Brainsway receives IDE approval from FDA for launching pivotal PTSD multicentre trial


Brainsway has announced that it has received an IDE (Investigational Device Exemptions) approval from the FDA for launching a multicentre 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 centres.

The trial launch is contingent upon receiving an IRB (Institutional Review Board) approval in the centres 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,” says Uzi Sofer, Brainsway’s chief executive officer. “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 multicentre trial, following which we will be holding four multicentre trials simultaneously – an immense challenge and a tribute to Brainsway’s technology,” remarks Sofer. “We intend to leverage our relationship with the American VA (Veteran’s Affairs) for including its members in the new trial.”