NeuroSigma Systems said today it won CE Mark approval in the European Union for its Monarch eTNS system to treat attention-deficit/hyperactivity disorder in adults and children 7 and older.
Los Angeles-based NeuroSigma said it is the 1st and only non-drug treatment for ADHD approved in the European Union.
“ADHD is estimated to affect up to 9.5% of school age children and 4.4% of adults, and many people have concerns about using stimulant medications. In research conducted at the University of California, Los Angeles, eTNS was well accepted by children and their parents, and produced significant improvements in the behavioral symptoms of ADHD as well as in cognition. eTNS is non-invasive, can be administered at home, and has none of the serious side effects of the stimulant medications that are currently being used to treat ADHD. As a result, we believe that eTNS will become a preferred, drug-free treatment for many children and adults in the EU with ADHD,” chief medical officer Dr. Ian Cook said in a press release.
The Monarch eTNS system delivers mild electrical signals through a forehead patch to stimulate branches of the trigeminal nerve. The company is marketing the device as an alternative to vagus nerve stimulation and deep-brain stimulation, both of which require surgical implants. NeuroSigma is also developing a subcutaneous, implantable version of the system.
The Monarch eTNS system is composed of a small pulse generator and single-use electric patch that attaches to the forehead, and can be self-administered at home, typically while sleeping.
In September, UCLA-spun out NeuroSigma withdrew its plans for an initial public offering that could have brought the company as much as $50 million for its noninvasive system to treat drug-resistant epilepsy.
Last August Neurosigma registered for the $50 million IPO, setting out plans for the funds to support its development.
In October, the company said it planned to sell 3.6 million shares on the NASDAQ exchange for between $13 and $15 each, reserving the symbol NSIG, according to a regulatory filing.
In an SEC filing posted in September, the company said it withdrew and had no plans to pursue an IPO at this time.
The company received approval to market its system in Europe and Canada and holds aninvestigational device exemption from the FDA to conduct U.S. trials.
