JERUSALEM, December 15, 2014 Brainsway® Ltd. (TASE:BRIN) announced that it received an IDE (Investigational Device Exemptions) approval from the FDA for launching a Multi-Center trial which will examine the effectiveness of Brainsway's Deep TMS (Deep Transcranial Magnetic Stimulation) for treating PTSD (Post Traumatic Stress Disorder) patients. The approval was given for 166 patients and 15 medical centers.
The trial launch is contingent upon receiving an IRB (Institutional Review Board) approval in the centers where the trial is conducted and in the patient recruitment process.
Over the next few months, Brainsway will hold a conference in the United States, participated by leading brain stimulation researchers, which will mark the launch of the new trial.
"We are excited to receive the IDE approval for the new PTSD trial" said Uzi Sofer, Brainsway's CEO. "The approval is for Brainsway's patented H-Coil, which was specially developed for treating PTSD, and is a key milestone in our strategy of building Deep TMS technology as a multi-application platform which treats diverse brain disorders. We intend to launch the trial in the near future, as it involves a severe illness, and is of major importance both for Brainsway and for PTSD patients.
"This is our fifth FDA approval for a pivotal multi-center trial, following which we will be holding four multi-center trials simultaneously – an immense challenge and a tribute to Brainsway's technology," remarked Sofer. "We intend to leverage our relationship with the American VA (Veteran's Affairs) for including its members in the new trial."
Brainsway Ltd. is dedicated to the development and marketing of Deep TMS (Deep Transcranial Magnetic Stimulation) systems, for treatment of brain disorders. The unique technology of Brainsway is based on patents filed by the National Institute of Health (NIH), and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Brainsway's technology was cleared by the FDA for treatment of depression patients who did not respond to any number of medication treatments in the current depressive episode. Brainsway's Deep TMS was enthusiastically received by the international academic community, with 60 clinical trials held in major institutions worldwide.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional
information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.