Humacyte to Host Virtual KOL Event on the Use of Acellular Tissue Engineered Vessel (ATEV™) for AV Access in Hemodialysis on October 31, 2024
Humacyte (Nasdaq: HUMA) announced a virtual KOL event scheduled for October 31, 2024, at 8:00 AM ET, focusing on their acellular tissue engineered vessel (ATEV™) for hemodialysis access. The event will feature expert speakers from Brigham and Women's Hospital and the University of Alabama at Birmingham who will discuss the current treatment landscape for arteriovenous (AV) access in hemodialysis patients.
The speakers will present case studies and highlight V007 Phase 3 clinical results comparing ATEV to arteriovenous fistula (AVF) in end-stage kidney disease patients. ATEV is an investigational, first-in-class bioengineered human tissue designed as a universally implantable vascular conduit, pending FDA approval.
Humacyte (Nasdaq: HUMA) ha annunciato un evento virtuale per KOL programmato per il 31 ottobre 2024, alle 8:00 ET, incentrato sul loro vaso ingegnerizzato acellulare (ATEV™) per l'accesso alla emodialisi. L'evento vedrà la partecipazione di relatori esperti provenienti dal Brigham and Women's Hospital e dall'Università dell'Alabama a Birmingham, che discuteranno l'attuale panorama terapeutico per l'accesso arterovenoso (AV) nei pazienti in emodialisi.
I relatori presenteranno casi studio e metteranno in evidenza i risultati clinici di V007 Fase 3 che confrontano ATEV con la fistola arterovenosa (AVF) nei pazienti con malattia renale in fase terminale. ATEV è un tessuto umano bio-ingegnerizzato sperimentale, progettato come un condotto vascolare impiantabile universalmente, in attesa di approvazione da parte della FDA.
Humacyte (Nasdaq: HUMA) anunció un evento virtual KOL programado para el 31 de octubre de 2024, a las 8:00 AM ET, centrado en su vaso tejido acelular (ATEV™) para el acceso a diálisis. El evento contará con expertos oradores del Brigham and Women's Hospital y la Universidad de Alabama en Birmingham, quienes discutirán el panorama actual del tratamiento para el acceso arteriovenoso (AV) en pacientes de hemodiálisis.
Los oradores presentarán estudios de casos y destacarán los resultados clínicos de Fase 3 V007 que comparan ATEV con la fístula arteriovenosa (AVF) en pacientes con enfermedad renal en etapa terminal. ATEV es un tejido humano bioingeniería experimental, diseñado como un conducto vascular implantable universalmente, pendiente de aprobación por parte de la FDA.
Humacyte (Nasdaq: HUMA)는 2024년 10월 31일 오전 8시 ET에 예정된 가상 KOL 이벤트를 발표했으며, 세포가 없는 조직 공학 혈관(ATEV™)에 중점을 두고 있습니다. 이 이벤트에는 Brigham and Women's Hospital 및 University of Alabama at Birmingham의 전문가들이 참석하여 헤모다이얼리시 환자의 동정맥 접근(AV)에 대한 현재 치료 환경에 대해 논의할 것입니다.
연사들은 사례 연구를 발표하고 말기 신장 질환 환자에서 ATEV와 동정맥루(AVF)를 비교한 V007 3상 임상 결과를 강조할 것입니다. ATEV는 FDA 승인 대기 중인 보편적으로 이식 가능한 혈관 전도체로 설계된 실험적인 1세대 생체 공학된 인체 조직입니다.
Humacyte (Nasdaq: HUMA) a annoncé un événement virtuel KOL prévu pour le 31 octobre 2024 à 8h00 ET, axé sur leur vaisseau ingénierie tissulaire acellulaire (ATEV™) pour l'accès à l'hémodialyse. L'événement mettra en vedette des experts du Brigham and Women's Hospital et de l'Université de l'Alabama à Birmingham qui discuteront du paysage actuel des traitements pour l'accès arteriovenous (AV) chez les patients sous hémodialyse.
Les intervenants présenteront des études de cas et mettrons en lumière les résultats cliniques de Phase 3 V007 comparant ATEV à la fistule artérioveineuse (AVF) chez les patients atteints de maladie rénale en phase terminale. ATEV est un tissu humain bio-ingénierie expérimental, conçu comme un conduit vasculaire implantable universellement, en attente d'approbation de la FDA.
Humacyte (Nasdaq: HUMA) hat ein virtuelles KOL-Event angekündigt, das für den 31. Oktober 2024 um 8:00 Uhr ET geplant ist und sich auf ihr zellfreies, gewebe-ingenieurtes Gefäß (ATEV™) für den Zugang zur Hämodialyse konzentriert. Die Veranstaltung wird Expertenreferenten des Brigham and Women's Hospital und der University of Alabama in Birmingham umfassen, die die aktuelle Behandlungslage für arteriovenöse (AV) Zugänge bei Hämodialyse-Patienten erörtern.
