Embolic Stroke

Sept. 17, 2024 -- Endomimetics, the developer of Bionanomatrix™, a peptide-based biomaterial to promote healing and improve outcomes following medical device implantation and other procedures, today announced the awarding of a $2.8 million Phase II Small Business Innovation Research (SBIR) grant to support research to evaluate the potential of Bionanomatrix™ to improve performance of flow diverters used in the treatment of brain aneurysms. This application of Bionanomatrix™ is one of several in development that provide further evidence of the broad utility of Bionanomatrix™ to improve performance and patient outcomes of implantable medical devices. The Phase II SBIR grant provides funding to support research for (1) manufacturing process scale up and optimization including long term stability of the Bionanomatrix™ coating and packaging validation and (2) assessment of two- and six-month efficacy and safety of the Bionanomatrix™ coating in a rabbit aneurysm model. Under the grant, Endomimetics will collaborate with Ramanathan Kadirvel, Ph.D., and David Kallmes, M.D., both professors of Radiology at the Mayo Clinic, Rochester, Minnesota, to evaluate the Bionanomatrix™ coating for flow diverters in the brain. “Brain aneurysms carry the devastating risk of rupture, leading to death or permanent disability,” said Joseph Garner, Ph.D., Chief Executive Officer of Endomimetics. “Flow diverters, commonly used to treat aneurysms, maintain a risk of thromboembolic complications until endothelialization and aneurysm closure has occurred. Use of anti-clotting medications to reduce the risk of clot formation place patients at increased risk of bleeding during the several months required to achieve endothelial healing. Application of the Bionanomatrix™ coating to flow diverters could accelerate endothelialization and reduce the risk of embolic stroke or brain hemorrhage and improve patient outcomes. If this research is successful, we plan to partner the technology with a flow diverter manufacturer and begin IND Enabling studies and clinical development.” Approximately 3% of the population has unruptured cerebral aneurysms or approximately six million people in the U.S. About 30,000 aneurysms rupture each year, with devastating consequences. About 40% of patients with ruptured aneurysms die, and four of seven who survive have significant disabilities. To address this issue, several devices have been developed that can be implanted to prevent aneurysm rupture, such as flow diverters, which are increasingly being used to cover the neck of the aneurysm providing more durable occlusion. However, until endothelialization and aneurysm occlusion has occurred patients are at increased risk of thromboembolic complications and increased intracranial hemorrhage due to treatment with dual antiplatelet therapy. The Bionanomatrix™ coating mimics the characteristic properties of native endothelium. The addition of the Bionanomatrix ™ to the flow diverter is anticipated to enhance endothelial coverage and accelerate aneurysm closure with the goal of reducing post treatment adverse events. The coating provides sustained release of nitric oxide, thus recruiting and retaining endothelial cells and reducing inflammation. It also incorporates an endothelial cell adhesive ligand that promotes endothelial cell retention and migration. Endomimetics is a privately held Company founded to develop applications for its proprietary BionanomatrixTM technology. The BionanomatrixTM, invented by bioengineering scientists and physicians at the University of Alabama Birmingham (UAB), is a peptide-based coating that can be engineered to perform a variety of functions, which may have broad application in medical device implantation and other surgical procedures. Endomimetics’ plans to develop different applications through the preclinical stage and then partner with medical device companies whose technology could benefit from BionanomatrixTM. The Company’s lead indication is the AVF GEL, which is designed to improve the maturation of arteriovenous fistulas. Other indications include coatings on stents and angioplasty balloons, dental direct pulp capping (DPC) and flow diverters. Additional information may be found on the Company’s website https://endomimetics.com/. The Small Business Innovation Research (SBIR) program, created in 1982 through the Small Business Innovation Development Act and reauthorized in 2011, is one of the largest public–private partnerships in the United States. The SBIR program encourages U.S. small businesses with fewer than 500 employees to provide quality research and to develop new processes, products and technologies in support of the missions of the U.S. government. Administered by DHS S&T, the DHS SBIR Program, supports a full spectrum of SBIR initiatives serving all components. The content above comes from the network. if any infringement, please contact us to modify.

