LUMA Vision Ltd.

DUBLIN & MUNICH--( BUSINESS WIRE )--LUMA Vision, developer of a novel four-dimensional (4D) cardiac imaging and navigation platform, today announced a total of $22 million in new financing for the company. The Series A3 financing added three new investors comprising an undisclosed multinational strategic investor, Atlantic Bridge Growth Fund and Bayern Kapital, and was led by existing investors EQT Lifesciences, ABV Uni Fund and imec.xpand. The new funding adds to prestigious grants won earlier by LUMA Vision from the Irish government’s Disruptive Technologies Innovation Fund ($6 million) and the European Union’s EIC Accelerator ($3 million). LUMA Vision will use the new funds to gain FDA clearance, prepare for U.S. commercialization and develop the next generations of its VERAFEYE platform for additional clinical applications in cardiology and beyond. LUMA Vision has developed VERAFEYE™, a novel all-in-one 4D imaging and navigation platform with data-driven software applications designed for cardiology. The technology uses a proprietary catheter sensor combined with advanced digital imaging and deep learning to provide unprecedented, high-resolution, 360-degree imagery of the beating heart and surrounding anatomy. VERAFEYE can be used with other catheters or systems during cardiac surgery and, with multiple applications in one platform, can provide all of the imaging guidance needed during cardiac surgery in real time without the need for external systems such as X-ray or CT. VERAFEYE will provide cardiologists with accurate, precise and comprehensive anatomical data required to guide personalized patient therapy across a variety of diseases, such as atrial fibrillation, left atrial appendage closure and cardiac valve replacement. Professor Gabor Szlepaki, Head of Cardiac Electrophysiology at the Mater Private Hospital Dublin and Centre Clinical lead of the Atrial Fibrillation Institute, added, “This new technology has the potential to help us deliver more precise therapies for patients suffering from abnormal heart rhythms or structural heart problems. This type of medical innovation is essential for the continuous progression of minimally invasive cardiac therapies that can improve patient care.” “Physicians require accurate, real-time data at the point of care in order to effectively treat patients,” said LUMA Vision CEO Fionn Lahart. “Our goal with VERAFEYE is to provide the data and imaging physicians need in one system to successfully treat as many of the conditions their patients face as possible. By developing a technology platform that can be tailored for specific therapies in cardiology, we believe that VERAFEYE can be a bedrock of medical imaging for many years to come.” He continued, “We are absolutely delighted to welcome to the company our new investors and gratified to secure the continued backing of our highly regarded existing investors. As a truly pan-European startup with offices in Dublin and Munich, we have grown our team significantly in the last three years and will continue to add world-class talent to help LUMA Vision achieve its goals.” ABOUT LUMA Vision LUMA Vision (formerly known as OneProjects Ltd) is a privately held, venture-backed medical device company based in Dublin, Ireland and Munich, Germany. LUMA Vision was originally a spin out company from Bioinnovate Ireland and Trinity College Dublin. The company designs and develops an innovative 4D imaging and navigation end-to-end platform for cardiac applications to deliver data at the point of therapy. LUMA Vision was founded by CEO Fionn Lahart and Chief Technology Officer Christoph Hennersperger. Learn more about LUMA Vision and VERAFEYE™ at www.lumavision.com

