|By PR Newswire||
|January 27, 2014 06:00 AM EST||
LOS ANGELES, Jan. 27, 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 neurologic and neuropsychiatric disorders, today announced the appointment of Gregory F. Brooks as Senior Vice President and Chief Commercial Officer.
Mr. Brooks brings more than 30 years of experience in the pharmaceutical, biologic and medical device industries to NeuroSigma. In his three decades at Allergan, he held roles of increasing responsibility, serving most recently as the VP Global Strategic Marketing. During his tenure there, he was responsible for global product line launches including BOTOX® for neurologic, cosmetic, and urologic conditions, as well as both pharmaceuticals and medical devices for ophthalmic and dermatologic conditions. Most recently, he oversaw Allergan's BOTOX franchise, where his leadership efforts resulted in successful launches of BOTOX for the treatment of idiopathic and neurogenic overactive bladder. Mr. Brooks also established Allergan's Health Economics organization responsible for creating and developing the data required to support global reimbursement policies, and identified new business opportunities for specialty pipeline products and indications. Prior to his position as Allergan's VP Global Strategic Marketing, he served in various senior strategic and commercial roles across the company's multiple product lines. Mr. Brooks received a Bachelor of Science in Marketing from Rider University.
"I am extremely pleased that Greg is joining NeuroSigma's management team and am confident that he will make valuable contributions," said Lodwrick M. Cook, Chairman of NeuroSigma.
"Greg's depth of experience in the pharmaceutical and medical device industries, his proven leadership in successful global product launches and marketing strategy, and his vision make him ideally suited to spearhead NeuroSigma's global commercialization initiatives and to build a pipeline of new indications with the Monarch eTNS System," added Leon Ekchian, Ph.D., NeuroSigma's President and CEO.
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. NeuroSigma is currently offering the Monarch™ eTNS™ System to patients in the European Union and Canada 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 (or United States) 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.
BOTOX® is a registered trademark of Allergan, 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 and www.monarch-etns.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.
SOURCE NeuroSigma, Inc.
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