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– The ATEV™ was observed to have superior duration of use over 24 months compared to autogenous fistula in high-need subgroups with historically poor outcomes with AV fistula procedures –

– 在历史上AV瘘手术效果不佳的高需求亚组中，ATEV™的使用持续时间超过24个月，优于自体瘘 –

– The significantly longer duration of ATEV use in these high-need patients could greatly reduce reliance on catheters for dialysis access, a major cause of complications, morbidity and cost in dialysis patients –

“这些高需求患者显著延长了ATEV的使用时间，这可能会大大减少对用于透析通路的导管的依赖，而导管是导致透析患者并发症、发病和费用的主要原因。”

DURHAM, N.C.

北卡罗来纳州达勒姆

,

，

Nov. 10, 2025

2025年11月10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 tissue at commercial scale, announced the presentation of positive two-year results from the V007

（纳斯达克：HUMA），一家商业阶段的生物技术平台公司，致力于大规模开发可普遍植入的生物工程人体组织，宣布了V007研究积极的两年结果展示。

Phase 3

第三阶段

clinical trial of the acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for hemodialysis patients at the

用于血液透析患者的动静脉（AV）通路的无细胞组织工程血管（ATEV）的临床试验

American Society

美国社会

of Nephrology’s (ASN)

美国肾脏病学会 (ASN) 的

Kidney Week 2025

2025年肾脏周

, the premier nephrology meeting, in

，顶级肾病学会议，在

Houston

休斯顿

.

。

In the V007

在V007中

Phase 3

第三阶段

trial, the ATEV was observed to have superior duration of use over 24 months as compared to autogenous fistula in female, obese and diabetic patients. Autogenous fistula is the current gold standard for hemodialysis access across all patients. However, female, obese and diabetic patients comprise high-need subgroups, having historically poor outcomes with AV fistula procedures.

在试验中，ATEV 在女性、肥胖和糖尿病患者中相较于自体瘘管显示出超过 24 个月的更长使用时间。自体瘘管是目前所有患者进行血液透析通路的黄金标准。然而，女性、肥胖和糖尿病患者属于高需求亚组，在 AV 瘘管手术中的历史结果较差。

The podium presentation, titled “Two-Year Outcomes from a Prospective Randomized Trial of Humacyte’s Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access,” was presented on .

podium 演讲标题为“Humacyte 的无细胞组织工程血管与自体动静脉瘘用于血液透析通路的两年结果：一项前瞻性随机试验”，于某日呈现。

Saturday, November 8, 2025

2025年11月8日，星期六

by

通过

Mohamad A. Hussain

穆罕默德·A·侯赛因

, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the

，医学博士，哲学博士，注册外周血管解读医师，美国心脏协会院士，加拿大皇家外科医学院院士，美国外科医师学会院士，布里格姆和妇女医院血管与腔内血管外科医生科学家，核心教员于

Center for Surgery and Public Health

外科与公共卫生中心

, and Assistant Professor of Surgery at

，以及外科助理教授 tại

Harvard Medical School

哈佛医学院

.

。

“In the V007 study the ATEV provided a clinically meaningful advantage in early usability and functional patency, enabling faster, more reliable dialysis initiation, especially in female, obese, and diabetic patients,” said

“在V007研究中，ATEV在早期可用性和功能性通畅方面提供了具有临床意义的优势，能够更快、更可靠地启动透析，尤其对于女性、肥胖和糖尿病患者，”表示

Dr. Hussain

胡赛因博士

. “As a biologic conduit, the ATEV could be game changing by improving arteriovenous access in many hemodialysis patients. Of particular importance were the positive results in female, obese, and diabetic patients, groups which typically have poor outcomes with autogenous fistula procedures and historically have limited treatment alternatives for hemodialysis access.

“作为一种生物导管，ATEV通过改善许多血液透析患者的动静脉通路，可能会带来变革。特别重要的是，在女性、肥胖和糖尿病患者中取得了积极的结果，这些群体通常在自体瘘手术中效果较差，并且历史上在血液透析通路方面治疗选择有限。”

The significantly higher duration of access over two years in these underserved patients could greatly reduce reliance on catheters for arteriovenous access, a major cause of complications and treatment costs in patient care.”.

