ANVISA Approval to Serve as Brainsway's Gateway to South America
JERUSALEM, July 8, 2014 - Brainsway® Ltd (TASE: BRIN) received an approval from the Brazilian Health Surveillance Agency (ANVISA) regarding the marketing and distribution of Brainsway dTMS for treating six brain disorders, including depression, bipolar disorder (manic depression), schizophrenia, Post Traumatic Stress Disorder (PTSD), Parkinson's disease and chronic pain.
Brainsway will market the system through UCB-Maizler. The company believes the approval will be highly significant, with a positive impact on its penetration of additional markets in South America.
Brainsway dTMS is designed to treat brain disorders in a safe, effective way. The device is based on a unique, patented electromagnetic coil which briefly stimulates brain regions relevant to each disorder and corrects abnormalities, bringing improvement to brain disorder patients.
"This is an important day for Brainsway," said Uzi Sofer, Brainsway's CEO. "The wide approval we received for six indications heightens the importance of the approval. We are already preparing to launch the product in the Brazilian market with our outstanding partner, UCB-Maizler, and acting upon our plans for the region."
Brainsway Ltd. is dedicated to the development and marketing of dTMS (deep Transcranial Magnetic Stimulation) systems, for treatment of brain disorders. The unique technology of Brainsway is based on patents filed by the National Institute of Health (NIH), and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Brainsway's technology was cleared by the FDA for treatment of depression patients who did not respond to any number of medication treatments in the current depressive episode. Brainsway's dTMS was enthusiastically received by the international academic community, with 60 clinical trials held in major institutions worldwide.
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.