Humacyte Announces Planned IND Filing in 2025 to Support First-In-Human Clinical Study of Small-Diameter ATEV™ for Coronary Artery Bypass Grafting
Humacyte (Nasdaq: HUMA) announced plans to file an Investigational New Drug (IND) application with the FDA in 2025 to initiate the first-in-human clinical study of its small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) for coronary artery bypass grafting (CABG). This decision follows a recent meeting with the FDA where agreements were reached.
Currently, only the 6.0mm ATEV configuration has been tested in human trials for vascular trauma repair, hemodialysis AV access, and peripheral artery disease. Preclinical studies of the sdATEV in CABG models have shown promising results, including sustained patency, recellularization, and effective remodeling to reduce size mismatch.
The results were presented at The American Heart Association's Scientific Sessions 2024. Humacyte's CEO, Dr. Laura Niklason, emphasized the potential of sdATEV as an off-the-shelf alternative to native vessel grafts. CABG is performed over 400,000 times annually in the U.S., but current autologous vessel grafts have limitations such as low patency rates and surgical wound infections.
Humacyte's ATEV aims to address these issues by providing an unlimited, off-the-shelf vascular conduit, potentially transforming CABG surgery.
Humacyte (Nasdaq: HUMA) ha annunciato piani per presentare una domanda di Nuovo Farmaco Investigazionale (IND) alla FDA nel 2025, per avviare il primo studio clinico su esseri umani del suo vaso ingegnerizzato acellulare a piccolo diametro (3,5 mm) (sdATEV) per il bypass coronarico (CABG). Questa decisione segue un recente incontro con la FDA, durante il quale sono stati raggiunti accordi.
Attualmente, solo la configurazione ATEV da 6.0 mm è stata testata in prove umane per la riparazione di traumi vascolari, accesso AV per emodialisi e malattia arteriosa periferica. Gli studi preclinici dello sdATEV nei modelli di CABG hanno mostrato risultati promettenti, inclusi patenza sostenuta, recellularizzazione e rimodellamento efficace per ridurre la discrepanza di dimensione.
I risultati sono stati presentati alle Sessioni Scientifiche 2024 dell'American Heart Association. Il CEO di Humacyte, Dr. Laura Niklason, ha sottolineato il potenziale dello sdATEV come alternativa pronta all'uso ai innesti vascolari nativi. Il CABG viene eseguito oltre 400.000 volte all'anno negli Stati Uniti, ma gli attuali innesti vascolari autologhi presentano limitazioni come bassi tassi di patenza e infezioni della ferita chirurgica.
L'ATEV di Humacyte mira a affrontare questi problemi fornendo un condotto vascolare illimitato e pronto all'uso, trasformando potenzialmente la chirurgia CABG.
Humacyte (Nasdaq: HUMA) anunció planes para presentar una solicitud de Nuevo Medicamento en Investigación (IND) a la FDA en 2025 para iniciar el primer estudio clínico en humanos de su vaso de tejido ingeniado acelular de pequeño diámetro (3.5 mm) (sdATEV) para el injerto de bypass de arteria coronaria (CABG). Esta decisión sigue a una reunión reciente con la FDA donde se alcanzaron acuerdos.
Actualmente, solo se ha probado la configuración ATEV de 6.0 mm en ensayos humanos para la reparación de traumas vasculares, acceso AV para hemodiálisis y enfermedad arterial periférica. Los estudios preclínicos del sdATEV en modelos de CABG han mostrado resultados prometedores, incluyendo patencia sostenida, recelularización y remodelación efectiva para reducir la desproporción de tamaño.
Los resultados se presentaron en las Sesiones Científicas 2024 de la American Heart Association. La CEO de Humacyte, Dra. Laura Niklason, enfatizó el potencial del sdATEV como una alternativa lista para usar a los injertos vasculares nativos. El CABG se realiza más de 400,000 veces al año en EE. UU., pero los injertos vasculares autólogos actuales tienen limitaciones como bajas tasas de patencia e infecciones en las heridas quirúrgicas.
El ATEV de Humacyte busca abordar estos problemas proporcionando un conducto vascular ilimitado y listo para usar, transformando potencialmente la cirugía de CABG.