这些服务不足的患者超过两年的通路使用时间显著延长，这可能会大大减少对动静脉通路导管的依赖，而导管是导致患者护理中并发症和治疗费用的主要原因。

The V007

V007

Phase 3

第三阶段

trial (NCT03183245) was a prospective, multi-center, randomized clinical study in 242 hemodialysis patients in

试验（NCT03183245）是一项前瞻性、多中心、随机临床研究，涉及242名血液透析患者。

the United States

美国

. Enrolled individuals were randomly assigned to receive either the ATEV or an AV fistula for hemodialysis access and were followed for up to 24 months. Under the statistical analysis plan for the trial, the primary efficacy assessment compared functional patency (usability for hemodialysis access) at six months and secondary patency (blood flow through the conduit) at 12 months, as co-primary endpoints.

登记的个体被随机分配接受ATEV或动静脉瘘进行血液透析通路，并随访长达24个月。根据试验的统计分析计划，主要疗效评估比较了六个月时的功能通畅性（用于血液透析通路的可用性）和十二个月时的次要通畅性（通过管道的血流量），作为共同主要终点。

As previously reported, the ATEV was observed to have superior patency and usability for dialysis at six and 12 months (co-primary endpoints), respectively, compared to autogenous fistula in all patients as well in the high-risk subgroups..

正如之前报道的，ATEV 在所有患者以及高风险亚组中，分别在六个月和十二个月时（共同主要终点）显示出比自体瘘管更优的通畅性和透析可用性。

The V007 study also had a secondary endpoint of duration access use over 24 months, which continued to show superiority of the ATEV over AV fistula in female, obese and diabetic patients. In female patients (n=70) over 24 months, patients implanted with the ATEV had 15.8 months of average duration of usage, compared to 10.0 months for patients receiving an AV fistula (p<0.0137).

V007研究还设有为期24个月的使用持续时间的次要终点，结果显示在女性、肥胖和糖尿病患者中，ATEV相对于动静脉瘘（AV fistula）继续保持优越性。在女性患者（n=70）中，经过24个月的观察，植入ATEV的患者平均使用时长为15.8个月，而接受动静脉瘘的患者为10.0个月（p<0.0137）。

In the target population of females, and males with obesity and diabetes (n=110), patients implanted with the ATEV had 14.8 months of average duration of access use compared to 9.1 months patients receiving an AV fistula (p=0.0114). For all patients in the study (n=242), patients receiving an ATEV had 13.3 months of average duration of access use compared to 12.3 months for AV fistula (p=0.7446).

在女性目标人群以及患有肥胖症和糖尿病的男性（n=110）中，植入ATEV的患者平均通路使用时间为14.8个月，而接受动静脉瘘（AV fistula）的患者为9.1个月（p=0.0114）。对于研究中的所有患者（n=242），接受ATEV的患者平均通路使用时间为13.3个月，而动静脉瘘为12.3个月（p=0.7446）。

The results are consistent with Humacyte’s stated strategy of targeting patients at higher risk of AV fistula failure: Females, and males with obesity and diabetes, which comprise over half of the hemodialysis population..

结果与Humacyte所述的针对AV瘘管失败高风险患者的战略一致：女性以及患有肥胖症和糖尿病的男性，这些人群占透析患者的一半以上。

“The two-year data from the V007 trial is truly groundbreaking,” said Dr.

“V007试验的两年数据确实具有开创性，”博士说道。

Roy Fujitani

藤谷罗伊

, Professor of Vascular and Endovascular Surgery at UC Irvine. “Seeing the ATEV outperform AV fistulae in high-risk patients—particularly women, diabetics, and those with obesity—is incredibly encouraging. This represents a pivotal shift in dialysis access strategy, introducing a durable, low-infection alternative that may dramatically improve outcomes for patients at elevated risk of fistula failure.”.

，加州大学欧文分校血管与腔内血管外科教授。“看到ATEV在高危患者（尤其是女性、糖尿病患者和肥胖患者）中表现优于动静脉瘘，这非常令人鼓舞。这代表着透析通路策略的关键转变，引入了一种持久且低感染风险的替代方案，可能会显著改善那些面临瘘管失败高风险患者的预后。”

Researchers concluded that after 24 months of follow up, there were no unexpected side effects observed in patients implanted with the ATEV. In the study, patients implanted with the ATEV had a comparable safety profile to patients receiving an AV fistula with low rates of infection and a lower need for maturation or surgical revision procedures compared to AV fistula.

研究人员得出结论，在24个月的随访后，植入ATEV的患者未观察到意外的副作用。在研究中，与接受动静脉瘘（AV fistula）的患者相比，植入ATEV的患者具有相似的安全性特征，感染率较低，并且与动静脉瘘相比，成熟或手术修正的需求更少。

Patients implanted with the ATEV experienced more thrombosis and narrowing/stenosis events requiring interventions than patients receiving an AV fistula, however the majority of these cases were successfully treated..

植入ATEV的患者比接受动静脉瘘的患者经历了更多的血栓形成和狭窄/梗阻事件，需要进行干预，但大多数病例都得到了成功治疗。

“These results are incredibly promising and the ATEV’s performance in high-risk patients signals a major advancement in dialysis access,” said

“这些结果非常有希望，ATEV在高危患者中的表现标志着透析通路方面的一项重大进步，”

Jason Burgess

杰森·伯吉斯

MD,

医生，

Surgical Specialists

外科专家

of

的

Charlotte

夏洛特

, PA. “As a clinician who participated in this study, I’m excited by the potential of a bioengineered vessel that not only improves usability but also reduces catheter dependence. I look forward to integrating ATEV into future treatment strategies for patients who historically have had poor outcomes with AV Fistula procedures.”.

，PA。“作为参与这项研究的临床医生，我对一种不仅提高可用性而且还减少导管依赖的生物工程血管的潜力感到兴奋。我期待将ATEV整合到未来治疗策略中，为那些历史上在动静脉瘘手术中效果不佳的患者提供更好的治疗方案。”

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之外的其他用途，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

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：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，旨在改善患者的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 Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in .

Humacyte公司针对血管创伤适应症的无细胞组织工程血管（ATEV）的生物制品许可申请已获得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’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，是第一个获得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用于肢体血管创伤后紧急动脉修复和晚期PAD的6毫米ATEV也获得了RMAT指定。

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

ATEV 获得优先指定用于治疗血管创伤。

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

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.

对于除FDA批准的肢体血管创伤适应症之外的其他用途，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”、“潜力”、“继续”、“正在进行”或这些术语的否定形式或其他类似表述，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 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 relative to existing alternatives; our plans and ability to execute product development, process dev.

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，我们产品候选者的成功及按预期时间表推进；市场对Symvess的接受程度以及第三方覆盖和报销的可用性，和如果获得监管机构批准，我们产品候选者的相关情况；我们制造Symvess的能力，以及如果获得监管机构批准，能否以足够数量满足我们的临床试验和商业需求；我们的ATEVs相较于现有替代品的预期优势；我们执行产品开发、工艺开发的计划和能力。

Humacyte

Humacyte

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10-K表格年报中“风险因素”标题下描述的那些。

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

March 31, 2025

2025年3月31日

, each filed by

，每份由

Humacyte

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：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·阿拉尔

LifeSci Advisors LLC

生命科学顾问有限责任公司

+1-617-435-6602

+1-617-435-6602

jallaire@lifesciadvisors.com

jallaire@lifesciadvisors.com

investors@humacyte.com

投资者@humacyte.com

Humacyte Media Contact:

Humacyte 媒体联系人：

Rich Luchette

里奇·卢切特

Precision Strategies

精准策略

+1-202-845-3924

+1-202-845-3924

rich@precisionstrategies.com

rich@precisionstrategies.com

media@humacyte.com

媒体@humacyte.com

Source: Humacyte, Inc

来源：Humacyte, Inc