JERUSALEM, Israel, Dec. 9, 2011 (GLOBE NEWSWIRE) -- Brainsway Ltd. (TASE:BRIN) is pleased to announce that patient recruitment in its multicenter clinical trial for major depression was completed in November 2011. 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 ("FDA") to obtain approval to market the Company's 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.
About Brainsway Inc.
Brainsway Ltd. is dedicated to the development and marketing of Deep TMS (Transcranial Magnetic Stimulation) systems - novel, noninvasive medical devices for treatment of a wide range of neurological and psychopathological disorders. In principle, any brain-related disorder that is associated with pathological activity of specific brain sites may be treated by this method. Potential applications include addiction, schizophrenia, obesity, eating disorders, Parkinson's disease, Alzheimer's disease, autism and post-traumatic stress disorder.
Our initial focus is the treatment of major depression. The unique technology of Brainsway is based on patents filed by the U.S. National Institute of Health (NIH) and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Headquartered in Jerusalem, Israel, the company's ordinary shares and warrants trade on the Tel Aviv Stock Exchange under the symbol 'BRIN.'
Forward-Looking Statements
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.