BOSTON--(BUSINESS WIRE)--Elucid has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its PlaqueIQ™ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). PlaqueIQ is the first FDA-cleared non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques.

波士顿--（商业新闻短讯）--Elucid宣布其PlaqueIQ™成像分析软件已获得美国食品和药物管理局（FDA）510（k）的许可，该软件可帮助医生诊断心血管疾病（CVD）。PlaqueIQ是FDA批准的第一个非侵入性软件，可以根据地面真实组织学（斑块表征的金标准）客观地量化和分类斑块形态。

PlaqueIQ is designed to give physicians new, clinically validated information to help stratify patients and inform patient-specific treatment pathways..

PlaqueIQ旨在为医生提供新的，经过临床验证的信息，以帮助对患者进行分层，并告知患者特定的治疗途径。。

Cardiovascular disease is the most common cause of death and disability globally, largely driven by myocardial infarction (MI) and ischemic stroke caused by atherosclerosis (plaque build-up and rupture in the arteries).1 While physicians look at many risk factors to evaluate patient risk, such as age, diet, and lifestyle, the strongest predictor of future events is the amount and type of plaque patients have in their arteries.2 About half of Americans between ages 45 and 84 have atherosclerosis and don’t know it.3.

心血管疾病是全球最常见的死亡和残疾原因，主要由心肌梗塞（MI）和动脉粥样硬化（斑块积聚和动脉破裂）引起的缺血性中风引起。1虽然医生会研究许多风险因素来评估患者的风险，如年龄，饮食和生活方式，但对未来事件的最强预测指标是患者动脉中斑块的数量和类型。2大约一半年龄在45至84岁之间的美国人患有动脉粥样硬化，并且不知道。

“The fact that low-risk, asymptomatic patients represent such a large portion of the population means that even a small fraction of them account for a substantial number of myocardial infarctions,” said Dr. Amir Ahmadi, Clinical Associate Professor of Medicine and Cardiology, Icahn School of Medicine at Mount Sinai, and co-director of the Cardiac Intensive Care Unit at Mount Sinai Fuster Heart Hospital at Morningside..

西奈山伊坎医学院医学与心脏病学临床副教授、莫宁塞德西奈山福斯特心脏医院心脏重症监护室联合主任阿米尔·艾哈迈迪博士说：“低风险、无症状患者占人口的很大一部分，这意味着即使是他们中的一小部分也会导致大量心肌梗塞。”。。

“It’s time to shift our focus from merely estimating risk and treating risk of MI to directly visualizing and treating the disease itself by looking at the coronary arteries,” continued Dr. Ahmadi. “I believe that PlaqueIQ will enable physicians to better ‘see’ the disease—specifically plaque quantity and type—so that we can treat patients with greater precision and in personalized manner, improve their quality of life, and ultimately prevent MI and stroke more effectively.”.

Ahmadi博士继续说道：“现在是时候将我们的重点从仅仅估计心肌梗死的风险和治疗风险转移到通过观察冠状动脉直接观察和治疗疾病本身了。”。“我相信PlaqueIQ将使医生能够更好地“看到”疾病，特别是斑块的数量和类型，以便我们能够以更精确和个性化的方式治疗患者，提高他们的生活质量，并最终更有效地预防MI和中风。”。

PlaqueIQ utilizes first-line diagnostic CCTA and develops comprehensive, interactive reports to help physicians virtually “see” plaque at the vessel level. With its basis in histology, the software is uniquely able to non-invasively quantify and characterize non-calcified plaque and its components such as lipid-rich necrotic core (LRNC), giving potential insights into high-risk plaques that are key drivers of risk of heart attack and stroke.3 In addition, use of the software has the potential to enable earlier identification of higher-risk plaque before presence of symptoms or major adverse events..

。该软件以组织学为基础，独特地能够无创地量化和表征非钙化斑块及其成分，如富含脂质的坏死核心（LRNC），为高风险斑块提供潜在的见解，这些斑块是心脏病发作和中风风险的关键驱动因素。此外，该软件的使用有可能在出现症状或重大不良事件之前尽早识别出高风险斑块。。

“PlaqueIQ’s underpinnings in histology is a novel approach to the field of non-invasive coronary plaque classification,” said Dr. Mark Rabbat, professor of Medicine and Radiology, director of Cardiac CT, and director of Structural Heart Disease Interventional Imaging in the Division of Cardiology at Loyola University Chicago.

芝加哥洛约拉大学心脏病学系医学与放射学教授、心脏CT主任、结构性心脏病介入成像主任马克·拉巴特博士说：“PlaqueIQ的组织学基础是非侵入性冠状动脉斑块分类领域的一种新方法。”。

“Armed with additional data on vulnerable plaque components, we can make more informed treatment decisions on drug therapy selection or the need to send the patient to the cath lab. I believe plaque quantification has the potential to greatly improve outcomes for patients while providing tremendous savings to the healthcare system.”.

