Fractures, Compression

随着人口老龄化程度的逐步加剧，骨质疏松症的发病率也在逐年上升。截至2020年，我国约有8000万人患有不同程度的骨质疏松症。 作为骨质疏松症的重要并发症，椎体压缩性骨折是骨质疏松症的常见首发症状或就医原因。WHO统计显示，全球每年有超过890万人发生骨质疏松性骨折。 骨质疏松性椎体压缩骨折，是指由于原发性骨质疏松症导致的脊柱椎体骨密度和骨质量下降、骨强度减低，椎体在轻微外伤甚至没有明显外伤的情况下即发生压缩骨折。由于发病隐匿，这一病症很多时候并无法被患者察觉。研究表明，如果不对骨折进行手术治疗，患者的发病率和死亡率将会增加。更严重的是，发生脊椎骨折后，未来12个月内发生再次骨折的可能性为 19.2%。 Lenoss Medical成立于2017年，是一家美国的生物技术公司，专注于骨质疏松性脊柱骨折的生理治疗技术。公司认为，通过自然疗法，患者可以获得更好的治疗效果。于是推出了其核心产品——OsteoPearl VBA 系统。该系统用于治疗脊柱骨折，利用健康骨骼的自然愈合特性与微创无骨水泥技术，颠覆了脊柱骨折的治疗方式。作为美国首款完全结构化的 VBA 系统，可提供无骨水泥、100% 皮质骨稳定的植入物，为治疗椎体压缩性骨折提供更优选择。 彻底消除骨水泥术式 带来的风险 20世纪80年代，法国医生Deramand和Galiber首先运用椎体成形术（Vertebroplasty）治疗血管瘤所致的椎体骨质破坏，迅速缓解了患者的长期疼痛。此后，这一技术广泛运用于治疗骨质疏松症以及肿瘤所致的椎体压缩骨折和骨质破坏，开创了椎体压缩骨折微创治疗的新纪元。目前，骨水泥填充术已成为治疗椎体压缩性骨折常见的治疗方式，经皮椎体后凸成形术（PKP）和椎体成形术（PVP）也成为了骨质疏松性椎体压缩骨折首选的微创手术治疗方法。 骨水泥是一种用于骨科手术的医用材料，可起到连接和填充的作用，其部分物理性质以及凝固后的外观和性状与建筑中常用的白水泥相似。在进行手术时，需要将患者病变处的椎体撑开，然后注入骨水泥，迅速稳定脊柱。 虽然骨水泥具有塑形快、可塑性好、生物相容性高等特点，但其副作用和风险也显而易见。 在经皮椎体成形术（PVP）的手术过程中，骨水泥由注射位置向周围无序扩散，因无法控制骨水泥弥散，导致渗漏风险很大。并且，椎体成形术无法生理性地愈合骨折或促进椎骨中新骨的形成。经皮椎体后凸成形术(PKP)可通过球囊扩张使压缩骨折得到一定程度的复位，球囊取出后在椎体内形成的空腔有利于骨水泥低压力注入，但与经皮椎体成形术(PVP)一样，也存在骨水泥渗漏、椎体再骨折及术后静脉栓塞等并发症。 不难看出，导致这些术式存在较多副作用和风险的一大原因，便是手术中使用的骨水泥。 有研究指出，在这些需要使用骨水泥的脊柱手术治疗中，骨水泥有超过20%的几率会从椎骨中泄漏出来。这种泄漏有时会导致骨水泥进入血液循环系统，并最终可能堵塞在心脏或肺部，增加患者患上肺动脉高压或需要进行心脏手术的风险。除此之外，骨水泥有可能会由椎体后壁的破裂部位渗漏到椎管内，造成椎管内占位，继而对脊髓或神经造成压迫，损害患者的神经系统。 另外，骨水泥凝固过程中，会产生大量热量，使得局部温度升高，可能引起骨质受热坏死。在骨水泥固化的过程当中，可能会产生一定程度的膨胀。如果在髓腔内部植入骨水泥，可能对骨髓腔内造成严重的挤压，髓腔内部的脂肪可能会由于压力过高进入到血管内部，继而形成脂肪栓塞。 那么，如何彻底消除骨水泥泄漏以及散热过程中带来的风险呢？Lenoss Medical提供了一个能够从根源解决问题的方案——无骨水泥技术。 利用经临床验证的生物骨组织 实现骨骼天然修复 谈起Lenoss Medical致力于革除骨水泥术式弊端的发心，就不得不提到其创始人Dom Messerli。 作为Lenoss Medical的创始人、总裁兼首席执行官，Dom Messerli在创立 Lenoss Medical 之前，曾担任研发总监，负责强生脊柱部门 DePuy Synthes Spine 的收购、整合和转型工作。在加入强生之前，Dom 在Synthes Spine的产品开发和市场营销领域担任领导职务，期间公司收入增长至超过5亿美元。Dom 带领全球团队完成了多个产品的商业化发布，并成功带领其部门从初创阶段发展至市场领导地位，以出色的创新产品推介节奏，将全球年销售额从1000万美元增加到1.5亿美元。 在 DePuySythnes 工作期间，椎体压缩性骨折的患病率之高与巨大的未被满足的临床需求让Dom感到震惊。 为了通过天然骨骼修复解决这一问题，Dom创办了 Lenoss Medical并开发了OsteoPearl 生物同种异体移植植入物，它以天然的替代品取代了目前复杂且风险高的骨水泥治疗方法。OsteoPearl 完全由同种异体皮质骨制成，利用经临床验证的生物骨组织治愈脊柱骨折。 OsteoPearl 植入物 “创意在于简单”，这是 Dom Messerli 的产品开发理念。在他深耕脊柱医疗器械领域的30 年里，作为发明家，他拥有多项与脊柱专科医疗设备相关的专利，也为OsteoPearl VBA 系统的研发奠定了深厚的基础。 与Dom的上述理念一脉相承，OsteoPearl VBA 系统秉持“简单高效”的设计理念，不仅提高了手术或治疗过程中的工作效率，而且减轻了供应链上的压力和复杂性。该系统采用了先进的无毒材料和技术，确保在操作过程中不会产生有毒害的烟雾。同时，能实现尽量减少使用步骤、减少带入手术室的器械数量，并针对门诊手术中心设置进行了优化。 用无骨水泥技术 促进骨骼生长并诱导新骨形成 OsteoPearl VBA 系统可通过微创手术植入，固定脊柱骨折部位，同时促进受损区域的自然恢复和愈合。该系统具有解剖学和生物学特性，能够更自然地融入人体，而非不能促进愈合的合成异物，且遵循AO 骨折复位和固定原则以恢复解剖关系、保护软组织和骨骼的血液供应。 据公司披露，OsteoPearl VBA系统是第一个也是唯一一个治疗VCF的全生物解决方案。该系统采用100% 皮质骨引入结构来治疗骨质疏松症。同时，作为首个采用完全生物学的无骨水泥技术系统，OsteoPearl VBA系统通过避免使用骨水泥消除了与骨水泥相关的栓塞风险，旨在立即稳定受损的椎体，并促进脊柱的长期愈合、恢复健康。 OsteoPearl VBA 系统采用专利的 OsteoPearl 植入技术，在植入时能够立即形成一个三维的骨结构支架，同时促进血液流动。该技术具有成骨导性和成骨诱导性，使得该支架不仅能够促进骨骼的生长，还能够引导新骨形成，并且利用完全的生物材料来实现高强度的压缩支持，从而在长期内为患者带来生物学上的获益。 右图为 OsteoPearl 植入物11个月后的情况 边缘模糊的部分显示了新骨正在最需要的地方形成 OsteoPearl VBA系统的专利工具——Elevoss腔体创建器，允许医生在处理椎骨损伤或骨折时，能够精确控制操作方向，并通过触觉反馈来感知操作情况，以便在患者体内准确地创建一个适合放置 OsteoPearl 植入物的空腔。OsteoPearl植入物由100%的皮质骨珠链组成，一旦重新水化，珠链会扩张40%，增加其体积和弹性，同时保持强度，从而更好地适应椎骨的形状并提供支持。 