如果说，人生是一场漫长的旅途，大多数时间我们都在徐步前行。但在脑卒中面前，我们必须奋力前行、跑赢死亡线，毕竟每一分钟就有190万个神经元因缺血死亡。根据GBD 2019的研究结果，2019年我国有卒中患者2876万例，其中缺血性卒中患者2418万例，脑出血患者436万例，蛛网膜下腔出血患者158万例。卒中成为威胁我国居民健康的主要疾病之一。 从医学分类来看，大部分卒中为缺血性卒中，其中一部分为不明原因栓塞性卒中。而在卒中的众多致病因素中，卵圆孔未闭（Patent Foramen Ovale，简称PFO）作为一个潜在的危险因素，近年来逐渐引起了研究者和临床医生的广泛关注，被认为可能与不明原因的栓塞性卒中有密切关联。 每一个胎儿在发育期间都需要一个生命通道获得氧气及营养物质，这个通道不是肺血管，而是卵圆孔。母亲的脐静脉血附带着氧气与营养物质经过卵圆孔进入胎儿的左心系统，然后分布到全身各个器官，使胎儿能够安全发育。胎儿出生后，右心压力减低，左心房压力高于右心房，卵圆孔会逐渐闭合。若大于三岁的幼儿卵圆孔还未闭合，就被称为卵圆孔未闭。 据《卵圆孔未闭相关卒中预防中国专家指南》、《卵圆孔未闭相关非卒中性疾病防治中国专家共识》、《卵圆孔未闭规范化诊疗中国专家共识2024》显示，PFO与不明原因脑卒中、偏头痛、短暂脑缺血等症状有关，国际上已有四项随机对照研究显示，在降低脑卒中复发风险方面，经导管封堵PFO优于单纯药物治疗。 卵圆孔未闭是临床上常见的心脏结构异常，近年来多种不同的封堵器相继上市，根据其材料特点可分为不可降解型封堵器及生物可降解封堵器，为PFO患者提供了不同选择。《中国心血管健康与疾病报告2019概要》指出，中国心血管病患病率及死亡率仍处于上升阶段，据推算，心血管病现患人数3.3亿，其中脑卒中2876万，其中25%缺血性脑卒中患者为不明原因栓塞性卒中（ESUS），而在ESUS人群中，PFO患病率高达49.3%。目前，PFO介入治疗跃居所有结构性心脏病数量之首。 在PFO手术呈现“井喷”之势下，动脉网关注到聚焦于心脏病尤其是结构性心脏病介入治疗领域的创新企业无忧跳动医疗科技（深圳）有限公司（简称“无忧跳动医疗”），其独立研发的ConBrella™可降解封堵器系统于5月成功斩获2024年度VBEF医疗健康产业创新力产品。该榜单面向医疗健康领域创新产品展开评选，旨在发掘并展示能代表中国乃至全球医疗健康产业具有全球竞争力和技术先进性、国产替代价值高、立足临床未满足需求、行业引领效应突出的医疗健康创新产品和创新解决方案。 医疗老兵的第三次创业，推动PFO手术量从千到万 “找谁都走不通的路，我必须自己走。”无忧跳动创始人康立标这样讲述创办无忧跳动的原因的。在医疗领域，康立标绝对称得上是创业“老兵”。从2006年开始，康立标便在医疗行业中摸爬滚打，从药物销售、器械代理到创办创新企业，从临床、研发到市场，可以说遍历了医疗行业各个关键环节。 无忧跳动创办于2021年，在这次创业之前，康立标还有两次创业经历。“第一次是从2006到2014年，我们主要做抗生素的代理，市场成绩特别好。但在临床上，抗生素滥用的现象极其严重，站在销售端的角度来说利好，但滥用药物的后果总是让我不安。”康立标说到。 资料显示，我国是最大的抗生素生产国和使用国，近几年数据显示，我国医院抗生素综合使用率达到70%以上，远超世界卫生组织推荐的30%院内使用率，已经达到了严重滥用的程度。 “但直到2012年我才开始明白抗生素的滥用的后果，其会导致免疫功能下降、体内菌群失调、体内菌群耐药性增加、药物不良反应增加等等。我开始与当时的合伙人商量，放弃代理抗生素，但说服对方是很难的。”从2013年底开始，康立标就离开了这家药品代理公司，决心要做更能提高患者生命质量的事，从而进入了医疗器械产业的大门。 2014年，康立标创办了一家医疗器械销售代理公司，并从2017年开始进入PFO产品领域。这一年，3项随机对照试验同时报告了隐源性卒中发作后进行PFO封堵术的安全性和有效性研究，宣告对于归因于PFO的隐源性卒中患者，PFO封堵术联合药物治疗优于药物单独治疗的研究进展。从2017年到2019年，康立标带领公司将PFO介入封堵这一新兴手术的数量从千例推向万例，如今中国市场已迈进近十万例，改善了无数患者的生活质量并挽救了其临床结局。 在这几年中，康立标往返于医疗器械公司和医院，发现当前治疗PFO的器械存在一些痛点，“PFO的临床获益无人质疑，但仍然存在一些缺陷，会影响患者的长期生活质量。”康立标说。此后一段时间内，康立标尝试将这些缺陷反馈给医疗器械公司，但都徒劳无功。为了彻底解决这些痛点，康立标决定自己亲自成立团队来解决临床真实存在的问题。就这样，2021年，无忧跳动在深圳成立，并将核心产品线瞄向PFO。 降解速率可控、贴合紧密、 内皮化快速且完全 临床上，PFO封堵术的并发症多种多样，包括心包积液或心脏压塞、残余分流、对封堵器过敏、心律失常、房间隔夹层、封堵器血栓形成、封堵器移位或脱落、感染性心内膜炎以及医源性房间隔缺损等。 同时，PFO封堵器植入后主要起到阻流血液和“临时桥梁”的作用，让组织能够沿封堵器覆盖攀爬最终完成对封堵器的内皮化，实现缺损部位的闭合。在完全内皮化后，人体实际不再需要封堵器，但金属封堵器无论如何改进，其基本构成一般都是由镍钛合金骨架与聚酯纤维阻流膜组成，均为不可降解材料，植入后终身留存体内，仍可能带来远期并发症风险，甚至部分患者存在心理问题。并且，还会影响患者其他需要经房间隔穿刺的手术，如左心耳封堵、二尖瓣夹闭等心脏介入手术。 据《卵圆孔未闭预防性封堵术中国专家共识》，中国有25％左右的成年人卵圆孔不完全闭合，几乎每4个人便有一个人患有卵圆孔不完全闭合，患者数量庞大。“从国内外诊疗指南来看，适用PFO封堵术的人群被限制在 16-60岁或18-60岁，需在发病后才适用该手术。换句话说，PFO是相对典型的中年病，一旦使用金属类的PFO封堵器，便会丧失未来进行介入手术的机会，只能开胸治疗。鉴于这些潜在风险，研发更理想、更安全的可降解PFO封堵器势在必行。”无忧跳动创始人康立标说。 目前来看，可降解PFO封堵器的研发已取得显著成果，并已有产品成功获批上市，在临床上展现出了其独特的优势。