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Agreement includes exclusive option to acquire novel, balloon-expandable transcatheter aortic valve made with proprietary rhenium alloy
协议包括收购由专有铼合金制成的新型球囊扩张经导管主动脉瓣的独家选择权。
MARLBOROUGH, Mass.
马尔伯勒,马萨诸塞州
,
,
May 18, 2026
2026年5月18日
/PRNewswire/ -- Boston Scientific Corporation (NYSE:
/PRNewswire/ -- 波士顿科学公司(纽约证券交易所:
BSX
BSX
) today announced it has invested $1.5 billion in return for an approximately 34% equity stake in MiRus LLC, a privately-held company developing and commercializing proprietary biomaterials, implants and procedural solutions for the treatment of cardiovascular and orthopedic diseases, including the SIEGEL™ Balloon Expandable Transcatheter Aortic Valve Replacement (TAVR) system.
)今天宣布已投资15亿美元,以换取私营公司MiRus LLC约34%的股权。MiRus LLC致力于开发和商业化用于治疗心血管和骨科疾病的专有生物材料、植入物和手术解决方案,其中包括SIEGEL™球囊扩张经导管主动脉瓣置换术(TAVR)系统。
As part of the investment agreement, Boston Scientific also received an exclusive option to acquire the MiRus TAVR system, subject to additional payments and the completion of certain milestones. The SIEGEL technology is built on a proprietary rhenium alloy and is the first nickel-free, balloon-expandable TAVR valve intended to restore function and normal blood flow of severely narrowed aortic valves..
作为投资协议的一部分,波士顿科学公司还获得了收购MiRus TAVR系统的独家选择权,但需支付额外款项并完成特定里程碑。SIEGEL技术基于一种专有的铼合金,是首个不含镍、球囊扩张型TAVR瓣膜,旨在恢复严重狭窄的主动脉瓣的功能和正常血流。
'The occurrence and recognition of aortic stenosis is growing rapidly and our investment in MiRus continues our pursuit to bring a differentiated TAVR system into our portfolio that we anticipate may improve outcomes for patients living with this life-threatening disease,' said Lance Bates, executive vice president and president, Interventional Cardiology and Vascular Therapies, Boston Scientific.
“主动脉狭窄的发生和认知正在迅速增长,我们对MiRus的投资继续了我们将一个差异化的TAVR系统引入产品组合的追求,我们预计这可能会改善患有这种危及生命疾病的患者的预后,”波士顿科学公司执行副总裁兼介入心脏病学和血管治疗部门总裁兰斯·贝茨表示。
'Built upon years of research and proprietary technology, we believe the distinctive design and impressive early clinical results of the SIEGEL valve may set it apart from currently available technology, potentially providing physicians an advanced option to treat a wide array of patients.'.
“基于多年的研究和专有技术,我们相信SIEGEL瓣膜的独特设计和令人印象深刻的早期临床结果可能使其与现有技术区别开来,为医生提供一种先进的选择,以治疗各种各样的患者。”
The SIEGEL TAVR valve is designed with leaflets made of dry porcine tissue and a nitric oxide-coated rhenium frame, which has a radial strength greater than cobalt or titanium.
SIEGEL TAVR瓣膜设计采用干式猪组织制成的小叶和涂有氧化亚氮的铼框架,其径向强度大于钴或钛。
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1
The open cell design of the frame is intended to eliminate foreshortening and aide precise placement in the heart. Uniquely, the valve is also pre-mounted directly onto the balloon and all sizes – 23 mm, 26 mm and 29 mm – can be precisely delivered through an 8 French expandable sheath, which is approximately 50% smaller.
框架的开放式蜂窝设计旨在消除缩短效应并帮助精确定位在心脏中。独特的是,该瓣膜还预先直接安装在球囊上,所有尺寸(23毫米、26毫米和29毫米)均可通过8法式可扩张鞘精确输送,其尺寸大约小50%。
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2
than current commercially available TAVR delivery sheaths and may minimize vascular injuries.
比目前市面上可买到的TAVR输送鞘管更先进,并且可以减少血管损伤。
MiRus recently initiated the STAR pivotal trial that is evaluating the safety and effectiveness of the three sizes of the SIEGEL valve in up to 1,025 patients with severe, symptomatic aortic stenosis considered to be at low, intermediate or high risk for surgical complications. Last year, MiRus presented findings from an early feasibility study assessing the safety and performance of the device..
MiRus最近启动了STAR关键试验,该试验正在评估三种尺寸的SIEGEL瓣膜在多达1,025名被认为手术并发症风险较低、中等或较高的重度症状性主动脉瓣狭窄患者中的安全性和有效性。去年,MiRus公布了早期可行性研究的结果,该研究评估了该装置的安全性和性能。
'The SIEGEL valve is a promising technology and has received enthusiastic feedback from physician investigators for its less invasive delivery, nickel-free construct, precise placement resulting from a lack of foreshortening and excellent hemodynamics,' said Jay Yadav, M.D., founder and chief executive officer, MiRus.
“SIEGEL瓣膜是一项很有前景的技术,由于其创伤较小的输送方式、无镍结构、因无缩短而实现的精确定位以及出色的血液动力学表现,已经收到了医生研究者们的热烈反馈,”MiRus创始人兼首席执行官Jay Yadav医学博士说道。
'This collaborative relationship with Boston Scientific alongside the exceptional capabilities of our Atlanta-based team can further accelerate our progress towards broad accessibility for patients and physicians for what we believe will be a transformational treatment.'.
