Navigation Links
NeuroSigma Announces FDA Approval to Commence Phase III Trial
Date:7/29/2013

LOS ANGELES, July 29, 2013 /PRNewswire/ -- NeuroSigma, Inc., today announced conditional approval by the U.S. Food and Drug Administration (FDA) of its Investigational Device Exemption (IDE) application to commence a Phase III pivotal trial of the Monarch™ eTNS™ System for treatment of drug resistant epilepsy.  The Company is planning to conduct a multi-center trial at leading medical institutions in the U.S., Europe and Canada.  The objective of the study is to evaluate the safety and effectiveness of the device and provide the basis for a Pre‐Market Approval (PMA) application to the FDA.

In earlier Phase 1 and Phase 2 clinical trials of external Trigeminal Nerve Stimulation (eTNS), over 40% of patients treated showed a 50% or greater reduction in seizures.  "We are eager to take this next key step in the regulatory approval process of eTNS in the United States," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma.  "We believe a safe, non-invasive and affordable alternative to pharmaceuticals and invasive treatments is urgently needed by the 50-million people with epilepsy worldwide."

The Monarch eTNS System is currently available with a physician's prescription in the European Union and Canada as adjunctive treatment of epilepsy and depression, for adults and children 9 years and older.

About TNS and The Monarch eTNS System

The Monarch eTNS System is composed of an external electric pulse generator and an electric patch, which is attached to a patient's forehead to safely stimulate branches of the trigeminal nerve through the skin.  The electric patch needs to be replaced daily for effective therapy and can be worn primarily in the evening while asleep.  In clinical trials, eTNS has been well tolerated and found to substantially reduce seizures in patients with epilepsy and reduce symptom severity in patients with depression, PTSD and ADHD.  For more information on the Monarch eTNS System, please visit the Monarch website.

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.
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. NeuroSigma Receives CE Certification
4. 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
5. NeuroSigma Awarded Fast Track SBIR Grant by the NIH for Development of Implantable sTNS System for Drug Resistant Epilepsy
6. NeuroSigma Invited to Present an Overview of eTNS for the Treatment of Epilepsy and Depression at The Royal Society of Medicine in London
7. NeuroSigma Receives Health Canada Approval for Its Monarch eTNS System for the Treatment of Drug-Resistant Epilepsy and Major Depressive Disorder
8. NeuroSigma Launches Dedicated Website to Introduce Its Monarch eTNS System for Epilepsy and Depression
9. NeuroSigma Announces Debut of Its Monarch eTNS System in Canada
10. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
11. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... Medivir AB (Nasdaq Stockholm: MVIR) ... Board of Directors that will be submitted to the ... representatives of the company,s three largest shareholders at the ... accepted a seat on the Nomination Committee, and the ... Nomination Committee was as follows:  ...
(Date:2/23/2017)... , Feb. 23, 2017  Genesis Healthcare Services has ... announcement was made by Bill Monast , President ... and Nathan Feltman , executives with Home ... Services, LLC. This acquisition helps Hospice ... of technology enabled durable medical equipment (DME) solutions for ...
(Date:2/23/2017)... and Markets has announced the addition of the "Menopause Drugs Price ... ... Analysis and Strategies - 2016, provides drug pricing data and benchmarks in ... What are the key drugs marketed for Menopause ... market? What are the unit prices and annual treatment ...
Breaking Medicine Technology:
(Date:2/24/2017)... , ... February 24, 2017 , ... ... newly designed TaskMate Go. Core benefits and advantages built into the home office ... stylish, functional look and feel. Ability to gain the benefits embedded in the ...
(Date:2/24/2017)... ... February 24, 2017 , ... WHAT: , The ... recognition opportunities as well as advocacy for the state and region‘s technology businesses, ... 23. The Council's Innovation Forecast event highlights innovation throughout the region from ...
(Date:2/24/2017)... ... , ... The Smart Machine Age is here, and it’s disrupting everything. Not ... all jobs in the United States may be taken over by technology in the ... know-it-all who steamrolls over colleagues is drawing to a close. Success will belong to ...
(Date:2/24/2017)... ... , ... Healthcare Associates of McKinney announced today that they have ... State Highway 121, Suite 210, McKinney, Texas 75070. It is in the heart ... the practice has grown, the need for more space has been paramount. This ...
(Date:2/24/2017)... Diego, CA (PRWEB) , ... February 24, 2017 , ... ... its 2017 national conference convening academic faculty engaged in or interested in palliative care ... and Research,” will be held in North County San Diego on Sept. 28 ...
Breaking Medicine News(10 mins):