Cephea Valve Technologies, Inc.

作为导致美国疾病患者死亡的主要原因，心脏病每年夺走近700万美国人的生命。东方证券研究所披露，美国2018年总共进行了17.53万枚心脏瓣膜置换，其中外科生物瓣9.98万枚，介入生物瓣6.03万枚。心脏瓣膜疾病属于结构性心脏病，临床表现为单个或多个瓣膜的形态、结构异常。瓣膜通过正常的开关闭合控制人体内动脉血与静脉血的流动，起到“单向阀门”的作用。若瓣膜出现瓣膜狭窄或者关闭不全等异常，则会妨碍正常的血液流动，进而引起心脏功能性损害。中重度瓣膜病患者如果不接受治疗，其5年的生存率仅有20%。根据心通招股书数据，2019年我国已有3630万心脏瓣膜疾病患者，并预测将于2025年增加至4020万人，在心脏瓣膜疾病治疗方面仍有巨大需求未被满足。Capstan Medical则致力于解决这一困境，并开创了心脏瓣膜疾病治疗的新范式。Capstan Medical是一家专注于开发治疗心脏瓣膜疾病的微创技术公司。公司于2020年在美国加利福尼亚州圣克鲁斯成立。该公司正在开发一套新一代心脏瓣膜植入物和首创的经导管机器人输送平台。Capstan Medical将手术机器人技术、导管技术和新一代心脏瓣膜植入物相结合，开发了一种能够在心脏跳动时通过导管治疗二尖瓣和三尖瓣疾病的方案。该方案为心脏直视手术提供了一种侵入性较小的替代选择，从而改善患者的治疗效果并缩短恢复时间。在心脏瓣膜疾病领域布局研发手术机器人由于技术难度太大、学习曲线长，经导管二尖瓣置换术（TMVR）和经导管三尖瓣置换术(TTVR)经过十多年发展至今几乎没有产品获得FDA批准。而想要降低学习难度、提升手术操作效率和普及率，就要将手术“标准化”，减少医生个人经验和技术水平对于手术造成的影响，而将手术机器人化则是一个重要的实现途径。虽然机器人已经在许多不同类型的手术中取得了进展，如骨关节置换、植入脊柱植入物、腹腔镜锁孔术等，但心脏瓣膜置换在很大程度上依然依靠手工。Capstan Medical正是抓住了这一点，开始在心脏瓣膜疾病领域布局研发手术机器人。Capstan Medical的技术信心来自于创始人Dan Wallace在手术机器人领域的丰富经验和履历。他拥有在Intuitive Surgical、Hansen Medical、Auris Health（被强生收购）、Cephea Valve Technologies（被雅培收购）等知名手术机器人和瓣膜公司的工作经验。其首席执行官Maggie Nixon曾经在达芬奇手术机器人公司任职，并拥有20多年的工作经验。公司开发的平台可以通过微创的方式将导管送入患者心脏，然后操作机器人输送平台，将心脏瓣膜植入物精确地定位到需要替换或修复的原有瓣膜的位置。该平台还可以实时监测和调整导管的位置和角度，以适应不同的解剖结构、病变类型和病理条件。接着，医生通过机器人输送平台释放心脏瓣膜植入物，使其展开并固定在原有瓣膜的位置。在此过程中，Capstan Medical将机器人辅助手段的精确性应用到心脏瓣膜疾病的微创手术中，实现了产品设计之初的目标。提供微创护理，将患者的康复时间缩短至几周目前二尖瓣和三尖瓣相关疾病大多通过心脏直视手术来治疗。所谓心脏直视手术，是指通过切开胸腔以获得视觉通路并对心脏肌肉、瓣膜或动脉进行的手术。心脏直视手术是传统的手术形式，不同于切口更小、更易恢复的微创手术。并且，心脏直视手术需要3-6个小时，医生要对患者进行全身麻醉以确保其在手术过程中处于无痛状态，手术过程中，患者胸部会被切开8到10英寸。开胸手术通常会引发多种并发症，如呼吸系统并发症、贫血、神经系统并发症、伤口及呼吸道感染、影响上肢活动、并发切口疝等。因此，许多患者在考虑到心脏直视的手术相关风险后，选择推迟治疗。这在不知不觉中增加了其健康风险，并可能造成身体虚弱，以致失去进行心脏直视手术的机会。“心脏直视手术是创伤性的，对许多人来说是一种不切实际的治疗选择”，Capstan Medical的首席执行官Maggie Nixon表示。因此，Capstan Medical为患者引入微创选择。其创新技术为传统的心脏直视手术提供了侵入性更小的替代方案，同时确保心脏瓣膜植入物的精确放置，能够显著缩短患者恢复时间并最大限度地降低并发症的风险。经导管治疗可以通过腹股沟的小切口来治疗心脏瓣膜疾病，而无需按照心脏直视手术的要求停止心脏跳动或打开胸部。这项技术可以将患者的康复时间从几个月缩短到几周，甚至病情最严重的患者也可以接受此类手术。完成3140万美元的B轮融资，为首次人体临床试验做准备2023年8月9日，Capstan Medical宣布完成3140万美元的B轮融资，本轮投资由管理着超过40亿美元的资产、拥有70多家投资组合公司的Eclipse Ventures领投，Puma Venture Capital、Intuitive Ventures参投。随着B轮融资的完成，Capstan Medical还宣布任命Eclipse的合伙人Justin Butler为其董事会成员。在未来几个月，Capstan Medical将扩大其工程、临床开发和运营团队，以推动该技术通过下一阶段的开发，并进入首次人体临床试验。从手术方式上来看，目前我国心脏瓣膜治疗仍然以外科手术为主。东方证券研究所披露，2017年我国心脏瓣膜开胸手术量已经达到6.57万例，而经介入方法治疗的患者仅有3000例左右，外科手术方式仍为主流。为了解决这一难题，国内不少企业正在相关医疗器械和技术方面不断进行创新。宁波健世科技股份有限公司是一家围绕结构性心脏病开发创新解决方案的医疗器械公司，其创新产品覆盖了三尖瓣、二尖瓣、主动脉瓣和心衰治疗。健世科技自主开发的经导管二尖瓣置换系统JensRelive为治疗重度二尖瓣返流患者而设计，可在不进行常规开胸手术的情况下置换患者具功能障碍的原生二尖瓣。其经导管三尖瓣置换系统LuX-Valve为治疗重度三尖瓣反流及高外科手术风险患者而设计，通过微创介入的方式以人工瓣膜支架替代患者具有功能障碍的原生三尖瓣的功能，已被FDA认定为突破性医疗器械，为中国在瓣膜领域首款获此认定的自主研发医疗器械。杭州启明医疗器械股份有限公司是中国领先的心脏瓣膜微创介入治疗领域的龙头企业，致力于结构性心脏病领域创新医疗器械的开发及商业化。2021年12月7日，启明医疗宣布收购Cardiovalve，该公司自主研发的Cardiovalve是一款同时可治疗二尖瓣反流和三尖瓣反流的经导管介入置换产品。相较于同类产品，Cardiovalve经股静脉的入路方式能显著提升治疗安全性。目前，在治疗二尖瓣反流适应症上，Cardiovalve已在欧洲进入临床研究阶段，并在美国进入早期可行性研究阶段。在治疗三尖瓣反流的适应症上，Cardiovalve于2020年1月获美国FDA授予的“突破性设备称号”，并已进入早期可行性研究(EFS)阶段。目前，我国心脏瓣膜行业的治疗需求还远未得到充分满足，治疗渗透率仍旧较低。但随着相关领域创新企业的不断涌现，心脏瓣膜植入物以及相关植入和置换技术也在不断更新迭代，将有助于解决这一难题，为患者带来更加安全、有效的治疗方案。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

