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 c
'/>"/>

SOURCE NeuroSigma, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

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:9/16/2014)... , Sept. 16, 2014  Denovo Biopharma, LLC, ... late-stage oncology drug, from Eli Lilly and Company ... manufacture and commercialize enzastaurin globally, including transfer of ... information. Lilly developed enzastaurin in ... and Phase 3 clinical trials for diffuse large ...
(Date:9/16/2014)... Wash. , Sept. 16, 2014 /PRNewswire/ ... a late stage development company engaged primarily ... medical isotopes for diagnostic and therapeutic applications, ... for technology related to its brachytherapy products.  ... arise from its license from Battelle, under ...
(Date:9/16/2014)... -- Russia,s pharmaceutical ... Pharma 2020 Strategy provides incentives for local producers to ... foreign markets. These trends, however, were affected by recent ... political and economic sanctions imposed on Russia ... Russia responded to the US ...
Breaking Medicine Technology:Denovo Biopharma Acquires Late-Stage Oncology Drug From lilly For Development As A Personalized Medicine 2Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 2Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 3Advanced Medical Isotope Corporation Licensed Brachytherapy Seed Patent Granted 4Global Medicines for Russia 2
(Date:9/17/2014)... Irvington, NY (PRWEB) September 17, 2014 ... youth sports, concussion prevention is top of mind ... developed five facts to remember about concussions and ... Treatment, developed for kids, parents, coaches and teachers ... , "As a pediatric orthopedic ...
(Date:9/17/2014)... Lee Berman, a seasoned veteran of ... on The Balancing Act® airing on Lifetime Television®. Berman ... segment will premiere on September 19 and re-air on ... on Lifetime Television®' with show host Julie Moran. Berman ... over a decade and is the Director of Marketing ...
(Date:9/17/2014)... Freeslate, Inc. , the leading ... development, today announced that Baylor University acquired a ... to both support Baylor research interests and provide ... throughput system is expected to significantly accelerate innovation ... for small molecule organic chemistry. , The ...
(Date:9/17/2014)... Presence Technology, a multinational provider ... Suite 10.0, which incorporates significant enhancements to meet ... , The Contact Center Agents and Supervisors will ... get a better feel for the performance of ... and who requires additional coaching or mentoring to ...
(Date:9/16/2014)... BamboofloorChina.com, the popular online supplier of elegant bamboo items, ... bamboo floors to its product catalogue. Along with ... new items; the current discount is up to 27 ... season. Therefore, BamboofloorChina.com spares no energy to offer more ... items offered by BamboofloorChina.com are in stock and ready ...
Breaking Medicine News(10 mins):Health News:Video Helps Kids and Adults Talk About Concussion Recognition and Treatment 2Health News:Lee Berman Will Appear On The Balancing Act® airing on Lifetime Television® 2Health News:Baylor University Selects Freeslate Reaction Screening System to Support New High Throughput Screening Lab 2Health News:Presence Technology’s 10.0 Release Drives Contact Center Web Supervisor Effectiveness While Reducing Operation Costs and Delivering Enterprise Grade Scalability 2Health News:BamboofloorChina.com Announces Its Promotion For Strand Woven Bamboo Floors 2
... VIEJO, Calif., Sept. 19 Clarient, Inc.,(Nasdaq: CLRT ... and the pharmaceutical industry, today announced,that it is scheduled ... Life Sciences Conference at 4:30 p.m. EDT on Wednesday, ... Grand Hyatt in New York City,September 24-27. A ...
... /Xinhua-PRNewswire-FirstCall/ -- To help buyers,identify suppliers offering ... GSOL ) and Bureau Veritas, one ... have launched the B2B industry,s,most comprehensive supplier ... ) Co-developed by the two companies, ...
... volunteers representing the Women,s Dermatologic Society (WDS) will, help ... free skin cancer screenings and sun safety ... PLANO, Texas, Sept. 18 Even though higher altitudes,mean ... balloon,enthusiasts enjoying the upcoming Plano Hot Air Balloon Festival ...
... following statement today on proposed legislation by Senators,Kent Conrad ... to create a,task force to reform Social Security and ... the most successful safety,nets in our nation and any ... be done by the committees of jurisdiction in Congress; ...
... and other tissue in the laboratory in conditions similar to ... The technology, developed and patented by scientists at Durham University ... which allows cells to be grown in a more realistic ... a Petri dish. , Evidence gathered by the research ...
... ELMHURST, Ill., Sept. 18 Secure Services Corp. ... Parke has joined,them as the Director of Business ... northwest suburbs for 22 years. He was an,acknowledged ... of the National Conference of Insurance Legislators (NCOIL). ...
Cached Medicine News:Health News:Clarient to Present at the UBS 2007 Global Life Sciences Conference 2Health News:Supplier Assessments to Help Buyers Identify Reliable China Exporters 2Health News:Supplier Assessments to Help Buyers Identify Reliable China Exporters 3Health News:Supplier Assessments to Help Buyers Identify Reliable China Exporters 4Health News:Sun Safety Outreach to Families Takes Flight at the Plano Hot Air Balloon Festival 2Health News:Sun Safety Outreach to Families Takes Flight at the Plano Hot Air Balloon Festival 3Health News:Cell growth technology promises more successful drug development 2Health News:Cell growth technology promises more successful drug development 3Health News:Former State Representative Terry Parke Joins Secure Services Corp. 2
... thin collagen coated highly compliant ... thin wall construction offers optimal ... Hemacarotid UltraThin Patch provides superb ... and healing, without suture hole ...
The VasoSeal Low Profile device is designed for smaller sheath angiography procedures. VasoSeal Low Profile. Seal your arterial punctures with confidence....
D-Stat Radial is a dry version of the D-Stat together with a compression band, and is designed for the control of surface bleeding from vascular access sites, including the sites on the radial artery...
... engineered to close arteriotomies with ease ... with a simple trigger actvated mechanism, ... deliver sheath gently locks onto the ... the site before, during, and after ...
Medicine Products: