Humacyte Presents Positive Long-Term Results of ATEV in Treatment of Vascular Trauma in Military Setting From Ukraine Humanitarian Program
Humacyte Presents Positive Long-Term Results of ATEV in Treatment of Vascular Trauma in Military Setting From Ukraine Humanitarian Program
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- Results presented at the Department of Defense's Military Health System Research Symposium (MHSRS) -
- 在國防部軍事健康系統研究學術研討會 (MHSRS) 上展示的結果 -
- In real-world military setting the ATEV was observed to have 12-month patency of 87.1% -
- 在實際軍事環境中觀察到 ATEV 具有 12 個月的通暢率爲 87.1% -
- There were zero instances of infection, amputation or death during the long-term follow-up period despite the severity of the wartime injuries treated -
- 儘管受傷嚴重,長期跟蹤期間沒有任何感染、截肢或死亡的情況 -
DURHAM, N.C., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, yesterday presented positive long-term results from a humanitarian program conducted in Ukraine under which the investigational acellular tissue engineered vessel (ATEV) was used to treat vascular injuries suffered during the ongoing conflict. Long-term follow-up results were presented for the first time and showed high rates of patency (blood flow) and the avoidance of amputation and infection despite the severe nature of the wartime injuries treated. The results were presented at the Military Health System Research Symposium (MHSRS), the U.S. Department of Defense's foremost scientific meeting, held in Kissimmee, Florida.
北卡羅來納州杜罕,2024 年 8 月 27 日 (Globe Newswire) - Humacyte, Inc. (納斯達克代碼: HUMA) 是一家臨床階段的生物技術平台公司,致力於以商業規模開發可廣泛植入的、生物工程的人體組織。昨天,該公司發佈了在烏克蘭進行的人道主義項目的積極的長期結果,該項目使用了研究性無細胞組織工程血管 (ATEV) 來治療在持續衝突期間遭受的血管損傷。首次公開呈報的長期跟蹤結果顯示血管通暢率(血液流動)高並避免截肢和感染,儘管治療的戰時傷情嚴重。這些結果是在美國國防部的主要科學會議Military Health System Research Symposium (MHSRS) 上公開呈報的,該會議於佛羅里達州基西米舉行。
The presentation highlighted the results for 16 extremity patients treated in Ukraine who provided consent for use of their results, a set of data known as the "V017 trial." The primary analyses for the V017 trial were at 30 days of follow up, and as previously reported the rate of success for treatment of patients with the ATEV at this time point was high with primary and secondary patency of 93.8%, zero amputations, and zero cases of infection of the ATEV. Longer-term results for the V017 patients were presented for the first time at the MHSRS meeting, with a mean follow-up duration of 357.9 days. Kaplan-Meier estimates of 12-month primary and secondary patency both were 87.1%. There were no instances of ATEV infections, amputation of affected limbs, or deaths related to ATEV through the end of long-term follow-up. There was one event of ATEV thrombosis after month six. There were no reports of ATEV aneurysm or pseudo-aneurysm. These results were achieved despite the fact that all patients had a high risk of wound infection and were severely injured, with a mean Injury Severity Score (ISS) of 20.1. Patients treated with the ATEV included those injured due to mine blasts, shrapnel and high velocity ballistics.
演講突出了在烏克蘭治療的 16 名四肢患者的結果,他們同意使用他們的結果,這是一組被稱爲 "V017 試驗" 的數據。V017 試驗的主要分析是在 30 天的隨訪時間點進行的,如先前報道的那樣,此時使用 ATEV 治療的患者的成功率很高,主要和次要通暢率都爲 93.8%,無截肢和 ATEV 感染症例。MHSRS 會議上首次呈報了 V017 患者的長期結果,隨訪時間平均爲 357.9 天。Kaplan-Meier 估計的 12 個月主要和次要通暢率都爲 87.1%。在長期隨訪期內,沒有 ATEV 感染、患肢截肢或與 ATEV 相關的死亡事件。6 個月後發生了一次 ATEV 血栓事件。未報告 ATEV 動脈瘤或假性動脈瘤。儘管所有患者都面臨高風險的創傷感染,並且受傷嚴重,平均傷情嚴重度評分 (ISS) 爲 20.1。接受 ATEV 治療的患者包括因地雷爆炸、彈片和高速子彈傷害而受傷的人員。
"We are pleased that the long-term results in a military setting are consistent with the 30-day results previously observed and support the potential durability of the ATEV in vascular trauma patients," said Shamik Parikh, M.D., Chief Medical Officer of Humacyte. "For repair or reconstruction of traumatic vascular injuries when autologous veins are not feasible, the ATEV may offer combat surgical teams an off-the-shelf and universally implantable alternative that has shown extremely low rates of infection, potentially offering durable performance and help with limb salvage."
「我們很高興在軍事環境中的長期結果與先前觀察到的30天結果一致,並支持ATEV在血管創傷患者中的潛在持久性,」 Humacyte首席醫務官Shamik Parikh萬.D說道。「對於創傷性血管損傷的修復或重建,當自體靜脈不可行時,ATEV可能爲戰鬥外科團隊提供一種現成且可普遍植入的替代選擇,其感染率極低,可能提供持久性能和幫助肢體挽救。」
"We are very grateful for the invaluable support during this difficult time," said Oleksandr Sokolov, M.D., Ph.D., a Ukrainian vascular surgeon who treated patients with the ATEV under the humanitarian program. "The ATEV implantations performed for those wounded by blast injuries have significantly reduced the time of acute ischemia following injury, which has a positive impact on the preservation of lives and limbs. These implantations are quicker due to the absence of the need for vein harvesting for graft preparation and have excellent immunological and infection resistance, making them particularly effective in the context of combat injuries."
