Humacyte宣布发布比较Symvess™与自体静脉在肢体动脉创伤中的新数据-动脉网

Humacyte Announces Publication of New Data Comparing Symvess™ to Autologous Vein in Extremity Arterial Trauma

Humacyte 等信源发布 2025-10-30 20:47

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- Results published in AAST’s

- 结果发布在AAST的

Trauma Surgery & Acute Care Open Journal

创伤外科与急性护理开放期刊

- Study compared outcomes of patients treated with Symvess with patients in PROOVIT registry who were treated with vein -

- 研究比较了接受Symvess治疗的患者与接受静脉治疗的PROOVIT注册患者的结局 -

- In a comparison to prior results in the PROOVIT registry, outcomes for Symvess and autologous vein were similar for treatment of vascular trauma -

- 与PROOVIT注册库中的先前结果相比，Symvess和自体静脉在治疗血管创伤方面的结果相似 -

DURHAM, N.C.

北卡罗来纳州达勒姆市

，

Oct. 30, 2025

2025年10月30日

(GLOBE NEWSWIRE) --

（环球新闻网）--

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 a new study comparing clinical outcomes of Symvess to autologous vein in the treatment of extremity arterial trauma.

（纳斯达克：HUMA），一家处于商业化阶段的生物技术平台公司，专注于大规模开发可普遍植入的生物工程人体组织，今天宣布了一项新研究的发布，该研究比较了Symvess与自体静脉在治疗肢体动脉创伤中的临床结果。

The study was published in the .

该研究发表在。

American Association for the Surgery of Trauma (AAST)'s

美国创伤手术协会 (AAST) 的

Trauma Surgery & Acute Care Open

创伤外科与急性护理开放

Journal

期刊

. The publication was entitled “Short-term Performance of Symvess™ Compared to External Control Data for Autologous Vein in Treatment of Extremity Arterial Trauma.” Compared to pre-existing patients in a trauma registry who were treated with autologous vein, patients treated with Symvess experienced similar short-term outcomes for patency, limb salvage, and infection.

出版物标题为“Symvess™与自体静脉治疗肢体动脉创伤的外部对照数据的短期性能比较。” 与创伤登记库中使用自体静脉治疗的患者相比，使用Symvess治疗的患者在通畅性、肢体保留和感染方面的短期结果相似。

。

“Autologous vein has long been the gold standard for the treatment of extremity arterial trauma, and for good reason — it resists infection and maintains patency,” said

“自体静脉长期以来一直是治疗肢体动脉创伤的黄金标准，而且理由充分——它能抵抗感染并保持通畅，”

Luigi Pascarella

路易吉·帕斯卡雷拉

, MD, Division Chief of Vascular Surgery,

医学博士，血管外科主任，

UNC School of Medicine

北卡罗来纳大学医学院

, and one of the authors of the publication. “The fact that Symvess achieved similar short-term outcomes in this analysis demonstrates its potential as a reliable, off-the-shelf alternative when use of autologous vein is not feasible.”

“,并且是该出版物的作者之一。“Symvess 在这次分析中取得了类似的短期结果，这证明了当自体静脉使用不可行时，它作为一种可靠、现成的替代品的潜力。”

The comparative analysis leveraged data from two clinical trials — Humacyte’s Phase 2/3 V005 study and the Humanitarian V017 study in

比较分析利用了来自两项临床试验的数据——Humacyte的2/3期V005研究和人道主义V017研究。

Ukraine

乌克兰

— and matched patients in those trials to patients from the Prospective Observational Vascular Injury Treatment (PROOVIT) registry, which is the world’s largest vascular trauma database. The study found patients treated with Symvess had statistically similar clinical outcomes to those for patients from the PROOVIT registry who received autologous vein.

——并将这些试验中的患者与世界上最大的血管创伤数据库——前瞻性观察性血管损伤治疗 (PROOVIT) 注册库中的患者进行匹配。研究发现，使用 Symvess 治疗的患者在临床结果上与接受自体静脉移植的 PROOVIT 注册库患者具有统计学上的相似性。

Primary patency for Symvess versus the autologous vein group was 86.6% vs. 91.8%; secondary patency was 91.0% vs. 97.7%; amputation was 7.5% vs. 8.2%; conduit infection was 1.5% vs. 0%; and death was 4.5% vs. 4.5%, respectively..