휴마사이트(Humacyte, NASDAQ: HUMA)는 2025년 FDA에 Investigational New Drug(IND) 신청서를 제출하여 관상 동맥 우회 수술(CABG)을 위한 세포가 없는 소형 혈관(tissue engineered vessel, sdATEV)의 최초 인간 임상 시험을 시작할 계획을 발표했습니다. 이 결정은 FDA와의 최근 회의를 통해 합의가 이루어진 결과입니다.
현재까지 6.0mm ATEV 구성만이 혈관 외상 수리, 혈액투석 AV 접근, 말초 동맥 질환 치료를 위한 인간 임상 시험에서 시험되었습니다. CABG 모델에서 sdATEV에 대한 전임상 연구는 지속적인 개방성, 세포화 및 크기 불일치를 줄이기 위한 효과적인 재모델링을 포함한 유망한 결과를 보여주었습니다.
결과는 2024년 미국심장협회(American Heart Association) 학술회에서 발표되었습니다. 휴마사이트의 CEO인 로라 닉라손(Dr. Laura Niklason)은 sdATEV가 고유 혈관 이식의 즉시 사용 가능한 대안으로서의 잠재력을 강조했습니다. CABG는 미국에서 매년 40만 건 이상 시행되지만, 현재 자가 혈관 이식은 낮은 개방률과 수술상 감염과 같은 제한 사항이 있습니다.
휴마사이트의 ATEV는 이러한 문제를 해결하여 무제한의 즉시 사용 가능한 혈관 경로를 제공함으로써 CABG 수술을 혁신할 가능성이 있습니다.
Humacyte (Nasdaq: HUMA) a annoncé son intention de déposer une demande de Médicament Nouveau en Investigation (IND) auprès de la FDA en 2025 afin de lancer la première étude clinique sur l'homme de son vaisseau de tissu ingéniosité acellulaire de petit diamètre (3,5 mm) (sdATEV) pour le pontage des artères coronaires (CABG). Cette décision fait suite à une réunion récente avec la FDA où des accords ont été atteints.
Actuellement, seule la configuration ATEV de 6,0 mm a été testée dans des essais humains pour la réparation de traumatismes vasculaires, l'accès AV pour hémodialyse et les maladies artérielles périphériques. Des études précliniques du sdATEV dans des modèles de CABG ont montré des résultats prometteurs, y compris une perméabilité durable, une recellularisation et une remodelage efficace pour réduire l'inadéquation de taille.
Les résultats ont été présentés lors des Sessions Scientifiques 2024 de l'American Heart Association. La PDG de Humacyte, Dr. Laura Niklason, a souligné le potentiel du sdATEV en tant qu'alternative prête à l'emploi aux greffes de vaisseaux natifs. Le CABG est réalisé plus de 400 000 fois par an aux États-Unis, mais les greffes de vaisseaux autologues actuelles présentent des limitations telles que des taux de perméabilité faibles et des infections de plaies chirurgicales.
L'ATEV de Humacyte vise à résoudre ces problèmes en fournissant un conduit vasculaire illimité et prêt à l'emploi, transformant potentiellement la chirurgie CABG.
Humacyte (Nasdaq: HUMA) hat Pläne angekündigt, 2025 einen Antrag auf einen Neuen Arzneimittel-Antrag (IND) bei der FDA einzureichen, um die erste klinische Studie am Menschen zu seinem kleinen Durchmesser (3,5 mm) zellfreien, gewebetechnisch hergestellten Gefäß (sdATEV) für die koronare Bypass-Operation (CABG) zu starten. Diese Entscheidung folgt auf ein kürzliches Treffen mit der FDA, bei dem Vereinbarungen getroffen wurden.
Derzeit wurde nur die 6,0 mm ATEV-Konfiguration in Humanstudien zur Reparatur von Gefäßverletzungen, AV-Zugang zur Hämodialyse und peripherer arterieller Erkrankung getestet. Vorklinische Studien zum sdATEV in CABG-Modellen haben vielversprechende Ergebnisse gezeigt, darunter eine nachhaltige Durchgängigkeit, Rezellulierung und effektive Umgestaltung zur Reduzierung von Größenanpassungen.
Die Ergebnisse wurden auf den Wissenschaftlichen Sitzungen 2024 der American Heart Association präsentiert. Die CEO von Humacyte, Dr. Laura Niklason, betonte das Potenzial des sdATEV als sofort verwendbare Alternative zu nativen Gefäßtransplantaten. CABG wird in den USA jährlich über 400.000 Mal durchgeführt, aber die derzeitigen autologen Gefäßtransplantate haben Einschränkungen, wie niedrige Durchgängigkeitsraten und chirurgische Wundinfektionen.
