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)
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.
北卡羅來納州杜罕,2024年11月22日(環球新聞社) - Humacyte公司(納斯達克:HUMA)是一家臨床階段的生物技術平台公司,在商業規模上開發通用可植入的生物工程人體組織。今天宣佈,將在第51屆血管和介入血管問題、技術與視野(VEITH)年會上,於2024年11月23日在紐約市介紹一項臨床研究的第3階段結果,比較Humacyte無細胞組織工程血管(ATEV)與自體AV瘻管在晚期腎病患者中的療效和安全性。
Details of the presentation are as follows:
演示的詳細信息如下:
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
報告主題:比較Humacyte組織工程血管與自體AV瘻管治療晚期腎病患者的療效和安全性的第3期研究結果
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
主講人:查爾斯·基思·尾崎博士(MD),血管外科醫生,是布里格姆婦女醫院血管外科研究主任;哈佛醫學院約翰·A·曼尼克外科學教授
Session Title: Novel Technologies in Hemodialysis Access
會議主題:透析通路中的新技術
Session Date/Time: Saturday, November 23, 2024, 2:15 – 2:22 PM ET
會議日期/時間:2024年11月23日(星期六),下午2:15 – 2:22 美國東部時間
For more information on the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH), please click here.
欲了解更多關於第51屆血管與內膜問題、技術及視野(VEITH)年會的信息,請點擊這裏。
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
ATEV是一種研究性產品,尚未獲得FDA或其他監管機構的銷售批准。
About Humacyte
關於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(納斯達克:HUMA)正在開發一種顛覆性的生物技術平台,用於提供可普遍植入的生物工程人體組織、先進的組織結構和器官系統,旨在改善患者生活並改變醫學實踐。該公司開發和生產無細胞組織,用於治療各種疾病、損傷和慢性病。Humacyte的首批產品候選品,一系列ATEV,目前正在針對多種血管應用進行後期臨床試驗,包括血管創傷修復、透析的動靜脈(AV)通路和周圍動脈疾病。ATEV在血管創傷適應症方面的生物製品許可申請目前正在FDA審查中,並獲得了優先審查。動物實驗前期開發也正在進行中,包括冠狀動脈旁路移植、小兒心臟手術、治療1型糖尿病以及多種新型細胞和組織應用。Humacyte 6mm ATEV用於透析的AV通路是第一個獲得FDA再生醫學先進療法(RMAT)指定的產品候選品,並且還獲得了FDA快速通道指定。用於急性肢體血管創傷後緊急動脈修復和用於晚期PAD的ATEV也獲得了RMAT指定。該ATEV已獲得美國國防部長對於血管創傷治療的優先指定。ATEV是一種研究性產品,尚未獲得美國食品藥品監督管理局或任何國際監管機構的銷售批准。
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte投資者聯繫方式:
喬伊斯·阿萊爾
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媒體聯繫人:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
譯文內容由第三人軟體翻譯。