JERUSALEM, Nov. 1, 2011 (GLOBE NEWSWIRE) -- Further to that stated in Brainsway's (TASE:BRIN) periodic report for 2010, the Company is pleased to announce that it has received an Investigational Device Exemption ("IDE") approval from the U.S. Food and Drug Administration ("FDA"), allowing it to begin a multicenter clinical trial to evaluate the efficacy of its Deep TMS device in the treatment of subjects with bipolar disorder. The IDE was granted in respect of nine medical centers and 120 patients.
The commencement of the trial is subject to receipt of Investigational Review Board approvals (the equivalent of Helsinki Committee approvals) from the participating sites, and to the recruitment of subjects.
The IDE granted to the Company did not specify the regulatory pathway that would be required for approval of its Deep TMS therapy for bipolar disorder. However, based on the regulatory pathway of FDA approval for the Company's depression therapy, as well as other considerations, the Company estimates that the therapy will be approved via the 510(k) PreMarket Notification process. As mentioned in the aforementioned periodic report, this process is the simpler and faster regulatory pathway for medical device clearance.
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.