Clinical Trial: Depression Maintenance Treatment
Shalvata Hospital, Hod Hasharon, Israel
5 June, 2008
Clinical Trial: Ministry of Health Approval for Maintenance Treatment of Major Depression
Brainsway Ltd. (the "Company") is pleased to announce that further to the approval of the Helsinki Committee of the Shalvata Hospital, the Company has received the Ministry of Health's approval for a maintenance treatment trial of the Company's deep TMS device in 20 medication-resistant major depression patients who previously participated in a trial for the treatment of major depression at the Shalvata Hospital whose results were reported in the Company's immediate report dated 14 February 2008 (the "Primary Trial").
The maintenance treatment trial is being held following requests by some of the patients who were treated successfully in the Primary Trial. Most of the patients who responded significantly to treatment in the Primary Trial maintained remission of depression for a period of at least three months following the Primary Trial (at which time a post-treatment follow-up visit was held, as per the clinical trial protocol). The maintenance treatment trial (for which approval was received) is due to begin immediately, and is expected to be carried out over the course of 16 weeks for each patient, during which the patients will receive both drug treatment and treatment with the Company's Deep TMS device.