Humacyte宣布美国专利局授予涵盖Symvess™及其他生物工程组织制造的专利-动脉网

Humacyte Announces Issuance of U.S. Patent Covering Manufacturing of Symvess™ and Other Bioengineered Tissues

Humacyte 等信源发布 2025-02-27 21:10

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– Patent provides coverage into 2040 for key aspects of the bioreactor manufacturing system –

– 该专利为生物反应器制造系统的关键方面提供了覆盖至2040年的保护 –

– Symvess, the acellular tissue engineered vessel, is manufactured in this patented system –

——Symvess，这种无细胞组织工程血管，是在这个专利系统中制造的——

DURHAM, N.C.

北卡罗来纳州达勒姆市

，

Feb. 27, 2025

2025年2月27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 issuance 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，今天宣布了一项颁布。

U.S.

美国

Patent covering key aspects of the manufacturing of Symvess (acellular tissue engineered vessel-tyod) and other bioengineered human tissues.

涵盖 Symvess（无细胞组织工程血管）及其他生物工程人体组织制造关键方面的专利。

U.S.

美国

Patent No. 12,195,711, titled “Drawer System for Cultivating Tissue,” covers key aspects of the bioreactor system that

专利号为12,195,711的专利，标题为“用于组织培养的抽屉系统”，涵盖了生物反应器系统的关键方面。

Humacyte

uses to manufacture bioengineered human tissues. The newly issued patent provides protection into 2040. The new patent complements a family of existing patents and patent applications encompassing the design and composition of Humacyte’s products, and their methods of manufacture.

用于制造生物工程人体组织。这项新颁发的专利提供保护至2040年。新专利补充了涵盖Humacyte产品设计和组成及其制造方法的现有专利和专利申请家族。

Humacyte’s lead product Symvess, or the ATEV™ (acellular tissue engineered vessel-tyod), is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. The ATEV is produced in proprietary manufacturing systems, including the LUNA200™ production equipment, that are covered by the newly issued .

Humacyte 的主要产品 Symvess，或称 ATEV™（无细胞组织工程血管），是一种首创的生物工程人类组织，旨在作为通用可植入的血管通道，用于动脉替换和修复。ATEV 在专有制造系统中生产，包括 LUNA200™ 生产设备，这些设备受到新发布的专利保护。

U.S.

美国

patent. The Company has an 83,000 square foot bioprocessing facility, with the ability to manufacture human tissue of different diameters and lengths at commercial scale.

专利。该公司拥有一个83,000平方英尺的生物处理设施，能够以商业规模制造不同直径和长度的人体组织。

The

U.S. Food and Drug Administration

美国食品药品监督管理局

(FDA) granted a full approval for Symvess on

(FDA) 完全批准了Symvess

December 19, 2024

2024年12月19日

for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. In contrast to harvesting a vein from the patient in the setting of acute trauma, which causes further injury and takes valuable time, Symvess is available off-the-shelf, and does not require further injuring the patient.

用于成人作为肢体动脉损伤的血管通道，当需要紧急再血管化以避免即将发生的肢体丧失，且自体静脉移植不可行时。与在急性创伤情况下从患者身上采集静脉相比（这会造成进一步损伤并耗费宝贵时间），Symvess可直接使用现成产品，无需进一步伤害患者。

The ATEV is also being evaluated in clinical trials in arteriovenous (AV) access for hemodialysis and peripheral artery disease, and preclinical development is underway in coronary artery bypass grafts..

ATEV 也正在针对血液透析和外周动脉疾病的动静脉 (AV) 通路进行临床试验评估，并且冠状动脉搭桥术的临床前开发正在进行中。

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.

对于除FDA批准的肢体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。

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.

（纳斯达克股票代码：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变革医学实践。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 的初始产品候选物是一组无细胞组织工程血管 (ATEV)，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。ATEV 在血管创伤适应症方面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型糖尿病的治疗以及多种新型细胞和组织应用的临床前开发也正在进行中。Humacyte 的 6mm 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) 指定的产品候选者，并且还获得了 FDA 快速通道指定。

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公司的6毫米ATEV用于肢体血管创伤后的紧急动脉修复和治疗晚期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

。

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 our ATEV in .

本新闻稿中的前瞻性陈述包括但不限于我们计划和有能力在商业化我们的ATEV。

the United States

美国

under the brand name SYMVESS in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals.

在血管创伤修复领域，品牌名为SYMVESS；关于我们临床前和临床试验的启动、时间安排、进展和结果的声明；我们ATEV的预期特性与性能；我们成功完成ATEV临床前和临床试验的能力；ATEV相对于现有替代方案的预期优势；我们ATEV的预期商业化及我们在商业规模制造的能力；我们业务模式的实施以及针对我们业务的战略计划；以及监管文件提交、接受和批准的时间或可能性。

We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that .

我们无法向您保证本新闻稿中的前瞻性陈述将会被证明是准确的。这些前瞻性陈述受到许多重大风险和不确定性的影响，可能导致实际结果与预期结果存在重大差异，其中包括适用法律或法规的变更、可能性等。

Humacyte

may be adversely affected by other economic, business, and/or competitive 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、业务和/或竞争因素的不利影响，以及其他风险和不确定性，包括我们在截至年度的10-K表格年报中“风险因素”标题下描述的那些风险和不确定性。

December 31, 2023

2023年12月31日

, our quarterly report on Form 10-Q for the quarter ended

，我们截至季度结束的10-Q表季度报告

September 30, 2024

2024年9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。这些因素大多数是Humacyte无法控制的，也很难预测。此外，如果前瞻性声明被证明是不准确的，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的保证，即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。

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·阿莱尔

LifeSci Advisors LLC

生命科学顾问有限责任公司

+1-617-435-6602

jallaire@lifesciadvisors.com

investors@humacyte.com

投资者@humacyte.com

Humacyte Media Contact: