NeuroSigma Receives Notice of Allowance from the Mexican Institute of Industrial Property Covering Subcutaneous Trigeminal Nerve Stimulation (sTNS)

Nov 03, 2014, 07:00 ET from NeuroSigma, Inc.

LOS ANGELES, Nov. 3, 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 Mexican Institute of Industrial Property has issued a Notice of Allowance for Mexican Patent Application No. MX/a/2012/004051. 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 a wide variety of medical disorders including neurological and neuropsychiatric disorders such as epilepsy, depression, PTSD, ADHD and TBI.

"NeuroSigma has previously received several U.S. patents related to our external and subcutaneous TNS systems.  We are very pleased to be receiving our first non-U.S. patent related to our minimally invasive, fully implantable sTNS system, which is currently under development. It is an important step in obtaining patent coverage in markets outside the U.S. in support of our global commercialization strategy," said David Hayes, Chief Administrative Officer and General Counsel of NeuroSigma.

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 injury (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 and sTNS are investigational devices and are 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 external TNS (eTNS) in drug-resistant epilepsy. Completion of that Phase III trial is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.

eTNS, sTNS, 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.

SOURCE NeuroSigma, Inc.



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