NeuroSigma Scores FDA Approval for ADHD Medical Device

Children diagnosed with attention deficit hyperactivity disorder (ADHD) may now have an alternative therapy option available to them and their families. Neurosigma, a California-based business specializing in bioelectronic devices, has just received FDA approval to market the first ever medical device for treatment of the disorder through low level electrical stimulation of specific nerve branches in the body.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Pena, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

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Called external Trigeminal Nerve Stimulation (eTNS), the treatment involves non-invasive neural modulation delivered via a medical device that is the size of a small cell phone. An external electrode patch is applied to a patient’s forehead – usually above the eyebrows – and a small amount of electrical stimulation is supplied to branches of the trigeminal nerve. The Trigeminal Nerve is a large cranial nerve that is uniquely suited as a distribution system for stimulation due to its placement close to the surface of the skin and its connection to key parts of the brain believed to be associated with certain neurological conditions – such as ADHD.

“We are extremely pleased by FDA’s clearance of the Monarch as a monotherapy for pediatric ADHD. We want to thank the FDA team for their efforts during the review process to bring it to a timely and successful completion,” said Leon Ekchian, president and CEO of NeuroSigma. “We also want to applaud the efforts of the clinical team at UCLA. We look forward to building a commercial organization in the U.S. to offer children, their parents and their physicians a compelling, low-risk, non-drug alternative to current medication treatment options for ADHD,” added Ekchian.

Neurosigma was originally founded by Lodwrick Cook and Leon Ekchian in 2008. The life sciences company secured their first patent in 2008 for innovative technologies related to transcutaneous and subcutaneous bilateral stimulation for treatment of neuropsychiatric and neurological disorders from the University of California, Los Angeles. The company also offers similar treatment options for neurological and psychiatric conditions including post-traumatic stress disorder, major depressive disorder, drug-resistant epilepsy, Lennox Gastaut Syndrome (LGS) and traumatic brain injury (TBI).

Co-founders Cook and Ekchian are both engineers by training, the former received his education as a petroleum engineer from Louisiana State University and the latter as an electrical engineer from the Massachusetts Institute of Technology. Cook is a noted philanthropist and has been invested as an honourary Knight Commander for the Most Excellent Order of the British Empire by Her Majesty the Queen. Prior to his work at NeuroSigma, Ekchian served as president of Arrowhead Research Corporation, a company that specialized in bringing innovative nanotechnologies in the electronic and biotech industries to the market.