在全球范围内，结直肠癌是第3大常见的恶性肿瘤，居恶性肿瘤死因第2位，居所有疾病和伤害死因第16位，已成为严重威胁人类健康的公共卫生问题。世界卫生组织披露，2020年，估计全球范围内有超过190万例结直肠癌新发病例和超过93万例结直肠癌死亡病例。在结直肠癌患者中，很大一部分人要接受手术切除肿瘤才能恢复肠道的正常功能。不幸的是，该手术存在一个主要的并发症——手术后渗漏。姚宏伟、许峰铭等学者在《直肠癌术后吻合口漏的早期诊断和预防研究进展》一文中指出，吻合口漏是直肠癌前切除术后常见的严重并发症，其发生率为2.4%~27.0%，病死率高达18%。肠内容物渗漏到腹部会严重危机患者健康，通常会导致败血症，需要紧急进行再次手术。这可能会延迟出院和化疗时间，增加并发症发生率、病死率，导致局部复发的风险。即便能够及时诊断和治疗，吻合口漏也同样可能会影响患者出院后的生活质量。为了解决这一难题，Plio Surgical选择入局。这是一家位于爱尔兰都柏林的医疗器械公司，作为欧洲医疗器械行业的领先创新者之一，该公司一直致力于提高手术效率和保障患者安全。Plio：消除传统吻合器的固有弊端二十世纪前，在外科手术中，几乎所有的缝合工作都要依靠医生的手工缝线完成。这不仅极度依赖医生的个人经验、拥有较高的操作技术门槛，而且是一个极为耗时费力的工作。遇上大型外科手术，医生要在缝合上花费几个甚至十几个小时。被称为“外科订书机”的吻合器的问世则将医生从繁重的缝合工作中解脱出来。与手动缝合相比，吻合器便于外科手术操作并且可缩短手术时间，在外科手术中的使用十分普遍，被广泛应用于心胸外科、胃肠外科、肝胆胰脾外科、泌尿外科、普外科等手术中。华安证券指出，需要使用吻合器的术式总计约30余种（不区别开放和微创手术）。自1908年，“外科缝合器之父”Hümer Hültl成功发明出第一款吻合器以来，吻合器已经走过了上百年的发展史。在这其中，传统缝合器的弊端逐渐暴露。传统的吻合器需要使用吻合钉，有可能导致组织损伤、感染、异物反应、钉腿脱落等并发症。并且，吻合器的尺寸和形状限制了其适用范围和灵活性，难以适应不同的吻合需求和难度。更重要的是，传统吻合器的使用需要一定的技术和经验，操作不当可能导致吻合不良、吻合口漏、吻合口狭窄等严重后果。Plio Surgical的磁性吻合器Plio的优势 图源Plio Surgical官网而Plio Surgical的磁性吻合器Plio则摆脱了对于吻合钉的依赖，并在吻和效果、可调节性等方面对传统的吻合器进行了革新。不需要缝合钉，大小可调节Plio手术植入物是一种可以用来连接肠道两端的医疗器械，它可以避免传统的缝合或钉合方法，减少手术时间和并发症，同时也不会对肠道造成长期的损伤。并且，Plio手术植入物利用了创新的微创技术，可以提高胃肠外科手术的效率和安全性。Plio Surgical的磁性吻合器Plio的工作流程 图源Plio Surgical官网Plio可以通过腹腔镜放置在肠道的健康腔内。完全腹腔镜下操作使其能够实现体内吻合，无需扩大切口或将肠道拉出体外。Plio的吻合环有一些类似于钩子的结构，具有抓握功能，它们可以紧紧地附着肠壁的内层，防止植入物滑动或脱落。并且，Plio可以用于上下消化道，不受解剖位置的限制。Plio的核心部分由两个磁环组成，它们可以相互吸引，通过磁力的压缩作用，在不需要缝合钉的情况下创建一个吻合口，将肠道两端拉近并紧密地贴合在一起，形成一个通道，让肠液可以流通。这样可以减少吻合口漏的风险，提高吻合质量和效率。也正因如此，Plio能够有效减少手术的复杂度和风险，提高了手术的效率和安全性。另外，Plio的使用方式简单易学，只需将两个磁环分别固定到需要吻合的肠道两端，然后将它们靠近，就可以完成吻合，操作时间短，操作难度低。值得注意的是，Plio磁环的大小可以根据需要调节。因此，它可以适应不同直径的肠道。且Plio的吻合环是一次性的，不会永久地留在体内，而是随着肠道的愈合而逐渐松动，最终脱落并随着粪便排出体外，不会对人体造成任何伤害。获得MedTech Innovator的非股权投资新型磁性吻合器的研发离不开强大的科研能力与完善的管理体系，Plio Surgical出色的核心团队具有交叉学科背景，为其提供核心支持。公司CEO Cristina Purtill在医疗保健行业和产品管理方面拥有超过15年的经验。她曾在美国通用电气医疗保健公司（GE Healthcare）担任全球产品经理，并在戴尔公司（Dell）担任营销职务。Cristina Purtill曾领导5款II级高敏锐度病人监护仪的开发，并在美国、欧洲和亚洲获得 510(k) 批准和 CE认证后管理产品的商业化。CSO Bruce Murphy在开发微创手术设备方面拥有深厚的技术专长。他的实验室在创新型专有医疗技术的开发和商业化方面取得了巨大成功，从他的实验室衍生出了 CroiValve、Proverum、Selio Medical 和 OneProjects 等公司，并与投资界有着良好的关系。CTO Gareth Gallagher是英国伦敦大学生物医学工程学硕士，在开发一系列胃肠道手术和诊断应用的医疗设备方面积累了7年以上的经验。他的工作经历既包括初创企业，也包括大型跨国企业，涵盖了从概念设计到产品上市的各个阶段。2023年5月12日，Plio Surgical团队在斯特拉斯堡IHU进行了第二轮临床前猪动物试验。在Lee Swanstrom博士和Juan Verde博士的支持下，Plio 植入物成功地在两头活猪体内形成了小肠端端吻合。2023年6月7日，Plio Surgical被纳入Medtech创新加速器计划，并被选为加利福尼亚州帕洛阿尔托MedTech创新者峰会2023年愿景奖竞赛的五名决赛入围者之一。该公司目前处于孵化器/加速器阶段，2023年6月，Plio Surgical完成了一轮非股权融资，投资方为MedTech Innovator，融资金额未公开。MedTech Innovator素有“医疗器械产业加速器”之称，是全球最大的医疗技术加速器，也是医疗技术行业首屈一指的非营利初创加速器，它专注于支持创造医疗技术和数字健康领域新技术的初创企业。获得MedTech Innovator的投资，意味着Plio Surgical产品具有创新性和价值，具有改善患者生活质量、提高医疗效率、降低医疗成本的潜力。同时，MedTech Innovator的强大支持也使得Plio Surgical能够接触到诸多行业内的优质资源，包括接触行业领先企业的高管导师、专业的商业化培训、全球性的行业会议和展示机会等。中国吻合器市场：仍有国产替代空间，国内企业正在发力随着微创手术渗透率的不断提升、中国医疗器械智能化转型步伐加快以及国家鼓励高性能医疗器械的发展和进口替代的良好政策，吻合器未来市场发展空间较为广阔。目前开放吻合器品种已基本完成国产替代，腔镜吻合器品种依然由进口品牌主导，仍有国产替代空间。为了提高吻合器国产化率、填补市场空白，国内一批企业正在发力。天臣医疗于2003年8月成立，是一家专注于高端外科手术吻合器研发创新和生产销售的高新技术企业。通过近17年来不断自主研发创新，公司已拥有管型吻合器、腔镜吻合器、线型切割吻合器、荷包吻合器和线型缝合吻合器5大类产品，应用范围涵盖心胸外科、胃肠外科、肝胆脾胰外科、普外科、泌尿外科等手术领域。截至2019年底，公司拥有境内外专利380项，其中发明专利228项，覆盖中国、欧洲、美国、日本等国家和地区，有效突破了美国医疗器械巨头在该领域垄断多年的知识产权壁垒，成为国内高端外科手术吻合器出口的领先企业。风和医疗是一家国内领先的专注于微创外科手术器械及耗材的研发、生产和销售的创新型企业，专注于电动智能吻合器领域。公司的第二代电动腔镜吻合器Lunar是一款完全自主研发的产品，Lunar及前一代蓝电系列电动腔镜吻合器已拿到 FDA、CE、NMPA三类产品注册证。其Lunar II ®一次性电动腔镜用直线型切割吻合器拥有OLED高清显示屏，手柄倾斜78°，提升了术者握持和操作手感，“拉链”功能还可以降低“卡枪”风险。苏州英途康医疗科技有限公司是一家专注于外科手术器械研发及生产的创新型高科技企业。其自主研发的产品目前申请了海内外专利达400余项，发明占比近6成授权，授权专利超过200余项。目前，英途康智能电驱动平台全系列吻合器均已获得CE认证。根据华安证券预测，预计2022-2030年，中国吻合器市场规模的复合增长率为8.2%，高于全球平均水平；到2025年中国吻合器市场规模将达到140.58亿元，到2030年中国吻合器市场规模有望达到206.03亿元。随着企业自主研发能力的增强和技术的不断迭代，相信国内企业将在促进吻合器国产化、电动化、智能化上更上一层楼。参考资料：1.GBD 2017 Causes of Death Collaborators.Global, regional, and national age－sex－specific mortality for 282 causes of death in 195 countries and territories, 1980－2017: a systematic analysis for the global burden of disease study 2017[J]. Lancet, 2018, 392(10159):1736-1788. DOI：10.1016/S0140-6736(18)32203-7.2.姚宏伟, 许峰铭, 安勇博, 等.  直肠癌术后吻合口漏的早期诊断和预防研究进展 [J] . 中华胃肠外科杂志, 2021, 24(6) : 480-486. DOI: 10.3760/cma.j.cn.441530-20210401-00140.3.华安证券：医药生物深度报告——稳中求进，微创时代铸就百亿吻合器市场近期推荐声明：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

