Non ST segment elevation acute coronary syndrome

— Data confirm the use of FFRCT and Plaque Analysis helps assess long-term risks, informing more personalized and effective treatment plans for patients with coronary artery disease -– FFRCT further validated in new study demonstrating diagnostic accuracy and greater ability than CCTA alone to rule out hemodynamically significant stenoses in patients with high-risk NSTE-ACS WASHINGTON, Oct. 27, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., the global leader in non-invasive artificial intelligence (AI) heart care solutions, today announced seven-year data confirming the use of HeartFlow’s AI-enabled fractional flow reserve computed tomography (FFRCT) and Plaque Analysis in the assessment of long-term risk of coronary artery disease (CAD) in clinically stable, symptomatic patients. The data show the HeartFlow platform provides clinicians with the insights needed to anticipate and mitigate adverse events, including myocardial infarctions, in symptomatic patients with stable chest pain. The data were presented at the 36th annual Transcatheter Cardiovascular Therapeutics® (TCT) conference in Washington, D.C. ADVANCE-DK is data from a subset of the larger ADVANCE Registry, which prospectively evaluated the use of a coronary computed tomography angiography (CCTA) and FFRCT diagnostic pathway in real-world settings to determine the impact on decision-making, downstream invasive coronary angiography (ICA), revascularization, and major adverse cardiovascular events (MACE). ADVANCE-DK assessed three patient sets: those with normal FFRCT, those with subsequent complete revascularization (CR), and those with subsequent incomplete revascularization (IR). Seven-year follow-up data from ADVANCE-DK demonstrates the completeness of revascularization predicts clinical outcomes and can be assessed non-invasively using coronary CCTA and FFRCT. Patients with IR, as assessed by FFRCT, had a higher long-term risk of adverse events than patients whose FFRCT assessment showed CR or patients who had normal FFRCT (16.2% IR versus 7.8% CR and 5.7% normal FFRCT, respectively)The combination of plaque quantification and characterization and lesion-specific physiology from FFRCT is a superior predictor of adverse cardiovascular events, through seven-year follow-up (AUC 0.73 vs 0.63 inclusive of baseline risk variables + CCTA) “We theorized that by leveraging non-invasive FFRCT we could identify critical issues that had previously gone unnoticed, such as significant coronary lesions that would likely have been mistakenly categorized as visually insignificant,” said Kristian Tækker Madsen, M.D., cardiologist at University Hospital of Southern Denmark. “The prospective data with long-term follow-up in ADVANCE-DK alongside Plaque Analysis data gave us far more than that. FFRCT remains valuable for patients across all categories, and the combination of FFRCT and quantitative plaque data, especially after four years of follow up, can offer providers invaluable insight into a patient’s long-term risks informing more personalized and effective treatment plans.” In a separate study, “Usefulness of FFRCT to Exclude Hemodynamically Significant Lesions in