Shockwave Medical, Inc.

Patrick Stephens, Vice President of Global Research, Technology and Development at Shockwave Medical, part of Johnson & Johnson A big challenge is that many patients are coming in with symptoms later, when each disease is more complex. If they’re treated earlier, chances are the arteries have softer plaque, which is easier to treat. When patients wait longer to get care, their disease is often more difficult to treat, because there is often calcification, or hardened plaque, in the artery. That calcification makes the artery much more difficult to dilate. As a result, when you go in with a balloon angioplasty catheter and then try to dilate the artery and ultimately restore blood flow, the chance of getting an adverse event—such as a dissection in the tissue or, in the worst case, a perforation of the artery—increases significantly. Shockwave IVL uses tuned ultrasonic acoustic pressure waves—or shock waves—to modify arterial calcification. Shock waves create small cracks when they come into contact with calcification and safely pass through healthy tissue due to the similar density between the tissue and the contrast/saline mix in the balloon. These small cracks allow improved relative movement of the artery and increase the compliance of the blood vessel.In other words, it feels more like a healthy blood vessel. But more importantly, the artery is more compliant, making it possible for a stent to hold it open with less risk of complications. Think of your car’s windshield, which has a membrane on it to make it shatterproof glass. If a large rock hits your window and it shatters, you can see all those little cracks throughout the glass, but the glass remains intact. That’s very similar to what happens to the calcification in your arterial wall when we make cracks with IVL. The calcification remains there. We’re not actually removing the calcification; we’re just modifying it with all these small cracks to allow it to become more compliant and stretch safely, so a balloon catheter or stent can be used to restore blood flow. An interventionalist using the Shockwave C2 IVL catheter to perform intravascular lithotripsy of a cardiac vessel. Calcification has been one of the biggest challenges to getting effective outcomes for patients with cardiovascular disease. What we’re trying to do is give physicians a tool where they can safely create these small cracks in arterial calcium, which allows them to then treat the patients like they would patients that don’t have calcifications. In the absence of the IVL technology, calcified patients will likely get suboptimal outcomes. For both CAD and PAD, we have two product platforms, one balloon-based, one catheter-based. We started with balloon-based technologies to treat each disease. These are designed to look and feel very much like what physicians are accustomed to using, which are balloon catheters to treat arterial disease. What we did was put an emission source for a shock wave inside the balloon catheters. So essentially, you inflate a balloon, and then you deliver energy with the Shockwave IVL device to create shock waves that effectively and safely modify the calcification in the artery, making it more compliant. As we’ve treated more and more challenging patients, it became clear that patients often had severe disease where the calcium made the artery really tight—so tight that you might not be able to fit a balloon catheter past the tightest location in the artery. We wanted a device that could treat those patients. So we created a non-balloon-based catheter therapy, which we call the Shockwave Javelin Peripheral IVL catheter.  With Shockwave Javelin, we were able to place the emission source—or emitter—of the shock wave close to the tip of the catheter. The result is you’re able to advance a catheter through very tight arteries with that device, which is something you can’t do with balloon-based IVL technology. When it comes to treating calcified lesions, there are other technologies that have been available longer than Shockwave IVL. The most common is rotational atherectomy, a procedure performed with a tiny burr on a catheter that’s used to grind down calcified plaque in narrowed arteries. People jokingly call it a “Roto-Rooter” for the heart. But it’s cumbersome and can be risky to use, and because of that, there are few physicians who are specialists in it. If you don’t know how to use it well, there can be safety challenges with it. Shockwave IVL is an incredibly safe and easy-to-use technology. That’s one of the reasons that it’s been adopted so broadly. The majority of hospitals have Shockwave IVL on their shelves. Shockwave IVL has favorable procedural complication rates compared to rotational atherectomy.When we talk to physicians, we hear something similar. That’s why our technologies are designed to simplify procedures and enhance safety, offering predictable and reliable results for both physicians and patients. The next IVL system, the Shockwave C2 Aero IVL catheter, is expected to come out in the first half of 2026. Shockwave C2 Aero will make it easier for interventionalists to deliver, reach and cross-target lesions with severe calcium as compared to our prior coronary device. The Shockwave C2 Aero IVL catheter, expected to come out in the first half of 2026 We’re also just finishing our Shockwave Javelin Coronary study, and I am certain we will identify ways we can improve on that design. We’ve been working on some development projects for difficult-to-treat lesions. We have some exciting prototypes that I think are going to address difficult cases more efficiently and more effectively than we do today. Every time we develop a new therapy or catheter, we always ask, “How can we treat more patients?” and “How can we allow physicians to more easily treat their current patient populations?” One of the things we’re talking about internally is smart devices. How can we get feedback from the catheter procedure that could ultimately optimize IVL treatment for every patient? Just like we’re getting smarter and more individualized with targeted dosages of medication, for example, the same could be true for Shockwave IVL. Right now, we have very effective devices. We want them to ultimately be smart devices.