Die Referenten werden Fallstudien präsentieren und die V007 Phase 3 klinischen Ergebnisse hervorheben, die ATEV mit der arteriovenösen Fistel (AVF) bei Patienten mit terminaler Nierenerkrankung vergleichen. ATEV ist ein experimentelles, erstklassiges bioengineering menschliches Gewebe, das als universell implantierbarer vaskulärer Leitfaden konzipiert ist und auf die Genehmigung durch die FDA wartet.
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DURHAM, N.C., Oct. 23, 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 host a virtual KOL event on Thursday, October 31, 2024 at 8:00 AM ET. To register, click here.
The event will feature Charles Keith Ozaki, MD (Brigham and Women’s Hospital), Mohamad Anas Hussain, MD, PhD (Brigham and Women’s Hospital), and Timmy Lee, MD, MSPH (University of Alabama at Birmingham), who will discuss the current treatment landscape and unmet need for improved arteriovenous (AV) access in hemodialysis patients.
During the event, the surgeons will share case studies and highlight the V007 Phase 3 clinical results for Humacyte’s acellular tissue engineered vessel (ATEV) product candidate versus arteriovenous fistula (AVF), for hemodialysis access in patients with end-stage kidney disease. 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 dialysis access.
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
About Charles Keith Ozaki, MD
Charles Keith Ozaki, MD is a Vascular Surgeon and the Director of Vascular Surgery Research at Brigham and Women’s Hospital (BWH). In addition, he is the John A. Mannick Distinguished Chair in Surgery at BWH. Dr. Ozaki earned his medical degree from Duke University School of Medicine. He completed a general surgery residency through the Deaconess/Harvard Surgical Service (now Beth Israel Deaconess Medical Center) and later completed a fellowship in vascular surgery at the University of Michigan Health System. He is board certified in general surgery and vascular surgery. He currently leads the Ozaki Basic Vascular Biology Lab within the Division of Vascular and Endovascular Surgery at BWH, which aims to delineate how physical forces alter the morphology of the blood vessel wall. Recent investigations have focused on inflammatory and adipose-driven mechanisms. His clinical interests include arterial aneurysm, cerebrovascular disease and wound healing. He has authored over 90 peer-reviewed publications. In addition to his clinical and laboratory responsibilities, Dr. Ozaki is the director of resident research. In this role, he prepares surgical trainees for their two to three years of academic enrichment time embedded in their surgical residency.
About Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS
Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS is a Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School in Boston. He is board certified in vascular surgery by both the American Board of Surgery and the Royal College of Physicians and Surgeons of Canada. He obtained his medical degree from the Michael G. DeGroote School of Medicine at McMaster University. He completed a vascular surgery residency and a PhD in clinical epidemiology and health services research through the Surgeon Scientist Training Program at the University of Toronto. He also completed a cardiovascular research fellowship at the Brigham. Dr. Hussain’s clinical practice is focused on general vascular and endovascular surgery, with special interests in complex hemodialysis access surgery, aortic dissection and aneurysm surgery, and thoracic outlet syndrome surgery. His research lab VESEL (Vascular & Endovascular Surgery Epidemiology Lab) conducts observational and clinical research to improve the care of patients with vascular diseases with special interests in population-based health services research, prediction with machine learning, enhancing causal inference research using target trial emulation, and clinical trials. Dr. Hussain also serves at the Director of Resident Education and Research in Vascular Surgery and Associate Clerkship Director in the Department of Surgery at the Brigham.
About Timmy Lee, MD, MSPH
Timmy Lee, MD, MSPH is a Professor of Medicine in the Department of Medicine and Division of Nephrology with a secondary appointment in the Department of Biomedical Engineering at the University of Alabama at Birmingham. Dr. Lee received his medical degree at the Louisiana State University Health Sciences Center in Shreveport and completed his Internal Medicine residency and Nephrology fellowship at the University of Alabama at Birmingham, Nephrology research fellowship at the University of Alabama at Birmingham, and Master of Science in Public Health at the University of Alabama at Birmingham. Dr. Lee is the Vice Chair for Research in the Department of Medicine at the University of Alabama at Birmingham and Section Chief of Nephrology at the Birmingham Veterans Affairs Medical Center. He also serves as the Associate Director of Interventional Nephrology, Associate Nephrology Fellowship Director, Associate Director of the Nephrology Research Training Center in the Division of Nephrology at the University of Alabama at Birmingham, and Director of the Hemodialysis Program at the Birmingham Veterans Affairs Medical Center. Dr. Lee has been involved in hemodialysis vascular access research since 2002 and has over 80 publications in vascular access research. He has active research programs in clinical trials and large epidemiologic studies in dialysis vascular access and a laboratory-based translational research program in dialysis vascular access studying human vascular access blood vessel tissue biorepositories and mechanisms of arteriovenous fistula dysfunction using animal models (mouse, rat, and pig). The goal of his research program is to develop novel therapeutics to prevent and treat complications of hemodialysis vascular access dysfunction and improve the delivery and processes of care for patients requiring a hemodialysis vascular access. Dr. Lee’s research program is currently funded by the National Institutes of Health, Veterans Affairs Medical Center, and foundation grants.
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
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