Healthcare Industry News: Cook
News Release - November 16, 2015
NeuroSigma's Monarch eTNS System Receives CE Mark Approval for ADHDTreatment of Attention-Deficit/Hyperactivity Disorder with Non-Invasive External Trigeminal Nerve Stimulation
LOS ANGELES, Nov. 16, 2015 -- (Healthcare Sales & Marketing Network) -- NeuroSigma®, Inc. (NeuroSigma) today announced that it has received CE Mark approval for its Monarch eTNS System® as treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and children age 7 and older. This CE Mark approval is the first for any non-drug treatment of ADHD in the European Union (EU).
"ADHD is estimated to affect up to 9.5% of school age children and 4.4% of adults, and many people have concerns about using stimulant medications. In research conducted at the University of California, Los Angeles (UCLA), eTNS® was well accepted by children and their parents, and produced significant improvements in the behavioral symptoms of ADHD as well as in cognition," said Ian A. Cook, M.D., NeuroSigma's Chief Medical Officer. "eTNS is non-invasive, can be administered at home, and has none of the serious side effects of the stimulant medications that are currently being used to treat ADHD. As a result, we believe that eTNS will become a preferred, drug-free treatment for many children and adults in the EU with ADHD."
Currently, a 90-subject double-blind trial of eTNS for ADHD is being conducted at UCLA with funding from the U.S. National Institutes of Health (www.ADHD-LA.com). The trial is led by James McGough, M.D., M.S., Professor of Clinical Psychiatry at UCLA. "I am excited and encouraged that we found a significant improvement in ADHD symptoms with eTNS in our Phase I open-label trial, and am eager to complete the current double-blind trial," said Dr. McGough.
NeuroSigma is a California-based life sciences company focused on commercialization of its non-invasive eTNS technology for the treatment of neurological and neuropsychiatric disorders. With this approval, NeuroSigma's Monarch eTNS system is now available in the European Union for the treatment of ADHD and for the adjunctive treatment of major depressive disorder and epilepsy for adults and children seven years and older.
The Monarch eTNS system is composed of a cell-phone sized pulse generator and a single-use electric patch that is applied to the forehead. Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there. Patients may conveniently self-administer the Monarch eTNS system at home and typically use the device while sleeping.
Background – TNS
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects directly or indirectly 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, attention-deficit hyperactivity disorder (ADHD), post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and other disorders.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, including those located near the surface of the forehead. Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.
CAUTION: In the United States, the Monarch eTNS System is an investigational device and is limited by Federal law to investigational use.
eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a California-based life sciences company established to develop bioelectronic technologies with the potential to transform medical practice and patients' lives. NeuroSigma is focused on TNS neuromodulation therapies based on intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, PTSD, ADHD, and TBI. 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 system. 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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