Acquisition to complement electrophysiology portfolio with solution to advance the treatment of complex atrial fibrillation

收购以补充电生理组合，并提供解决方案，以推进复杂心房颤动的治疗

MARLBOROUGH, Mass., Nov. 4, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Cortex, Inc., an Ajax Health company. Cortex is a privately held medical technology company focused on the development of a diagnostic mapping solution which may identify triggers and drivers outside of the pulmonary veins that are foundational to atrial fibrillation (AF), a heart rhythm disorder affecting nearly 38 million people globally.1 .

马萨诸塞州马尔堡，2024年11月4日/新闻专线/--波士顿科学公司（纽约证券交易所：BSX）今天宣布，它已经签署了一项最终协议，收购阿贾克斯健康公司Cortex，Inc。Cortex是一家私营医疗技术公司，专注于开发诊断绘图解决方案，该解决方案可以识别肺静脉外的触发因素和驱动因素，这些因素是心房颤动（AF）的基础，心房颤动是一种影响全球近3800万人的心律失常。

Cardiac ablation – the process of delivering energy to areas of the heart responsible for creating abnormal heart rhythms – is a common treatment for AF. During these procedures, physicians often use a mapping system to examine and analyze a heart's electrical patterns to guide therapeutic applications.

心脏消融是将能量传递到负责产生异常心律的心脏区域的过程，是房颤的常见治疗方法。在这些过程中，医生经常使用绘图系统检查和分析心脏的电模式，以指导治疗应用。

The OptiMap™ System developed by Cortex uses a basket catheter and proprietary algorithm to identify potential active AF sources, providing physicians with precise insights to efficiently deliver an individualized ablation strategy for their patients. .

Cortex开发的OptiMap™系统使用篮式导管和专有算法来识别潜在的活动房颤源，为医生提供精确的见解，以有效地为患者提供个性化的消融策略。

'We believe the addition of the Cortex technology complements our electrophysiology portfolio with a differentiated cardiac mapping offering to assist with complex AF cases,' said Nick Spadea-Anello, global president, Electrophysiology, Boston Scientific. 'The OptiMap System has demonstrated it can help physicians devise a targeted ablation strategy for complex cases, which can lead to improved procedural efficiency and outcomes in patients with challenging atrial arrhythmias.2 We look forward to advancing this technology and driving future clinical evidence generation with the goal of making it accessible to physicians and patients globally in the years ahead.' .

波士顿科学公司（Boston Scientific）全球电生理总裁尼克·斯帕迪亚·阿内洛（NickSpadeaAnello）说：“我们相信，皮质技术的加入补充了我们的电生理组合，提供了一种差异化的心脏标测服务，以帮助治疗复杂的房颤病例。”OptiMap系统已经证明，它可以帮助医生为复杂病例设计有针对性的消融策略，从而提高具有挑战性的房性心律失常患者的手术效率和预后。2我们期待着推进这项技术，推动未来的临床证据生成，目标是在未来几年让全球医生和患者都能使用它。”

Cortex received U.S. Food and Drug Administration 510(k) clearance for the OptiMap System in 2023 and recently completed the randomized, controlled FLOW-AF clinical trial with data demonstrating that OptiMap-guided treatment of AF sources in patients with persistent AF improved freedom from AF one year after an ablation by 51% compared with patients who received conventional pulmonary vein isolation therapy alone.

Cortex于2023年获得美国食品和药物管理局510（k）对OptiMap系统的许可，最近完成了随机对照FLOW-AF临床试验，数据表明OptiMap指导的持续性房颤患者房颤源治疗与单独接受常规肺静脉隔离治疗的患者相比，消融后一年房颤的自由度提高了51%。

Earlier this year, the company initiated a 300 patient, global clinical trial, RESOLVE-AF, evaluating the effectiveness of the OptiMap System in identifying extra-pulmonary vein sources.  .

今年早些时候，该公司启动了一项300名患者的全球临床试验RESOLVE-AF，评估OptiMap系统在识别肺外静脉源方面的有效性。

'Cortex was established to provide physicians with a more intelligent and precise solution for patients with AF,' said Duke Rohlen, chief executive officer, Cortex. 'Joining Boston Scientific will allow us to further develop this technology, which we believe has the ability to transform the treatment of AF for patients around the world.' .

Cortex首席执行官杜克·罗伦（DukeRohlen）说，Cortex的成立旨在为医生提供一种更智能、更精确的房颤患者解决方案加入Boston Scientific将使我们能够进一步开发这项技术，我们相信这项技术能够改变世界各地患者的房颤治疗方法。”

Boston Scientific expects to complete the transaction in the first half of 2025, subject to customary closing conditions. The transaction is expected to have an immaterial impact on adjusted earnings per share in 2025 and is expected to be slightly dilutive on a GAAP basis due to amortization expense and acquisition-related net charges.

