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SOURCE NeuroSigma, Inc.
LOS ANGELES, June 03, 2014 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive Monarch™ eTNS™ System for the treatment of neurological and neuropsychiatric disorders, today announced that Ian A. Cook, M.D., has joined NeuroSigma on June 1, 2014 as Chief Medical Officer and Senior Vice President.
Dr. Cook is a physician and bioengineer who has been an innovator in medical therapeutics and diagnostics for over 25 years. A Professor of Psychiatry and Biobehavioral Sciences at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and of Bioengineering at its Henry Samueli School of Engineering, Cook was the first physician to use trigeminal nerve stimulation (TNS) as a treatment for depression and for post-traumatic stress disorder. His pioneering work as an inventor of TNS for neuropsychiatric disorders took place at the UCLA Depression Research & Clinic Program, of which he is founding Director.
During his tenure at UCLA, Dr. Cook was an investigator in the landmark STAR*D and Co-MED clinical trials in depression, conducted by the National Institutes of Health (NIH). At UCLA he served as Chair of the Faculty of the School of Medicine, Chief of Staff at the Resnick Neuropsychiatric Hospital, Founding Chief of the Transcranial Magnetic Stimulation (TMS) Treatment Service, and Director of the Neuromodulation Scholars Training Program at the Semel Institute for Neuroscience and Human Behavior. He was the inaugural incumbent of the Joanne and George Miller and Family Endowed Chair in Depression Research. In national leadership, he has served on both standing and ad hoc Integrated Review Groups for the NIH, and was a member of the Executive Committee on Practice Guidelines of the American Psychiatric Association, of which he is a Distinguished Fellow. He is a member of the Board of Directors of the Clinical TMS Society as well as co-chair of its Clinical Standards Committee. Dr. Cook is a magna cum laude graduate of Princeton University and of the Yale University School of Medicine. He has authored over 100 scientific publications and is an inventor on over a dozen issued and pending patents. He will continue his academic affiliation with UCLA, on a leave of absence.
"I am extremely pleased that Dr. Cook is taking this new role at NeuroSigma. As a leader in psychiatry and an inventor of TNS, he will be invaluable as a member of our senior management team," said Lodwrick M. Cook, Chairman of NeuroSigma.
Leon Ekchian, Ph.D., NeuroSigma's President and CEO, expressed his enthusiasm at Dr. Cook's role in NeuroSigma, saying, "Ian brings a wealth of experience in neuromodulation for CNS disorders as well as expertise in clinical neurosciences, psychiatric care, and medical device development. We are pleased and fortunate to have such a distinguished and accomplished leader join NeuroSigma at this important point in our company's growth with the Monarch eTNS device and other pipeline products."
Background – The Monarch eTNS System from NeuroSigma
In August 2012, NeuroSigma received CE Mark approval to market NeuroSigma's first TNS product, the Monarch™ eTNS™ System in the European Union, for the adjunctive treatment of drug-resistant epilepsy (DRE) and major depressive disorder (MDD) for adults and children 9 years and older. In addition, the Monarch™ eTNS™ System also received a Class II medical device license from Health Canada in April of 2013 allowing NeuroSigma to market the system for treatment of DRE and MDD for adults and children 9 years and older. In April of 2014, NeuroSigma received approval from the Australian Therapeutic Goods Administration (TGA) to market the system in Australia for treatment of DRE in adults and children 9 years and older. NeuroSigma is currently offering the Monarch™ eTNS™ System to patients in these jurisdictions with a physician's prescription.
The Monarch™ eTNS™ System is composed of a cell-phone sized pulse generator and a single-use 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 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 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, eTNS™ is an investigational device and is limited by Federal law to investigational use. The U.S. Food and Drug Administration has given NeuroSigma approval to proceed with a pivotal Phase 3 clinical trial of eTNS in drug resistant epilepsy. Completion of that Phase 3 study is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.
eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based life sciences company established to develop TNS 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, 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™ 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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