「我們非常感謝在這個困難時期的寶貴支持,」烏克蘭血管外科醫生Oleksandr Sokolov萬.D.,Ph.D說道。他在人道主義項目下曾用ATEV治療患者。「ATEV植入物對於遭受爆炸傷害的患者縮短了急性缺血的時間,對於保護性生命和肢體的保持產生了積極影響。由於無需採集靜脈進行移植準備,這些植入物的操作更快,並具有出色的免疫和抗感染能力,在戰鬥傷害的情況下特別有效。」
The ATEV is an investigational, first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair, and for use as hemodialysis access. While harvesting vein from a trauma patient requires critical surgical time, the ATEV is designed to be available off-the-shelf. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
ATEV是一種調查性的、首創的人類生物工程組織,旨在成爲一種通用的可植入的血管導管,用於動脈置換和修復,以及用作血液透析入口。從創傷患者取靜脈需要關鍵的手術時間,而ATEV則設計成可隨時獲取。ATEV是一種調查性產品,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. For more information, visit .
Humacyte, Inc.(納斯達克:HUMA)正在開發一種顛覆性的生物技術平台,以提供可普遍植入的生物工程人類組織、先進的組織構造和器官系統,旨在改善患者的生活並改變醫學實踐。該公司開發和製造非細胞組織以治療多種疾病、傷害和慢性疾病。Humacyte的首批產品候選者是一系列針對多種血管應用的ATEV,目前處於晚期臨床試驗階段,包括血管創傷修復、透析的動脈靜脈(AV)通路和周圍動脈疾病。ATEV在血管創傷指標中的生物製品許可申請目前正在FDA審核中,並被授予「優先審查」。在冠狀動脈搭橋移植、兒童心臟手術、治療1型糖尿病以及多個新的細胞和組織應用方面,也正在進行臨床前開發。Humacyte的ATEV可用於透析的6mm AV通路是首個獲得FDA再生醫學高級療法(RMAT)指定的產品候選者,並已獲得FDA快速通道指定。Humacyte的6mm ATEV可用於緊急肢體血管創傷修復和高級PAD也已獲得RMAt指定。作爲軍事部長的研究和創新副局局長,ATEV在血管創傷治療方面獲得了優先使用權。有關更多信息,請訪問 。
Forward-Looking Statements
前瞻性聲明
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. 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, the outcome of the FDA's review of our BLA seeking approval of the ATEV in the vascular trauma indication; 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 ATEV 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. 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 described under the header "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, 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.
本新聞稿包含基於信念和假設以及目前可用信息的前瞻性聲明。在某些情況下,您可以通過以下詞語識別前瞻性聲明:「可能」、「將」、「可能」、「會」、「應該」、「期望」、「意圖」、「計劃」、「預期」、「相信」、「估計」、「預測」、「項目」、「潛力」、「繼續」、「進行中」或這些術語的負面形式或其他可比較的術語,儘管並非所有前瞻性聲明都包含這些詞語。這些陳述涉及風險、不確定性和其他因素,可能導致實際結果、活動水平、績效或成就與這些前瞻性聲明所表達的信息有着顯著的不同。儘管我們認爲本新聞稿所包含的每個前瞻性聲明都有合理依據,但我們提醒您,這些聲明是基於目前我們已知的事實和因素的組合以及我們對未來的預測。本新聞稿中的前瞻性聲明包括但不限於:FDA審核我們的ATEV在血管創傷指標中獲取批准所帶來的結果;關於我們臨床前和臨床試驗的啓動、時間、進展和結果的聲明;關於我們ATEV的預期特性和性能的聲明;我們能否成功完成ATEV的臨床前和臨床試驗;ATEV相對於現有替代品的預期利益;我們ATEV的商業化預期和我們的製造能力;我們的商業模式和業務戰略計劃的實施;以及監管申請、驗收和批准的時間或可能性的聲明。我們無法向您保證本新聞稿中的前瞻性聲明將證明是準確的。這些前瞻性聲明受到許多重大風險和不確定性的影響,可能導致實際結果與預期的結果有着重大的不同,其中包括但不限於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因素,包括Humacyte向SEC提交的有關Humacyte在2023年12月31日年報10-k中的「風險因素」標題下所述以及未來的SEC文件中所述。這些因素大多超出了Humacyte的控制範圍,並且難以預測。此外,如果前瞻性聲明證明是不準確的,則這種不準確可能是重大的。鑑於這些前瞻性聲明中的重大不確定性,您不應將這些聲明視爲我們或任何其他人在任何指定時間框架內或根本未能實現我們的目標和計劃的代表或保證。除法律規定外,我們目前沒有意圖更新本新聞稿中的任何前瞻性聲明。因此,您不應將這些前瞻性聲明作爲我們或任何其他人在本新聞稿發佈日期後任何日期的意見。
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
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Source: Humacyte, Inc
來源:Humacyte,Inc