NeuroSigma Continues to Build a Substantial Global Bioelectronics Patent Portfolio

LOS ANGELES, March 11, 2021 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company that is commercializing trigeminal nerve stimulation (TNS) technology to treat neurological and neuropsychiatric disorders, announced today that the following patents have issued or received notices of allowance in Canada and Japan:

• Canadian patent no. 2776694 entitled Devices, Systems, and Methods for Treatment of Neuropsychiatric Disorders; issued November 17, 2020
• Canadian patent no. 2821981 entitled Devices, Systems and Methods for Treatment of Medical Disorders; issued January 12, 2021
• Japanese patent application no. 2019-107209 entitled Devices and Methods for Treatment of Psychiatric Disorders; notice of allowance received

In keeping with NeuroSigma's commercialization strategy of partnering outside the US, these patents (i) facilitate NeuroSigma's licensing activities in Japan and Canada and (ii) further build out NeuroSigma's intellectual property portfolio, including over twenty other patents issued across the United States, Europe, Japan, Canada and Australia since NeuroSigma's Monarch eTNS System® (Monarch) became the first non-drug treatment for pediatric ADHD to be cleared by the FDA. The patent portfolio covers the use of both the non-invasive external TNS (eTNS®) and the minimally-invasive subcutaneous TNS (sTNS) embodiments to treat a wide spectrum of indications, including neurological, neuropsychiatric, cardiac, and autoimmune disorders, along with enabling features enhancing product safety, ease of use, adaptive feedback control, and wireless and network interconnectivity with digital health infrastructure.

Researchers at the University of California, Los Angeles (UCLA) were pioneers in exploring the use of TNS technology which generated patents owned by the Regents of the University of California (Regents).  NeuroSigma is the exclusive licensee of the Regent's rights in all TNS-related patents owned by the Regents or co-owned by the Regents and NeuroSigma.

Haynes and Boone LLP represented NeuroSigma in the successful prosecution of these patent applications and other related applications.

"These recent patent issuances and allowances further bolster the intellectual property portfolio protecting NeuroSigma's Monarch eTNS System, which represents over 10 years of technological development at NeuroSigma and UCLA," said Ian Cook, M.D., co-inventor of TNS and Chief Medical Officer of NeuroSigma.   

"Our expansive patent portfolio has been an important factor in attracting significant investment in NeuroSigma's TNS therapies, which are providing children, their parents, and their physicians with an affordable, non-invasive alternative to standard drug treatment," said Colin Kealey, M.D., the VP of Medical Affairs for NeuroSigma, adding, "With robust intellectual property protections well beyond the US, we are prepared to commercialize and further develop with our partners eTNS technologies to treat a large global population of patients with a variety of disorders."

"We are extremely pleased by the recent flurry of patent issuances, which have resulted from the pioneering work of Dr. Ian Cook and Dr. Chris DeGiorgio at UCLA and the strong effort by the teams at UCLA and NeuroSigma, including Vista IP Law Group and Haynes and Boone, to protect the TNS technology in the US and key international markets.  With the addition of the new patents, the broader patent portfolio we have amassed exceeds 50 patents," said Leon Ekchian, Ph.D., NeuroSigma's President and CEO. "We now have in place the requisite building blocks needed for a successful commercial launch in the US of the Monarch system to treat pediatric ADHD, namely the patents, FDA clearance and CMS Level II HCPCS codes," added Ekchian.

Background – eTNS
In the United States NeuroSigma's Monarch eTNS System is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep. The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events have been associated with use of the device.

In the European Union, the Monarch eTNS System is approved as adjunctive therapy for drug resistant epilepsy and major depressive disorder, as well as monotherapy for ADHD, all in patients 7 years and older.

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 attention-deficit hyperactivity disorder (ADHD) and other disorders.

Trigeminal Nerve Stimulation (TNS) is mild electrical stimulation of branches of the trigeminal nerve, including those 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.

eTNS is the external embodiment of TNS and is patent protected in the United States and other major potential markets. eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc. 

For more information on eTNS, please visit the Monarch eTNS website.

About NeuroSigma, Inc.
NeuroSigma is a California-based life sciences company established to develop bioelectronic technologies with the potential to transform medical practice and patients' lives. NeuroSigma is focused on TNS bioelectronics therapies based on intellectual property, licensed on an exclusive basis from the University of California, Los Angeles (UCLA), covering a wide-spectrum of disorders, including 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 reimbursement and 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.

Media Contact
Leon Ekchian, Ph.D.
President and CEO
[email protected]

SOURCE NeuroSigma, Inc.

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