Core Insights - BrainsWay Ltd. reported a 27% year-over-year revenue growth in Q4 2025, reaching a record $14.5 million, with a significant increase in operating income and adjusted EBITDA [1][5][8] - The company anticipates continued growth in 2026, projecting revenue between $66 million and $68 million, representing a growth rate of 27% to 30% [1][12] Financial Performance Highlights - Q4 2025 operating income was $1.9 million, compared to $0.4 million in Q4 2024, while adjusted EBITDA increased by 53% to $2.3 million [1][5] - Full year 2025 revenue was $52.2 million, a 27% increase from 2024, with net income rising by 161% to $7.6 million [1][5][8] - Remaining performance obligations increased by 43% to approximately $70 million, indicating strong future revenue potential [1][5] Operational Developments - The company shipped 95 Deep TMS™ systems in Q4 2025, a 27% increase from the previous year, bringing the total installed base to approximately 1,700 systems [5] - The FDA granted label expansion for the Deep TMS™ system, allowing its use as an adjunct therapy for adolescents aged 15 to 21 with major depressive disorder [5][8] - BrainsWay launched a multicenter clinical trial for the new Deep TMS 360™ system targeting individuals with Alcohol Use Disorder, addressing a significant health issue affecting around 29 million Americans [5][8] Strategic Outlook - The CEO highlighted strong demand for Deep TMS, supported by expanding customer adoption and regulatory clearances, as key growth catalysts for 2026 [8] - The company is focusing on a targeted investment strategy to support clinical expansion and increase awareness of innovative therapies within mental health networks [8]

Core Viewpoint - BrainsWay Ltd. has launched a multicenter clinical trial to evaluate its next-generation Deep TMS 360™ technology for treating Alcohol Use Disorder (AUD), which affects approximately 29 million Americans and has a high relapse rate among patients [1][3]. Group 1: Clinical Trial Details - The trial will be randomized, double-blind, and sham-controlled, enrolling over 200 patients aged 18–86 with moderate to severe AUD based on DSM-5 criteria [3]. - Participants will receive either active or sham treatments for about six months, with an intensive treatment phase in the first 3–5 weeks, followed by weekly maintenance sessions [3]. - The primary endpoint is the proportion of participants with no heavy drinking days during the initial four-month treatment period, a measure recognized by the FDA as clinically meaningful [3]. Group 2: Technology Overview - The new Deep TMS 360 technology is designed for more comprehensive and uniform stimulation of targeted brain regions, potentially addressing challenges in treating complex clinical populations like those with chronic AUD [2]. - The multichannel architecture of the system may enhance stimulation levels, particularly in patients with cortical atrophy [2][4]. Group 3: Company Perspective - The CEO of BrainsWay emphasized the significance of this trial in addressing a major public health challenge and the potential of the new technology to aid patients in overcoming alcohol dependence [3]. - The Vice President of Medical Affairs highlighted the study's potential to advance understanding of noninvasive neuromodulation in reducing alcohol cravings and promoting long-term recovery [4]. Group 4: Research Locations - The study will be conducted at multiple research sites across the US, including states like Alabama, California, Florida, Illinois, New York, and West Virginia, as well as select international sites in Israel and Sweden [4].