Oct. 14, 2021 11:30 UTC DUBLIN & MUNICH--(BUSINESS WIRE)-- OneProjects, developer of four-dimensional (4D) cardiac imaging technology, today announced a total of $17 million in new financing for the company, including an $8 million Series A2 financing and two grants worth $9 million. This press release features multimedia. View the full release here: Co-founders of OneProjects, Fionn Lahart (left) and Christoph Hennersperger (right) (Photo: Business Wire) The Series A2 financing was led by imec.xpand, with participation from the European Innovation Council (EIC) Fund and existing investors, including LSP and Atlantic Bridge Ventures. It is an extension to the company’s 2020 Series A1 funding that was led by LSP and co-led by Atlantic Bridge Ventures. The grants were awarded by the Irish government’s Disruptive Technologies Innovation Fund ($6 million) and the EIC Accelerator ($3 million). The company will use the new funds to complete product development, conduct clinical trials, gain FDA clearance and prepare for U.S. commercialization of the first product developed from its proprietary 4D cardiac imaging platform, VERAFEYE™. This technology is designed to improve the treatment of atrial fibrillation and other cardiac arrhythmias, and can also be applied to benefit structural heart procedures. Atrial fibrillation (AFib) is characterized by an irregular heartbeat caused by chaotic electrical signals entering and overriding the natural heart rhythm, and affects more than 38 million people globally. It is one of the most frequent causes of strokes and other heart conditions. A principal treatment for AFib is catheter ablation to block unwanted signals. In up to 50 percent of cases, full ablation of the tissue is unsuccessful, requiring a large percentage of patients to undergo repeat procedures, often with a worsening condition that requires continued medical management. The VERAFEYE™ imaging technology uses a proprietary catheter-based sensor combined with advanced imaging and machine learning to provide unprecedented live 360-degree, high-resolution imagery of the beating heart, as well as real-time tissue analysis to determine where tissue has been fully ablated. The goal is to enable physicians to optimize outcomes and safety during catheter ablation procedures in order to improve their success rate, which has the potential to reduce overall costs to the healthcare system. “It’s no surprise that AFib success rates are sub-optimal given the complexity of the procedure and information currently available to physicians,” said OneProjects CEO Fionn Lahart. “Our 4D imaging platform improves upon currently available imaging by providing high precision navigation, procedural planning pre-ablation, and expansive real-time imagery of the heart and tissue during the procedure. We believe that our proprietary cardiac imaging technology can help physicians deliver precision therapy and has value beyond AFib to improve any cardiac procedure that can benefit from precise navigation, detailed 4D anatomical imaging and tissue assessment within the heart.” He continued, “We are delighted to have the continued backing of our highly regarded existing investors, LSP and Atlantic Bridge, and to welcome our two new investors, Belgium-based imec.xpand and the European Innovation Council Fund. As a European company with offices in