Humacyte宣布扩大管道产品的知识产权，获授美国生物工程食管新专利-动脉网

Humacyte Announces Expansion of Intellectual Property for Pipeline Products with Granting of New U.S. Patent for Bioengineered Esophagus

Humacyte 等信源发布 2025-09-29 20:06

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– Patent covers esophagus produced using Humacyte’s proprietary bioengineered regenerative tissue platform, designed for implant in patients with damaged esophagus –

－专利涵盖使用Humacyte专有的生物工程再生组织平台生产的食管，旨在为食管受损的患者进行植入－

– Patent provides coverage into 2041 for the composition of novel bioengineered esophagus –

– 专利为新型生物工程食管的组成提供至2041年的保护 –

DURHAM, N.C.

杜伦，北卡罗来纳州

，

Sept. 29, 2025

2025年9月29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 allowance of a

（纳斯达克：HUMA），一家处于商业化阶段的生物技术平台公司，致力于大规模开发可普遍植入的生物工程人体组织，今天宣布了一项许可。

U.S.

美国

Patent covering the composition of a bioengineered esophagus that can be produced using the Company’s proprietary regenerative tissue engineering platform. The patent, titled “Tubular Prostheses (Esophagus),” provides protection into 2041 of key structural and mechanical attributes for its designed use as an esophageal replacement including size, strength, and methods of production.

涵盖使用公司专有再生组织工程平台生产的生物工程食管组成的专利。该专利名为“管状假体（食管）”，保护其作为食管替代物设计使用时的关键结构和机械特性，包括尺寸、强度和生产方法，有效期至2041年。

Humacyte’s Tubular Prostheses patent family encompasses composition and methods claims for advanced tissue constructs intended to replace damaged airways, upper digestive, and urinary tracts in patients..

Humacyte的管状假体专利家族涵盖了用于替代患者受损气道、上消化道和尿路的先进组织构建物的组成和方法权利要求。

“Bioengineered trachea, esophagus, and urinary conduits represent novel treatment programs that target high unmet patient needs as well as highlight the versatility of our regenerative tissue engineering platform and the breadth of our product pipeline,” said

“生物工程气管、食道和尿路导管代表了针对患者高度未满足需求的新疗法，同时也展示了我们再生组织工程平台的多功能性以及产品管线的广泛性，”表示。

Rob Kirkton

罗布·柯克顿

, Ph.D., Executive Director of New Product and

，博士，新产品与执行董事

Process Development

工艺开发

at Humacyte. With the most recent grant of patent,

在Humacyte。随着最近的专利授予，

Humacyte

has now secured coverage for composition of matter for bioengineered trachea, esophagus, and urinary conduits in

现已确保生物工程气管、食道和尿路物质组成的专利覆盖范围。

the United States

美国

，

Europe

欧洲

，

Canada

加拿大

, and Australia. This represents an important expansion of the patent coverage for Humacyte’s platform.

，以及澳大利亚。这代表了Humacyte平台专利覆盖范围的重要扩展。

Advanced tissue constructs for tracheal, esophageal, and urinary conduit replacement have been evaluated in early preclinical models with plans for future optimization and testing in large animal models. The advanced tissue construct product candidates are one component of Humacyte’s broad product pipeline that also includes acellular tissue engineered vessels (ATEV™), Coronary Tissue Engineered Vessels (CTEV) and the BioVascular Pancreas™ (BVP™).

先进的气管、食管和尿路替代组织构建体已在早期临床前模型中进行了评估，并计划在未来优化并在大型动物模型中进行测试。这些先进的组织构建体候选产品是 Humacyte 广泛产品线的一部分，该产品线还包括无细胞组织工程血管 (ATEV™)、冠状动脉组织工程血管 (CTEV) 和生物血管胰腺 (BVP™)。

Each of these products can be produced using the same bioengineering technology and manufacturing platform as Humacyte’s Symvess™ product..

每种产品都可以使用与Humacyte的Symvess™产品相同的生物工程技术及生产平台来制造。

“We are pleased to continue to expand the protection surrounding our bioengineered tissue platform and related novel product candidates,” said

“我们很高兴能够继续扩大围绕我们的生物工程组织平台及相关新型候选产品的保护，”

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

. “We plan to align ourselves with corporate partners where appropriate to accelerate the development of these programs.”

“我们计划在适当的情况下与企业伙伴合作，以加速这些项目的开发。”

The esophageal replacement and other advanced tissue constructs are investigational products and have not been approved for sale by the FDA or any other regulatory agency.

食管替代品和其他先进的组织构建体属于研究性产品，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.

胡马赛特公司

(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.

（纳斯达克：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。该公司开发和制造无细胞组织，用于治疗多种疾病、损伤和慢性病。

Humacyte’s initial product candidates, a portfolio of acellular tissue engineered vessels (ATEVs), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication was approved by the FDA in .

Humacyte公司的初始产品候选者，一组无细胞组织工程血管（ATEVs），目前正处于针对多种血管应用的晚期临床试验阶段，包括血管创伤修复、血液透析的动静脉（AV）通路以及外周动脉疾病。该ATEV用于血管创伤适应症的生物制品许可申请已获得FDA批准。

December 2024

2024年12月

. 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. 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.

冠状动脉搭桥术、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再生医学高级疗法（RMAT）认定的产品候选者，并且还获得了FDA快速通道认定。

Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the .

Humacyte的6毫米ATEV用于肢体血管创伤后的紧急动脉修复以及晚期PAD，也获得了RMAT指定。ATEV还获得了用于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批准的四肢血管创伤适应症以外的用途，ATEV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。

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术语，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、不确定性以及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。尽管我们相信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已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 advanced tissue constructs relative to existing alternatives; our plans and ability to execu.

本新闻稿中的前瞻性陈述包括但不限于：我们计划和能力将Symvess商业化，并且如果获得监管机构批准，我们的候选产品也将按预期时间表成功推出；市场对Symvess的接受程度以及第三方对其覆盖和报销的可用性，若监管机构批准，也适用于我们的候选产品；我们制造Symvess并满足临床试验和商业需求的能力，若监管机构批准，也适用于我们的候选产品；我们的ATEV和先进组织构建体相对于现有替代品的预期优势；我们的计划和执行能力。

Humacyte

休曼赛特

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，包括我们在截至年度的Form 10-K年报中“风险因素”标题下描述的那些风险和不确定性。

December 31, 2024

2024年12月31日

and Form 10-Q for the quarter ended

截至季度末的10-Q表格

June 30, 2025

2025年6月30日

, each filed by

，各自提交由

Humacyte

with the

随着

SEC

证券交易委员会

, and in future

，以及在未来

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。这些因素中的大多数都是Humacyte无法控制的，也很难预测。此外，如果前瞻性陈述被证明是不准确的，这种不准确性可能会非常重要。鉴于这些前瞻性陈述中存在重大不确定性，您不应将这些陈述视为我们或任何其他人的保证：我们将在任何特定时间框架内或根本无法实现我们的目标和计划。

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声明。因此，您不应依赖这些前瞻性声明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

LifeSci Advisors有限责任公司

+1-617-435-6602

jallaire@lifesciadvisors.com

杰拉尔@生命科学顾问公司.com

investors@humacyte.com

投资者@humacyte.com