High-Risk NSTE-ACS,” lesion-specific FFRCT was further validated in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). The authors found that the use of CCTA with or without FFRCT “would have avoided 54% to 64% of unnecessary invasive assessments” in the high-risk population studied. At the lesion level, FFRCT far outperformed CCTA alone in identifying significant lesions likely to benefit from revascularization (AUC 0.84 versus 0.65, p<0.01), suggesting an enhanced capability to avoid unnecessary invasive coronary angiography (ICA). The data were published concurrently in the EuroIntervention journal in a peer-reviewed article titled “Usefulness of FFR-CT in Patients with High-risk NSTE-ACS.”1 “The ADVANCE-DK data show that our technologies go beyond identifying the immediate risks of CAD to include long-term residual risks across the spectrum of the disease. Data from patients with high-risk NSTE-ACS further suggest lesion-specific FFRCT provides an enhanced capability to avoid unnecessary invasive tests. With HeartFlow, clinicians receive actionable insights and data that are currently missing from traditional non-invasive and invasive diagnostic tools,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of HeartFlow. “We’re grateful to all the participants and investigators who supported the collection of these valuable data as we build upon our clinical evidence demonstrating the value of HeartFlow ONE including FFRCT Analysis and AI-enabled Plaque Analysis in managing CAD.” Cardiovascular diseases are the most common cause of death globally for both men and women, yet four out of five heart attacks and strokes are preventable with lifestyle and nutrition changes if patients at high risk are identified early.1 Understanding plaque burden – where plaque is in the coronary arteries, the amount of plaque, and the type of plaque – is one of the best ways for physicians to identify patients at high risk of death from a heart attack.2 HeartFlow is dedicated to defeating heart disease through partnering with physicians to generate robust, high-quality clinical evidence. HeartFlow has been adopted by more than 1,300 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population worldwide. About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered, non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™ Analysis, and Plaque Analysis. More than 500 peer-reviewed publications have validated our approach and more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media Contact:Elliot Levymedia@heartflow.com Investor Contact:Nick Laudiconlaudico@heartflow.com References1. Meier, D. et al, Usefulness of FFR-CT in Patients with High-risk NSTE-ACS. EuroIntervention. 2024; In press.2. World Heart Federation. Prevention. Accessed Oct. 25, 2024.3. Thomsen, C., Characteristics of high-risk coronary plaques identified by computed tomographic angiography and associated prognosis: a systematic review and meta-analysis. EHJ. 2016; 17, 120-129. A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fa3731a5-d3f1-4e09-bfc8-6af4b78d11ab

