Brainsway Ltd. (TASE:BRIN) today announced good results of its multicenter trial of its Deep TMS (transcranial magnetic stimulation) device for the treatment of severe depression. The treatment was found to be effective and safe, with no side effects.
The trial included 233 patients at four medical centers in Israel, fourteen in the US, one in Canada, and two in Germany. The patients in the trial had previously failed to respond to therapeutic treatments, or suffered from side effects of those treatments.
After five weeks of treatment, there was a statistically significant difference between the patients treated with Deep TMS and the control group, based on the Hamilton Depression Rating Scale: 30.4% of the patients treated with Deep TMS achieved remission, compared with 14.5% of the control group.
The final results of the trial will be received when the database is closed and full statistical analysis of the results is completed.
Brainsway CEO Uzi Sofer said, "We will make a presentation about the results to investors in a few days. We will submit an application to the US Food and Drug Administration (FDA) for this indication by the end the second quarter of 2012."
Since 2008, the FDA has approved use of Deep TMS up to a depth of 1.5-2 centimeters into the brain tissue, although the device can penetrate up to 6-7 centimeters to the parts of the brain that are the source of depression and addiction.
Brainsway has CE Mark for use of Deep TMS for the treatment of depression, manic-depression, and post traumatic stress syndrome. The company expects to begin marketing the device in Latin America this year. A few months ago, it obtained Israel Ministry of Health approval for use of the device for the treatment of depression, manic-depression, and schizophrenia.
Brainsway's share price rose 38.2% by midday to NIS 27.80, giving a market cap of NIS 320 million.
Published by Globes [online], Israel business news - www.globes-online.com - on April 17, 2012
© Copyright of Globes Publisher Itonut (1983) Ltd. 2012