波士顿科学预计在2025年上半年完成交易，但须遵守惯例成交条件。预计该交易将对2025年的调整后每股收益产生无关紧要的影响，并且由于摊销费用和收购相关净费用，预计在GAAP基础上会略有稀释。

Specific terms of the transaction have not been disclosed. .

交易的具体条款尚未披露。

About Boston ScientificBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care.

。作为全球医疗技术领导者已有45多年的历史，我们通过提供广泛的高性能解决方案来解决未满足的患者需求并降低医疗保健成本，从而推动生命科学的发展。

Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.  .

我们的设备和疗法组合可帮助医生诊断和治疗复杂的心血管、呼吸、消化、肿瘤、神经和泌尿系统疾病和病症。请访问www.bostonscientific.com了解更多信息，并在LinkedIn和X（前身为Twitter）上进行连接。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like 'anticipate,' 'expect,' 'project,' 'believe,' 'plan,' 'estimate,' 'intend' and similar words.

本新闻稿包含《1933年证券法》第27A节和《1934年证券交易法》第21E节所指的前瞻性声明。前瞻性陈述可以用“预期”、“预期”、“项目”、“相信”、“计划”、“估计”、“打算”等词来识别。

These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding our business plans, the financial and business impact of the transaction and the anticipated benefits of the transaction, the closing of the transaction and the timing thereof, clinical trials, and product performance and impact.

这些前瞻性陈述是基于我们的信念、假设和估计，并使用我们当时可用的信息，并不旨在保证未来的事件或表现。这些前瞻性陈述除其他外，包括关于我们的业务计划、交易的财务和业务影响以及交易的预期收益、交易的结束及其时间安排、临床试验以及产品性能和影响的陈述。

If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.

如果我们的基本假设不正确，或者出现某些风险或不确定性，实际结果可能与我们的前瞻性陈述所表达或暗示的预期和预测有很大差异。

As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.  .

因此，提醒读者不要过度依赖我们的任何前瞻性陈述。

Factors that may cause such differences include, among other things: future economic, political, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; market competition for our products; expected procedural volumes; new product introductions; demographic trends; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Cortex's operations; business disruptions (including disruptions in relationships with employees, customers and suppliers) following the announcement and/or closing of the proposed transaction; intellectual property; litigation; financial market conditions; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of any required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed..

可能导致这种差异的因素包括：未来的经济、政治、竞争、报销和监管条件；地缘政治事件；制造、分销和供应链中断以及成本增加；网络安全事件造成的中断；公共卫生突发事件或极端天气或其他气候变化相关事件造成的中断；劳动力短缺和劳动力成本增加；正在进行和未来的临床试验和市场研究结果的变化；我们产品的市场竞争；预期的程序量；新产品介绍；人口趋势；收购的结束和整合，包括我们实现拟议交易的预期收益并成功整合Cortex运营的能力；宣布和/或完成拟议交易后的业务中断（包括与员工、客户和供应商的关系中断）；知识产权；诉讼；金融市场状况；；完成拟议交易的条件，包括收到任何所需的监管批准和许可，可能根本无法或无法及时满足；拟议交易的结束可能不会发生或可能会延迟。

All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk F.

所有这些因素都很难或不可能准确预测，其中许多因素超出了我们的控制范围。有关这些以及其他可能影响我们未来运营的重要风险和不确定性的进一步列表和描述，请参阅我们最近向美国证券交易委员会提交的10-K表格年度报告中的第一部分第1A项-风险因素，我们可能会在第二部分第1A项-风险F中对其进行更新。

CONTACTS:Becca Johnson Media Relations +1 (952) 994-8526Rebecca.johnson@bsci.com

联系人：Becca Johnson Media Relations+1（952）994-8526Rebecca.johnson@bsci.com

Jon MonsonInvestor Relations+1 (508) 683-5450BSXInvestorRelations@bsci.com

Jon MonsonInvestor关系+1（508）683-5450BSXInvestorRelations@bsci.com

1Lippi G, Sanchis-Gomar F., et al. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021; Feb 16:217-221. 2Reddy VY, Langbein A, Petru J, Szili-Torok T, Funasako M, Dinshaw L, Wijchers S, Rillig A, Spitzer SG, Bhagwandien R, Metzner A, Kong MH, Neuzil P.

。Int J笔划。2021年；2月16日：217-221。2Reddy VY，Langbein A，Petru J，Szili Torok T，Funasako M，Dinshaw L，Wijchers S，Rillig A，Spitzer SG，Bhagwandien R，Metzner A，Kong MH，Neuzil P。

A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF). JACC Clin Electrophysiol. 2024 Aug;10(8):1856-1869. doi: 10.1016/j.jacep.2024.03.040. Epub 2024 Jun 5. PMID: 38842972..

非阵发性心房颤动（Flow-AF）的电图血流引导重做消融的随机试验。JACC临床电生理学。2024年8月；10（8）：1856-1869年。doi:10.1016/j.jacep.2024.03.040。Epub 2024年6月5日。

SOURCE Boston Scientific Corporation

来源波士顿科学公司