Humacyte Presents Preclinical Results of Small-Diameter ATEV™ for Coronary Artery Bypass Grafting at American Heart Association’s Scientific Sessions 2024
Humacyte presented positive preclinical results for their small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in a non-human primate model of coronary artery bypass grafting. The six-month study showed that sdATEV maintained blood flow, recellularized with host cells, and adapted to match the native artery size. The study involved five baboons where sdATEV was implanted between the aorta and right coronary artery. All implants remained patent throughout the study period. The results are significant as over 400,000 CABG procedures are performed annually in the US, with current options having limitations including potential complications and low patency rates.
Humacyte ha presentato risultati preclinici positivi per il loro vaso ingegnerizzato acellulare a piccolo diametro (3,5 mm) (sdATEV) in un modello di primate non umano per il bypass coronarico. Lo studio di sei mesi ha dimostrato che lo sdATEV ha mantenuto il flusso sanguigno, è stato recellularizzato con cellule ospiti e si è adattato per corrispondere alla dimensione dell'arteria nativa. Lo studio ha coinvolto cinque babbuini in cui è stato impiantato lo sdATEV tra l'aorta e l'arteria coronaria destra. Tutti gli impianti sono rimasti pervi durante l'intero periodo dello studio. I risultati sono significativi poiché oltre 400.000 procedure di CABG vengono eseguite annualmente negli Stati Uniti, con le opzioni attuali che presentano limiti, tra cui potenziali complicazioni e bassi tassi di pervietà.
Humacyte presentó resultados preclínicos positivos para su vaso tejido ingenierizado acelular de pequeño diámetro (3,5 mm) (sdATEV) en un modelo de primate no humano para el injerto de bypass de arteria coronaria. El estudio de seis meses mostró que el sdATEV mantuvo el flujo sanguíneo, se recelularizó con células del huésped y se adaptó para coincidir con el tamaño de la arteria nativa. El estudio involucró a cinco babuinos en los que se implantó el sdATEV entre la aorta y la arteria coronaria derecha. Todos los implantes permanecieron patentados durante todo el periodo del estudio. Los resultados son significativos, ya que se realizan más de 400.000 procedimientos de CABG anualmente en EE. UU., con las opciones actuales que presentan limitaciones, incluidas complicaciones potenciales y bajas tasas de patencia.
Humacyte는 비인간 영장류 모델에서 그들의 소형 세포 없는 조직 공학 혈관(sdATEV, 직경 3.5mm)의 긍정적인 전임상 결과를 발표했습니다. 6개월 연구에서 sdATEV는 혈류를 유지하고, 숙주 세포로 재세포화되었으며, 자연 동맥 크기에 맞게 적응한 것으로 나타났습니다. 이 연구에는 sdATEV가 대동맥과 우측 관상동맥 사이에 이식된 다섯 마리의 바분이 포함되었습니다. 모든 이식물은 연구 기간 동안 개방 상태를 유지했습니다. 이 결과는 미국에서 매년 400,000 건 이상의 CABG 수술이 시행되며, 현재 옵션들은 잠재적인 합병증과 낮은 개통률 등의 한계를 가지고 있다는 점에서 중요합니다.
Humacyte a présenté des résultats précliniques positifs pour son vaisseau de tissu ingénié acellulaire de petit diamètre (3,5 mm) (sdATEV) dans un modèle de primate non humain pour le pontage coronarien. L'étude de six mois a montré que le sdATEV maintenait le flux sanguin, était re-cellularisé avec des cellules hôtes et s'adaptait à la taille de l'artère native. L'étude a impliqué cinq babouins où le sdATEV a été implanté entre l'aorte et l'artère coronaire droite. Tous les implants ont été patent pendant toute la durée de l'étude. Les résultats sont significatifs car plus de 400 000 procédures de pontage coronarien (CABG) sont réalisées chaque année aux États-Unis, les options actuelles ayant des limites, y compris des complications potentielles et de faibles taux de perméabilité.