Symvess与自体静脉组的主要通畅率为86.6% vs. 91.8%；次要通畅率为91.0% vs. 97.7%；截肢率为7.5% vs. 8.2%；管道感染率为1.5% vs. 0%；死亡率为4.5% vs. 4.5%。

The use of autologous vein to repair or replace a damaged blood vessel is the current standard of care for treating extremity arterial trauma because it offers excellent long-term patency and low infection rates. However, in many cases, suitable autologous vein may not be available due to extreme limb damage, prior surgeries, or poor vein quality.

使用自体静脉修复或替换受损血管是目前治疗肢体动脉创伤的护理标准，因为其长期通畅性佳且感染率低。然而，在许多情况下，由于肢体严重损伤、既往手术或静脉质量差，可能无法获得合适的自体静脉。

Even when available, harvesting the vein is a time-consuming procedure, and therefore not an option for many patients with severe traumatic injuries. Symvess (acellular tissue engineered vessel, or ATEV™) is designed to be immediately available off-the-shelf — saving critical surgical time in traumatic situations..

即使可用，静脉采集也是一个耗时的过程，因此对于许多严重创伤患者来说并非可行选择。Symvess（无细胞组织工程血管，或ATEV™）旨在实现即时可用的现货供应——在紧急创伤情况下节省关键的手术时间。

“Trauma and vascular surgeons treat some of the most complex and urgent cases imaginable — from gunshot injuries to wounds from blasts or ammunition on the battlefield,” said

“创伤和血管外科医生治疗一些最复杂和最紧急的病例，从枪伤到战场上的爆炸或弹药造成的伤口，”

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

. “However, innovation in recent years has failed to provide them with good alternatives to autologous vein grafts for instances when treatments with these grafts is not feasible. The results of this study underscore Symvess’ potential as a much needed safe, effective, and lifesaving alternative for treatment.”.

“然而，近年来的创新未能为他们在自体静脉移植不可行的情况下提供良好的替代方案。本研究的结果强调了Symvess作为一种急需的安全、有效且挽救生命的治疗替代方案的潜力。”

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，在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的情况下，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

框架警告：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.

切勿在急性损伤治愈后存在长期抗血小板治疗（如阿司匹林或氯吡格雷）禁忌症的患者中使用Symvess。

WARNINGS AND PRECAUTIONS

警告和注意事项

●

Graft Rupture

移植破裂

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，若出现任何移植物破裂的迹象或症状，如出血、疼痛和肢体肿胀，或肢体缺血的迹象，应立即寻求紧急医疗评估。

●

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.

使用Symvess治疗的患者发生了吻合口失败。在Symvess的临床研究中，吻合口失败发生在植入后的前36天内。监测患者吻合口失败的迹象，如手术部位疼痛和肿胀、血红蛋白下降或其他出血的体征和症状。

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、肿胀或疼痛加重或覆盖皮肤的颜色变化，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..

接受Symvess治疗的患者已发生血栓。在Symvess的临床试验中，患者在植入Symvess后接受了抗血小板治疗以降低血栓风险。停用抗血小板治疗的患者血栓风险可能会增加。建议在使用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 是使用可能传播感染性疾病或感染因子的细胞和试剂制造的。用于制造 Symvess 的细胞来源于一名符合传播性感染疾病捐赠者资格要求的供体，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.

细胞库检测结果为阴性，未发现人类和动物病毒、逆转录病毒、细菌、真菌、酵母和支原体。虽然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变异型克雅氏病的罕见致命疾病的病因。在临床试验期间，未报告有任何可传播的病原体感染。

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

请参阅完整的处方信息 tại

www.symvess.com

, including Boxed Warning, for Symvess.

，包括对Symvess的加框警告。

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：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目前也正处于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用于治疗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认定。

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

。

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。

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风险、不确定性和其他因素。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 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实施及预期时间表；市场对Symvess的接受程度以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ATEV相对于现有替代品的预期优势；我们执行产品开发和工艺开发的计划与能力。

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，包括我们在截至某年的Form 10-K年度报告中“风险因素”标题下描述的内容。

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

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。这些因素大多数都是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@生命科学顾问公司.com

investors@humacyte.com

投资者@humacyte.com