FDA approves Brainsway's depression treatment device

The approval is also an important breakthrough for the company, and opens an important US market.

Brainsway Ltd. (TASE:BRIN) today announced that it has obtained US Food and Drug Administration (FDA) clearance for use of its Deep TMS (transcranial magnetic stimulation) device for the treatment of depression in patients who fail to respond to therapeutics during a depression episode. The company adds that the FDA approval for this indication is generally broader than the definition given by the company's TMS device rival.

Brainsway said that the FDA certification of the Deep TMS device for use in the US for such a broad indication is further demonstration of the device's efficacy and safety in treating depression, and could be an important milestone in changing the treatment for depression. The approval is also an important breakthrough for the company, and opens an important US market, which the company estimates at tens of billions of dollars a year.

Brainsway said that it was considering how to market and distribute the Deep TMS device in the US and other countries, including collaborations with experienced companies in the business.

Brainsway's share price rose 35% by midday, after trading in the share was resumed, to NIS 44.79, giving a market cap of over NIS 500 million.

Published by Globes [online], Israel business news - www.globes-online.com - on January 9, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

View comments in rows
Update by email about comments talkback
Your name
Please insert your name
Hyperlink in a new window Hyperlink Right Left underline italic bold Bulleted List Ordered List Face1 Face2 Face3 Face4 Face5 Face6
Your comment

You comment was recieved and soon will be published.
In posting comments, I agree to abide by the Terms of Use
Globes encourages lively and frank debate, but posts that the editors consider merely abusive or otherwise inappropriate will be removed. Report inappropriate content
Thank you for posting your comment, which will be reviewed for publication.
Loading Comments...load
Load more comments
Twitter Facebook Linkedin RSS Newsletters גלובס Capital  Markets Conference 2017