This is the company's last trial before applying to the FDA for a large trial at several medical centers.
Transcranial magnetic stimulation developer Brainsway Ltd. (TASE:BRIN) today reported "clear improvements" in additional interim results of the clinical trial at Hadassah Medical Organization on 15 patients suffering from depression. The trial is testing the effect of the company's non-invasive deep transcranial magnetic stimulation technique to treat depression. The company said that the improvements were seen in two measurements for assessing depression in the patients since the start of the trial.
Brainsway said that this was the final trial before filing an application for marketing approval with the US Food and Drug Administration (FDA). The licensing procedure for premarket approval (PMA) for medical devices is prolonged, and will include a large trial at several medical centers aimed at demonstrating the treatment's safety and effectiveness for treating depression that does not respond to drugs.
Brainsway did not disclose the timetable for these clinical trials, but assuming that they usually take a year, no FDA marketing approval can be expected before 2009.
Published by Globes [online], Israel business news - www.globes-online.com - on January 2, 2008
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