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BrainsWay Receives FDA Clearance of Next Generation Stimulator, Enhancing Its Current Deep Transcranial Magnetic Stimulation (Deep TMS) System for Treatment of Major Depressive Disorder

The company will now have the most advanced stimulator on the market, with enhanced
features that increase the ease of use for physicians and integrate a patient management system

BrainsWay will be demonstrating the new stimulator at their booths at the American
Psychiatric Association and Clinical Transcranial Magnetic Stimulation Society Annual
Meetings taking place in NYC May 6-13, 2018

HACKENSACK, N.J., May 06, 2018 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (TASE:BRIN), the parent company of BrainsWay USA, Inc., and a global leader in the advanced non-invasive treatment of brain disorders, announces today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new stimulator to be integrated into BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) System for the treatment of Major Depressive Disorder (MDD).

BrainsWay’s next-generation stimulator enhances the complete Deep TMS system and streamlines treatment for physicians and their patients. It is the most advanced stimulator in its class and custom-designed with the Company’s proprietary H-Coil helmet for the treatment of MDD. BrainsWay’s Deep TMS proprietary H-Coil technology reaches deeper and larger surface areas of the brain than standard TMS treatments.

The new stimulator provides enhanced features focused on increasing the ease of use for the physician, integrating enhanced energy utilization, a patient management system with the built-in depression treatment protocol and a user-friendly tool for accurate, rapid motor threshold detection. These features will decrease set up time and increase office efficiencies.

“BrainsWay’s new stimulator represents a very important product advancement that solidifies the company’s leading innovative position within the US market. Furthermore, it sets the foundation for BrainsWay to become a fully integrated company that develops, produces and commercializes our innovative, non-invasive medical systems for the treatment of brain disorders globally,” said Yaacov Michlin, CEO of BrainsWay.

About Major Depressive Disorder (MDD)
Overall, there are more than 15 million people in the U.S. who suffer from depression, making MDD a remarkably common disease. Within the total population of individuals with MDD, there is a subpopulation associated with even greater individual costs related to the disease. This subgroup of MDD patients experience treatment-resistant depression (TRD), which is defined as depression that does not respond to treatment with antidepressant medications. Roughly 29% to 46% of MDD patients fail to respond adequately to antidepressant medications, and only approximately 30% of patients achieve remission from first-line pharmacological treatment. Patients who are more resistant to treatment (fail to respond to a greater number of medications) tend to experience lower rates of remission. MDD is often recurrent, and at least 50% of those who experience a single episode and 80% of those who experience two episodes will have another in their lifetime. MDD is considered to be the psychiatric disorder with the greatest economic burden in the U.S., with costs totaling $210 billion annually, and antidepressant expenditure totaling roughly $15 billion annually.

About BrainsWay
BrainsWay is engaged in the research, development and marketing of a medical system for non-invasive treatment of common brain disorders. The medical system developed and manufactured by the company is based on a unique and breakthrough technology called Deep TMS, which can reach the depth of the brain and produce nerve stimulation or suppression. About 90% of US depression patients currently have coverage for BrainsWay treatment. The company's systems, which are sold worldwide, have received FDA clearance for Major Depressive Disorder (MDD), and CE clearance for MDD and other indications.

Forward-Looking Statement
This press release is for information purposes only. Company may make improvements and/or changes in the features or content presented herein at any time. Company shall not be liable for any loss, claim, liability or damage of any kind resulting from the investor's reliance on or reference to any detail, fact or opinion presented herein. The press release is not intended to provide a comprehensive description of Company’s activities, and Company urges investors to consider the information presented herein in conjunction with its public filings including its annual and other periodic reports. Nothing in this press release should be considered "investment advice", as defined in the Regulation of Investment Advice, Investment Marketing and Portfolio Management Law, 1995.

Certain statements made over the course of this press release may be forward-looking in nature, as defined in Section 32A of the Israel Securities Law, 5728-1968. Such forward-looking statements involve known and unknown risks, uncertainties, forecasts, assessments, estimates or other information, which relates to a future event or matter whose occurrence is not certain and which is not within the sole control of Company, and other factors which may cause the actual results, performance and achievements of Company to be materially different from any future results, performance and achievements implied by such forward-looking statements. The realization of these forward-looking statements will be affected by factors that cannot be assessed in advance and which are not within the control of Company. Company assumes no obligation to update the information in this press release and disclaims any obligation to publicly update or revise any such forward-looking statements to reflect any change in its expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

BrainsWay Ltd.
Hadar Levy
Chief Financial Officer

Bob Yedid
LifeSci Advisors

Linda Dyson, MPH
LifeSci Public Relations

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