The US Food and Drug Administration has given the green light to US marketing of a noninvasive medical device developed by Jerusalem-based Brainsway Ltd. to treat obsessive-compulsive disorder.
OCD is a common, chronic disorder in which the sufferer has uncontrollable, recurring thoughts and feels compelled to repeat certain behaviors over and over. It is typically treated with medication, psychotherapy or a combination of the two. According to the National Institute of Mental Health, about 1 percent of US adults had OCD in the past year. Although most patients respond to treatment, some continue to experience symptoms, the FDA said in a statement announcing its decision on August 17.
Brainsway’s technology uses Deep Transcranial Magnetic Stimulation (TMS) — a procedure that uses a coil and magnetic fields to stimulate nerve cells in the brain — to treat the disorder, which can be very disruptive to the patient’s daily routine.
The FDA permitted marketing of TMS as a treatment for major depression in 2008 and expanded the use to include treating pain associated with certain migraine headaches in 2013.
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” said Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health in the statement. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”
Brainsway shares were trading 17 percent higher at 11:21 a.m. in Tel Aviv, bringing the firm’s market cap to NIS 286 million ($78 million).
For the approval, the FDA studied data from a randomized, multi-center study of 100 patients using the Brainsway technology. Out of the patients in the study, 49 were treated with the Brainsway device and 51 with a sham device.
Using a common metric for measuring the severity of a patient’s OCD — the Yale-Brown Obsessive-Compulsive Scale (YBOCS) score — the results indicated that 38 percent of patients responded to the Brainsway device, whereas 11 percent of patients responded to the sham device.
“No serious adverse reactions related to the Brainsway device were reported,” said the FDA in its statement.
In a filing to the Tel Aviv Stock Exchange on Sunday, Brainsway said that at the moment, Brainsway is the only company to receive FDA approval for a device to treat OCD using the TMS system.
The firm’s device for OCD will be available for marketing and commercial sale in the US “immediately,” the firm said.