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NeuroSigma Receives Approval from Australian Therapeutic Goods Administration to Market its Monarch™ eTNS™ System for the Adjunctive Treatment of Drug-Resistant Epilepsy

LOS ANGELES, April 1, 2014 /PRNewswire/ -- NeuroSigma, Inc., 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 received approval from the Therapeutic Goods Administration (TGA) to market its Monarch™ eTNS™ System in Australia.  The approval allows NeuroSigma to market the Monarch eTNS System for the adjunctive treatment of drug-resistant epilepsy (DRE) in patients nine years of age and older.

DRE is a serious medical disorder, and affects approximately 30% to 37% of all patients with epilepsy. The Monarch eTNS System is a non-invasive adjunctive therapy for DRE that delivers low-intensity electrical current through a single-use adhesive patch to stimulate branches of the trigeminal nerve near the surface of the forehead. Patients may conveniently self-administer the therapy at home and typically use the device while sleeping. The Monarch eTNS System will be sold by prescription to patients in Australia under a physician's supervision.

TGA approval was supported by data generated in Phase I and Phase II clinical trials in the United States measuring safety and efficacy. Results from a Phase II randomized controlled trial of eTNS for epilepsy were published in the February 26, 2013 issue of Neurology®, the medical journal of the American Academy of Neurology.  

Mark Cook, M.D., Chair of Medicine, St. Vincent's Hospital in Melbourne, Australia noted, "I am pleased that eTNS is now available to be prescribed for the treatment of drug-resistant epilepsy in Australia.  I have been following with interest the experiences that my colleagues in Europe and Canada have had with their patients and look forward to prescribing eTNS to my patients."

"We are very pleased to have received TGA approval to market our Monarch eTNS System for the adjunctive treatment of drug-resistant epilepsy.  I look forward to working with Dr. Mark Cook and other epilepsy thought leaders in Australia in introducing the Monarch eTNS System to major epilepsy centers in Australia," said Greg Brooks, Chief Commercial Officer of NeuroSigma.

"This approval is another major milestone for NeuroSigma and enables us to bring our non-invasive therapy to a new physician and patient population in Australia. NeuroSigma intends to make eTNS available in relevant markets worldwide," added Leon Ekchian, Ph.D., President and CEO of NeuroSigma.

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 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 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.

SOURCE NeuroSigma, Inc.

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