Dublin and Munich, we appreciate having exposure and access to these top-tier investors who will enable us to bring VERAFEYE™ to market and to develop the next generations of our platform technology. In addition to hitting key company milestones, we will use this funding to continue to build on the world-class team we have across Dublin and Munich.” Frank Bulens, partner at imec.xpand, commented, “A wide range of therapeutic modalities are available today for the treatment of atrial fibrillation, with more to come. We made the investment in OneProjects as its superior VERAFEYE™ imaging technology will serve all of these treatment options, a win for both the patient and the hospital. Accurate real-time imaging is also a prerequisite to allow part of this intervention to eventually become automated, which will be the next level of innovation.” Laura González-Estéfani, member of the EIC Fund Investment Committee, added: “We are glad to back this cutting-edge technology aimed at improving the treatment of cardiac arrhythmias. The EIC Fund support will help OneProjects to bring its technology, VERAFEYE™, to the market, which we believe will increase procedural safety for patients and reduce cost to the healthcare system.” In a separate announcement, OneProjects has added Steven Girouard as an independent board director. Steven is the former President and CEO of Securus Medical Group, which was acquired by Boston Scientific. He is a veteran of the medical device industry and has held executive management positions at Johnson & Johnson, Guidant Corporation, Cleveland Clinic, and Oakwood Medical Investors. He has extensive experience in early-stage research and development, preclinical and clinical research, business development, and venture capital. ABOUT ONEPROJECTS OneProjects is a privately held, venture-backed medical device company based in Dublin, Ireland and Munich, Germany. The company designs and develops an innovative 4D imaging platform for cardiac applications that operates at the intersection of hardware, software, and data science. Originating from Bioinnovate Ireland and spun out of Trinity College Dublin, OneProjects was founded by CEO Fionn Lahart and CTO Christoph Hennersperger in 2017. Learn more about OneProjects and VERAFEYE™ at . ABOUT imec.xpand Imec.xpand is an early stage and growth fund with a game-changing approach to turn hardware driven nanotechnology innovation into successful global companies. The fund is independently managed by a team of entrepreneurs, seasoned venture capitalists and business experts, and is targeting ambitious tech start-ups that meet all the criteria to become successful, scalable ventures with the potential to change the world, and where imec knowledge, expertise and infrastructure can play a determining role in their success. For more information about imec.xpand, please visit . ABOUT EIC FUND Established in June 2020, the European Innovation Council Fund (EIC Fund) is a breakthrough initiative of the European Commission to make direct equity and quasi-equity investments (between €500.000 and €15 million) in European high impact and deep tech start-ups and scale ups. With a long-term perspective, the EIC Fund invests in companies from any sector, across all EU member states as well as in associated countries. The EIC Fund aims to fill a critical financing gap and its main purpose is to support companies in the development and commercialization of disruptive technologies. This is achieved by crowding-in market players and further sharing risk by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The Fund pays particular attention to the empowerment and support of female founders, as well as the ambition to reduce the innovation divide among EU countries.