NeuroSigma Receives Notice of Allowance of U.S. Patent Application

LOS ANGELES, Oct. 21, 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, announced today that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 12/898,685 entitled "Extracranial implantable devices, systems and methods for the treatment of neuropsychiatric disorders." The patent application is co-owned by NeuroSigma and the Regents of the University of California (Regents) as a result of research conducted by physicians and scientists at NeuroSigma and the University of California, Los Angeles (UCLA).  NeuroSigma is the exclusive licensee of the Regents' rights to the patent application.

The patent application is related to the use of trigeminal nerve stimulation (TNS) with minimally-invasive, subcutaneously-implanted electrodes and pulse generator for the treatment of neuropsychiatric disorders, including but not limited to depression, ADHD, PTSD and TBI.

"This is an important milestone in the commercialization of TNS.  We had previously received patents related to our external eTNS system.  We are very pleased to be receiving our first patent related to our minimally-invasive, fully-implantable sTNS system, which is currently under development," said David Hayes, Chief Administrative Officer and General Counsel of NeuroSigma.

"A major challenge faced by other implantable neuromodulation systems such as vagus nerve stimulation and deep brain stimulation is the inability to screen patients with an external system prior to implanting the implantable system. We believe that our eTNS system can be used to screen for sTNS because they both stimulate the same branches of the trigeminal nerve.  We plan to conduct clinical trials to demonstrate this unique screening capability that would minimize the likelihood of implanting our sTNS system in a patient who does not respond. The potential benefits of TNS in neuropsychiatric disorders may be related to the way it increases activity in regions of the brain associated with mood and attention, as shown by PET scan findings," said Ian A. Cook, M.D., NeuroSigma's Chief Medical Officer and Senior Vice President who previously led TNS development in neuropsychiatric applications at UCLA.

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), traumatic brain disorder (TBI), 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 investigationaldevice 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, ADHD, and TBI. 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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SOURCE NeuroSigma

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