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DURHAM, N.C., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease was accepted for an oral presentation at the American Society of Nephrology’s (ASN) Kidney Week 2024.
北卡罗来纳州达勒姆,2024年10月8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,以商业规模开发通用植入式生物工程人体组织,宣布其关于无细胞组织工程血管(ATEV™)在终末期肾病患者动静脉通路中的V007 3期临床试验的最新摘要已被美国肾脏病学会(ASN)2024肾脏周的口头介绍所接受。
The late-breaking abstract titled “Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access” will be presented at the ASN meeting in San Diego on October 26, 2024..
题为“Humacyte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前瞻性随机试验”的最新摘要将于2024年10月26日在圣地亚哥举行的ASN会议上发表。。
Details of the presentation are as follows:
Late-Breaking Presentation Title: Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access
最新报道标题:Humacyte脱细胞组织工程血管与自体动静脉瘘用于血液透析通路的前瞻性随机试验
Presenter: Dr. Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School
主持人:Mohamad A.Hussain博士,医学博士,博士,RPVI,FAHA,FRCSC,FACS,布莱根妇女医院血管和血管内外科医生科学家,外科和公共卫生中心核心教员,哈佛医学院外科助理教授
Session Title: High-Impact Clinical Trials - 2
课程名称:高影响力临床试验-2
Session Date/Time: Saturday, October 26, 2024 from 10:30 AM PT to 12:30 PM PT
Session Date/Time: Saturday, October 26, 2024 from 10:30 AM PT to 12:30 PM PT
For more information on the American Society of Nephrology (ASN) Kidney Week 2024, please click here.
有关2024年美国肾脏病学会(ASN)肾脏周的更多信息,请单击此处。
Humacyte expects to provide additional details from the oral presentation in a future press release that will be posted to the News & Events section on the Investors page of the Humacyte website.
Humacyte希望在未来的新闻稿中提供口头陈述的更多细节,该新闻稿将发布在Humacyte网站投资者页面的新闻与事件部分。
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. Humacyte 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。Humacyte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。。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 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 our ATEVs 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.
本新闻稿中的前瞻性声明包括但不限于关于我们临床前和临床试验的开始,时间,进展和结果的声明;我们ATEV的预期特性和性能;我们成功完成ATEV临床前和临床试验的能力;;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;以及监管备案、接受和批准的时间或可能性。
We cannot assure you that the forward-looking statements in this p.
我们无法向您保证本页中的前瞻性声明。
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