Articles from NeuroSigma, Inc.

Company dispensed over 1,000 FDA-cleared systems in pilot phase; unveils new website and second-generation device for early 2026 launch

Peer-reviewed results of PET neuroimaging demonstrate rapid and profound changes to humans receiving eTNS

LOS ANGELES, June 10, 2025 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing the Monarch external Trigeminal Nerve Stimulation (eTNS) device for treating attention-deficit hyperactivity disorder (ADHD), today announced a notice of allowance in China for a patent protecting the Monarch eTNS System. The patent, titled Pulse Generator for Trigeminal Nerve Stimulation, protects certain embodiments of NeuroSigma’s core eTNS technology, including its second-generation Monarch device. The patent was allowed by China’s National Intellectual Property Administration on May 27, 2025. In 2022, NeuroSigma licensed rights to the Monarch eTNS System for treating ADHD in China to Ignis Therapeutics, a leader in the development of novel therapeutics for central nervous system (CNS) conditions.

LOS ANGELES, April 30, 2025 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing the Monarch external Trigeminal Nerve Stimulation (eTNS) device for treating ADHD, today announced a new clinical trial of the Monarch for treating symptoms of ADHD in children with fetal alcohol syndrome (FAS). The 2-year trial will be led by Professor Joseph O’Neill, Adjunct Professor of Psychiatry at UCLA, and is being funded by an initial $350,000 grant from the National Institute of Alcohol Abuse and Alcoholism (NIAAA). Monarch devices and supplies for the trial will be provided by NeuroSigma.

LOS ANGELES, Jan. 22, 2025 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing the Monarch external Trigeminal Nerve Stimulation (eTNS) device for treating ADHD, today announced the filing of a new patent related to use of eTNS for treating neurodevelopmental disorders. The patent filing, Trigeminal Nerve Stimulation as Treatment for Neurodevelopmental Disorders and for Increasing Cognitive Performance, builds on scientific and clinical observations suggesting that eTNS may help improve reading performance in children with dyslexia and other learning disabilities, which tend to occur along with ADHD.

LOS ANGELES, Jan. 13, 2025 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company, announced today that the ATTENS trial, a double-blind randomized multicenter placebo-controlled trial of NeuroSigma’s Monarch® eTNS System for treating attention-deficit/hyperactivity disorder (ADHD), has completed enrollment. The trial is being funded by an Efficacy and Mechanism Evaluation grant from the United Kingdom’s National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC) and is being led by Professor Katya Rubia of the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London (King’s).  

LOS ANGELES, Dec. 11, 2024 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company, announced today that the Center for Evidence-Based Psychiatry (CEBP) in Denmark has approved commencing enrollment of a clinical trial of NeuroSigma’s Monarch® eTNS System for treating pediatric attention-deficit hyperactivity disorder (ADHD). The trial, to be conducted at several Danish child and adolescent psychiatry centers, is being led by Professor Ole Jakob Storebø, principal investigator and head of the CEBP. The trial is funded by the government of Denmark, Region Zealand's Health Sciences Research Foundation, Region Southern Denmark Research Foundation, AP Møller, and the Jascha Foundation. The Monarch eTNS System employs external trigeminal nerve stimulation (eTNS) for treating neuropsychiatric conditions, and NeuroSigma is currently commercializing the medical device in the United States for treating pediatric ADHD.

LOS ANGELES, May 09, 2024 (GLOBE NEWSWIRE) -- NeuroSigma, Inc. today announced its acceptance into the 2024 cohort of the KidsX Accelerator Program. KidsX is a global leader in pediatric digital health innovation that facilitates collaboration between leading children’s hospitals, providers, payers, investors, entrepreneurs, and corporate partners to solve the most pressing problems in pediatric care delivery. KidsX is anchored by a consortium of leading children’s hospitals in the United States and other parts of the world and leverages this unique network to help companies developing solutions for the pediatric healthcare market achieve product and business model validation.  

LOS ANGELES, Jan. 17, 2024 (GLOBE NEWSWIRE) -- NeuroSigma today announced that the U.S. Food and Drug Administration (FDA) cleared use of NeuroSigma’s second-generation Monarch eTNS System for treating pediatric attention deficit hyperactivity disorder (ADHD). The second-generation Monarch eTNS System (i.e., Monarch 2.0) is indicated for treatment of pediatric ADHD as a monotherapy for patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.   Monarch 2.0 significantly improves upon the first-generation Monarch eTNS System. The device is approximately one-third the size, includes a high-resolution color LCD screen and optimized user interface, and, eventually, will serve as a hub for NeuroSigma’s planned digital health platform.

LOS ANGELES, Nov. 07, 2023 (GLOBE NEWSWIRE) -- NeuroSigma today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its second-generation Monarch eTNS System™ (Monarch 2.0). The Monarch eTNS System was the first-ever wearable medical device to receive FDA clearance as a treatment for pediatric ADHD, and the 510(k) submission is the first step in the FDA review process to obtain clearance for Monarch 2.0.

LOS ANGELES, Oct. 03, 2023 (GLOBE NEWSWIRE) -- NeuroSigma today announced approval of the Monarch eTNS System by Singapore’s Health Sciences Authority (HSA), the national body that regulates medical devices, therapeutics, and other healthcare products. The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric attention deficit hyperactivity disorder (ADHD) as a monotherapy for patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.

Enables Strategic Research Partnerships and Platform for Southeast Asia Commercialization

LOS ANGELES, March 01, 2023 (GLOBE NEWSWIRE) -- NeuroSigma today announced a new option for patients and caregivers seeking a telehealth evaluation for the Monarch eTNS System®. NeuroSigma is a Los Angeles-based bioelectronics company commercializing external trigeminal nerve stimulation (eTNS) technology for treating neurological and neuropsychiatric disorders. Its lead product is the Monarch eTNS System, the first-ever FDA cleared non-pharmaceutical treatment for pediatric ADHD.

LOS ANGELES, Jan. 31, 2023 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing external trigeminal nerve stimulation (eTNS) technology for treating neurological and neuropsychiatric disorders, today announced the commencement of a strategic digital marketing partnership with Data360, a leading provider of targeted, online marketing for the healthcare industry.

Trials recruiting subjects at UCLA and Seattle Children’s Hospital in the United States, and at King’s College London and the University of Southampton in the United Kingdom

New co-pay program will increase access to the Monarch eTNS® System for commercially insured children ages 7 – 12 with a diagnosis of ADHD