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NeuroSigma's Second-Generation Monarch eTNS System Receives FDA Clearance for Pediatric ADHD Treatment

• NeuroSigma's Monarch eTNS System 2.0 has been cleared by the FDA for treating pediatric ADHD as a monotherapy for patients aged 7-12 not on medication. • The Monarch 2.0 device is a smaller, enhanced version of the original, featuring a high-resolution color LCD screen and improved user interface. • Clinical trials are underway at UCLA, Seattle Children’s Hospital, and King’s College London to further establish eTNS therapy's role in ADHD treatment. • NeuroSigma plans to scale commercial operations in the U.S. and worldwide, with potential expansion into other neurological disorders like epilepsy and autism.

NeuroSigma has announced that the U.S. Food and Drug Administration (FDA) has cleared its second-generation Monarch eTNS (external Trigeminal Nerve Stimulation) System for the treatment of pediatric attention deficit hyperactivity disorder (ADHD). This clearance marks a significant advancement in non-drug treatments for ADHD, offering a new option for children aged 7 to 12 who are not currently taking prescription medications for the condition.
The Monarch 2.0 system represents a substantial improvement over its predecessor. The device is approximately one-third the size of the first-generation model and features a high-resolution color LCD screen and an optimized user interface. NeuroSigma envisions the Monarch 2.0 serving as a central hub for its planned digital health platform.

Clinical Trials and Commercial Expansion

According to Dr. Colin Kealey, President and CEO of NeuroSigma, 2024 is expected to be a transformative year for the company. Following the initial commercial rollout of the first-generation eTNS therapy in 2023, the FDA clearance of Monarch 2.0 paves the way for scaling commercial operations to address the millions of children in the U.S. and worldwide affected by ADHD.
Currently, academic partners at UCLA, Seattle Children’s Hospital, and King’s College London are conducting two multicenter, double-blind trials involving 375 subjects to evaluate eTNS for pediatric and adolescent ADHD. The data from these trials are anticipated to solidify the role of eTNS in ADHD treatment, potentially accelerating commercial adoption and payer coverage.

Future Applications

NeuroSigma is also exploring the potential of the Monarch eTNS system for other neurological and neuropsychiatric disorders, including drug-resistant epilepsy and autism spectrum disorder (ASD). C. Thomas Paschall, Director of NeuroSigma and CEO of Checkmate Capital Group, anticipates further global partnerships and the development of a comprehensive dataset for ADHD and other indications.

About the Monarch eTNS System

The Monarch eTNS System is the first non-drug treatment for pediatric ADHD cleared by the FDA. It delivers mild electrical stimulation to the trigeminal nerve, which may modulate brain activity in regions associated with ADHD. The device is intended for use as a monotherapy in patients who are not currently taking prescription ADHD medications.
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Reference News

[1]
NeuroSigma Announces FDA Clearance of its Second- ...
biospace.com · Jan 17, 2024

NeuroSigma's second-generation Monarch eTNS System, cleared by the FDA, treats pediatric ADHD in children aged 7-12 not ...

[2]
NeuroSigma Announces FDA 510(k) Submission for ...
biospace.com · Nov 7, 2023

NeuroSigma, Inc. submitted a 510(k) premarket notification to the FDA for its second-generation Monarch eTNS System™ (Mo...

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