Brainsway's Deep Transcranial Magnetic Stimulation (Deep TMS) system has showed positive data in the double-blind multicentre clinical trial.
The clinical trial enrolled 233 patients with major depression at 14 medical centres in US, four in Israel, two in Germany and one in Canada, as per the US Food and Drug Administration (FDA) approved clinical trial protocol.
The study showed that 30.4% of patients in the REAL treatment group achieved remission from depression compared to 14.5% in the SHAM control group, and 36.7% of patients in the treatment group showed significant response to treatment compared to 20.5% in the control group.
Shalvata Mental Health Hospital, Israel, Day Care Unit and the Emotion and Cognition Research Center director Hilik Levkovitz said the multicentre clinical trial demonstrated that the Deep TMS device is safe and effective for the treatment of major depression.
Brainsway scientific consultant and University of Ben-Gurion professor Abraham Zangen said the rates of response and remission are high considering the target population of patients who failed to respond to previous treatment with medications.
The company plans to submit the application to the FDA for obtaining approval to market its Deep TMS system before the end of Q2, 2012.