Navigation Links
NeuroSigma Receives Global Quality Control Certification
Date:7/2/2012

LOS ANGELES, July 2, 2012 /PRNewswire/ -- Today NeuroSigma, Inc., a Los Angeles-based medical device company, announced that it received ISO 13485: 2003 certification, indicating that it operates a Quality Management System for the design, manufacturing and distribution of its external Trigeminal Nerve Stimulation (eTNS™) system for the treatment of neurological and neuropsychiatric disorders.  This certification is an important first step in a two-step process towards CE Mark approval in the European Union.

ISO 13485: 2003, published by the International Organization for Standards (ISO), is the globally recognized standard of medical device quality control.  This standard calls for a risk management approach to product development, validation of processes, effective product traceability and recall systems. 

NeuroSigma anticipates submitting the Technical File in pursuit of European regulatory approval for its first generation eTNS system, called theMonarch™, in July 2012.  The company is preparing to commence marketing and distribution of this new therapy for epilepsy and depression in Europe after CE Mark certification.

"We are proud to have achieved ISO certification, which will serve to provide assurance that our systems meet the stringent standards established for medical device manufacturers.  We are very grateful to our suppliers, consultants and employees, particularly our Manager of Operations, Patrick Miller, who have all worked hard to make this happen," said Lodwrick M. Cook, Chairman of NeuroSigma.

The clinical development of trigeminal nerve stimulation for epilepsy was spearheaded by Christopher DeGiorgio, M.D., NeuroSigma's Vice-President of Neurology and Professor at the UCLA School of Medicine.  Pioneering clinical and human mechanism of action studies in major depression were led by Ian 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 novel and non-invasive therapy, trigeminal nerve stimulation may represent a paradigm shift in the way we treat major depression, post-traumatic stress disorder (PTSD), and epilepsy, and offers the potential to significantly improve the lives of millions of people without the side-effects common to drug treatment," said Dr. Ian Cook.

"All of us at NeuroSigma are excited that the groundbreaking research of these eminent physicians is coming closer to becoming commercially available to doctors and their patients as an external and drug-free alternative to current therapies," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma.  "We have received an increasing number of inquiries from the public as they become aware of eTNS via sources such as the recent article in the Daily Mail in the United Kingdom."

Background - TNS

NeuroSigma is commercializing two embodiments of trigeminal nerve stimulation (TNS): eTNS™ (external electrodes and an external pulse generator) and sTNS™ (subcutaneous electrodes and implantable pulse generator).  The eTNS system utilizes a self-adhesive conductive pad 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 trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain.  In clinical studies, eTNS is well tolerated and the low-energy stimulus is confined to the soft tissues of the face without direct penetration into the brain – hence the term "USB Port to 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 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.  Once approved by regulatory agencies, patients who respond well to eTNS can opt to switch to the implantable sTNS system.  NeuroSigma has completed development of its eTNS system and is seeking CE Mark approval in Europe for the treatment of epilepsy and depression.  NeuroSigma is concurrently developing its implantable sTNS system.

CAUTION: Both eTNS™ and sTNS™ systems are investigational devices and at this time 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.


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

Related medicine technology :

1. NeuroSigma Subsidiary Acquires Thin-Film Nitinol Fabrication Patent Portfolio
2. Lifeline Biotechnologies, Inc. Receives Patent Award, a Device for Breast Tissue Temperature Analysis for Determining Cancer Conditions
3. Daiichi Sankyo, Inc. Receives FDA Approval to Package Product at New Facility in Bethlehem, PA
4. China Biologic Receives SFDA Manufacturing Approval Certificate for Human Coagulation Factor VIII
5. Bluechiip Receives First Sales Order from ATCC after Completion of Successful Pilot Trial
6. Surefire Medical Receives FDA Clearance For High-Flow Microcatheter
7. Tetra Discovery Partners Receives Major NIH Award To Develop New Alzheimers Drug
8. Celladon Corporation Receives Notice of Allowance from European Patent Office
9. GSK Receives FDA Approval for MenHibrix®
10. Cardiosolutions, Inc. Receives FDA 510(k) Clearance for Dexterity™ Steerable Introducer
11. Cochlear Americas Receives FDA Approval of the Worlds Thinnest, Full Length Electrode for Cochlear Implantation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA:CTIC) today announced ... Food and Drug Administration (FDA) on February 4, 2016, ... on the clinical studies being conducted under the Company,s ... hold impacts part of the clinical work currently being ... clinical trials. --> ...
(Date:2/5/2016)... 2016  Despite the recent explosion in Big Data, ... to embrace Big Data due to the inherent costs ... side, organizations have begun looking to Big Data as ... adherence. --> --> ... LLC, Big Data has started informing many decisions. In ...
(Date:2/5/2016)... -- Redwood Scientific Technologies, Inc. announced today the development and ... balance their hormones. This product will be featuring Redwood,s ... Cardiff , President and CEO. "I am proud that ... of women across the country and around the world ... research and development team is confident that through the ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... If you are feeling that your ... are not alone. According to the Center for Disease Control and Prevention (CDC), 34.9% ... diabetes and certain types of cancer, some of the leading causes of preventable death. ...
(Date:2/8/2016)... ... February 08, 2016 , ... Steve Helwig & Associates Insurance & ... community enrichment program, has teamed up with Citizens Opposed to Domestic Abuse in support ... abuse. To support all those victimized by the fear of violence in their own ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... serving the greater Venice, FL area, has initiated a fundraiser for a two ... accident just four days after Christmas. To support this beautiful child who is ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... firm, announced today that nominations will be accepted February 8, 2016 through ... , Awards include the Information Security Executive® of the Year, which ...
(Date:2/8/2016)... ... February 08, 2016 , ... Eating disorders and post-traumatic stress ... women and men with eating disorders report a history of trauma, research suggests ... of an eating disorder. , At the 2016 iaedp Symposium, the workshop, ...
Breaking Medicine News(10 mins):