JERUSALEM, July 18, 2013 Brainsway® Ltd. (TASE:BRIN) announced that it received a CE Marketing Approval allowing the marketing and distribution of its Deep TMS (Transcranial Magnetic Stimulation) device for the treatment of Autism, Alzheimer's Disease and smoking cessation.
For more information on the CE Marketing certification, please see article 1.17.2 in the company's periodic report for 2012, reference no. 2013-01-004663, published on March 13th 2013.
This CE approval follows the recent FDA (U.S. Food and Drug Administration) indication in January 2013, which cleared Brainsway's Deep TMS for the treatment of Major Depressive Disorder in patients who failed to respond to antidepressant medications in their current episode of depression.
"The CE Marketing Approval is yet another key landmark for Brainsway's technology," said Uzi Sofer, Brainsway's CEO. "Our ever-widening circle of indications re-affirms the efficacy and safety of our Deep TMS technology for treatment of an immense variety of brain disorders and addictions. We are awed by the prospect of using our technology to make a true difference in the lives of millions of people worldwide."
Brainsway Ltd. is dedicated to developing and providing advanced technology solutions for treatment of a variety of brain disorders. The unique technology is based on patents registered by the National Institute of Health (NIH) and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. The company's technology has already been applied in thousands of cases worldwide in the framework of clinical studies. It has also been enthusiastically embraced by leading research institutions worldwide, with over 60 clinical trials performed. Brainsway technology is also optimized for research, including an integrated Double-Blind Placebo-Controlled system to aid clinical studies.