Shortened Acute Treatment Period Could Enhance Appeal and Market Opportunities of Deep TMS™BURLINGTON, Mass. and JERUSALEM, June 10, 2024 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today 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 (MDD).The clinical trial is anticipated to enroll over 100 patients with major depressive disorder (MDD) 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.

缩短急性治疗期可以提高马萨诸塞州伯灵顿市和耶路撒冷市Deep TMS™的吸引力和市场机会，2024年6月10日（环球通讯社）-BrainsWay有限公司（纳斯达克和塔斯社：BWAY）（“BrainsWay”或“公司”），一家全球领先的先进无创神经刺激治疗精神健康障碍的公司，今天宣布启动一项前瞻性，随机，对照，多中心临床试验，评估该公司专有的深度经颅磁刺激（Deep TMS™）系统的加速治疗方案，以治疗重度抑郁症（MDD）。该临床试验预计将招募100多名重度抑郁症（MDD）患者，他们将分为两组：一组接受新型加速治疗方案，在几个治疗日内出现急性期，另一组接受FDA批准的标准护理方案，该方案需要数周的急性期。

The design of this non-inferiority trial, which was determined in discussion with the U.S. Food and Drug Administration (FDA), aims to compare the outcomes achieved with the accelerated Deep TMS protocol versus the current standard-of-care Deep TMS protocol.“We are excited to begin this important clinical trial,” said Colleen Hanlon, Ph.D., Vice President of Medical and Clinical Affairs of BrainsWay.

这项非劣效性试验的设计是在与美国食品和药物管理局（FDA）的讨论中确定的，旨在比较加速深度TMS方案与当前护理标准深度TMS方案取得的结果。BrainsWay医学和临床事务副总裁科琳·汉隆博士说：“我们很高兴开始这项重要的临床试验。”。

“Previously published post-marketing data has shown outcomes achieved with accelerated protocols to be comparable with those from longer, traditional protocols. We seek to explore this hypothesis more conclusively during this multicenter study,” concluded Dr. Hanlon.In the study, the standard-of-care Deep TMS protocol will involve the traditional four week acute treatment phase, with one session per each day of treatment.

Hanlon博士总结道：“之前公布的上市后数据显示，加速方案取得的结果与更长时间的传统方案相当。我们试图在这项多中心研究中更确切地探索这一假设。”。在这项研究中，标准护理深度TMS方案将涉及传统的四周急性治疗阶段，每天治疗一次。

The accelerated .

加速。

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy.

BrainsWay是治疗精神健康障碍的先进无创神经刺激疗法的全球领导者。该公司凭借其专有的深度经颅磁刺激（Deep TMS™）平台技术，大胆推进神经科学，以改善健康和改变生活。BrainsWay是第一家也是唯一一家获得FDA批准的三种适应症的TMS公司，这些适应症得到了关键临床研究的支持，证明了临床证明的疗效。

Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence.

目前的适应症包括重度抑郁症（包括减轻焦虑症状，通常称为焦虑抑郁），强迫症和吸烟成瘾。该公司致力于通过卓越的科学领先，并以其无与伦比的临床证据为基础。

Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.Forward Looking Statements.

深度TMS在各种精神，神经和成瘾性疾病中的其他临床试验正在进行中。BrainsWay成立于2003年，在马萨诸塞州伯灵顿和以色列耶路撒冷设有办事处，致力于提高全球对深度TMS的认识和广泛访问。有关BrainsWay的最新新闻和信息，请访问www.BrainsWay.com.Forward Looking Statements。

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性声明”。这些陈述之前可能会有“打算”、“可能”、“将会”、“计划”、“期望”、“预期”、“项目”、“预测”、“估计”、“目标”、“相信”、“希望”、“潜在”或类似的词语。

These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise.

这些前瞻性声明及其影响仅基于公司管理层当前的期望，并受到许多因素和不确定性的影响，这些因素和不确定性可能导致实际结果与前瞻性声明中描述的结果存在重大差异。此外，科学研究和临床研究的历史结果或结论不能保证未来的结果会提出类似的结论，或者本文提到的历史结果会根据其他研究或其他方式进行类似的解释。

The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Com.

除其他因素外，以下因素可能导致实际结果与前瞻性报表中描述的结果存在重大差异：财务资源不足，无法满足未来的资本要求；技术和市场需求的变化；启动和/或成功完成计划研究和临床试验的延迟或障碍；未能在公司预期的时间范围内或根本没有获得监管机构的批准；无法留住或吸引对Deep TMS产品开发至关重要的关键员工；深度TMS产品和流程出现不可预见的困难，和/或无法开发必要的增强功能；与Deep TMS产品相关的意外成本；未能获得并维持对公司知识产权的充分保护，包括许可给Com的知识产权。

BrainsWay:

BrainsWay公司：

Ido Marom

伊多·马龙

Chief Financial Officer

首席财务官

Ido.Marom@BrainsWay.comInvestors:

Ido.Marom@BrainsWay.comInvestors[笑]

Brian Ritchie

布莱恩·里奇

LifeSci Advisors

LifeSci顾问

britchie@lifesciadvisors.comMedia Contact:

britchie@lifesciadvisors.comMedia联系

Ross Mitchell

罗斯·米切尔

Vice President of Global Marketing

全球营销副总裁

Ross.Mitchell@BrainsWay.com

Ross.Mitchell@BrainsWay.com