“与波士顿科学公司的这种合作关系,再加上我们亚特兰大团队的卓越能力,可以进一步加快我们为患者和医生实现广泛可及性的进展,我们相信这将是一种变革性的治疗。”
The investment in MiRus is expected to be immaterial to adjusted earnings per share for Boston Scientific in 2026. Boston Scientific may exercise the option to acquire the MiRus TAVR business by making additional aggregate cash payments totaling $3 billion, at Boston Scientific's option following MiRus' achievement of certain clinical and regulatory milestones, that would result in 100% ownership of the TAVR business, subject to customary closing conditions.
对波士顿科学公司2026年的调整后每股收益而言,对MiRus的投资预计不会产生重大影响。根据MiRus达成某些临床和监管里程碑后的情况,波士顿科学公司可以选择行使收购MiRus TAVR业务的期权,通过额外支付总计30亿美元的现金,获得该TAVR业务的100%所有权,但需符合惯例的交割条件。
If Boston Scientific exercises the option, MiRus will have the right to receive additional payments based on net sales of the SIEGEL TAVR valve over a specified period and Boston Scientific will also have an exclusive option to acquire mitral and tricuspid replacement valve assets from MiRus for an additional payment. .
如果波士顿科学公司行使该选择权,MiRus 将有权在特定时期内根据 SIEGEL TAVR 瓣膜的净销售额获得额外付款,波士顿科学公司还将拥有以额外付款从 MiRus 购买二尖瓣和三尖瓣置换资产的独家选择权。
Caution: The SIEGEL™ Balloon Expandable Transcatheter Aortic Valve Replacement (TAVR) system is an investigational device, which is not yet approved for commercial distribution in any country.
注意:SIEGEL™球囊扩张经导管主动脉瓣置换(TAVR)系统是一种研究性器械,尚未在任何国家获得商业销售的批准。
1 Per ASTM standards specification
1 根据ASTM标准规范
2 Edwards eSheath+ Introducer Set Instructions for Use (2023-08 10058349001 A)
2 Edwards eSheath+ 引入器套装使用说明(2023-08 10058349001 A)
About Boston Scientific
关于波士顿科学公司
Boston 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 healthcare.
波士顿科学通过创新的医疗技术改善全球患者的健康,从而改变生活。作为拥有45年以上历史的全球医疗技术领导者,我们通过提供广泛的高性能解决方案,满足患者未被满足的需求并降低医疗成本,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 .
我们的设备和疗法组合帮助医生诊断和治疗复杂的心血管、呼吸系统、消化系统、肿瘤学、神经学和泌尿系统疾病及病症。欲了解更多信息,请访问。
www.bostonscientific.com
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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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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条(经修订)和1934年《证券交易法》第21E条(经修订)所指的前瞻性陈述。前瞻性陈述可以通过“预期”、“预计”、“展望”、“相信”、“计划”、“估计”、“意图”等类似词语加以识别。
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 the financial and business impact of the investment and the anticipated benefits of the investment, the exercise of the option and the timing thereof, business plans and strategy, clinical trials, product approvals and product performance and impact.
这些前瞻性声明基于我们根据当时可获得的信息所作出的信念、假设和估计,并不旨在作为对未来事件或业绩的保证。这些前瞻性声明包括但不限于关于投资的财务和业务影响及预期收益、期权的行使及其时间安排、业务计划与战略、临床试验、产品批准、产品性能及影响的声明。
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 forward-looking statements expressed in this press release.
如果我们的基本假设被证明是错误的,或者某些风险或不确定性成为现实,实际结果可能会与我们前瞻性声明中表达或暗示的预期和预测存在重大差异。这些因素在某些情况下已经影响,并且未来(连同其他因素)可能会影响我们实施业务战略的能力,并可能导致实际结果与本新闻稿中所表达的前瞻性声明中设想的结果存在重大差异。
As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements..
因此,提醒读者不要过分依赖我们的任何前瞻性声明。
Factors that may cause such differences include, among other things: economic conditions, including the impact of foreign currency fluctuations; future U.S. and global political, competitive, reimbursement and regulatory conditions, including changing trade and tariff policies; geopolitical events, conflicts and tensions; 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 or determination to exercise the option and our ability to achieve the anticipated benefits of the investment or the option (if exercised); clinical trial results; business disruptions (including disruptions in relationships with employees, customers and suppliers) following the announcement and/or closing of the investment or the exercise of the option; intellectual property; litigation; financial market conditions; future business decisions made by us and our competitors; the execution and effect of our business strategy, including our cost-savings and growth initiatives; the conditions to the completion of the investment or the exercise of the option, including the receipt of any required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the fact that the exercise of the option may not occur or may be delayed.
可能导致此类差异的因素包括但不限于:经济状况,包括外汇波动的影响;未来的美国和全球政治、竞争、报销和监管环境,包括贸易和关税政策的变化;地缘政治事件、冲突和紧张局势;制造、分销和供应链的中断及成本增加;网络安全事件引发的中断;公共卫生紧急事件或极端天气及其他与气候变化相关的事件引发的中断;劳动力短缺和劳动力成本上升;正在进行和未来临床试验及市场研究结果的变化;我们产品面临的市场竞争;预期的手术量;新产品推出;人口结构趋势;收购的完成与整合,包括我们行使期权的能力或决定以及我们实现投资或期权(若行使)预期收益的能力;临床试验结果;在宣布和/或完成投资或行使期权后业务中断(包括与员工、客户和供应商关系的中断);知识产权;诉讼;金融市场状况;我们及竞争对手作出的未来商业决策;我们的商业战略的执行和效果,包括我们的成本节约和增长计划;完成投资或行使期权的条件,包括是否能及时获得所需的监管批准和许可,可能无法全部满足或及时满足;以及行使期权可能不会发生或可能延迟的事实。
New risks and uncertainties may arise from time to time and are difficult.
新的风险和不确定性可能不时出现,并且难以应对。
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