JERUSALEM, Sept. 11, 2013 (GLOBE NEWSWIRE) -- Brainsway Ltd. (TASE:BRIN) is pleased to announce that the U.S. Food and Drug Administration ("FDA") has approved an IDE ("Investigational Device Exemption") that allows the Company to begin implementing a double-blind, multi-center study to assess the efficacy of the its Deep TMS device in inducing smoking cessation using a specialized coil developed for this purpose.
The IDE approval was granted on the basis of the FDA's determination that this is a non-significant risk ("NSR") study. Accordingly, Brainsway intends to act quickly in order to initiate the study. Approximately 10 medical centers in the United States, Europe and Israel are expected to participate in the study, which will involve approximately 220 patients. The trial subjects will be divided into two groups: a sham treatment group and a real stimulation treatment group. The primary outcome measure for therapeutic efficacy will be the change in patients' cigarette consumption levels, as measured both by self-report and by urinary cotinine (a metabolite of nicotine) levels at the end of the treatment period, and again six months after the end of treatment using only self-report.
Brainsway develops a medical device for the noninvasive treatment of common brain disorders. The device is based on a uniquely shaped electromagnetic coil connected to a rapidly changing current supply, which produces magnetic fields capable of affecting different areas of the brain. Deep brain areas can be either excited or inhibited, depending on the frequency of the magnetic field.
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.
FOR FURTHER INFORMATION, PLEASE CONTACT: Stephen Kilmer President Kilmer Lucas Inc. (212) 618-6347