Humacyte宣布发布关于使用CTEV作为冠状动脉旁路移植术（CABG）的临床前数据出版物-动脉网

Humacyte Announces Publication of Preclinical Data on Use of the CTEV as a Coronary Artery Bypass Graft (CABG)

Humacyte 等信源发布 2025-09-18 19:32

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- Results were published in JACC: Basic to Translational Science -

- 结果发表在《JACC：基础到转化科学》-

- Publication evaluated coronary tissue engineered vessel (CTEV) as a conduit for CABG in a nonhuman primate model -

- 发表物评估了冠状动脉组织工程血管（CTEV）作为非人类灵长类动物模型中冠状动脉旁路移植术（CABG）的导管 -

- All implanted CTEVs remained patent through six months, demonstrated adaptive remodeling, and recellularized with host coronary artery cells –

- 所有植入的CTEV在六个月期间保持通畅，表现出适应性重塑，并通过宿主冠状动脉细胞重新细胞化 -

Humacyte

plans to advance CTEV into first-in-human study in CABG -

计划将CTEV推进到CABG的首次人体研究 -

DURHAM, N.C.

杜伦，北卡罗来纳州

，

Sept. 18, 2025

2025年9月18日

(GLOBE NEWSWIRE) --

（环球新闻社）--

Humacyte, Inc.

Humacyte公司

(Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the publication of new preclinical data as part of a study evaluating the coronary tissue engineered vessel (CTEV) as a coronary artery bypass graft conduit in a non-human primate model.

（纳斯达克：HUMA），一家商业阶段的生物技术平台公司，致力于大规模开发生物工程化的人体组织以实现普遍植入，今天宣布了一项新临床前数据的发布。该数据是一项研究的一部分，旨在评估冠状动脉组织工程血管（CTEV）作为冠状动脉搭桥移植导管在非人类灵长类动物模型中的应用。

In the study, published in .

在研究中，发表于。

JACC: Basic to Translational Science,

JACC：基础到转化科学，

a specialist journal launched by the

由...创办的专业期刊

Journal of the American College of Cardiology

美国心脏病学会杂志

(JACC),

（JACC），

the CTEV was observed to sustain blood flow, recellularize with the animals’ host cells, and remodel to reduce the initial size mismatch between the CTEV and the animals’ native artery.

观察到CTEV能够维持血流，通过动物宿主细胞进行再细胞化，并进行重塑以减少CTEV与动物自身动脉之间的初始尺寸不匹配。

“Innovation in CABG has been stagnant for far too long,” said

“冠状动脉搭桥术的创新长期以来一直处于停滞状态，”他说。

Alan Kypson

艾伦·基普森

, MD, FACS, Cardiothoracic Surgeon,

医学博士，FACS，心胸外科医生，

UNC REX Hospital

UNC REX医院

. “Our results suggest that we may be on the verge of a new option — one that remodels to match the native artery and recellularizes with host cells, potentially providing superior patency relative to saphenous vein grafts. The CTEV has the potential to address a significant unmet clinical need in coronary bypass surgery and ultimately improve patient outcomes.”.

“我们的研究结果表明，我们可能即将迎来一种新的选择——这种选择可以重塑以匹配原生动脉，并通过宿主细胞重新细胞化，相较于隐静脉移植，可能提供更优的通畅性。CTEV 有潜力满足冠状动脉搭桥手术中未被满足的重大临床需求，并最终改善患者的预后。”

Cardiovascular disease is the leading cause of death worldwide, comprising one in every three deaths in

心血管疾病是全球死亡的主要原因，占所有死亡人数的三分之一。

the United States

美国

in 2023. The most common form is coronary artery disease (CAD), which affects 1 in 20 adults aged 20 and older. Coronary artery bypass grafting, a procedure that improves blood flow to the heart by using the internal mammary artery and saphenous vein to bypass narrowed or blocked coronary arteries, remains the current standard of care.

2023年。最常见的形式是冠心病（CAD），它影响着20岁及以上成年人中的1/20。冠状动脉旁路移植术，通过使用内乳动脉和大隐静脉绕过狭窄或阻塞的冠状动脉，从而改善心脏的血液流动，仍然是目前的标准治疗方法。

However, saphenous vein grafts - used in 80%-90% of CABG cases - demonstrate poor long-term patency, with approximately 50% failing at 10 years. Many patients also lack usable autologous veins or arteries due to prior harvest, ablation, or poor quality, highlighting the unmet clinical need for alternative conduits.

