Brainsway® Ltd. (TASE:BRIN) is pleased to announce positive results from its double-blind multicenter clinical trial for the assessment of the safety and efficacy of Deep Transcranial Magnetic Stimulation ("Deep TMS") with the Company's device (the "H-Coil") in the treatment of major depression.
Based on a U.S. Food and Drug Administration ("FDA") approved clinical trial protocol, the study involved 233 patients at 14 medical centers in the United States, four in Israel, two in Germany and one in Canada. All trial subjects suffered from major depression and had previously failed to respond to therapeutic treatments or could not tolerate antidepressant medication due to side effects.
The effects of five weeks of treatment were assessed using the Hamilton Depression Rating Scale ("HDRS-21"), a widely accepted scale for rating the severity of depression. At the end of five weeks of treatment, considerably lower levels of depression were recorded, with a clinically and statistically significant difference between the REAL treatment group and the SHAM control group:
- 30.4% of patients in the treatment group achieved remission from depression (defined as an HDRS-21 score of less than 10) compared to 14.5% in the control group (p=0.0148).
- Significant response to treatment (defined as a greater than 50% decrease from baseline HDRS-21 scores) was experienced by 36.7% of patients in the treatment group, compared to 20.5% in the control group (p=0.0148).
- A statistically significant difference of 3 points on the HDRS-21 was found between the treatment group and the control group (p=0.0126).
The trial data support historical clinical and commercial experience with respect to the safety of the Deep TMS procedure, with observed side effects that are typical for depression therapy clinical trials. According to FDA-approved clinical trial protocol, epileptic-seizure rates of up to 5% of all patients and suicide-attempt rates of up to 3% are considered acceptable. In the present study, only one case of epileptic seizure was reported (0.43%), and there were no suicide attempts. The Data and Safety Monitoring Board has, therefore, determined that the trial has met all of the safety requirements set out in the clinical trial protocol.
A preliminary analysis of the results from 16 weeks of treatment indicates a significant difference in the response to treatment between the treatment and control groups. The full results will be available once the database is complete and the statistical analysis has been performed.
Brainsway expects these positive results to support its application with the FDA to obtain approval to market its Deep TMS system for the treatment of major depression in the United States. The Company further anticipates that application will be submitted to the FDA before the end of Q2-2012.
Uzi Sofer, CEO of Brainsway, commented, "This is a very exciting day for Brainsway. We are gratified to see all our hard work rewarded by such excellent results. We thank God and all the people involved in creating our product, down to the last employee. We will be presenting our results in detail to investors and other stakeholders over the coming days."
Prof. Hilik Levkovitz, Director of the Day Care Unit and the Emotion and Cognition Research Center at the Shalvata Mental Health Hospital, said, "This multicenter clinical trial, which was carried out in some of the finest psychiatric treatment centers, shows us that the Deep TMS device is safe and effective for the treatment of major depression. The proof of the safety and efficacy of the device is nothing less than a breakthrough, a beacon of hope for psychiatric patients, and a real source of pride of Israel."
Prof. Abraham (Boomy) Zangen of the University of Ben-Gurion, one of the inventors of the deep TMS technology and Brainsway's Scientific Consultant, commented, "These results are very favorable. The rates of response and remission are very high considering the target population of patients who failed to respond to previous treatment with medications. There is no doubt that the device we've developed can help a lot of patients."