FDA approves BrainsWay Deep TMS system to treat Obsessive Compulsive Disorder.- Brainsway Ltd.

BrainsWay Ltd., the parent company of BrainsWay USA, Inc., and a global leader in the advanced non-invasive treatment of brain disorders,announces that it has received De Novo clearance from the FDA for its deep transcranial magnetic stimulation (Deep TMS) system for the treatment of obsessive-compulsive disorder (OCD) in adults. 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 cleared 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�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.

The FDA reviewed the Brainsway device through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.

Comment: Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain. The FDA permitted marketing of TMS as a treatment for major depression in 2008 and expanded the use to include TMS for treating pain associated with certain migraine headaches in 2013.