BrainsWay said it has won de novo clearance from the FDA for its deep transcranial magnetic stimulation (Deep TMS) system for treatment of obsessive-compulsive disorder (OCD) in adults.
The clearance marks the second indication granted for BrainsWay Deep TMS, and the first noninvasive medical device clearance for the treatment of OCD. The FDA cleared the device for treatment of major depressive disorder (MDD) in 2013. Deep TMS treatment is non-invasive, requires no anesthesia and has been demonstrated to be safe and well-tolerated, according to a statement by the Jerusalem, Israel-based company.
BrainsWay’s H7- coil targets the anterior cingulate cortex, a region known for many years to be centrally implicated in the pathophysiology of OCD, according to Abraham Zangen, a scientific founder and a neurobiological consultant to the company. BrainsWay uses a different coil, the H-1 coil, to treat depression by targeting the lateral pre-frontal cortex.
BrainsWay’s FDA clearance for its OCD treatment was based on a pivotal, multicenter study demonstrating that after six weeks of treatment, there was a statistically significant improvement in the primary endpoint results for the active treatment group when compared to sham (p=0.0127). The improvement was maintained when measured again in a single follow-up meeting with the patients one month after the end of treatment at week 10, the company said.
The primary outcome measure of this study was the OCD Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the gold standard measure of OCD symptoms’ severity. More than 38% of patients in the active group achieved a response of a greater than 30% reduction in symptoms’ severity as measured by Y-BOCS, compared with just 11.1% in the sham group (p=0.0033). Nearly 55% of patients in the active group achieved a partial response of more than 20% reduction in symptoms’ severity, versus 26.7% in the sham group (p=0.0076).
The study was conducted in 11 medical centers, including nine in the U.S. and one each in Canada and Israel. Patients who did not sufficiently respond to pharmacological or psychological treatment were enrolled in the trial and continued their pharmacological or psychological treatment during the study. The BrainsWay OCD treatment protocol consisted of 29-minute sessions conducted five times per week, over the course of six weeks.
“With the clearance of our BrainsWay OCD device, we are now able to provide an effective and safe treatment option for U.S. patients who are suffering from OCD,” said Yaacov Michlin, president & CEO of BrainsWay, in the statement. “With more than two million U.S. adults suffering from OCD, this clearance provides us with a significant market opportunity. Importantly, this clearance further establishes Deep TMS as a platform technology that will provide treatments for additional psychiatric indications, subject to successful completion of our currently ongoing multicenter studies and regulatory approvals.”
“The clearance of BrainsWay’s OCD device marks a historic milestone in the treatment of this neurological disorder,” added principal pivotal trial investigator Dr. Joseph Zohar, a professor of psychiatry at Tel Aviv University and chairman of the International College of Obsessive-Compulsive Spectrum Disorders. “This is a new, groundbreaking treatment option for patients looking for a meaningful and potentially life-changing solution for OCD.”
The company intends to start installing BrainsWay OCD immediately as an upgrade of its current systems and as part of new installations. Clinics that have or will have a Deep TMS system can now treat MDD and OCD patients.