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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將在第51屆血管和血管內問題、技術和前沿研討會(VEITH)上展示V007三期AV接入臨床試驗的有效性和安全性結果。
GlobeNewswire ·  2024/11/22 05:00

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.

北卡羅來納州達勒姆,2024年11月22日(GLOBE NEWSWIRE)——Humacyte, Inc.(納斯達克股票代碼:HUMA)是一家臨床階段的生物技術平台公司,正在開發商業規模的通用植入、生物工程人體組織。該公司今天宣佈,它將公佈一項比較Humacyte無細胞組織工程血管(ATEV)與自體房室瘻的療效和安全性的臨床研究的3期結果終末期腎臟疾病患者於11月23日在紐約州紐約參加第51屆血管和血管內問題、技術和視野年度研討會(VEITH),2024。

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

演講題目:一項比較Humacyte組織工程血管與自體房室瘻對終末期腎臟疾病患者的療效和安全性的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

主持人:Charles Keith Ozaki博士,醫學博士,布里格姆婦女醫院血管外科醫生兼血管外科研究主任;哈佛醫學院約翰·曼尼克外科教授

Session Title: Novel Technologies in Hemodialysis Access

會議標題:血液透析准入中的新技術

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

會議日期/時間:美國東部時間 2024 年 11 月 23 日星期六下午 2:15 — 2:22

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

有關第51屆血管和血管內問題、技術和視野年度研討會(VEITH)的更多信息,請點擊此處。

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

ATEV 是一種研究產品,尚未獲得 FDA 或任何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, Inc.(納斯達克股票代碼:HUMA)正在開發一個顛覆性的生物技術平台,以提供普遍可植入的生物工程人體組織、先進的組織結構和器官系統,旨在改善患者生活和改變醫學實踐。該公司開發和製造用於治療各種疾病、損傷和慢性病的脫細胞組織。Humacyte的初始候選產品,即ATEV產品組合,目前正處於後期臨床試驗階段,目標是多種血管應用,包括血管創傷修復、血液透析的動靜脈(AV)通路和外周動脈疾病。血管創傷適應症中ATEV的生物製劑許可證申請目前正在接受美國食品藥品管理局的審查,並已獲得優先審查。冠狀動脈旁路移植術、小兒心臟手術、1型糖尿病治療以及多種新型細胞和組織應用的臨床前開發也在進行中。Humacyte的用於血液透析中AV通路的6mm ATEV是第一個獲得美國食品藥品管理局再生醫學高級療法(RMAT)稱號的候選產品,還獲得了美國食品藥品管理局的快速通道認證。Humacyte的6mm ATEV也獲得了RMAT認證,用於四肢血管創傷後的緊急動脈修復,以及用於晚期PAD。ATEV被美國國防部長指定爲優先治療血管創傷。ATEV 是一種研究產品,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批准銷售。

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

Humacyte 投資者聯繫人:
喬伊斯·阿萊爾
LifeSci 顧問有限公司
+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
精準策略
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com


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