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- Results presented at the Department of Defense’s Military Health System Research Symposium (MHSRS) -

-在国防部军事卫生系统研究研讨会（MHSRS）上发表的结果-

- In real-world military setting the ATEV was observed to have 12-month patency of 87.1% -

-在现实世界的军事环境中，ATEV的12个月通畅率为87.1%-

- There were zero instances of infection, amputation or death during the long-term follow-up period despite the severity of the wartime injuries treated -

-尽管战时受伤情况严重，但在长期随访期间，没有发生感染、截肢或死亡的情况-

DURHAM, N.C., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, yesterday presented positive long-term results from a humanitarian program conducted in Ukraine under which the investigational acellular tissue engineered vessel (ATEV) was used to treat vascular injuries suffered during the ongoing conflict.

北卡罗来纳州达勒姆，2024年8月27日（环球通讯社）--Humacyte，Inc.（纳斯达克：HUMA），一家临床阶段生物技术平台公司，以商业规模开发普遍植入的生物工程人体组织，昨天在乌克兰进行的一项人道主义计划取得了积极的长期结果，根据该计划，研究性无细胞组织工程血管（ATEV）被用于治疗正在进行的冲突中遭受的血管损伤。

Long-term follow-up results were presented for the first time and showed high rates of patency (blood flow) and the avoidance of amputation and infection despite the severe nature of the wartime injuries treated. The results were presented at the Military Health System Research Symposium (MHSRS), the U.S.

首次提出了长期随访结果，结果显示，尽管所治疗的战时伤害性质严重，但通畅率（血流）很高，并且避免了截肢和感染。研究结果发表在美国军事卫生系统研究研讨会（MHSRS）上。

Department of Defense’s foremost scientific meeting, held in Kissimmee, Florida..

国防部最重要的科学会议在佛罗里达州基西米举行。。

The presentation highlighted the results for 16 extremity patients treated in Ukraine who provided consent for use of their results, a set of data known as the “V017 trial.” The primary analyses for the V017 trial were at 30 days of follow up, and as previously reported the rate of success for treatment of patients with the ATEV at this time point was high with primary and secondary patency of 93.8%, zero amputations, and zero cases of infection of the ATEV.

该报告重点介绍了在乌克兰接受治疗的16名肢体患者的结果，他们同意使用他们的结果，这是一组被称为“V017试验”的数据。V017试验的主要分析是在30天的随访中，正如先前报道的那样，此时治疗ATEV患者的成功率很高，一级和二级通畅率为93.8%，无截肢，无ATEV感染病例。

Longer-term results for the V017 patients were presented for the first time at the MHSRS meeting, with a mean follow-up duration of 357.9 days. Kaplan-Meier estimates of 12-month primary and secondary patency both were 87.1%. There were no instances of ATEV infections, amputation of affected limbs, or deaths related to ATEV through the end of long-term follow-up.

V017患者的长期结果首次在MHSRS会议上提出，平均随访时间为357.9天。Kaplan-Meier估计12个月的原发性和继发性通畅率均为87.1%。在长期随访结束时，没有ATEV感染，患肢截肢或与ATEV相关的死亡病例。

There was one event of ATEV thrombosis after month six. There were no reports of ATEV aneurysm or pseudo-aneurysm. These results were achieved despite the fact that all patients had a high risk of wound infection and were severely injured, with a mean Injury Severity Score (ISS) of 20.1. Patients treated with the ATEV included those injured due to mine blasts, shrapnel and high velocity ballistics..

六个月后发生了一次ATEV血栓形成事件。没有ATEV动脉瘤或假性动脉瘤的报道。尽管所有患者都有伤口感染的高风险，并且严重受伤，平均损伤严重程度评分（ISS）为20.1，但仍取得了这些结果。。。

“We are pleased that the long-term results in a military setting are consistent with the 30-day results previously observed and support the potential durability of the ATEV in vascular trauma patients,” said Shamik Parikh, M.D., Chief Medical Officer of Humacyte. “For repair or reconstruction of traumatic vascular injuries when autologous veins are not feasible, the ATEV may offer combat surgical teams an off-the-shelf and universally implantable alternative that has shown extremely low rates of infection, potentially offering durable performance and help with limb salvage.”.

