Monarch eTNS System Approved by Singapore Regulators

NeuroSigma’s Monarch eTNS System has been approved 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 designed to treat 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.

“We are pleased to announce this approval and look forward to introducing the Monarch in Singapore. This approval will allow NeuroSigma to deepen its clinical, and scientific relationships with Singapore’s world class physicians and scientists, while also providing a new, non-pharmaceutical treatment option for children suffering from ADHD,” NeuroSigma President/CEO Colin Kealey, M.D., said. “Singapore’s unique position makes it a key part of NeuroSigma’s strategy in Southeast Asia and beyond.”
 
NeuroSigma recently announced its formation of a Singapore-based subsidiary (NeuroSigma Singapore). The HSA approval represents the company’s first authorization for the Monarch eTNS System in Asia and adds to its existing U.S. Food and Drug Administration (FDA) approval. The Monarch is the first-ever medical device to receive HSA approval as a treatment for pediatric ADHD.
 
“We are delighted to achieve this regulatory milestone in Singapore and are grateful to NeuroSigma’s regulatory advisor, George Clinical, whose expeditious work over the summer led to receiving HSA approval so quickly. This is an initial step in a plan to commercialize the Monarch in Asia, where there is tremendous demand for a non-drug, non-invasive alternative therapy for ADHD and other neuropsychiatric conditions, particularly in light of recent drug shortages,” said NeuroSigma Director C. Thomas Paschall, who also is CEO of Checkmate Capital Group. “NeuroSigma has, in a short period, seen great progress in Singapore, which is—in terms of scientific research and commerce—a leading biotechnology center of Asia. NeuroSigma will continue its research and clinical collaborations with leading academic and medical institutions in Singapore to support the scientific foundation behind this therapy and with a goal to expand the label indications beyond pediatric ADHD monotherapy. We look forward to long-term commercial success resulting from these efforts in ADHD and other neuropsychiatric indications.”
 
NeuroSigma is a Los Angeles-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, and depression.