Long-term outcomes data from ADVANCE-DK Registry with HeartFlow FFRCT and Plaque Analysis and ongoing clinical studies highlighting CCTA and FFRCT diagnostic pathway to be discussed in six presentations New data build upon the growing body of clinical evidence supporting non-invasive FFRCT technology and plaque analysis in the diagnosis and management of coronary artery disease MOUNTAIN VIEW, Calif., Oct. 14, 2024 (GLOBE NEWSWIRE) -- HeartFlow, the global leader in non-invasive artificial intelligence (AI) heart care solutions, today announced it will present seven-year data from the ADVANCE-DK study, a subset from the larger ADVANCE Registry, which evaluated utility and clinical outcomes of HeartFlow’s AI-enabled FFRCT and Plaque Analysis in clinically stable, symptomatic patients with coronary artery disease (CAD). Data from the ADVANCE-DK study and other clinical studies will be presented at the 36th annual Transcatheter Cardiovascular Therapeutics® (TCT) conference, which will take place October 27-30, 2024 in Washington, D.C. “The ADVANCE registry helps us better understand whether more complete revascularization, as defined by FFRCT, is associated with improved long-term cardiovascular outcomes,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of HeartFlow. “Three-year data from this registry confirmed that patients with both abnormal FFRCT and high plaque burden had two-and-a-half to three times greater risk of adverse cardiac events compared to patients with only abnormal FFRCT or high plaque volume. We are excited to present seven-year data and build on our body of evidence demonstrating FFRCT and AI-enabled plaque assessment as non-invasive approaches which can help physicians better quantify CAD risk in their patients.” At TCT, HeartFlow will also present: Late-breaking data evaluating the capacity of FFRCT and coronary computed tomography angiography (CCTA) to rule out significant lesions in high-risk non-ST elevation acute coronary syndromes (NSTE-ACS).Data from FUTURE-AS, an international, prospective, multicenter registry of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR) being assessed for CAD with CCTA and FFRCT.New data from FASTTRACK-CABG, a single-arm, multicenter, prospective study assessing safety and feasibility of bypass surgery in patients with complex CAD solely based on CCTA combined with FFRCT.Data highlighting the value for pre-procedural planning of combining FFRCT, virtual percutaneous coronary intervention (PCI), and myocardial mass.Analysis of initial FFRCT-based virtual PCI for pre-procedural planning in the U.S. Details of each presentation are as follows: Title: Completeness of Revascularization by FFRCT and Long-term Prognosis in Stable Angina: A Seven-Year Follow-up of the ADVANCE-DK RegistryPresenter: Kristian Taekker Madsen, M.D., Ph.D.Date: Sunday, October 27, 2024Time: 7:30-8:45 AM EDTSession: TCT WorldLink Forum: Best Global Research in Coronary ImagingLocation: Presentation Theater 3, Innovation & Exhibit Hall (Halls A-C) Title: TCT 288: Comparative Analysis of FFR Derived From CCTA, Murray Law-Based Quantitative Flow Ratio and Quantitative Flow Ratio at Sequential Side Branches in Patients With Complex CAD: Insights From the FASTTRACK CABG StudyPresenter: Kotaro Miyashita, M.D.Date: Sunday, October 27, 2024Time: 9:00-9:50 AM EDTSession: Moderated Abstracts