BrainsWay announced the initiation of a prospective, randomized, controlled, multicenter clinical trial evaluating an accelerated treatment protocol for the Company’s proprietary Deep Transcranial Magnetic Stimulation, Deep TMS, system to treat major depressive disorder. The clinical trial is anticipated to enroll over 100 patients with major depressive disorder who will be split into two groups – one receiving a novel accelerated treatment protocol featuring an acute phase over several treatment days, and the other receiving the FDA-cleared standard-of-care protocol which entails an acute phase over several weeks. The design of this non-inferiority trial, which was determined in discussion with the U.S. Food and Drug Administration, aims to compare the outcomes achieved with the accelerated Deep TMS protocol versus the current standard-of-care Deep TMS protocol.
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