BrainsWay Ltd. (NASDAQ:BWAY) saw its stock rise 6.3% on Tuesday after the U.S. Food and Drug Administration (FDA) approved an accelerated treatment protocol for the company’s Deep Transcranial Magnetic Stimulation (Deep TMS) system for major depressive disorder (MDD).
The new clearance allows the acute treatment phase to be completed in just six days rather than four weeks, with five daily sessions over six days across two weeks, followed by twice-weekly sessions for four weeks. Each session lasts under ten minutes.
“More than just another clearance, this marks a pivotal advancement in the treatment of depression with Deep TMS because it expands the ways in which we can use Deep TMS to treat depression,” said Hadar Levy, BrainsWay’s Chief Executive Officer.
The FDA based its decision on a multicenter trial showing that the accelerated protocol delivers outcomes similar to the standard regimen while requiring far fewer clinic visits. The study reported response and remission rates of 87.8% and 78.0% for the accelerated group versus 87.5% and 87.5% for the standard approach. Median time to remission was 21 days for the accelerated protocol compared with 28 days for the traditional schedule, and no severe adverse events occurred.
BrainsWay plans to educate healthcare providers on the updated protocol in the coming months and aims to secure revised reimbursement policies that reflect the new accelerated schedule. Current reimbursement allows up to two treatments per day.
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