the world.  In the United States, we will be submitting a request to the FDA for an Investigational Device Exemption (IDE) to commence a multi-center eTNS pivotal trial in epilepsy.  Over thirty major centers in the US and Europe have expressed interest in being part of this pivotal trial."

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

Dr. Christopher DeGiorgio, Vice-President of Neurology at NeuroSigma and Professor of Neurology at the UCLA School of Medicine, spearheaded clinical development of eTNS for epilepsy.  "CE Certification of eTNS is one of the greatest moments of my life, marking the culmination of over 10 years of research.  I wish to thank all of my colleagues at UCLA and USC, without whom this achievement would not have been possible, and recognize each and every patient in our clinical trials, who helped pioneer this breakthrough treatment.  I am especially grateful to NeuroSigma's management team for their faith in this technology and for their vision and commitment to patients suffering epilepsy and depression," said Dr. DeGiorgio.

Clinical and human mechanism of action studies of eTNS in major depression were led by Ian A. Cook M.D., a Senior Medical Advisor to NeuroSigma and a Professor-in-Residence at the UCLA School of Medicine's Department of Psychiatry, where he serves as Director of the UCLA Depression Research and Clinic Program.  "As a non-invasive neuromodulation therapy, trigeminal nerve stimulation may represent a paradigm shift in the way we treat major depression and offers the potential to significantly improve the lives of millions of people without the side-effects common to medication treatment," said Dr. Cook.

Background - TNS

There are two embodiments of trigeminal nerve stimulation: eTNS™ (external electrodes and an external pulse generator, currently being commercialized) and sTNS™ (subcutaneous electrodes and implantable pulse generator, currently being developed).  The eTNS system utilizes a customized self-adhesive conductive patch applied to the forehead to stimulate 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.  eTNS is a stand-alone therapy, but once approved by regulatory agencies, patients who respond well to eTNS may opt for the implantable sTNS system, which NeuroSigma is currently developing.

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

About NeuroSigma, Inc.

NeuroSigma is a Los Angeles-based medical technology 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.

NeuroSigma Contacts:

Dr. Leon Ekchian, President & CEO
Tel: +1-310-479-3100
Email: lekchian@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


'/>"/>
SOURCE NeuroSigma
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. NeuroSigma Subsidiary Acquires Thin-Film Nitinol Fabrication Patent Portfolio
2. NeuroSigma Receives Global Quality Control Certification
3. PAREXEL Chief Operating Officer Dr. Mark A. Goldberg Receives Special Recognition Award
4. Leica Biosystems Receives FDA Approval for the Fully Automated Bond Oracle™ HER2 IHC System on the Leica BOND-MAX
5. Nephros Receives 510(k) Clearance for Hemodiafiltration System
6. ProUroCare Medical Receives FDA Clearance for ProUroScan Elasticity Imaging System
7. BONESUPPORT Receives Red Herring 2012 Top 100 Europe Award
8. Diabecline Antibiotic Receives Edison Award for Best New Pharmaceutical Product
9. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
10. Alexza Receives Complete Response Letter for Adasuve™ NDA
11. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... -- One of Australia,s successful biotechnology scientists, ... new biotechnology company, Noxopharm Limited [ABN 50 608 966 123] ("Noxopharm"). ... list on the ASX. Noxopharm is a clinic-ready company ... Phase 1 clinical study later this year. ... biggest problems facing cancer patients - the ability of cancers to ...
(Date:6/26/2016)... -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... Improvements Act of 1976, as amended ("HSR"), with respect ... Nasdaq: CPXX ) expired effective June 24, ... As previously announced on May 31, 2016, Jazz Pharmaceuticals ... which Jazz Pharmaceuticals has commenced a tender offer for ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, ... Board will take whatever measures required to build a ... stock which is currently listed on the OTC Markets-pink ... Company Chairman and CEO, "We are seeing an anomaly ... to understand, not only by the Company, but shareholders ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... , ... Quality metrics are proliferating in cancer care, and are derived from ... of the beholder, according to experts who offered insights and commentary in the current ... For the full issue, click here . , For the American Society of ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned ... developed to enhance the health of felines. The formula is all-natural and is made ... in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root ...
(Date:6/25/2016)... Washington, D.C. (PRWEB) , ... June 25, 2016 ... ... will discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June ... share their work on several important health care topics including advance care planning, ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
Breaking Medicine News(10 mins):