NeuroSigma and the U.S. Veterans Administration (VA) Enter into Cooperative Research and Development Agreement (CRADA)

Phase 1 Clinical Trial - External Trigeminal Nerve Stimulation for Traumatic Brain Injury

15 Oct, 2014, 07:00 ET from NeuroSigma, Inc.

LOS ANGELES, Oct. 15, 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 it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Veterans Affairs (VA) for a clinical trial to evaluate the benefits of non-invasive, external Trigeminal Nerve Stimulation (eTNS) for patients with traumatic brain injury (TBI) in a Phase I clinical trial.

Jean-Philippe Langevin, M.D., an expert in neurotrauma and a neurosurgeon at the Veterans Affairs Greater Los Angeles (VAGLA) medical center, will lead the study as Principal Investigator.  The project will enroll U.S. military veterans with TBI in an eight-week treatment protocol, and will examine change in cognitive function and regional brain activity as people receive nightly eTNS treatment at home.

TBI is a condition that arises after mechanical injury to the brain. According to the Centers for Disease Control and Prevention, an estimated 5.3 million Americans currently live with TBI-related disability, with an annual total cost in 2010 estimated at $76.5 billion, including $11.5 billion in direct medical costs and $64.8 billion in indirect costs including lost wages, lost productivity, and nonmedical expenditures.  The Department of Defense has reported approximately 200,000 cases of TBI in troops between 2000 and June 2010.  While many individuals recover fully, approximately 15 to 34 percent of individuals with mild or moderate TBI have persistent symptoms that may interfere with their return to work or school, including difficulties with memory, decision making, attention, movement, and emotional functioning.  These issues not only impact the injured individuals, but also can have lasting effects on their families and communities.

"We are excited to be working with Dr. Langevin and his colleagues on this important project. There is an acute need for more non-invasive TBI treatment options, not only for our veterans returning from overseas combat operations but also for the millions of Americans involved in motor vehicle accidents, falls, and sports-related concussions," said Lodwrick M. Cook, Chairman of NeuroSigma.

"Neuroimaging data from PET scans suggest that eTNS can influence the activity of certain brain areas associated with the cognitive functions that are disrupted in TBI.  This effect may be able to help these individuals overcome their impairments and the purpose of this study is to gather evidence related to this hypothesis." added Ian A. Cook, M.D., NeuroSigma's Chief Medical Officer and Senior Vice President.

"We owe it to our veterans to evaluate whether eTNS can help with TBI and are delighted to support this important Phase I clinical trial by supplying Monarch eTNS systems.  We are excited to be adding TBI to our pipeline of therapies under development," 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 trigeminal nerve stimulation (TNS) product, the Monarch eTNS System, in the European Union, for the adjunctive treatment of epilepsy and major depressive disorder (MDD) for adults and children nine 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 drug-resistant epilepsy (DRE) and MDD for adults and children nine years and older.  In April of 2014, NeuroSigma received approval from the Australian Therapeutic Goods Administration (TGA) to market the system in Australia for the adjunctive treatment of DRE in adults and children nine 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 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, post-traumatic stress disorder (PTSD), attention-deficit hyperactivity disorder (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 (FDA) has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of eTNS in drug-resistant epilepsy. Completion of that Phase III 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 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 and 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.

SOURCE NeuroSigma, Inc.