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- Results published in Oxford Academic’s

- 结果发表在牛津学术的

Military Medicine Journal

《军事医学杂志》

-

-

- After up to 18 months of follow-up patients were observed to have zero infections, amputations or deaths and a high rate of patency -

- 在长达18个月的随访中，观察到患者零感染、零截肢、零死亡，并且通畅率很高 -

DURHAM, N.C.

杜伦，北卡罗来纳州

,

，

Oct. 06, 2025

2025年10月6日

(GLOBE NEWSWIRE) --

（环球新闻网）--

Humacyte, Inc.

哈马赛特公司

(Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the publication in Oxford Academic’s

(Nasdaq: 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，今天宣布在牛津学术出版物上发表文章。

Military Medicine

军事医学

of positive long-term results from its humanitarian program using Symvess to treat wartime vascular trauma injuries in

其使用 Symvess 治疗战时血管创伤的人道主义计划取得了积极的长期结果

Ukraine

乌克兰

. The publication, titled 'Evaluating the Safety and Efficacy of Humacyte Acellular Tissue-Engineered Vessel in a Real-World Combat Setting: A Retrospective Observational Multicenter Study,” reported that trauma patients with wartime injuries treated with Symvess were observed to have a continued high rate of patency (87.1%), 100% limb salvage, and zero cases of conduit infection in 17 patients with extremity injuries followed for up to 18 months.

该出版物题为“在现实世界战斗环境中评估Humacyte无细胞组织工程血管的安全性和有效性：一项回顾性观察多中心研究”，报告称，接受Symvess治疗的战伤患者在长达18个月的随访中，观察到持续的高通畅率（87.1%）、100%肢体保全率，且17名肢体受伤患者中未发生任何导管感染病例。

.

。

“War is changing, and our military medicine needs to keep pace,” said

“战争正在改变，我们的军事医学需要跟上步伐，”

Oleksandr Sokolov

奥列克桑德尔·索科洛夫

, M.D., Ph.D., a Ukrainian vascular surgeon who treated patients with Symvess under the humanitarian program. “With the growing scale and complexity of missile- and drone-related trauma, prolonged delays and infection risk amplify the medical challenge, exposing critical gaps in timely treatment and long-term recovery.

，医学博士，乌克兰血管外科医生，曾在人道主义项目下使用Symvess治疗患者。“随着导弹和无人机相关创伤的规模和复杂性增加，治疗延误时间延长且感染风险上升，医疗挑战更加严峻，暴露了及时治疗和长期康复中的关键缺口。

Immediate availability of a biologic conduit enables faster reconstruction and offers a practical alternative even when autologous vein is not feasible. Long-term outcomes reinforce my conclusion from using Symvess: Biologic conduits hold strong potential to advance vascular trauma care by shortening reconstruction time, reducing acute ischemia duration, lowering complication rates, and improving limb salvage.”.

生物导管的即时可用性使得更快的重建成为可能，即使自体静脉不可行时也提供了一个实用的替代方案。长期结果印证了我使用Symvess得出的结论：生物导管通过缩短重建时间、减少急性缺血持续时间、降低并发症发生率以及提高肢体保全率，在血管创伤护理方面具有强大的潜力。"

Battlefield vascular injuries are some of the most difficult for surgeons to treat because of time pressure and the potential for infection. Unlike traditional autologous vein grafts, which require harvesting a patient’s vein during surgery, Symvess (acellular tissue engineered vessel (ATEV™)) is designed to be immediately available off-the-shelf — saving critical surgical time in wartime situations.

战场上的血管损伤是外科医生最难处理的问题之一，因为时间紧迫且存在感染风险。传统的自体静脉移植需要在手术过程中采集患者的静脉，而Symvess（无细胞组织工程血管（ATEV™））则设计为可立即从货架上获取——在战时情况下节省了宝贵的手术时间。

Symvess has also showed low rates of infection..

Symvess的感染率也很低。

The publication described the outcomes of 17 patients treated with treated with Symvess whose injuries included combat-related extremity vascular trauma from gunshots, blasts, and shrapnel. At 30 days of follow up, the primary measurement point in the study, patients treated with Symvess had incurred zero deaths, zero amputations, and zero cases of infection.

该出版物描述了17名接受Symvess治疗的患者的治疗结果，这些患者的损伤包括由枪伤、爆炸和弹片造成的与战斗相关的肢体血管创伤。在30天的随访中，即研究的主要测量点，接受Symvess治疗的患者实现了零死亡、零截肢和零感染。

The 30-day primary and secondary patency rate was 93.8%. The long-term results published for the first time in .

30天一期和二期通畅率为93.8%。长期结果首次发表于。

Military Medicine

军事医学

confirmed these earlier positive outcomes. At up to 18 months of follow up, patients were observed to have suffered zero deaths, zero infections, and zero amputations. Furthermore, Symvess demonstrated continued high levels of patency (87.1%) and no instances of immunological rejection.

