공시 • 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. 공시 • 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. 공시 • 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 공시 • Mar 11
BrainsWay Ltd. Provides Earnings Guidance for Full Year 2026 BrainsWay Ltd. provided earnings guidance for full year 2026. For the period, the company expects 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% to 14%. 공시 • Mar 05
BrainsWay Ltd Unveils Swift Deep TMS Accelerated Treatment For Depression BrainsWay Ltd. unveiled new clinical data showing a significantly faster, noninvasive way to treat depression without compromising the efficacy of one of psychiatry’s most impactful treatments. Two new peer-reviewed manuscripts in Brain Stimulation found that BrainsWay’s exclusive FDA-cleared SWIFT™ accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for the treatment of Major Depressive Disorder (MDD) achieved comparable remission and response rates when compared to the traditional standard protocol. The accelerated protocol reduces the traditional 20-visit acute treatment phase to just 6 half days, followed by weekly maintenance visits for 4 weeks. Widespread adoption of the SWIFT approach, which reduces the number of clinic visits in the acute phase by ~70%, could alter how interventional psychiatry is delivered, improving patient retention and expanding clinical options at a time when demand for non-drug depression therapies is rising. In a large, randomized, multisite non-inferiority trial, patients treated with BrainsWay’s accelerated protocol achieved: · 87.8% response rate · 78.0% remission rates · Median time to remission of 21 days, compared with 28 days under the standard daily protocol. Over 20 million U.S. adults live with MDD, at an estimated USD 333,000 million annual economic burden. Yet logistical barriers – time away from work, caregiving responsibilities, and travel – reduce the number of people who initiate access to this life-saving treatment. SWIFT™ lowers one of the most persistent barriers in interventional psychiatry: Time. The second published manuscript, focusing on the patients’ own ratings of perceived impact of the treatment on their lives, highlights the human impact of that efficiency. Key secondary outcomes in this study include: · ~70% of the participants no longer suffered from severe quality of life impairment · Approximately 60% returned to normal-range functioning after treatment. Patients also reported earlier symptom improvement across a range of measures, consistent with clinician-rated outcomes, suggesting not only statistical success, but lived recovery. As clinical innovation improves access, payers are also reducing administrative barriers, including the previously announced move by Evernorth Behavioral Health to eliminate prior authorization requirements for Deep TMS. Study Design and Results The trial incorporated input from both patients and providers in both urban and rural areas, reflecting a patient-centric approach uncommon in studies of this type. Each manuscript highlights different but complementary findings from the same clinical trial. Manuscript 1: Accelerated TMS with the H1-coil for Depression: A Multisite, Randomized Non-Inferiority Trial In the randomized non-inferiority comparison, the accelerated SWIFT protocol achieved an 87.8% response rate and a 78.0% remission rate on the clinician-rated Hamilton Depression Rating Scale (HDRS-21), establishing efficacy comparable to the standard once-daily protocol while requiring substantially fewer treatment days. The standard protocol consists of an acute phase of 5 daily sessions over 4 weeks, followed by 2 daily sessions per week for 2 weeks. Median time to remission was 21 days for SWIFT versus 28 days for the standard protocol. Outcomes were consistent across diverse patient subgroups, including individuals with moderate-to-severe depression and comorbid anxiety symptoms. Manuscript 2: Patient-Reported Outcomes Following Accelerated vs. Standard Deep TMS with the H1 coil for Major Depression: A Multisite Randomized Trial Clinician-rated measures remain the gold standard in depression trials; however, patient-reported outcomes provide critical insight into real-world experiences. Daily patient assessments confirmed substantial improvements in quality of life, functioning, and symptom burden among patients receiving accelerated treatment. By 6 weeks, quality-of-life scores improved by approximately 32 percentage points from those measured at baseline. The proportion of patients reporting severe functional impairment declined from 85–100% at baseline to 15–17% at the end of treatment, and approximately 60% reached normal-range functioning by the end of treatment. Patients receiving SWIFT also reported earlier perceived symptom improvement across a range of symptoms, consistent with clinician-rated findings. 공시 • Feb 25
BrainsWay Ltd. to Report Q4, 2025 Results on Mar 11, 2026 BrainsWay Ltd. announced that they will report Q4, 2025 results Pre-Market on Mar 11, 2026 