Station 2Location: Innovation & Exhibit Hall (Halls A-C) Title: TCT 172: Usefulness of FFRCT to Exclude Hemodynamically Significant Lesions in High-Risk NSTE-ACS Presenter: Georgios Tzimas, M.D.Date: Monday, October 28, 2024Time: 4:00-5:30 PM EDTSession: Moderated Abstracts Station 2Location: Innovation & Exhibit Hall (Halls A-C) Title: TCT 830: Feasibility and Utility of Anatomical and Physiological Evaluation of Coronary Disease With Cardiac CT in Severe Aortic Stenosis (FUTURE-AS Registry)Presenters: Abdul Rahman Ihdayhid, M.D., Ph.D.Moderators: Philippe PM Garot, M.D., Marie-France Poulin, M.D.Date: Tuesday, October 29, 2024Time: 8:00-9:00 AM EDTSession: TAVR and CAD - 1Location: Moderated Abstracts Station 5, Innovation & Exhibit Hall (Halls A-C) Title: TCT 221: Coronary Computed Tomography Angiography-Guided Bifurcation Percutaneous Coronary Intervention: Role of FFRCT Virtual PCI and Myocardial Mass for Pre-Procedural PlanningPresenters: Pedro Carvalho, M.D.Moderators: Hector M. Garcia-Garcia, M.D., Ph.D., John J. Lopez, M.D.Date: Tuesday, October 29, 2024Time: 2:00-3:00 PM EDTSession: Anatomy-derived Coronary Physiology – 2Location: Moderated Abstracts Station 2, Innovation & Exhibit Hall (Halls A-C) Title: TCT 96: Coronary Computed Tomography Angiography for Percutaneous Coronary Intervention: Initial US Experience With FFRCT-Based Virtual PCI for Pre-Procedural PlanningPresenters: Pedro Carvalho, M.D.Moderators: Louis A. Cannon, M.D., Christopher Irobunda. M.D.Date: Wednesday, October 30, 2024Time: 9:00-9:56 AM EDTSession: Novel Percutaneous TechniquesLocation: Moderated Abstracts Station 6, Innovation & Exhibit Hall (Halls A-C) Heartflow invites attendees to a lunch symposium, “Utilizing Coronary CTA & HeartFlow AI to Non-Invasively Assess Anatomy, Physiology and Plaque,” led by a panel of well-respected physicians including Ziad A. Ali, M.D., Suzanne J. Baron, M.D., Nick Curzen, M.D., Jimmy Lee Kerrigan, M.D. and Akiko Maehara, M.D. The symposium will take place on Tuesday, October 29, 2024, from 12:30-1:30 PM EDT in the FDA Theater, Innovation & Exhibit Hall (Halls A-C). About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered, non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™ Analysis, and Plaque Analysis. More than 500 peer-reviewed publications have validated our approach and more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media ContactElliot Levymedia@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com

百奥泰生物制 药 股份有限公司 ( 上交所代 码 ： 688177) 是一家位于中国广州，基于科学而 创 新的全球性生物制 药 企 业 ，以下 简 称 “ 百奥泰 ” 或 “ 公司 ” 。公司致力于开 发 新一代 创 新 药 和生物 类 似 药 ，用于治 疗肿 瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人 类 生命或健康的重大疾病 。公司今日宣布收到国家 药 品 监 督管理局核准 签发 的关于枸 橼 酸倍 维 巴 肽 注射液（ BAT2094 ，商品名： 贝 塔宁 ® ）的《 药 品注册 证书 》，用于 进 行 经 皮冠状 动 脉介入 术 （包括 进 行冠状 动 脉内支架置入 术 ）的急性冠脉 综 合征患者，以降低急性 闭 塞、支架内血栓、无复流和慢血流 发 生的 风险 。 贝 塔宁 ® （ BAT2094 ，枸 橼 酸倍 维 巴 肽 注射液） 为 百奥泰自主开 发 且 拥 有自主知 识产权 的 1 类 化学 药 品，是一种 肽类 的 β3 整合素受体抑制 剂 。 血小板糖蛋白受体 αIIbβ3 （又称 为 IIb/IIIa ）受体是在血小板聚集 过 程中起主 导 作用的血小板表面受体。枸 橼 酸倍 维 巴 肽 阻止 纤维 蛋白原、 Von Willebrand 因子和其它粘附配体与糖蛋白受体 αIIbβ3 结 合，因而阻断血小板的交 联 及血小板的聚集。同 时 枸 橼 酸倍 维 巴 肽 也能抑制与血管壁 细 胞增生相关的整合素受体 αvβ3 ，从而抑制血管平滑肌的生 长 ，降低 动 脉血管再阻塞 风险 。 行 经 皮冠状 动 脉介入 术 （包括 进 行冠状 动 脉内支架置入 术 ）的急性冠脉 综 合征患者 药 物 辅 助治 疗进 入一个全新的 时 代！ 