“有了关于易损斑块成分的额外数据，我们可以就药物治疗选择或需要将患者送往cath实验室做出更明智的治疗决定。我相信斑块定量有可能大大改善患者的预后，同时为医疗保健系统提供巨大的节省。”。

Physicians simply send patient images to Elucid with a single mouse click. Then Elucid applies PlaqueIQ’s image-restoration algorithms to the file to mitigate motion and calcium blooming artifacts. Specially trained analysts segment the data creating a 3D model of the patient’s coronary arteries. The software then identifies, classifies and quantifies tissue structure and composition..

医生只需单击鼠标即可将患者图像发送给Elucid。。经过专门训练的分析员对数据进行分割，创建患者冠状动脉的3D模型。然后，该软件识别，分类和量化组织结构和组成。。

“Elucid’s mission is to commercialize proven technologies that can make a meaningful difference in the prevalence of heart attack and stroke, and the FDA clearance of PlaqueIQ is a huge step forward towards that goal,” Kelly Huang, CEO of Elucid. “We know that plaque is the key contributor to these devastating events, and, specifically, high-risk plaque components, but you can’t treat what you can’t see.

Elucid首席执行官黄凯利（KellyHuang）表示：“Elucid的使命是将经过验证的技术商业化，这些技术可以对心脏病发作和中风的患病率产生有意义的影响，FDA批准PlaqueIQ是朝着这一目标迈出的一大步。”。。

With PlaqueIQ, physicians can gain new and insightful histology-based information to help better understand plaque composition and get ahead of the disease.”.

有了PlaqueIQ，医生可以获得新的和有见地的基于组织学的信息，以帮助更好地了解斑块的组成并战胜疾病。”。

Elucid is currently performing beta testing on PlaqueIQ and anticipates making the software available for limited release later in Q4 2024. The company is also pursuing an indication for non-invasive measurement of fractional flow reserve (FFRCT™), uniquely derived from its PlaqueIQ technology, to measure coronary blockages and the extent of ischemia..

Elucid目前正在PlaqueIQ上进行beta测试，预计该软件将于2024年第四季度晚些时候限量发布。该公司还寻求一种非侵入性测量分数血流储备（FFRCT™）的适应症，该技术独特地源自其PlaqueIQ技术，用于测量冠状动脉阻塞和缺血程度。。

About Elucid

关于Elucid

Elucid is a Boston-based AI medical technology company dedicated to developing technology designed to provide physicians with a more precise view of atherosclerosis (coronary plaque buildup), the root cause of cardiovascular disease. The company’s PlaqueIQ™ product is designed to help physicians prioritize and personalize treatment based on actual disease, rather than population-based risk of disease.

Elucid是一家总部位于波士顿的人工智能医疗技术公司，致力于开发技术，旨在为医生提供更精确的动脉粥样硬化（冠状动脉斑块积聚）视图，动脉粥样硬化是心血管疾病的根本原因。该公司的PlaqueIQ™产品旨在帮助医生根据实际疾病而不是基于人群的疾病风险来优先考虑和个性化治疗。

PlaqueIQ is the only FDA-cleared computed tomography angiography (CTA) algorithm that objectively quantifies plaque morphology validated against ground truth histology, the gold standard for characterization of plaque, as indicated by renowned pathologists. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke.

PlaqueIQ是唯一一种FDA批准的计算机断层扫描血管造影（CTA）算法，它可以客观地量化斑块形态，并根据著名病理学家指出的斑块表征的金标准ground truth组织学进行验证。PlaqueIQ为医生提供了有关可能导致心脏病发作和中风的动脉斑块类型和数量的关键信息。

Elucid is also pursuing an indication for FFRCT™, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively. For more information, visit elucid.com..

Elucid也在寻求FFRCT™的适应症，该适应症源自其斑块算法，以帮助无创地识别冠状动脉阻塞和缺血程度。有关更多信息，请访问elucid.com。。

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1 World Health Organization (WHO), Cardiovascular diseases (CVDs) fact sheet. 11 June 2021; Available from: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).

1世界卫生组织（WHO），心血管疾病（CVDs）概况。2021年6月11日；可从以下地址获得：https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-（CVD）。

2 Pahwa R, Jialal I. Atherosclerosis. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507799/ (accessed 03.17.2023)

2 Pahwa R，Jialal I.动脉粥样硬化。[于2023年8月8日更新]。在：StatPearls[互联网]。金银岛（佛罗里达）：StatPearls出版社；2020年1月-。可从以下地址获得：https://www.ncbi.nlm.nih.gov/books/NBK507799/（2023年3月17日访问）

3 A. Hafiane, Vulnerable plaque, characteristics, detection, and potential therapies, J. Cardiovasc. Dev. Dis. 6 (3) (2019).

3 A.Hafiane，《易损斑块，特征，检测和潜在疗法》，J.Cardiovasc。偏差Dis。6（3）（2019）。