Brainsway Ltd. (TASE:BRIN) has begun a second multicenter trial of its deep TMS (transcranial magnetic stimulation) device for the treatment of bipolar disorder (manic depression). Yesterday, the company announced that it had signed with 18 medical centers in Israel, Canada, and the US, and that some of them had already begun recruiting patients. The start of the trial is in line with the timetable the company set early this year, under which the trial would begin in the third quarter of 2012.
In April, Brainsway announced the successful completion of a multicenter trial of its Deep TMS device for the treatment of depression. The results have been submitted to the US Food and Drug Administration (FDA), which is due to respond within two months, and it may give marketing permission for the product for this indication in the US. The Deep TMS device is already approved for marketing in Europe and in other countries for the treatment of depression. Company sales have been sporadic.
The trial of the Deep TMS for depression lasted two and a half years, but it is possible the experience that Brainsway accumulated in the conduct of clinical trials and by the medical centers working with the device may shorten the current trial compared with the previous one. This is especially the case if the Deep TMS device is approved for marketing in the meantime, as it will remove some of the concerns of doctors and of patient about the treatment.
Brainsway's share price rose 1.2% by early afternoon today to NIS 22.67, giving a market cap of NIS 278 million. The share price has risen 30% since the beginning of the year, mainly because of the good results of the depression trial.
Published by Globes [online], Israel business news - www.globes-online.com - on August 20, 2012
© Copyright of Globes Publisher Itonut (1983) Ltd. 2012