Healthcare Industry News: neuromodulation
News Release - February 25, 2014
David Hayes, Former Partner at O'Melveny & Myers LLP and Haynes and Boone LLP, Joins NeuroSigma As Chief Administrative Officer, General Counsel and Sr. Vice PresidentLOS ANGELES, Feb. 25, 2014 -- (Healthcare Sales & Marketing Network) -- 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, announced the appointment of David Hayes, Esq. as Senior Vice President, Chief Administrative Officer, General Counsel and Corporate Secretary.
Prior to joining NeuroSigma, Mr. Hayes was a partner at Hayes and Boone, LLP, since 2012, a partner at Dorsey & Whitney LLP from 2003 to 2012, a partner at Brobeck, Phleger & Harrison LLP from 2001 to 2003, a partner at O'Melveny & Myers LLP from 1996 to 2001 and an associate at Gibson, Dunn & Crutcher LLP from 1990 to 1996. During his tenure at these law firms, Mr. Hayes' legal practice focused on a wide range of transactions in the pharmaceutical, medical device, high technology and entertainment industries. His experience has included corporate financings; mergers and acquisitions; joint ventures; co-promotion agreements; intellectual property protection strategies; financing, selling, leasing, distribution, licensing and development of life sciences and high technology products and services; commercialization of intellectual property assets; trademark licensing; copyright and trademark registration prosecution. Mr. Hayes received a B.A. in psychology with honors from the University of California, Irvine and a J.D. with honors from Cornell Law School in 1990.
"I am delighted that David has become a member of the NeuroSigma leadership team. His extensive experience at several of the finest law firms in this country have provided him with knowledge, experience and judgment that will be a great asset to NeuroSigma," said Lodwrick M. Cook, Chairman of NeuroSigma.
"I have known and worked closely with David since 1996, dating back to when he was at O'Melveny & Myers and I was at Lockheed Martin. NeuroSigma has greatly benefited from David's legal and business acumen as our outside General Counsel. We are very fortunate that he has now transitioned to a full-time role in our executive management team, serving as Chief Administrative Officer and General Counsel. David will oversee all legal, compliance, business development, human resources and information technology functions of the Company," said 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 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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