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August 27, 2015 By Alex Keown , BioSpace.com Breaking News Staff CHICAGO – Abbott Laboratories will not pursue a deal to acquire St. Jude Medical Inc. , contrary to earlier reports, Reuters reported this morning. Chicago-based Abbott nixed any acquisition rumors this morning, Reuters said. Citing anonymous sources “familiar with the matter,” several media outlets, including Reuters, the Irish Times and the Street Insider, reported Abbott was preparing to make a $25 billion bid for the medical device maker. Street Insider reported Abbott had been working with several financial advisers at J.P. Morgan and Citi to line up the financing for the deal. Miles White , Abbott ’s chief executive officer, has a solid reputation as a dealmaker. Abbott ’s earnings have increased since it spun off its pharmaceutical unit AbbVie . In his 13 years helming Abbott , White has been behind several big deals, including the 2006 acquisition of Guidant ‘s coronary stent business for $4.5 billion and the $6.9 billion purchase of Knoll Pharmaceuticals in 2001, Chicago Business said . The 2001 acquisition of Knoll placed Humira, which treats a range of ailments, including arthritis and Crohn disease, into Abbott ’s portfolio, although, Humira went into AbbVie ’s pipeline in 2012 when the company became separate. Earlier this year, White said he was interested in pursuing a deal in the medical device arena, which helped spur the rumors of the St. Jude acquisition. In April, Debbie Wang of Morningstar Inc. told Chicago Business that Abbott , while having a broadly diversified portfolio, lacked strength in its medical devices pipeline. Since the 2012 spinoff of AbbVie , Abott has focused on increasing its generic-drug offerings in emerging markets, most particularly China, as well as adding new technology to the company’s device and diagnostics businesses, Bloomberg Business reported in May. Earlier this year Jeff Jonas , a fund manager at Gabelli , told Bloomberg White could be eying St. Jude , which has a value of about $20 billion, to transform Abbott into a “cardiovascular powerhouse.” Another potential acquisition target for Abbott is 161404, which could also boost Abbott ’s cardiovascular business, Igor Golalic of Diamond Hill Capital Management , told Bloomberg. Just two months after those analysts talked about Abbott boosting its cardiovascular offerings, White engineered a $250 million deal to purchase Tendyne Holdings, Inc. , a private medical device company focused on developing minimally invasive mitral valve replacement therapies. At the same time, Abbott also acquired Cephea Valve Technologies , a private company developing a catheter-based mitral valve replacement therapy. Financial terms of that deal were not disclosed. were up slightly this morning, trading at $45.10 per share. was up as well this morning on news of the rumor of the bid. St. Paul, Minn.-based St. Jude was trading at $69.34 this morning, although in premarket trading this morning the stock had jumped about 15 percent to $79.69 per share. Abbott has increased its value through smart investments, including the backing of Mylan NV ’s deal making earlier this year. Abbott is the largest shareholder in Mylan , and the company’s stake has increased in value as Mylan sought an acquisition of Perrigo Company and fended off Teva Pharmaceutical Industries Ltd. ’s takeover attempts.