NeuroSigma, which recently received regulatory approval of its device for certain uses in Europe and Canada, last month reported positive results in a clinical trial that might help the company toward U.S. approval. The UCLA study used NeuroSigma’s system to stimulate a nerve in children and adolescents to reduce symptoms of attention deficit hyperactivity disorder.
The trigeminal nerve, found in the forehead, is the largest cranial nerve and is responsible for sensation in the face and for certain motor functions such as biting and chewing. It also serves as a key on-ramp to what NeuroSigma senior medical adviser Dr. Ian Cook described as a highway of other nerves responsible for a wide variety of bodily functions.
The device, called the Monarch eTNS, provides gentle stimulus to the trigeminal nerve via disposable electrode pads that a typical patient can wear while sleeping at night. In Europe and Canada, the device is approved for epilepsy and depression that hasn’t responded to other treatment, and is now being rolled out for sale in those markets.
“It’s really an elegant approach to nerve stimulation,” said Cook, who holds a chair at UCLA’s department of psychiatry. He co-developed the technology with the company’s vice president, Dr. Christopher DeGiorgio, vice chairman of UCLA’s department of neurology.
NeuroSigma was formed in 2008 and later licensed the core technology for the system from UCLA. Chief Executive Leon Ekchian is a former president at Pasadena’s Arrowhead Research Corp., which is developing nanotech approaches to disease treatment. Ekchian brought on board as NeuroSigma’s chairman one of his former bosses, Lodwrick Cook, retired chief executive of oil giant Atlantic Richfield Co.
Ekchian said the Monarch meets a key market need because of its relatively low cost. Other neuromodulation devices can cost thousands of dollars. The U.S. price hasn’t been set, but in Europe and Canada, patients pay about $1,000 for the stimulator and a month’s worth of electrodes.
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