然而，隐静脉移植物（在80%-90%的冠状动脉旁路移植术中使用）表现出较差的长期通畅性，约50%在10年内失效。许多患者由于先前的采集、消融或质量不佳，缺乏可用的自体静脉或动脉，突显了对替代移植物未满足的临床需求。

For the past half century, no novel CABG conduits have gained routine clinical use..

在过去的半个世纪中，没有新型的冠状动脉搭桥术（CABG）管道获得常规临床应用。

The recent JACC study, titled

最近的JACC研究，标题为

“Acellular Tissue Engineered Vessels as Coronary Artery Bypass Grafts”,

“无细胞组织工程血管作为冠状动脉搭桥术移植物”

follows five adult baboons undergoing CABG to the right coronary artery with the CTEV. All CTEVs remained patent throughout the 6-month study. At the end of follow-up, the CTEV was observed to have recellularized with host cells to form a multi-layered tissue, including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the right coronary artery (RCA).

对五只成年狒狒进行右冠状动脉（RCA）使用CTEV的冠状动脉旁路移植术（CABG）。在为期6个月的研究中，所有CTEV均保持通畅。在随访结束时，观察到CTEV已被宿主细胞再细胞化，形成了多层组织，包括跨吻合口的新内膜组织，有效减少了与右冠状动脉（RCA）初始的尺寸不匹配。

The results suggest that the CTEV may be a durable alternative CABG conduit. The CTEV is 3.5mm blood vessel produced in the same bioengineering manufacturing system as Humacyte’s acellular tissue engineered vessel (ATEV™). The CTEV is also referred to as the small-diameter ATEV, or sdATEV..

结果表明，CTEV可能是一种持久的CABG替代导管。CTEV是通过与Humacyte的无细胞组织工程血管（ATEV™）相同的生物工程制造系统生产的3.5毫米血管。CTEV也被称为小直径ATEV，或sdATEV。

Humacyte

also announced that it plans to advance the CTEV into its first-in-human study in CABG. To support human study, the Company anticipates filing an Investigational New Drug (IND) application with the

还宣布计划将其CTEV推进到冠状动脉旁路移植术（CABG）的首次人体研究。为支持人体研究，该公司预计将向

U.S. Food and Drug Administration

美国食品药品监督管理局

(FDA) during the 4

（FDA）在第4

Quarter of 2025. The Company’s current plans for filing an IND are based on the outcome of a meeting held early this year with the FDA, including agreements reached with the agency.

2025年第一季度。公司目前提交IND的计划是基于今年年初与FDA举行的会议结果，包括与该机构达成的协议。

“We’re pleased that this new publication of preclinical data demonstrates the promise of CTEVs as an alternative for native vessel grafts in CABG,” said

“我们很高兴这项新的临床前数据发表，证明了CTEVs作为CABG中自体血管移植替代物的潜力，”

Laura Niklason

劳拉·尼克拉森

, M.D., Ph.D., Founder and Chief Executive Officer of

医学博士，哲学博士，创始人兼首席执行官

Humacyte

. “As one of the leading causes of early death, coronary artery disease poses unique challenges for patient care. We are looking forward to proceeding into the first-in-human study of the CTEV in CABG and hopefully offering surgeons another option for treating this disease.”

“作为早死的主要原因之一，冠心病给患者护理带来了独特的挑战。我们期待着进入CTEV在冠状动脉搭桥术（CABG）中的首次人体研究，并希望为外科医生提供另一种治疗该疾病的选择。”

The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

CTEV是一种研究性产品，尚未获得FDA或任何其他监管机构的销售批准。

About

关于

Humacyte

Humacyte, Inc.

Humacyte公司

(Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions.

(Nasdaq: HUMA) 正在开发一种颠覆性的生物技术平台，以提供可普遍植入的生物工程人体组织、先进的组织构建体和器官系统，旨在改善患者生活并转变医学实践。该公司开发和生产用于治疗多种疾病、损伤和慢性病的无细胞组织。

Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in extremity vascular trauma was approved by the FDA in .

