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Investing.com -- BrainsWay Ltd. (NASDAQ:BWAY) stock jumped 6.3% Tuesday after the U.S. Food and Drug Administration (FDA) granted clearance for an accelerated treatment protocol using the company’s Deep Transcranial Magnetic Stimulation (Deep TMS) system for major depressive disorder (MDD).
The expanded clearance allows for a significantly shortened treatment timeline, reducing the acute phase from four weeks of daily sessions to just six treatment days. The new protocol includes five sessions per day for six days over a two-week period, followed by twice-weekly sessions for four weeks, with each session lasting under 10 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’s decision was based on a multicenter clinical study showing comparable outcomes between the accelerated and standard protocols, with the accelerated approach requiring substantially fewer clinic visits. The study reported similar reductions in depression scores, with response and remission rates of 87.8% and 78.0% for the accelerated group compared to 87.5% and 87.5% for the standard group.
Notably, the median time to remission was 21 days for patients using the accelerated protocol versus 28 days for the standard approach. No severe adverse events were reported during the study.
BrainsWay plans to train healthcare providers on the new protocol in the coming months while pursuing updated reimbursement policies to match the accelerated treatment schedule. Current reimbursement allows for up to two treatments per day.
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