LOS ANGELES, Oct. 17, 2019 /PRNewswire/ -- Teijin Limited (Teijin) and NeuroSigma, Inc. (NeuroSigma), a Los Angeles-based bioelectronics company focused on developing Trigeminal Nerve Stimulation (TNS) technology for the treatment of neuropsychiatric and neurological indications, today announced entering into a partnership based on an exclusive license agreement that grants Teijin Pharma, the core company of Teijin's healthcare business, exclusive rights: (i) to NeuroSigma's TNS patent rights in Japan related to attention deficit hyperactivity disorder (ADHD) and (ii) to market the Monarch eTNS System® for the non-invasive treatment of ADHD in Japan. As part of the agreement, Teijin Pharma will seek regulatory approval in Japan for the Monarch eTNS System (Monarch) for the treatment of ADHD.
The Monarch® is the first non-drug treatment cleared by the US FDA for the treatment of pediatric ADHD. In the US, the prescription-only Monarch device is indicated for treatment of pediatric ADHD as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device 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 Monarch use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events are associated with use of the device.
Teijin Pharma, a global leader in the use of home therapies to improve the quality of life for patients, seeks to expand its home healthcare product portfolio. NeuroSigma will support Teijin's activities in securing regulatory approval in Japan for the Monarch for the treatment of ADHD. Teijin Pharma also offers home healthcare services for respiratory conditions, including home oxygen therapy (HOT), and continuous positive airway pressure (CPAP) therapy for sleep apnea treatment.
"The Monarch eTNS System is a non-invasive, non-drug treatment for pediatric ADHD and is designed for home use. NeuroSigma's corporate strategy is to focus on the U.S. market while partnering with leading life sciences companies outside the U.S.," said Leon Ekchian, Ph.D., CEO of NeuroSigma. "As a leading global pharmaceutical and home healthcare company, Teijin Pharma is NeuroSigma's ideal partner for the commercialization of eTNS for the treatment of ADHD in Japan," added Ekchian.
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 believed to be involved in 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, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
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 neuromodulation 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
About the Teijin Group Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has over 170 companies and around 20,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY888.6 billion (USD 8.1 billion) and total assets of JPY 1020.7 billion (USD 9.3 billion) in the fiscal year ending March 31, 2019. Please visit www.teijin.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.