Humacyte公司用于肢体血管创伤的无细胞组织工程血管（ATEV）的生物制品许可申请已获FDA批准。

December 2024

2024年12月

. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications.

ATEVs目前也正在进行针对其他血管应用的晚期临床试验，包括用于血液透析的动静脉（AV）通路和外周动脉疾病（PAD）。冠状动脉搭桥移植、小儿心脏手术、1型糖尿病治疗以及多种新型细胞和组织应用的临床前开发也在进行中。

Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations.

Humacyte的6毫米ATEV用于血液透析的动静脉通路，是首个获得FDA再生医学先进疗法（RMAT）认定的产品候选者，并且还获得了FDA快速通道认定。Humacyte的6毫米ATEV用于肢体血管创伤后的紧急动脉修复和晚期PAD也获得了RMAT认定。

The ATEV received priority designation for the treatment of vascular trauma by the .

ATEV获得了治疗血管创伤的优先指定。

U.S.

美国

Secretary of Defense. For more information, visit

国防部长。欲了解更多信息，请访问

www.Humacyte.com

。

For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

对于FDA批准的肢体血管创伤适应症以外的用途，ATEV是一种试验性产品，尚未获得FDA或任何其他监管机构的销售批准。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

本新闻稿包含基于信念、假设以及当前可获得信息的前瞻性陈述。在某些情况下，您可以通过以下词语识别前瞻性陈述：“可能”、“将”、“可以”、“会”、“应该”、“预期”、“打算”、“计划”、“预见”、“相信”、“估计”、“预测”、“项目”、“潜在”、“继续”、“正在进行”或这些术语的否定形式或其他类似用语，尽管并非所有前瞻性陈述都包含这些词语。

These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain.

这些声明涉及风险、不确定性和其他可能导致实际结果、活动水平、表现或成就与这些前瞻性声明中明示或暗示的信息有重大差异的因素。尽管我们认为本新闻稿中包含的每一项前瞻性声明都有合理的依据，但我们提醒您，这些声明是基于我们目前所知的事实和因素以及我们对未来的预测，而这些预测并不确定。

Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs and our CTEVs relative to existing alternatives; our plans and ability to execute product developmen.

本新闻稿中的前瞻性声明包括但不限于：我们商业化Symvess的计划和能力，以及如果获得监管机构批准，我们产品候选物的成功及按预期时间表推进；市场对Symvess及如果获得监管机构批准，对我们产品候选物的接受程度及第三方覆盖和报销的可用性；我们制造Symvess的能力，以及如果获得监管机构批准，生产足够数量的产品以满足我们的临床试验和商业需求；我们的ATEV和CTEV相较于现有替代品的预期优势；我们执行产品开发的计划和能力。

Humacyte

哈马赛特

may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended

可能受到其他经济、商业、竞争和/或声誉因素的不利影响，以及其他风险和不确定性，包括我们年度报告表格10-K中“风险因素”标题下所述的内容，截至本年度结束。

December 31, 2024

2024年12月31日

and Form 10-Q for the quarter ended

截至季度末的表格10-Q

June 30, 2025

2025年6月30日

, each filed by

，每份由

Humacyte

with the

随着

SEC

证券交易委员会

, and in future

，以及未来

SEC

证券交易委员会

filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all.

备案文件。这些因素大多不在Humacyte的控制范围内，且难以预测。此外，如果前瞻性声明被证明不准确，这种不准确性可能是重大的。鉴于这些前瞻性声明中存在重大不确定性，您不应将这些声明视为我们或任何其他人士对我们将在任何特定时间框架内或完全实现我们的目标和计划的保证或担保。

Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release..

除非法律要求，我们目前无意更新本新闻稿中的任何前瞻性陈述。因此，您不应依赖这些前瞻性陈述来代表我们自本新闻稿发布日期之后的任何日期的观点。

Humacyte Investor Contact:

Humacyte 投资者联系人:

Joyce Allaire

乔伊斯·阿拉尔

LifeSci Advisors LLC

生命科学顾问有限责任公司

+1-617-435-6602

jallaire@lifesciadvisors.com

杰拉尔@生命科学顾问.com

investors@humacyte.com

投资者@humacyte.com