不过，由于材料的特殊性会导致封堵器成型不理想、存在术后残余分流、甚至因内皮化不完全产生新的血栓并导致栓塞风险等情形使可降解PFO封堵器仍然存在痛点。 基于此，无忧跳动自主研发了全球首创无铆点柔性连接一体化设计的ConBrella™ PFO封堵器系统，其具有操作简单、降解速率可控、贴合紧密、内皮化快速且完全的独特优势。“在过去的PFO封堵术中，铆点能够帮助医生进行介入手术定位，我们通过预装一体化，最大程度缩短手术时间并有效降低术者和患者受到的辐射剂量的同时，采用无铆点设计，真正实现了全降解，确保患者体内无残留。目前无忧跳动的PFO封堵器能够实现1年内完全降解，最大程度降低对患者生活的影响。”康立标介绍。  无忧跳动ConBrella™  PFO封堵器系统 此外，无忧跳动采用腰部可调设计，封堵器形态可控，能适应不同的卵圆孔解剖结构，输送装置与封堵器柔性连接方式，提升了器械安全性，封堵器主体和阻流膜采用同步降解的材料组成，降解速度可控，促进内皮修复，长效闭合，有助于减少远期并发症，如血栓事件和心律失常，从而降低远期的治疗成本。 在知识产权方面，无忧跳动具备在产品核心原理、产品结构设计、材料制备、产品外观等多方向的自主核心专利50余项。   打造诊疗一体化， PFO封堵器完成临床试验入组 围绕卵圆孔未闭展开，除PFO封堵器外，无忧跳动还打造了全自动心脏分流诊断设备、超顺应性球囊等五款自主创新性产品，覆盖有源产品和无源产品，提供全套完善的PFO诊、治一体化方案。 目前，无忧跳动ConBrella™ PFO封堵器系统的临床试验入组工作圆满完成。此次临床试验由中国医学科学院阜外医院深圳医院和武汉大学中南医院联合牵头，携手全国多家顶尖医院，包括中国医学科学院阜外医院、广东省人民医院、中南大学湘雅医院、香港大学深圳医院、武汉亚洲心血管病医院、四川省人民医院、云南省阜外心血管病医院、兰州大学第一医院、江苏省人民医院、新疆自治区人民医院、河北医科大学第一医院和襄阳市中心医院等（排名不分先后）。该试验为前瞻性、多中心、随机对照临床试验，旨在全面验证ConBrella™系统的卓越安全性和有效性，预计该产品将于今年底提交注册。 此外，无忧跳动的ConSuper™封堵器输送系统（国械注准20243030961）已获批上市，其他产品也将于今年陆续上市，能满足PFO诊、治一体化的临床需求。依靠创始人康立标强大的渠道能力、创始团队多年的市场经验和丰富的临床专家资源，产品将得到高效入院并快速上量，成功商业化也指日可待。 当前无忧跳动已通过国家高新技术企业认定，被评为大学生实习基地、四川大学实习基地、坪山区高成长性企业、科技型中小企业等。未来，背靠强大的研发专家团队，借助省内外知名高校、研究所等转化平台，无忧跳动将在心脏病尤其是结构性心脏病介入治疗领域持续创新。 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

Funding supports commercial expansion of inHEART's digital twin of the heart in the US, EU, Asia Pacific, and Middle East markets, as well as the development of new software solutions across the cardiac care continuum CAMBRIDGE, Mass. and BORDEAUX, France, May 6, 2024 /PRNewswire/ -- inHEART, a medical device company delivering the world's most advanced, AI-driven digital twin of the heart, has raised $11M to drive commercial growth of its therapeutic software solution for cardiac ablation procedures and advance the development of its predictive cardiac models for heart failure, sudden cardiac death, and cardio-embolic stroke. Continue Reading inHEART - Digital Twin of the Heart The financing was led by Vesalius Biocapital IV and co-led by Elaia Partners with participation from NACO, Sagana, Sofia Angel Ventures, CWR Funds, and Webit Investment Network. In addition, inHEART received funds from a successful crowdequity campaign on Tudigo and from the UK impact fund Astorg Foundation. "We welcome this strong international group of investors to our latest round of financing," said Todor Jeliaskov, Chairman and CEO of inHEART. "This new round allows us to go further in addressing the needs of cardiac patients from early screening and disease detection through advanced therapeutic support. It's exciting for us to be at the forefront of transforming the healthcare industry with