Brainsway Ltd.

Brainsway Ltd.

September 01, 2011 15:21 ET

Brainsway Reports Positive Preliminary Results of Study Using Deep TMS to Open the Blood-Brain Barrier in Patients With Brain Tumors

JERUSALEM, ISRAEL--(Marketwire - Sept. 1, 2011) - Brainsway Ltd. (TASE:BRIN) is pleased to announce that it has received the preliminary results of a clinical trial performed by Advanced Technologies Innovation Distribution SRL ("Atid") in Italy to explore the efficacy of Deep TMS in the opening of the blood-brain barrier ("BBB") in patients with brain tumors. The study was conducted in the framework of a collaboration between Ben-Gurion University (Principal Investigator – Dr. Alon Friedman) and the University of Rome (Principal Investigator – Dr. Maurizio Inghilleri).

The preliminary results are for nine patients with malignant brain tumors (glioblastoma multiforme) who had undergone surgery more than a year before the trial. These results indicate that high-intensity Deep TMS treatment protocols induced transient opening of the BBB in seven out of nine patients (78%). This clinical trial confirms and extends the findings of a previous animal study conducted at Ben-Gurion University.

BBB opening was observed in patients shortly after the stimulation protocol (which included magnetic field intensities higher than those used in other Deep TMS clinical trials), and was quantified using magnetic resonance imaging (MRI) and special protocols for BBB permeability measurement developed at the Zlotowski Center for Neuroscience at Ben Gurion University.

The changes in BBB permeability were measured in each patient following both active Deep TMS treatment and sham stimulation. Active Deep TMS treatment (in comparison to sham stimulation) induced significant opening of the BBB in most patients, and produced no side effects.

It should be noted that the opening of the BBB is transient. It is believed that timing this transient opening to coincide with drug delivery could focus and enhance drug delivery, thereby increasing the effectiveness of existing drugs. The researchers hope that this new method will prove effective in enhancing delivery of chemotherapy drugs to brain tumors, and perhaps even in the treatment of other central nervous system diseases. Furthermore, the prospect of timed opening of the BBB opens possibilities for the development of new and/or hitherto impractical drugs.

Dr. Friedman, commented, "These preliminary results suggest that this non-invasive method for opening the BBB is safe and effective, but of course, this conclusion will have to be borne out by the final results of this trial and the results of follow up studies."

Depending on the final results of the present trial, the Company may examine the possibility of performing a multicenter clinical trial in patients with other kinds of brain tumors to examine the safety and efficacy of this novel method. At the same time, researchers at Ben Gurion University are continuing to perform animal studies to elucidate the mechanisms whereby electromagnetic stimulation induces changes in BBB permeability.

About Brainsway Ltd.

Brainsway Ltd. is dedicated to the development and marketing of Deep TMS (Transcranial Magnetic Stimluation) 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.

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