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Monarch 2.0 is about one-third the size, has a high-resolution color LCD screen, and an optimized user interface.
January 18, 2024
By: Sam Brusco
Associate Editor
NeuroSigma has achieved U.S. Food and Drug Administration (FDA) clearance for its second-generation Monarch eTNS system to treat pediatric attention deficit hyperactivity disorder (ADHD). The second-gen system (Monarch 2.0) treat pediatric ADHD as a monotherapy for patients aged seven through 12 who aren’t taking prescription ADHD medications. Monarch 2.0 is about one-third the size, has a high-resolution color LCD screen, and an optimized user interface. The company said it will eventually be a hub for its planned digital health platform, as well. “We believe that 2024 will be a transformative year for NeuroSigma,” said president and CEO Dr. Colin Kealey. “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,” added 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.” The company established its first foreign subsidiary, located in Singapore, in September 2023.
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