LOS ANGELES, May 2, 2013 /PRNewswire/ -- NeuroSigma, Inc., a California-based medical device company, today announced that it has received a Class 2 medical device license for its Monarch™ eTNS™ (external trigeminal nerve stimulation) System from Health Canada. The license covers the use of the Monarch eTNS System for treatment of drug-resistant epilepsy (DRE), major depressive disorder (MDD), and treatment-resistant depression.
The Monarch, CE Mark approved in the European Union in 2012, but not yet approved in the United States (US), is now available to patients in Canada. Drug resistant epilepsy (DRE) is a serious medical disorder, and affects approximately 30% of all patients with epilepsy. Major depressive disorder is a prevalent condition, affecting up to 16% of the population at some point during their lives.
The Health Canada approval was supported by years of safety and efficacy data generated in Phase I and Phase II clinical trials in the US, in which the therapy was shown to substantially reduce seizure frequency and significantly improve mood. Results from a Phase II Randomized Controlled Trial of eTNS for epilepsy were published online in the January 26, 2013 issue of Neurology®, the medical journal of the American Academy of Neurology. The clinical trial enrolled 50 patients, and was conducted at the University of California Los Angeles (UCLA) and the University of Southern California (USC). After 18 weeks of eTNS therapy, 40.5% of patients in the treatment group had a reduction in seizures of at least 50%. In addition to clinical trials in epilepsy, NeuroSigma has funded clinical trials at UCLA for the treatment of major depression, PTSD and ADHD.
The Monarch eTNS System will be sold by prescription in Canada to patients under physician supervision. The system is composed of an external pulse generator and disposable external electric patches placed on the forehead that are replaced daily. The patches are worn primarily in the evening while asleep.
"We are very pleased to have received the license from Health Canada," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma. "It is another major milestone for NeuroSigma in the commercialization of trigeminal nerve stimulation and enables us to work with a new physician population and their patients. We are committed to making eTNS affordable and available worldwide."
"I am delighted as an inventor that this therapy is now available to physicians and patients in Canada," added Christopher DeGiorgio, M.D., Vice President of Neurology and Professor of Neurology at UCLA. "In the United States, we have completed our pre-IDE meeting with the FDA and are preparing our IDE submission to commence a multi-center pivotal trial of eTNS for epilepsy. Over twenty-five major epilepsy centers have expressed strong interest in being part of this trial."
"As a psychiatrist, I'm excited to see that this new treatment paradigm will be available to physicians in Canada to address the unmet needs for their patients with depression," added Ian Cook, M.D., Director of the UCLA Depression Research & Clinic Program and Senior Medical Advisor to NeuroSigma.
Background - TNS
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 skin in the forehead. The low-energy stimulus is confined to the soft tissues of the forehead without direct penetration into the brain. 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.
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 the 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). For more information about NeuroSigma, please visit www.neurosigma.com.
NeuroSigma's first TNS product, the Monarch™ eTNS™ System, is currently being marketed to patients in the European Union (EU), with a physician's prescription. In September 2012, NeuroSigma received CE Mark approval for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older in the EU. The Monarch was recently unveiled in London at the 10th European Congress on Epileptology. The Monarch™ eTNS™ System consists of a small stimulator that can be placed in a pocket or worn at the waist, and an electric patch that is placed on the forehead. The patch stimulates the trigeminal nerve through the surface of the skin, and is used primarily while the patient is asleep.
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.