LOS ANGELES, June 6, 2013 /PRNewswire/ -- NeuroSigma, Inc., a California-based medical device company, today announced the launch of www.monarch-etns.com, its dedicated website for the Monarch™ eTNSTM System. The new site provides a comprehensive resource for those in the European Union and Canada who are considering use of the non-invasive Monarch system to treat their epilepsy and depression in conjunction with their existing drug treatment program. The therapeutic neuromodulation system is not yet approved for use in the United States.
Visitors to the site will find information on:
Patients and physicians who want more in-depth knowledge will find:
"Those who visit the site to learn more about the Monarch will become not only informed but also empowered to take the next step in managing their condition with this safe, easy-to-use and non-invasive system," said Ian Cook , M.D., Director of the UCLA Depression Research & Clinic Program and Chief Medical Advisor to NeuroSigma. "Patients and physicians alike can ask questions of the NeuroSigma team, share insights, and make suggestions. In this way the site will become an online home to a growing population of patients whose lives have been transformed by the Monarch system, as well as an expanding number of physicians who have tapped into its therapeutic potential for their patients," added Dr. Cook.
Background – The Monarch eTNS System from NeuroSigma
NeuroSigma's flagship product, the Monarch™ eTNS™ System, is currently being marketed to patients in the European Union (EU), and Canada 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 non-surgical system also recently received a Class 2 medical device license from Health Canada in May of 2013. The license covers use of the system for treatment of drug-resistant epilepsy (DRE), major depressive disorder (MDD), and treatment-resistant depression.
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.
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.
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.
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