Announcement • Jun 10
BrainsWay Presents First SWIFT Accelerated Deep TMS 12-Month Durability Data at Clinical TMS Society Annual Meeting BrainsWay presented new prospective 12-month durability data demonstrating sustained clinical benefits following accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) for Major Depressive Disorder (MDD). The findings were recently presented in a poster by Colleen Hanlon, PhD, Vice President of Medical Affairs for BrainsWay, at the 14 Annual Clinical TMS Society (CTMSS) Meeting which was held on June 4-6, 2026. The data represented outcomes from the first multisite, randomized, controlled trial evaluating the long-term outcomes of BrainsWay's SWIFT protocol, an FDA-cleared Deep TMS protocol which reduces the number of clinic visits in the acute phase by 70% in comparison to the traditional standard protocol. Over 80% of patients treated with the SWIFT protocol were in remission through the 12-month follow-up period, based on clinician-rated assessments. Among those that received the SWIFT protocol, the percent of patients with severe functional impairment decreased dramatically from 85% at baseline to 0% at 12 months, supporting the real-world impact of Deep TMS on work performance, social engagement, relationships, and overall well-being. Less than 25% of patients had a change in their prescribed medication or another course of TMS within the 12-month period to treat their depression. The durable remission, response, and quality of life changes with the SWIFT protocol were also present in the group that received standard once a day Deep TMS, highlighting the overall durability of the Deep TMS technology for treating depression. The new prospective study followed patients that had enrolled in BrainsWay's original FDA pivotal non-inferiority trial which had compared the SWIFT accelerated protocol (5 sessions per day for 6 half days, followed by 4 weekly follow up visits) with BrainsWay's standard Deep TMS protocol (1 daily session, 5 days per week over 4 weeks, followed by 2 daily sessions per week for 2 weeks). Of the 89 patients that had completed the original pivotal trial (Phase 1), 73% (65 patients) consented to participate in this new one-year durability trial (Phase 2). These participants were evaluated at 3, 6, 9, and 12 months using clinician-rated and patient-reported outcome measures. The durability study outcomes build upon the previously reported pivotal trial results that supported FDA clearance of the BrainsWay SWIFT protocol for the treatment of Major Depressive Disorder in September 2025. Together, the data demonstrates both rapid antidepressant effects and sustained long-term outcomes, without the need for neuronavigation equipment. Announcement • May 15
Brainsway Ltd. Reiterates Earnings Guidance for the Year 2026 BrainsWay Ltd. reiterated earnings guidance for the year 2026. For the year, the company expects full-year 2026 revenue of $66 million to $68 million, which represents growth of 27% to 30% compared with revenue for 2025. The Company anticipates continued profitability and positive cash flow, targeting operating income of 13%-14% of revenue. Announcement • Apr 29
BrainsWay Ltd. to Report Q1, 2026 Results on May 13, 2026 BrainsWay Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026