确认了这些早期的积极结果。在长达18个月的随访中，观察到患者零死亡、零感染、零截肢。此外，Symvess 显示出持续的高通畅率（87.1%），且没有出现免疫排斥的情况。

“These outcomes not only validate the strong results we saw at the 30-day mark, but also demonstrate that patients can sustain these benefits over time, even when sustaining devastating combat wounds,” said

“这些结果不仅验证了我们在30天时看到的强劲结果，还表明患者即使在遭受严重的战斗伤口时，也能够随着时间的推移持续获得这些益处，”

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

哈马赛特

. “Humacyte’s goal has always been to improve outcomes and reduce complications for patients, and we know that goes far beyond immediate follow up. Our soldiers — and surgeons — deserve the cutting-edge in patient care, and we are excited to be offering them a new option.”

“Humacyte 的目标一直是改善患者的治疗效果并减少并发症，我们知道这远不止是短期的跟进。我们的士兵——和外科医生——值得拥有最先进的患者护理，我们很高兴能为他们提供一个新的选择。”

INDICATION

适应症

Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.

Symvess是一种无细胞组织工程血管，适用于成人，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，作为肢体动脉损伤的血管通道。

IMPORTANT SAFETY INFORMATION

重要安全信息

BOXED WARNING: GRAFT FAILURE

黑框警告：移植失败

Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.

由于移植物中段破裂或吻合口失败导致Symvess完整性丧失，可能引发危及生命的出血。

CONTRAINDICATIONS

禁忌症

DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries.

在急性损伤治愈后，对于有医疗状况会妨碍长期抗血小板治疗（如阿司匹林或氯吡格雷）的患者，切勿使用Symvess。

WARNINGS AND PRECAUTIONS

警告和注意事项

Graft Rupture

移植物破裂

Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia..

接受Symvess治疗的患者已发生血管移植物破裂。告知患者动脉出血可能危及生命，并建议在出现任何移植物破裂的体征或症状（如肢体出血、疼痛和肿胀，或肢体缺血迹象）时寻求紧急医疗评估。

Anastomotic Failure

吻合口失败

Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding.

接受Symvess治疗的患者已发生吻合口失败。在Symvess的临床研究中，吻合口失败发生在植入后的前36天内。监测患者是否出现吻合口失败的迹象，如手术部位疼痛和肿胀、血红蛋白减少或出血的其他体征和症状。

Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin..

建议患者如果出现任何可能提示吻合口失败的体征或症状，如手术部位出血、肿胀、疼痛加重或皮肤颜色改变，应立即寻求紧急医疗评估。

Thrombosis

血栓形成

Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess..

使用Symvess治疗的患者已出现血栓形成。在Symvess的临床试验中，患者在接受Symvess植入后接受了抗血小板治疗以降低血栓形成的风险。停用抗血小板治疗的患者血栓形成的风险可能会增加。建议在接受Symvess治疗后进行抗血小板治疗。

Transmission of Infectious Diseases

传染病的传播

Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum).

Symvess 是使用可能传播传染性疾病或传染性因子的细胞和试剂制造的。用于制造 Symvess 的细胞来源于符合传染性疾病供体资格要求的捐赠者，这些要求包括对人类免疫缺陷病毒 1 型（HIV-1）、人类免疫缺陷病毒 2 型（HIV-2）、乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和梅毒（苍白密螺旋体）相关风险的筛查和检测。

The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents.

细胞库对人类和动物病毒、逆转录病毒、细菌、真菌、酵母和支原体检测呈阴性。尽管所有动物源性试剂在使用前都经过动物病毒、细菌、真菌和支原体的检测，但这些措施并不能消除传播这些或其他可传播的传染性疾病和病原体的风险。

Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing..

胎牛血清的来源经过筛选，以尽量减少传播引起牛海绵状脑病的朊病毒蛋白的风险，这种蛋白也是导致人类患上罕见致命疾病——变异型克雅氏病的原因。在临床试验期间，未报告有传染性病原体感染的情况。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain.

最常见的不良反应（发生率≥10%）为血管移植物血栓形成、发热和疼痛。

Please see full Prescribing Information at

请查看完整的处方信息

www.symvess.com

www.symvess.com

, including Boxed Warning, for Symvess.

，包括加框警告，适用于Symvess。

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，旨在改善患者生活并变革医学实践。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 the vascular trauma indication was approved by the FDA in .

Humacyte公司用于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目前还在针对其他血管应用的晚期临床试验中，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

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：我们对Symvess商业化的计划和能力，以及如果获得监管机构批准，我们的候选产品的商业化计划和预期时间表；市场对Symvess的接受程度及第三方覆盖和报销的可用性，以及如果获得监管机构批准，我们候选产品的情况；我们制造Symvess的能力，以及如果获得监管机构批准，我们是否有能力以足够的数量满足临床试验和商业化需求；我们的ATEVs相对于现有替代品的预期优势；我们在产品开发、工艺开发方面的计划和执行能力。

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，包括我们年度报告Form 10-K中“风险因素”标题下所述的内容，截至 năm kết thúc

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。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很重要。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范围内实现我们的目标和计划，或者根本无法实现。

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

生命科学顾问有限公司

+1-617-435-6602

+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

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

media@humacyte.com

Source: Humacyte, Inc

来源：Humacyte, Inc