Brainsway CEO Uzi Sofer said that the results would now pave the way for an application for CE Mark certification from the EU. "We filed an application with the US Food and Drug Administration (FDA) for a multicenter trial of the product when the interim results were released a month ago. We expect a decision in the near future, and we have already contracted with a number of large medical centers, including Columbia, Harvard, and John Hopkins, to carry out trials together with them," he added.
Brainsway has developed a method for treating neurological and cognitive disorders by magnetic stimulation of the brain, with differing disorders treated by focusing on specific sites in the brain. The 64 patients tested in the latest trial had failed to respond to at least two antidepressant drugs. 95% of the participants responded to the Brainsway method and 45% showed a significant response. 40% of the patients in the trial were found to have regressed after treatment and a regression was seen in 50% of the patients after three months.
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