NeuroSigma Announces FDA Clearance of its Second-Generation Monarch eTNS System for Treating Pediatric ADHD

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.

“We believe that 2024 will be a transformative year for NeuroSigma,” said Dr. Colin Kealey, President and CEO of NeuroSigma. “In 2023, NeuroSigma executed on the first part of its commercial rollout by introducing patients, families, and physicians across the United States to eTNS therapy. With FDA clearance and a mid-year launch of Monarch 2.0, we can begin scaling our commercial operations to help treat the millions of children in the U.S. and worldwide suffering from ADHD. In the second half of 2024, our academic partners at UCLA, Seattle Children’s Hospital, and King’s College London are projected to complete enrollment of 375 subjects in two multicenter double-blind trials of eTNS for pediatric and adolescent ADHD. We believe that data from these trials will definitively establish the role of eTNS for the treatment of ADHD and further accelerate commercial adoption and payer coverage of this innovative treatment.”

“FDA clearance of Monarch 2.0 is a major commercial and strategic milestone for NeuroSigma, and we look forward to further progress in 2024,” said C. Thomas Paschall, Director of NeuroSigma and CEO of Checkmate Capital Group. “Monarch 2.0 is a scalable device platform that will facilitate rapid commercialization not just in the United States, but also in China, Singapore, Korea and ultimately throughout the world. We anticipate NeuroSigma announcing additional global partnerships and continuing to build a world class dataset for ADHD and other indications, such as drug resistant epilepsy and autism spectrum disorder.”

About NeuroSigma
NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients’ lives. The company is commercializing the Monarch eTNS System, which is the first non-drug treatment for pediatric ADHD cleared by the FDA. Pipeline indications for the Monarch and NeuroSigma’s TNS platform include a wide spectrum of neurological and neuropsychiatric disorders, such as ADHD, drug-resistant epilepsy, autism spectrum disorder (ASD), and depression. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.

Contact:
Colin Kealey, M.D., President of NeuroSigma at CKealey@neurosigma.com


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