Humacyte hat positive präklinische Ergebnisse für ihr zellfreies, gewebetechnisch hergestelltes Gefäß mit kleinem Durchmesser (3,5 mm) (sdATEV) in einem nichtmenschlichen Primatenmodell für die Koronararterien-Bypassoperation vorgestellt. Die sechsmonatige Studie zeigte, dass das sdATEV den Blutfluss aufrechterhielt, mit Wirtszellen reziproziert wurde und sich an die Größe der natürlichen Arterie anpasste. Die Studie umfasste fünf Paviane, bei denen das sdATEV zwischen der Aorta und der rechten Koronararterie implantiert wurde. Alle Implantate blieben während der gesamten Studienzeit durchgängig. Die Ergebnisse sind von Bedeutung, da in den USA jährlich über 400.000 CABG-Verfahren durchgeführt werden, wobei die aktuellen Optionen Einschränkungen aufweisen, die potenzielle Komplikationen und niedrige Patente- und Durchgängigkeitsraten umfassen.
- Successful maintenance of blood flow throughout the 6-month study period
- Demonstrated ability to recellularize with host cells and adapt to native artery size
- Potential to address large market with 400,000 annual CABG procedures in US
- Could provide alternative to current saphenous vein grafts which show only 75% patency at one year
- Product is still in preclinical phase
- Study to only five subjects
- Requires FDA approval before commercialization
Insights
The preclinical results for Humacyte's small-diameter ATEV in coronary artery bypass grafting show significant promise. The key findings demonstrate sustained patency over six months, successful host cell integration and adaptive remodeling to match native artery size. These outcomes address critical challenges in CABG procedures where current saphenous vein grafts show
The market opportunity is substantial with over 400,000 CABG procedures annually in the US alone. The potential for an off-the-shelf solution could revolutionize the field by eliminating harvesting complications and providing options for patients lacking suitable autologous vessels. However, investors should note that extensive clinical trials and FDA approval are still required before commercialization.
– sdATEVs maintained sustained patency throughout the six-month study –
– sdATEV was observed to recellularize with host cells and remodel to effectively reduce the initial size mismatch between the sdATEV and the animal’s native artery –
DURHAM, N.C., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced the presentation of positive preclinical results of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in a non-human primate model of coronary artery bypass grafting (CABG). In the six-month preclinical CABG model the sdATEV was observed to sustain patency (blood flow), recellularized with the animals’ host cells, and remodeled to effectively reduce the initial size mismatch between the sdATEV and the animals’ native artery.
The preclinical results were presented in a poster titled “Acellular Tissue Engineered Vessels as Conduits for Coronary Artery Bypass Grafting” at The American Heart Association’s (AHA) Scientific Sessions 2024 meeting on Saturday, November 16, 2024, in Chicago, IL by two of the study researchers, Rob Kirkton, PhD, Humacyte Director of New Product Development and Alan Kypson, MD, FACS, FACC, Cardiothoracic Surgeon, UNC REX Hospital.
In the preclinical study, the sdATEV was implanted between the aorta and right coronary artery (RCA) in five baboons to simulate a CABG procedure. Animals were followed for six months after sdATEV implantation and all sdATEVs maintained patency throughout the study. The baboon study provided an effective model for demonstrating the feasibility, mechanical durability and capacity for host-cell remodeling of the sdATEV for CABG. After implantation, the sdATEV was observed to recellularize with host cells and remodel to form a multi-layered tissue including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the RCA. The neomedial tissue observed at six months was predominantly composed of quiescent contractile smooth muscle cells under a lining of functional endothelial cells.
“Our results show that the sdATEV not only supports coronary blood flow but also host recellularization and adaptive remodeling in a challenging preclinical surgical model,” said Dr. Kirkton.
There are over 400,000 CABG procedures each year in the United States and the surgery has been shown to improve the survival and quality of life for many patients with coronary artery disease. The current conduits used for CABG are autologous vessels including the left internal mammary artery and saphenous vein, which is used in 80
“This study suggests that the sdATEV may be a promising off-the-shelf alternative to saphenous vein grafts in CABG, which is a major unmet clinical need,” said Dr. Kypson.
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
About 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. Humacyte 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 www.Humacyte.com.
Forward-Looking Statements
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 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 our ATEVs 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 subsequent 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.
Humacyte Investor Contact:
Joyce Allaire
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
FAQ
What were the key findings of Humacyte's (HUMA) sdATEV preclinical trial in November 2024?
How does Humacyte's (HUMA) sdATEV compare to current CABG options?
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