share_log

Humacyte to Host Virtual KOL Event "Hemodialysis Access: A Crossroads of Care," on March 28, 2024

Humacyte to Host Virtual KOL Event "Hemodialysis Access: A Crossroads of Care," on March 28, 2024

Humacyte將於2024年3月28日舉辦虛擬KOL活動 “血液透析准入:護理的十字路口”
Humacyte ·  03/26 00:00

DURHAM, N.C., March 26, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Thursday, March 28, 2024 at 8:00 AM ET, featuring Timmy Lee, MD, MSPH (University of Alabama at Birmingham) and Prabir Roy-Chaudhury MD, PhD, FRCP (University of North Carolina School of Medicine) who will discuss the profiles of patients receiving an AV Access who have higher rates of complications and the associated costs of treating them. To register, click here.

北卡羅來納州達勒姆,2024年3月26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,今天宣佈將在美國東部時間2024年3月28日星期四上午8點舉辦虛擬KOL活動,醫學博士、醫學博士(阿拉巴馬大學伯明翰分校)和PrabSPH將出席 Roy-Chaudhury 醫學博士,FRCP(北卡羅來納大學醫學院),他將討論接受 AV Access 且併發症發生率較高的患者的概況治療它們的相關費用。要註冊, 點擊這裏。

Title Hemodialysis Access: A Crossroads of Care
Confronting Complications, Challenges, and Costs with Innovation
Date Thursday, March 28, 2024
Time 8:00 AM Eastern Time
Webcast Click Here
標題 血液透析可及性:護理的十字路口
通過創新應對複雜性、挑戰和成本
日期 2024年3月28日,星期四
時間 美國東部時間上午 8:00
網絡直播 點擊這裏


Humacyte recently announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte's Biologics License Application (BLA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. In addition, in April 2023Humacyte completed enrollment in a Phase 3 trial in AV Access comparing the HAV to the current standard of care, autologous arteriovenous fistula. Top-line results are planned to be available during 2024.


Humacyte最近宣佈,美國食品藥品監督管理局(FDA)已接受並批准Humacyte的生物製劑許可證申請(BLA)的優先審查,該申請要求批准在四肢血管創傷後進行緊急動脈修復,且不宜使用自體靜脈時,Humacyte的生物製劑許可證申請(BLA)。此外,2023年4月,Humacyte完成了AV Access的3期試驗的入組,該試驗將HAV與當前的護理標準——自體動靜脈瘻進行了比較。最高結果計劃於2024年公佈。

A live question and answer session will follow the formal presentations. A replay will be made available here after the call.

正式演講之後將進行現場問答環節。將提供重播 這裏 通話之後。

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 opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. 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 HAV 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 HAV for urgent arterial repair following extremity vascular trauma also has received RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

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,旨在改善患者的生活並改變醫學實踐。該公司開發和製造用於治療各種疾病、損傷和慢性病的無細胞組織。Humacyte最初的機會是HAV產品組合,目前正在進行鍼對多種血管應用的後期臨床試驗,包括血管創傷修復、血液透析的AV通路和外周動脈疾病。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6mm HAV用於血液透析的AV,是第一款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,也獲得了美國食品藥品管理局的快速通道稱號。Humacyte 的 6mm HAV 用於四肢血管創傷後的緊急動脈修復,也獲得了 RMAT 稱號。HAV 被美國國防部長指定爲治療血管創傷的優先項目。欲了解更多信息,請訪問 www.humacyte.com

Forward-Looking Statements

前瞻性陳述

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. 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. Forward-looking statements in this press release include, but are not limited to, statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our HAVs; our ability to successfully complete, preclinical and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the anticipated commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; the outcome of our ongoing discussions with the FDA concerning the design of our ongoing V005 Phase 2/3 clinical trial, including determination of trial size, and the scope of any approved indication for our HAVs; and our estimated available market opportunity. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those included under the header "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022, filed by Humacyte with the SEC and in future SEC filings. Most of these factors are outside of Humacyte's control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

本新聞稿包含前瞻性陳述,這些陳述基於信念和假設以及當前可用的信息。在某些情況下,你可以用以下詞語來識別前瞻性陳述:“可能”、“將”、“將”、“應該”、“期望”、“打算”、“計劃”、“預期”、“相信”、“估計”、“預測”、“項目”、“潛力”、“繼續”、“持續” 或這些術語或其他類似術語的負面內容,儘管並非所有前瞻性陳述都包含這些術語或其他類似術語話。這些陳述涉及風險、不確定性和其他因素,這些因素可能導致實際業績、活動水平、業績或成就與這些前瞻性陳述所表達或暗示的信息存在重大差異。儘管我們認爲本新聞稿中包含的每項前瞻性陳述都有合理的依據,但我們提醒您,這些陳述是基於我們目前已知的事實和因素以及我們對未來的預測,對此我們無法確定。本新聞稿中的前瞻性陳述包括但不限於以下方面的聲明:我們的臨床前和臨床試驗的啓動、時機、進展和結果;我們的 HAV 的預期特徵和表現;我們成功完成 HAV 臨床前和臨床試驗的能力;我們的 HAV 相對於現有替代品的預期好處;我們的 HAV 的預期商業化以及我們在商業規模上的製造能力;我們的商業模式和戰略的實施的計劃我們的業務;監管申請和批准的時間或可能性;我們的 HAV 的報銷時間、範圍和費率;我們正在與美國食品藥品管理局就我們正在進行的V005 2/3期臨床試驗的設計(包括試驗規模的確定)進行討論的結果,以及我們估計的可用市場機會。我們無法向您保證,本新聞稿中的前瞻性陳述將被證明是準確的。這些前瞻性陳述存在許多重大風險和不確定性,這些風險和不確定性可能導致實際業績與預期業績存在重大差異,包括適用法律或法規的變化,Humacyte可能受到其他經濟、商業和/或競爭因素的不利影響,以及其他風險和不確定性,包括Humac提交的截至2022年12月31日的10-K表年度報告中標題爲 “風險因素” 的風險和不確定性 YTE 在美國證券交易委員會以及未來的美國證券交易委員會申報。這些因素中的大多數都超出了Humacyte的控制範圍,很難預測。此外,如果前瞻性陳述被證明不準確,則不準確性可能是嚴重的。鑑於這些前瞻性陳述中存在重大的不確定性,您不應將這些陳述視爲我們或任何其他人對我們將在任何規定的時間範圍內或根本實現目標和計劃的陳述或保證。除非法律要求,否則我們目前無意更新本新聞稿中的任何前瞻性陳述。因此,在本新聞稿發佈之日之後的任何日期,您都不應依賴這些前瞻性陳述來代表我們的觀點。

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

Primary Logo

Source: Humacyte, Inc

資料來源:Humacyte, Inc

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論