BrainsWay wins FDA approval for brain stimulation system

Brainsway Photo: Rafi Kotz

The Israeli company has received FDA approvals for its deep transcranial magnetic stimulation (Deep TMS) system for the treatment of obsessive-compulsive disorder (OCD) in adults.

Israeli developer of non-invasive brain disorder treatments Brainsway Ltd. (TASE:BRIN) announced that it has received clearance from the US Food and Drug Administration (FDA) for its deep transcranial magnetic stimulation (Deep TMS) system for the treatment of obsessive-compulsive disorder (OCD) in adults. The company's share price was up 16% today on TASE on the news.

This clearance represents the first ever non-invasive medical device clearance for the treatment of OCD, and the second indication granted for BrainsWay Deep TMS, which was approved in 2013 for the treatment of treatment-resistant major depressive disorder (MDD). BrainsWay 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 systems can now treat MDD and OCD patients.

Brainsway president and CEO Yaacov Michlin said, “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. 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 multi center studies and regulatory approvals.”

“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health said in a statement from the FDA. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”

BrainsWay’s Deep TMS technology differs from that of other focal TMS devices as it has broad applicability and can directly stimulate areas of the brain at a greater depth and breadth than any other TMS device on the market safely and efficiently. While other focal TMS devices are limited to treating MDD, BrainsWay can now directly target previously unreachable areas of the brain with its proprietary H7-coil, allowing it to effectively treat OCD as well.

Published by Globes [online], Israel business news - www.globes-online.com - on August 19, 2018

© Copyright of Globes Publisher Itonut (1983) Ltd. 2018

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Brainsway Photo: Rafi Kotz
Brainsway Photo: Rafi Kotz
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