|By PR Newswire||
|February 11, 2013 03:01 AM EST||
LOS ANGELES, Feb. 11, 2013 /PRNewswire/ -- NeuroSigma, Inc., a California-based medical device company, today announced that Christopher DeGiorgio, M.D., Vice President of Neurology at NeuroSigma and Professor of Neurology at the University of California, Los Angeles (UCLA), and Colin Kealey, M.D., Manager of Business Development at NeuroSigma, will present in London, an overview of external trigeminal nerve stimulation (eTNS™) for the treatment of epilepsy and depression at The Royal Society of Medicine's Sixth Medical Innovations Summit on February 16, 2013.
Now available in the European Union, with a physician's prescription, 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.
A Phase II randomized controlled clinical trial, conducted at UCLA and the University of Southern California (USC), for the use of eTNS™ for the treatment of drug-resistant epilepsy showed a robust effect on seizure frequency and mood. At the end of the eighteen week treatment period, more than 40% of patients experienced a greater than 50% reduction in seizure frequency when using the device, as recently reported in the January 30, 2013 on-line issue of Neurology®.
"Dr. Kealey and I are very excited to have been invited to present at the Royal Society of Medicine. The summit is described as a forum for 'bright ideas in medicine' and we appreciate this opportunity to meet the UK medical community and, with their help, make this therapy available to patients suffering epilepsy and depression," said Dr. DeGiorgio.
"All of us at NeuroSigma applaud the work done by Dr. DeGiorgio and the teams at UCLA and USC who have worked long and hard to generate promising clinical data and establish the science behind this paradigm shift treatment of epilepsy and depression," added Lodwrick M. Cook, Chairman of NeuroSigma. "Britain is the place where so many great ideas in medicine have first been adopted. We would like our 'patch for epilepsy' to follow in this long and distinguished line of innovation."
eTNS in the European Union
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 System was recently unveiled in London at the 10th European Congress on Epileptology.
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 potential 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.
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.
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