Das ATEV von Humacyte zielt darauf ab, diese Probleme zu lösen, indem es ein unbegrenztes, sofort verfügbares Gefäßsystem bereitstellt, das die CABG-Chirurgie potenziell transformieren kann.
- Humacyte plans to file an IND with the FDA for first-in-human trials of sdATEV in CABG.
- Preclinical studies show promising results including sustained patency and effective remodeling.
- Potential to transform CABG surgery by providing an off-the-shelf alternative to native vessel grafts.
- CEO emphasizes the potential of sdATEV in improving CABG outcomes.
- Current conduits used for CABG have limitations such as low patency rates and surgical wound infections.
Insights
The planned IND filing for small-diameter ATEV in CABG represents a strategic expansion of Humacyte's vascular platform following their recent FDA approval for Symvess™ in December 2024. The 400,000+ annual CABG procedures in the US present a substantial market opportunity, especially given the limitations of current saphenous vein grafts (SVGs) which show only
The preclinical data demonstrating sustained patency and host cell recellularization in primate models suggests promising biological integration properties. The 3.5mm diameter configuration addresses a critical need in coronary applications, distinct from the currently approved 6.0mm version. The potential elimination of SVG harvest complications and availability for patients lacking suitable autologous vessels could significantly improve surgical outcomes and recovery times.
Most importantly, this development follows close consultation with the FDA, indicating a well-aligned regulatory pathway. With their first FDA approval already secured for vascular trauma, Humacyte demonstrates execution capability in navigating complex regulatory requirements for tissue-engineered products.
This regulatory advancement positions Humacyte to potentially capture a significant share of the CABG market, valued at several billion dollars annually. The company's market cap of
The off-the-shelf nature of ATEV provides compelling economic advantages: reduced procedure times, lower complication rates and potentially shorter hospital stays could translate to substantial cost savings for healthcare systems. The elimination of harvest site complications could significantly reduce liability risks and associated costs.
The recent full FDA approval for Symvess™ in vascular trauma establishes credibility and reduces regulatory uncertainty for this new indication. However, investors should note that clinical trials and eventual commercialization will require significant capital investment over the next several years before revenue generation from this specific indication.
– Plans for filing an IND was agreed with the FDA in a recent meeting –
– Positive preclinical results of the small-diameter ATEV were recently presented at The American Heart Association’s Scientific Sessions 2024 meeting –
DURHAM, N.C., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that it plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to allow first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG). The Company’s current plans for filing an IND are based on the outcome of a recent meeting held with the FDA, including agreements reached with the agency. To date only the 6.0mm configuration of the ATEV has been studied in human trials, specifically in studies conducted in vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease (PAD).
To enable the IND filing, the sdATEV has been studied in multiple preclinical CABG models. The results of a six-month preclinical study in primates were presented in November 2024 at The American Heart Association’s Scientific Sessions 2024 meeting. In the 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.
“We are very pleased to be moving closer to human clinical studies of the sdATEV in CABG, and our planned IND filing and initiation of first-in-human study after the FDA clearance will be a major milestone for Humacyte,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Our preclinical results suggest that the sdATEV may be a promising off-the-shelf alternative to native vessel grafts in CABG, and we look forward to evaluating this possibility in human clinical studies.”
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
“Coronary artery bypass graft (CABG) surgery can be lifesaving in appropriately selected patients with coronary artery disease,” said John H. Alexander, MD, MHS, Professor of Medicine, Department of Medicine, Division of Cardiology, Senior Investigator at the Duke Clinical Research Institute at Duke University. “A long-standing, major limitation of CABG surgery has been the availability of ideal conduits to use as bypass grafts. If clinical trials are successful, this tissue-engineered graft could have the potential to transform CABG surgery by providing an unlimited supply of an off-the-shelf conduit to use in patients undergoing CABG surgery. We look forward to helping to advance this technology into human studies.”
The ATEV is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. Harvesting vein from a CABG patient may lead to complications and may not be feasible due to missing or diseased veins, ATEV is designed to be available off-the-shelf, and does not require further injuring the patient to obtain arterial replacement material.
The FDA granted a full approval for the ATEV (Symvess™) on December 19, 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. For uses other than the FDA approval, 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. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery 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 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 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 expected success of our sales team; the validity of our Budget Impact Model; 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
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