Humacyte首席医疗官Shamik Parikh医学博士说：“我们很高兴在军事环境中的长期结果与之前观察到的30天结果一致，并支持ATEV在血管创伤患者中的潜在耐久性。”。“对于自体静脉不可行时创伤性血管损伤的修复或重建，ATEV可能为作战外科团队提供现成且普遍可植入的替代方案，其感染率极低，可能提供持久的性能并有助于肢体挽救。”。

“We are very grateful for the invaluable support during this difficult time,” said Oleksandr Sokolov, M.D., Ph.D., a Ukrainian vascular surgeon who treated patients with the ATEV under the humanitarian program. “The ATEV implantations performed for those wounded by blast injuries have significantly reduced the time of acute ischemia following injury, which has a positive impact on the preservation of lives and limbs.

乌克兰血管外科医生OleksandrSokolov医学博士说：“我们非常感谢在这段困难时期提供的宝贵支持，他在人道主义计划下治疗了ATEV患者。“为爆炸伤伤员进行的ATEV植入术显着缩短了受伤后急性缺血的时间，这对保护生命和四肢有积极影响。

These implantations are quicker due to the absence of the need for vein harvesting for graft preparation and have excellent immunological and infection resistance, making them particularly effective in the context of combat injuries.”.

由于不需要静脉采集进行移植物制备，这些植入更快，并且具有优异的免疫和感染抵抗力，使其在战斗伤害的情况下特别有效。”。

The ATEV is an investigational, first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair, and for use as hemodialysis access. While harvesting vein from a trauma patient requires critical surgical time, the ATEV is designed to be available off-the-shelf.

ATEV是一种研究性的，一流的生物工程人体组织，旨在成为一种普遍植入的血管导管，用于动脉置换和修复，并用作血液透析通路。虽然从创伤患者那里采集静脉需要关键的手术时间，但ATEV的设计是现成的。

The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency..

ATEV是一种研究产品，尚未获得FDA或任何其他监管机构的批准销售。。

About Humacyte

关于腐殖酸盐

Humacyte, Inc. (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.

Humacyte，Inc.（纳斯达克股票代码：HUMA）正在开发一个颠覆性的生物技术平台，以提供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改变医学实践。该公司开发和制造无细胞组织，用于治疗各种疾病、伤害和慢性病。

Humacyte’s initial product candidates, a portfolio of 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 is currently under review by the FDA and was granted Priority Review.

Humacyte最初的候选产品是一系列ATEV，目前正在进行针对多种血管应用的晚期临床试验，包括血管创伤修复，血液透析的动静脉（AV）通路和外周动脉疾病。目前，FDA正在审查ATEV在血管创伤适应症中的生物制剂许可证申请，并获得优先审查。

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.

冠状动脉旁路移植术，儿科心脏手术，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用于血液透析AV通路的6mm ATEV是第一个获得FDA再生医学高级治疗（RMAT）指定的候选产品，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 U.S. Secretary of Defense. For more information, visit www.Humacyte.com..

Humacyte的6mm ATEV用于肢体血管创伤后的紧急动脉修复和高级PAD也已获得RMAT指定。ATEV被美国国防部长优先指定用于治疗血管创伤。有关更多信息，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和假设以及当前可用信息的前瞻性声明。在某些情况下，您可以通过以下词语来识别前瞻性陈述：“可能”，“将”，“可能”，“将”，“应该”，“期望”，“打算”，“计划”，“预期”，“相信”，“估计”，“预测”，“项目”，“潜在”，“继续”，“正在进行”或这些术语或其他类似术语的否定词，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、不确定性和其他因素，这些因素可能导致实际结果、活动水平、绩效或成就与这些前瞻性声明所表达或暗示的信息存在重大差异。虽然我们相信本新闻稿中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，对此我们无法确定。

Forward-looking statements in this press release include, but are not limited to, the outcome of the FDA’s review of our BLA seeking approval of the ATEV in the vascular trauma indication; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, the anticipated characteristics and performance of our ATEV; 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 f.

本新闻稿中的前瞻性声明包括但不限于FDA对我们的BLA的审查结果，寻求ATEV在血管创伤适应症中的批准；关于我们的临床前和临床试验的开始，时间，进展和结果，我们的ATEV的预期特征和性能的声明；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效益；我们ATEV的预期商业化以及我们的商业规模制造能力；我们业务模式和战略计划的实施；以及监管f的时间或可能性。

Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com

Humacyte投资者联系人：Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com

Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Humacyte媒体接触：Rich-LuchettePrecision策略+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Source: Humacyte, Inc

资料来源：Humacyte，Inc