枸 橼 酸倍 维 巴 肽 注射液的有效性和安全性 已通 过 一 项 多中心、随机、双盲、安慰 剂 平行 对 照 设计 的 II 期 临 床 试验 ，以及一 项 多中心、随机、双盲、安慰 剂 平行 对 照 设计 的 III 期 临 床 试验 确 认 。 临 床 II 期研究 结 果 显 示， PCI 患者 围 手 术 期 静脉 单 次 给 予本品 220ug/kg 及 2.5ug/min/kg 静脉恒速滴定， 术 后 4h ， 24h 分 别测 定血小板聚集抑制率， 发现 相比安慰 剂组 ，枸 橼 酸倍 维 巴 肽给药 后血小板聚集抑制率快速达到 80% 以上，并在恒速滴定 时 保持 稳 定， 给药结 束后迅速恢复血小板聚集功能。 枸 橼 酸倍 维 巴 肽 注射液 临 床 III 期的主要 疗 效 为 PCI 术 后 30 天的死亡、心肌梗死、急性靶血管血运重建、包括急性 闭 塞、无复流或其他 类 似 PCI 并 发 症 的抗血栓治 疗 的需求 以及无复流和 严 重的慢血流 的复合 终 点 。枸 橼 酸倍 维 巴 肽试验组 相 对 于 对 照 组发 生复合 终 点事件的 HR 为 0.57 （ 95% CI ： 0.35 ， 0.94 ， P=0.026 ），枸 橼 酸倍 维 巴 肽 注射液在 现 有 标 准治 疗 的基 础 上 进 一步降低 发 生复合 终 点事件 风险 超 过 43% 。 急性冠状 动 脉 综 合征（ ACS ）是以冠状 动 脉粥 样 硬化斑 块 破裂或侵 蚀 ， 继发 完全或不完全 闭 塞性血栓形成 为 病理基 础 的一 组临 床 综 合征，包括 ST 段抬高型心肌梗死（ STEMI ）和非 ST 段抬高型急性冠脉 综 合征（ NSTE-ACS ），后者包括非 ST 段抬高型心肌梗死（ NSTEMI ）和不 稳 定型心 绞 痛（ UA ）。全球每年 约 有 700 多万人被 诊 断 为 ACS ， 虽 然 ACS 常 见 于 老年人群，但是年 轻 人群的 ACS 发 病率正在逐 渐 增加 [1] 。整合素受体在急性冠状 动 脉 综 合征（ ACS ）病理的 发 生 发 展 过 程中 起着极其重要的作用。 β3 整合素受体不 仅 直接在血小板聚集 引起的血栓形成中起主 导 作用，并 且通 过 与 αv 亚 基 结 合形成整合素受体 αvβ3 。整合素受体 αvβ3 在促 进 血管壁内皮 细 胞和平滑肌 细 胞的增生、 动 脉血管再阻塞起着重要的作用。 现 今急性冠状 动 脉 综 合征（ ACS ）最 为 有效的治 疗 手段是 PCI 术 治 疗 ，而 PCI 术 常常伴随血栓性并 发 症， 重者 导 致 心肌梗死。 枸 橼 酸倍 维 巴 肽 注射液的 临 床 III 期主要研究者，中国科学院院士，葛均波院士 评论 道 ： “ 通 过 一个 1442 例大 样 本的随机 对 照 临 床研究表明，在阿 司匹林，肝素和 氯 吡格雷的基 础 上增加枸 橼 酸倍 维 巴 肽 能 够显 著降低 PCI 围术 期血栓性并 发 症事件如急性 闭 塞、支架内血栓、无复流和慢血流等的 发 生，具有重要的 临 床意 义 。 ” 公司 创 始人李 胜 峰博士表示 ： “ 随着社会老年化程度加深，急性冠状 动 脉 综 合征（ ACS ）患者以及需要行 PCI 术 治 疗 的患者逐年增加，而 围术 期和 术 后血栓性并 发 症是最常 见 的影响 PCI 术 成功与否的主要因素之一。枸 橼 酸倍 维 巴 肽 注射液 给临 床 专 家 增加了一个新的更好的治 疗选择 。 公司将再接再 厉 ， 围绕 患者未 满 足 的治 疗 需求 为 研 发 出 发 点 ，开 发 更多更好的能 够 真正意 义 上降低心血管事件 发 生 的 创 新 产 品 。 ” 关于百奥泰 百奥泰是一家位于中国广州，基于科学而 创 新的全球性生物制 药 企 业 。公司致力于开 发 新一代 创 新 药 和生物 类 似 药 ，用于治 疗肿 瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人 类 生命或健康的疾病。作 为 新一代抗体 药 物研 发 的 领导 者，百奥泰已推 动 多款候 选药 物 进 入后期 临 床 试验 ，其中格 乐 立 ® （阿达木 单 抗）、普 贝 希 ® （ 贝 伐珠 单 抗）、施瑞立 ® （托珠 单 抗） 、 贝 塔宁 ® （ β3 整合素受体抑制 剂 ） 已在中国 获 批上市。 TOFIDENCE™ （托珠 单 抗） 已在美国和欧盟 获 批 ， Avzivi® （ 贝 伐珠 单 抗） 已在美国 获 批。 公司 现 有 20 多款在研 产 品 处 于不同 临 床研究 阶 段， 其中 肿 瘤 领 域主要聚焦后 PD-1 时 代的 肿 瘤免疫治 疗 和抗体 药 物偶 联 体（ ADC ）靶向 药 物开 发 。百奥泰始 终 以患者的福祉作 为 首要核心价 值 ，通 过创 新研 发 ， 为 患者提供安全、有效、可 负 担的 优质药 物，以 满 足亟待解决的治 疗 需求。欲了解更多信息， 请访问 www.bio-thera.com ，或关注我 们 的推特（ @bio_thera_sol ）和微信公众号（百奥泰）。 1. 格 乐 立 ® 是百奥泰的注册商 标 2. 普 贝 希 ® 是百奥泰的注册商 标 3. 施瑞立 ® 是百奥泰的注册商 标 4. 贝 塔宁 ® 是百奥泰的注册商 标 5. TOFIDENCETM 是渤健的注册商 标 6. Avzivi® 是山德士的注册商 标 百奥泰前瞻性声明 本新 闻 稿包含了 贝 塔宁 ® （ BAT2094 ，枸 橼 酸倍 维 巴 肽 注射液 ）或百奥泰及 产 品 线 相关的前瞻性声明。由于某些重要因素可能会影响公司的 实际结 果，特此提醒 读 者注意不要 过 分依 赖该 前瞻性声明。 这 些前瞻性 语 句包括但不限于包含意愿、将要、可能、潜在性、 预测 、 计 划、估 计 、 预 期等 类 似 陈 述。它 们 都 应 被 视为 百奥泰基于截至本新 闻 稿 发 布之日可 获 得的信息的合理假 设 ，并不保 证 未来的表 现 或 发 展。由于多种因素， 实际结 果和事件可能与前瞻性声明中包含的信息存在重大差异， 这 些因素包括但不限于本 产 品可能不会 获 得受理或批准，以及 药 物研究、开 发 和商 业 化中固有的 风险 和不确定性，例如 临 床前和 临 床研究的 风险 和不确定性以及 能否 获 得 药 政部 门 的批准。其他 风险 因素包括生 产 、分 销 、 营销 、 竞 争、知 识产权 、 药 物功效和安全性方面的 风险 和不确定性，国家及全球 财务 与医 疗 状况的 变 化，公司 财务 状况的 变 化以及适用法律法 规 的 变 化等。本新 闻 稿中包含的任何前瞻性声明 仅针对 截止于作出声明之日的情况。除非法律要求，否 则 百奥泰没有 义务 更新本新 闻 稿中包含的任何前瞻性声明，以反映本新 闻 稿 发 布之日以后的新信息和事件，公司 观 点的改 变 或其他情况。 参考文献： 【1】 Bhatt DL, Lopes RD, Harrington RA. Diagnosis and Treatment of Acute Coronary Syndromes: A Review [published correction appears in JAMA. 2022 May 3;327(17):1710]. JAMA. 2022;327(7):662-675. doi:10.1001/jama.2022.0358