|By PR Newswire||
|September 5, 2012 04:00 AM EDT||
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).
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.