the power of AI technology by improving the efficiency of care, quality of decision-making, and effectiveness and safety of medical interventions." "We are enthusiastic to continue our support and co-lead this financing round for inHEART," said Samantha Jérusalmy, board member at inHEART and Partner at Elaia. "inHEART's AI-driven 3D cardiac mapping enables unprecedented precision in targeting and treating arrhythmias, setting new standards in the treatment of heart conditions." "At Vesalius Biocapital IV, we're dedicated to supporting advancements in medical technology that improve patient care." said Jean-Christophe Renondin, Managing Partner at Vesalius Biocapital IV. "inHEART's AI-driven solutions exemplify the future of cardiac care, offering personalized therapy options and predictive models that can enhance clinical outcomes and streamline treatment processes. We're excited to contribute to inHEART's journey as they revolutionize cardiac care and address global healthcare needs with cutting-edge technology and innovation." Optimizing cardiac care inHEART's current therapeutic solution addresses the challenges of conventional cardiac ablations. The inHEART solution creates highly detailed, interactive 3D heart models with proprietary AI-driven cardiac CT or MR image segmentation. These 3D models of the heart allow physicians to optimize treatment strategies based on each patient's unique cardiac anatomy and to support pre-procedural planning for faster ablation procedures and improved clinical outcomes. AI-driven predictive models Financing from this round will also support the development of new product verticals for AI-driven predictive software models for sudden cardiac death and cardio-embolic stroke, as well as a new therapeutic software solution to help physicians treat heart failure patients. Currently, inHEART is commercially available in the US and EU through a direct sales force model, with plans to establish a global distribution network in the coming months to further accelerate growth. About inHEART inHEART is delivering the world's first AI-driven, digital twin of the heart to advance the care of patients living with cardiac disease. We are committed to addressing the needs of the cardiac care continuum by providing personalized therapy in a predictive manner for screening and early detection of cardiac diseases. At inHEART, we believe all patients deserve access to world-class cardiac imaging expertise to optimize treatment strategies, improve clinical outcomes, and return patients to full, healthy lives. For more information, visit inheartmedical.com Logo -