Brainsway obtains FDA go-ahead for bipolar disorder trial

Brainsway Ltd. (TASE:BRIN) has obtained US Food and Drug Administration (FDA) approval to begin a clinical trial of its non-invasive Deep TMS (transcranial magnetic stimulation) device for the treatment of bipolar disorder. The multicenter trial will include 120 patients at nine medical centers.

Although the FDA did not state the licensing procedure for the device for this indication, on the basis of the approval of the licensing procedure for the device for the treatment of depression, Brainsway believes that it will receive fast-track approval for the device.

Brainsway CEO Uzi Sofer said, "It was faster and easier to obtain FDA approval for the trial this time. Brainsway had a major advantage that many of the same centers where the first multicenter trial took place are participating in the current trial. The basic systems are in place, except for the addition of helmets for the indication and trial adjustments for this protocol. Installation time will be faster and cheaper.

Sofer added, "We hope that in the coming months we'll successfully meet the other milestones we set through the end of the year."

Brainsway's share price rose 3.7% by early afternoon to NIS 20.67, giving a market cap of NIS 242 million.

Published by Globes [online], Israel business news - www.globes-online.com - on November 1, 2011