一、悬崖边的巨人 2023年，全球制药行业宣布了46笔上市公司并购交易，总价值超过1000亿美元——这是自2019年以来的最高水平。其中，辉瑞以430亿美元收购ADC先驱Seagen，成为当年最大的一笔交易。 这只是开始。2024年，强生以131亿美元收购心脏设备公司Shockwave Medical；2025年初，强生再次出手，以146亿美元收购神经药物公司Intra-Cellular——这是2023年以来生物技术领域金额最大的一笔并购。 诺华、默沙东、阿斯利康、GSK……几乎所有跨国制药巨头都在疯狂扫货。他们收购的对象，大多是成立不过十几年、甚至几年的生物技术小公司。这些小公司往往只有几十名员工，几条在研管线，有的甚至还没有一款药物上市。 为什么这些市值数千亿美元的巨头，会对这些"小虾米"如此渴求？ 答案藏在一个令所有大药企CEO夜不能寐的词汇里：专利悬崖。 二、2000亿美元的恐惧 "专利悬崖"是制药行业的独特现象。新药研发需要10-15年、数十亿美元的投入，作为回报，专利制度给予原研药企20年左右的市场独占期。但专利一旦到期，仿制药蜂拥而入，原研药的销量往往在几年内暴跌70%-90%。 数据显示，2025-2030年，全球将有价值超过2000亿美元的药品失去专利保护。 最令人恐惧的案例来自默沙东。他们的王牌产品Keytruda——2024年销售额294.8亿美元，占公司总收入40%以上——关键专利将于2028年到期。预测显示，默沙东将在2025-2029年间因专利悬崖遭受470亿美元的销售损失。 辉瑞到2030年将有33款药物失去专利保护，涉及170亿美元销售额。百时美施贵宝的Revlimid在仿制药进入后，收入从2021年的129亿美元骤降至2023年的60亿美元。 这就是为什么这些巨头会如此疯狂地扫货。他们不是在"购物"，而是在"逃命"。 三、买时间的游戏 2023年12月，辉瑞完成了对Seagen的430亿美元收购。当时引发争议——Seagen年销售额才20亿美元，为何支付如此高溢价？ 辉瑞CEO的解释是："收购所得产品将在2030年贡献200亿美元的收入，足以抵消核心产品失去市场独占期带来的损失。" 辉瑞买的不是Seagen现有的销售额，而是它的未来。Seagen是抗体药物偶联物（ADC）领域的先驱，ADC被称为肿瘤治疗的"生物导弹"。这笔交易点燃了整个ADC赛道——2023年全球ADC项目交易总额高达530亿美元，创历史新高。 这种"买未来"的逻辑贯穿整个并购狂潮。百时美施贵宝140亿美元收购Karuna Therapeutics，获得精神分裂症新药；默沙东自2021年以来通过战略合作投入约400亿美元，三期临床管线规模扩大近三倍。 这是一场与时间的赛跑——在专利悬崖到来之前，尽可能多地储备下一代产品。 四、小公司的命运 被收购的小公司，大多是2010年代成立的生物技术初创企业，创始人往往是学术界的顶尖科学家。他们带着革命性的技术理念，从风投那里筹集资金，在实验室里日夜攻关。 以Ambrx为例。2003年成立，拥有独特的ADC技术。2015年被中国资本收购，2021年在纽交所上市，2024年被强生以20亿美元收入囊中。整整20年，没有一款药物上市，但技术平台为强生提供了进入ADC领域的钥匙。 对小公司来说，被大药企收购往往是最好的结局。因为另一条路是死亡——2023年，全球近40家制药和生物技术企业倒闭，申请破产的美国Biotech数量创近十年新高。原因大同小异：研发失败、融资困难、现金流枯竭。 进入临床试验的新药，最终能够上市的不到10%。一次关键临床试验的失利，就可能导致整个公司的崩溃。而大药企的收购，为它们提供了一条"上岸"的通道。 这形成了一种奇特的产业生态：小公司负责"冒险"，大公司负责"买单"。 五、创新的代价 这种生态似乎是合理的——小公司灵活敢于冒险，大公司资源丰富有全球销售网络，并购是二者之间的桥梁。 但这种模式也有阴暗面。 首先是创新的同质化。当所有大药企都追逐同一类热门资产时，ADC赛道变得异常拥挤，而其他领域却无人问津。 其次是价格的扭曲。并购狂潮推高了估值，让没有产品上市的公司动辄被标价数十亿美元。这些成本最终转嫁到药价上。 更深层的问题是：大药企自身的研发能力正在萎缩。当"买"比"做"更容易时，内部研发的激励就会减弱。跨国药企的研发回报率已从2010年的10.1%降至2023年的1.2%。越来越多的大药企变成了"并购机器"，核心能力不再是创新，而是筛选、谈判和整合。 六、中国的机遇 在这场并购狂潮中，一个意想不到的角色正在崛起：中国。 阿斯利康12亿美元收购亘喜生物，BioNTech 8亿美元收购普米斯生物，Genmab 18亿美元收购普方生物……这些交易表明，中国生物技术公司的创新能力已获得国际认可。 不过，当中国资本培养出的公司被海外巨头高价收购时，最大的赢家往往是外资基金。从另一个角度看，这种"出海"也在倒逼中国提升创新能力——当全球顶级药企愿意为中国的ADC、双抗、CAR-T技术支付数十亿美元时，说明中国的创新已走到世界前沿。 七、没有终点的竞赛 为什么大药企会疯狂收购小公司？ 因为在制药行业，创新是生存的唯一法则。专利悬崖如同达摩克利斯之剑，悬在每一个巨头的头顶。无论你今天多么强大，如果没有下一代产品，明天就可能被市场无情抛弃。 历史已反复证明这一点。全球前十大药企的排名每十年就会剧烈更迭。默沙东收购先灵葆雅，获得了日后的全球药王Keytruda；辉瑞收购惠氏，获得了畅销疫苗Prevnar。今天的430亿美元Seagen收购，可能正在孕育下一个百亿美元的重磅药物。 这是一场没有终点的竞赛。大药企们必须不断奔跑，不断收购，才能避免被专利悬崖吞噬。而小公司们，则扮演着"弹药供应商"的角色——它们的创新成果，成为巨头们延续生命的燃料。 并购狂潮不是一种病态，而是制药行业的生存本能。它确保了创新的火种不会熄灭——总有人在冒险，总有人在买单，总有新药在诞生。 2030年的专利悬崖正在逼近。这场并购狂潮，才刚刚开始。

