BrainsWay Receives ARTG Approval for Marketing its Deep TMS Treatment for Depression in Australia

BrainsWay to Expand its Activities in Australia, Previously Focused on Research

JERUSALEM, June 29, 2015. BrainsWay® Ltd(TASE: BRIN) received the Australian Register of Therapeutic Goods (ARTG) approval for marketing and distribution of BrainsWay Deep TMS (Transcranial Magnetic Stimulation) in Australia, for treating major depressive disorder patients who did not respond to previous medication treatment in the current depressive episode.

Receiving the regulatory mark enables the company to provide BrainsWay Deep TMS to medical and research entities in Australia who have already expressed interest in its Deep TMS technology, and to expand the company’s existing activities in this country, which previously focused on research. In recent years, BrainsWay held a double-blind placebo-controlled study examining Deep TMS treatment for autism at the Alfred Hospital and Monash University in Melbourne, with successful results.

The ARTG mark joins BrainsWay’s additional health administration clearances, including an FDA clearance for depression, CE marks for a variety of brain disorder treatments, from bipolar disorder and Parkinson’s disease to autism and stroke rehabilitation, and ANVISA approvals for several brain disorders.

“Receiving the Australian ARTG mark is a significant milestone in realizing our vision of being the world leader in brain disorder treatment,” said Guy Ezekiel, President  & CEO. “We are excited to deepen our activities in Australia, and to be able to help thousands of new patients, and bring them new hope with BrainsWay Deep TMS.”

About BrainsWay

BrainsWay Ltd. is dedicated to the development and marketing of Deep TMS (Deep Transcranial Magnetic Stimulation) systems, for treatment of brain disorders. The unique technology of BrainsWay is based on patents filed by the National Institute of Health (NIH), and by the company. BrainsWay has an exclusive license from the NIH for the patent and technology. BrainsWay’s technology was cleared by the FDA for treatment of depression patients who did not respond to any number of medication treatments in the current depressive episode. BrainsWay’s Deep TMS was enthusiastically received by the international academic community, with 60 clinical trials held in major institutions worldwide.

Forward-Looking Statements

This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company’s ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.