Girardi P1, Rapinesi C, Chiarotti F, Kotzalidis GD, Piacentino D, Serata D, Del Casale A, Scatena P, Mascioli F, Raccah RN, Brugnoli R, Digiacomantonio V,Ferri VR, Ferracuti S, Zangen A, Angeletti G. ...Read More
This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
Shalvata Mental Health Center, Hod Hasharon, Israel
28 June, 2010
Further to Brainsway’s periodic report for 2009 regarding the maintenance treatment clinical trial performed by the Company on patients who responded to the previous clinical trial of the Deep TMS device for acute treatment of drug-resistant major depression, the Company is pleased to announce that final results in respect of 30 patients have been obtained.
These results indicate that the statistically significant improvement displayed by approximately half of the patients in the acute treatment trial persisted in these same patients following maintenance treatment administered using the Deep TMS device for 6 months, with treatments administered initially twice weekly and subsequently once weekly.
There were no adverse side effects to the maintenance treatment, and the treatment was well tolerated by all the patients.
Brainsway would note that the trial was conducted with no control group, and that a multi-center clinical trial is currently underway in the US, Canada, Europe and Israel, which follows a similar design to the abovementioned trial, but includes a control group.