以上特性使得 OsteoPearl VBA 系统成为一种有益于骨骼健康和修复的长期、自然的解决方案。 在开发 OsteoPearl VBA 系统的过程中，Lenoss Medical面临的主要挑战是如何高效地大批量生产。与金属或塑料植入物不同，其产品由珍贵的原材料——捐赠的人体组织制成，珍贵而又神圣。 为了尽可能保护并使这些原材料的利用率最大化，Lenoss Medical应用迭代设计和一般制造原则，采用高效的固定装置和工具，在不造成原材料浪费的情况下进行大批量生产。同时，公司还应用了大量的工程创新，每当找到一种提高制造流程效率的方法时，都会为这种方法申请专利。 目前，OsteoPearl VBA 系统成功实施了首次人体手术，迄今共计完成近 50 例手术，无任何静脉栓塞情况发生。2024年5月11日，Lenoss Medical宣布于5月9日完成400万美元A融资。由Xcellerant Ventures、Highpoint Ventures、Vodia Capital、RightHill Ventures和多家天使投资集团投资。接下来，Lenoss Medical将继续专注于临床数据的收集，并且对所有新客户都采用注册数据收集。OsteoPearl VBA 系统已经获得在骨科手术中使用同种异体组织的出色临床证据，并计划将这些数据更具体地应用于脊椎骨折治疗。 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

Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures. La Ciotat, FRANCE, June 12, 2024 /PRNewswire/ -- Avicenna.AI, a leading medical imaging AI company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for CINA-VCF, a triage and notification AI tool that detects unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans. Often resulting from the deterioration of bone structure (osteoporosis), VCFs can cause significant pain, deformity, and height loss. In the USA, approximately 750,000 adults suffer from osteoporotic VCFs each year, but around two-thirds of those go undetected or unreported. The CINA-VCF algorithm identifies and prioritizes vertebral compression fractures detected during routine CT scans for patients undergoing medical imaging for entirely different health conditions, notifying clinicians within seconds. The tool was validated on 474 CT scans (performed for other clinical indications than for VCF evaluation) acquired on 38 different scanner models from four different manufacturers, achieving excellent sensitivity and specificity results. By facilitating the early detection of vertebral compression fractures, CINA-VCF aims to help prevent further bone density loss and additional fractures, enhancing patient care and outcomes. The tool enables vertebral fractures to be addressed before they multiply, reducing the risk of complications and potentially lowering medical expenses. "Osteoporosis is a global burden affecting millions, especially postmenopausal women, and often goes unnoticed until symptoms like pain and loss of mobility appear," said Cyril Di Grandi, co-founder and CEO of Avicenna.AI. "By detecting vertebral compression fractures early, we aim to help patients maintain better mobility and independence, enhance the well-being of those at risk, and reduce the burden on healthcare systems worldwide. We have also partnered with the International Osteoporosis Foundation to increase awareness about this debilitating condition." CINA-VCF is the latest tool from Avicenna.AI to secure FDA clearance, joining its AI solutions for automatic detection of a host of conditions from CT imaging. It is also the company's second tool FDA-cleared for incidental findings, alongside CINA-iPE, which identifies unsuspected cases of pulmonary embolism in oncology patients. The company's other AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and quantification of stroke severity (CINA-ASPECTS). All of Avicenna.AI's AI tools are seamlessly integrated into radiologists' clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists. About Avicenna.AI Founded in 2018, Avicenna.AI specializes in providing healthcare AI solutions that utilize deep learning to identify, detect, and quantify severe pathologies from CT medical images. Co-founded by Cyril Di Grandi, a successful entrepreneur who previously co-founded Olea Medical, and Dr. Peter Chang, an internationally recognized radiologist, and an expert in AI and deep learning, Avicenna.AI aims to accelerate therapeutic decision-making processes and enhance patient outcomes through its AI-based radiology solutions. For additional details, stay connected with us on social media and explore Avicenna.AI's website at . For more information, contact: Stéphanie Bellavia, Marketing Manager, Avicenna.AI Email: [email protected] SOURCE Avicenna.AI

Aidoc aiOS™ integration across 13 hospitals focuses on enhancing clinical outcomes and streamlining workflow with access to 17 FDA-cleared AI algorithms CLEVELAND, June 12, 2024 /PRNewswire/ -- University Hospitals (UH) has announced a major advancement in its AI strategy with the deployment of Aidoc's comprehensive AI platform (aiOS™) across 13 of its hospitals and dozens of its outpatient locations. This initiative marks a significant leap forward in leveraging cutting-edge technology for superior patient outcomes. Continue Reading Image of University Hospitals Medical Center Campus in Cleveland, Oh. (PRNewsfoto/Aidoc) University Hospitals Logo (PRNewsfoto/Aidoc) Driven by a commitment to provide the highest standard of care, UH sought a standardized, hyper-accurate AI platform that could be seamlessly integrated across its network of academic hospitals and outpatient locations. Having utilized AI in various small-scale applications, UH chose to expand its capabilities with Aidoc to empower care teams with the information they need to address some of today's most pressing medical issues. Patients at UH will benefit from faster diagnosis and treatment of acute conditions such as pulmonary embolism, aortic dissection, vertebral compression fracture and pneumothorax. When a patient arrives at a UH facility and undergoes a CT scan for an injury or pain, Aidoc's AI analyzes the scan using its comprehensive algorithms. The technology identifies both expected and unexpected findings, helps physicians prioritize urgent cases and ensures all flagged conditions are reviewed by the care team. Aidoc's AI facilitates communication between the care team to enhance collaboration and speed up treatment. Key Benefits of Aidoc for University Hospitals Seamless integration across the entire health network Immediate access to critical patient information Expedited care and improved patient outcomes Access to all 17 FDA-cleared AI algorithms for triage, quantification and care coordination "Today's care delivery is incredibly complex with numerous moving parts," shared Dr. Donna Plecha, Chair of Radiology at University