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Anumana Inc. , a leader in AI-powered cardiovascular detection algorithms, today announced the appointment of Kevin Ballinger and Jean-Luc Butel to its Board of Directors. In their roles, Ballinger and Butel will provide strategic guidance to Anumana’s leadership team as the company advances its AI-driven capabilities, expands clinical adoption, and scales operations. “Kevin and Jean-Luc bring a depth of experience that will be an asset to Anumana,” said Maulik Nanavaty, CEO of Anumana. “Their decades of diverse and extensive understanding of healthcare organizations will help guide us as we move into our next phase of growth and expand the commercialization of cardiovascular deep learning AI solutions and product offerings.” Ballinger is a seasoned healthcare executive with deep experience across the medtech and life sciences sectors. He has been a member of CVRx’s board since September 2024 and most recently served as Chief Executive Officer of Aldevron, LLC, a privately held genomics company acquired by Danaher Corporation in 2021. Prior to Aldevron, Ballinger spent 25 years at Boston Scientific Corporation, including nine years as Executive Vice President and Global President of the Interventional Cardiology division. Ballinger has also served on the boards of Silk Road Medical, Inc. and Shockwave Medical, Inc. He holds a B.S. in mechanical engineering from Michigan Technological University and an M.B.A. from the University of Minnesota’s Carlson School of Management. Butel is a global healthcare advisor with decades of experience across public institutions and private industry. He currently serves on the boards of Takeda Pharmaceutical Company, Novo Holdings Advisory Group Asia, ICON, JanaCare, Rani Therapeutics, and Diagnostics Development Hub. Previously, Butel was Corporate Vice President and President at Baxter International and Executive Vice President and Group President, International, at Medtronic. He held senior leadership roles at Becton Dickinson and Johnson & Johnson, and served as a senior advisor to McKinsey’s Healthcare Practice. He has also served on the boards of Varian Medical Systems, SGInnovate, and Singapore’s Economic Development Board. He was awarded the Singapore Public Service Medal in 2013 and holds a BA in international affairs from The George Washington University and an MBA in international management. About Anumana Anumana is an AI-driven health technology company committed to transforming cardiovascular care. Co-founded by nference and Mayo Clinic, Anumana is developing software-as-a-medical-device (SaMD) solutions that apply multimodal AI to support early detection, clinical decision-making, and intraoperative guidance across the continuum of care. The company’s portfolio includes ECG-based algorithms, generative imaging applications, and real-time procedural support tools designed to improve outcomes in both diagnostic and perioperative settings. The company’s FDA-cleared ECG-AI™ LEF algorithm is currently available in the U.S. and eligible for reimbursement as of January 2025. Please visit for more information and follow Anumana on LinkedIn for company updates. Contacts Media Contact Andrea Sampson President/CEO, Sampson Public Relations Group asampson@sampsonprgroup.com