Brainsway Receives IDE Approval to Begin Multicenter Clinical Trial for Bipolar Disorder
1 November, 2011
Further to that stated in Brainsway’s periodic report for 2010, the Company is pleased to announce that it has received an Investigational Device Exemption (IDE) approval from the FDA, allowing it to begin a multicenter clinical trial to evaluate the efficacy of the Deep TMS device in the treatment of subjects with bipolar disorder. The IDE was granted in respect of 9 medical centers and 120 patients.
The commencement of the trial is subject to receipt of Investigational Review Board (IRB) approvals (the equivalent of Helsinki Committee approvals) from the participating sites, and to recruitment of subjects.
The IDE granted to the Company did not specify the regulatory pathway that would be required for approval of the Company's Deep TMS therapy for bipolar disorder. However, based on the regulatory pathway of FDA approval for the Company's depression therapy, as well as other considerations, the Company estimates that the therapy will be approved via the 510(k) PreMarket Notification process. As mentioned in the periodic report, this process is the simpler and faster regulatory pathway for medical device clearance.