Hospitals." Aidoc's AI technology assists our radiologists in evaluating various patient images, allowing our clinicians to access precise, actionable data quickly. The AI technology enables our care teams to be more accurate and efficient leading to even more exceptional care for our patients." The agreement leverages Aidoc's proprietary aiOS™, a groundbreaking platform that addresses common AI implementation challenges such as integrating with existing IT systems, ensuring EHR compatibility, and managing data and reporting. This comprehensive approach ensures that UH can provide leading-edge care while maintaining operational efficiency and clinical excellence. "We are thrilled to collaborate with University Hospitals to drive healthcare innovation through our AI solutions," said Elad Walach, CEO, Aidoc. "University Hospitals' visionary approach to healthcare and dedication to integrating technology sets a new standard for patient care. UH is not only enhancing care coordination and streamlining workflows but also ensuring every patient receives the precise, timely and exceptional care they deserve. UH's commitment to medical ingenuity and excellence is truly transformative." By integrating Aidoc's AI platform, University Hospitals ensures seamless deployment and minimal technical challenges, allowing for a collaborative approach to continuous monitoring and governance. This partnership not only enhances patient safety and care but also enables UH to maintain high standards in AI performance and reliability. Through this collaborative effort, UH can focus more on patient care, ensuring every patient receives the best possible treatment with the aid of AI technology. About University Hospitals Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 21 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system's flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, the Technion Israel Institute of Technology and National Taiwan University College of Medicine. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including "America's Best Hospitals" from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org. About Aidoc Aidoc is a pioneering force in clinical AI. We focus on aiding and empowering healthcare teams to optimize patient treatment, which results in improved economic value and clinical outcomes. Our clinically proven AI solutions eliminate silos, increase efficiencies, and improve outcomes by delivering critical information when and where care teams need it leading to immediate collective action. Built on Aidoc's proprietary aiOS™, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Used in more than 1,000 medical centers worldwide, Aidoc has the most FDA clearances (17) in clinical AI and its AI-based solutions cover 75 percent of patient populations, enabling physicians to make informed decisions based on real-time data. Aidoc AI is always on, running in the background to change the foreground. Visit Aidoc.com to see how we are connecting all points of care with always on AI. Photo - Logo - Logo - SOURCE Aidoc