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Humacyte to Present Efficacy and Safety Results From V007 Phase 3 AV Access Clinical Trial at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH)

Humacyte to Present Efficacy and Safety Results From V007 Phase 3 AV Access Clinical Trial at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH)

Humacyte将在第51届血管和血管内问题、技术和前沿研讨会(VEITH)上展示V007三期AV接入临床试验的有效性和安全性结果。
GlobeNewswire ·  11/22 21:00

DURHAM, N.C., Nov. 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it will present Phase 3 results from a clinical study comparing efficacy and safety of Humacyte's acellular tissue engineered vessel (ATEV) with autologous AV fistulas in patients with end stage renal disease at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH) in New York, NY on November 23, 2024.

北卡罗来纳州杜罕,2024年11月22日(环球新闻社) - Humacyte公司(纳斯达克:HUMA)是一家临床阶段的生物技术平台公司,在商业规模上开发通用可植入的生物工程人体组织。今天宣布,将在第51届血管和介入血管问题、技术与视野(VEITH)年会上,于2024年11月23日在纽约市介绍一项临床研究的第3阶段结果,比较Humacyte无细胞组织工程血管(ATEV)与自体AV瘘管在晚期肾病患者中的疗效和安全性。

Details of the presentation are as follows:

演示的详细信息如下:

Presentation Title: Results of a Phase 3 Study Comparing Efficacy and Safety of Humacyte Tissue-Engineered Vessel with Autologous AV Fistulas in Patients with End Stage Renal Disease

报告主题:比较Humacyte组织工程血管与自体AV瘘管治疗晚期肾病患者的疗效和安全性的第3期研究结果

Presenter: Dr. Charles Keith Ozaki, MD, Vascular Surgeon and Director of Vascular Surgery Research at Brigham and Women's Hospital; John A. Mannick Professor of Surgery at Harvard Medical School

主讲人:查尔斯·基思·尾崎博士(MD),血管外科医生,是布里格姆妇女医院血管外科研究主任;哈佛医学院约翰·A·曼尼克外科学教授

Session Title: Novel Technologies in Hemodialysis Access

会议主题:透析通路中的新技术

Session Date/Time: Saturday, November 23, 2024, 2:15 – 2:22 PM ET

会议日期/时间:2024年11月23日(星期六),下午2:15 – 2:22 美国东部时间

For more information on the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH), please click here.

欲了解更多关于第51届血管与内膜问题、技术及视野(VEITH)年会的信息,请点击这里。

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

ATEV是一种研究性产品,尚未获得FDA或其他监管机构的销售批准。

About Humacyte

关于Humacyte

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'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. 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. 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. The ATEV is an investigational product and has not been approved for sale by the Food and Drug Administration or any international regulatory agency.

Humacyte公司(纳斯达克:HUMA)正在开发一种颠覆性的生物技术平台,用于提供可普遍植入的生物工程人体组织、先进的组织结构和器官系统,旨在改善患者生活并改变医学实践。该公司开发和生产无细胞组织,用于治疗各种疾病、损伤和慢性病。Humacyte的首批产品候选品,一系列ATEV,目前正在针对多种血管应用进行后期临床试验,包括血管创伤修复、透析的动静脉(AV)通路和周围动脉疾病。ATEV在血管创伤适应症方面的生物制品许可申请目前正在FDA审查中,并获得了优先审查。动物实验前期开发也正在进行中,包括冠状动脉旁路移植、小儿心脏手术、治疗1型糖尿病以及多种新型细胞和组织应用。Humacyte 6mm ATEV用于透析的AV通路是第一个获得FDA再生医学先进疗法(RMAT)指定的产品候选品,并且还获得了FDA快速通道指定。用于急性肢体血管创伤后紧急动脉修复和用于晚期PAD的ATEV也获得了RMAT指定。该ATEV已获得美国国防部长对于血管创伤治疗的优先指定。ATEV是一种研究性产品,尚未获得美国食品药品监督管理局或任何国际监管机构的销售批准。

Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com

Humacyte投资者联系方式:
乔伊斯·阿莱尔
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com

Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com

Humacyte媒体联系人:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com


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