LOS ANGELES, Dec. 17, 2020 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders, announces that the Monarch eTNS System® was recognized by Medical Device and Diagnostic Industry (MD+DI), an industry publication focused on medical device original equipment manufacturers and diagnostic products, as one of the"10 cleared or approved wearable medical devices by FDA that have caused a paradigm shift in healthcare." NeuroSigma thanks MD+DI for its recognition of NeuroSigma's FDA cleared Monarch eTNS System for Pediatric ADHD in its list of the 10 FDA Cleared or Approved Wearable Medical Devices that Redefined Healthcare.
"NeuroSigma's Monarch eTNS System was the first non-drug treatment for pediatric ADHD cleared by the FDA. It was the culmination of over 10 years of hard work at NeuroSigma and UCLA, starting with the vision of developing a non-invasive neuromodulation platform technology for the treatment of neurological and neuropsychiatric conditions. Providing children, their parents, and treating physicians with an alternative to standard drug treatment is important and we are honored that MD+DI recognizes that the Monarch eTNS System redefines the treatment of children with ADHD," said Ian Cook, M.D., Chief Medical Officer of NeuroSigma and co-inventor of the core technology exclusively licensed by NeuroSigma from the University of California, Los Angeles (UCLA).
"We are delighted over this special recognition as we end a productive year in 2020 for NeuroSigma. This builds momentum for increased adoption and better awareness of the unique therapeutic advantages the Monarch eTNS System offers. The eTNS bioelectronics platform, once widely adopted, can serve as the source of substantial real-time patient data that can drive distributed digital health systems and infrastructure," said Leon Ekchian, Ph.D., CEO of NeuroSigma.
Background – eTNS In the United States NeuroSigma's Monarch eTNS Systemis 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.
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.
Contact: NeuroSigma, Inc. Dr. Leon Ekchian, President & CEO +1-310-479-3100 [email protected]