Brainsway has announced that patient recruitment in its multi-center clinical trial for major depression was completed in November. The projected number of patients for the trial is 225. The company noted that the actual number of patients may exceed this figure slightly.
The multicenter clinical trial for major depression is being conducted in 22 medical centers in the United States, Canada, Europe and Israel. If successful, the trial results are expected to support Brainsway's application with the U.S. Food and Drug Administration to obtain approval to market its Deep TMS device for the treatment of major depression in the United States.
The company estimates the trial will be completed in April 2012. The trial results, which will be submitted to the FDA, are expected to be available during the second quarter of 2012.