Humacyte to Present Efficacy and Safety Results from V007 Phase 3 AV Access Clinical Trial at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH)
Humacyte (Nasdaq: HUMA) announced it will present Phase 3 results comparing the efficacy and safety of its acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in end-stage renal disease patients. The presentation will be delivered by Dr. Charles Keith Ozaki at the 51st Annual VEITH Symposium in New York on November 23, 2024. Dr. Ozaki is the Vascular Surgery Research Director at Brigham and Women's Hospital and John A. Mannick Professor of Surgery at Harvard Medical School. The ATEV remains an investigational product pending FDA approval.
Humacyte (Nasdaq: HUMA) ha annunciato che presenterà i risultati della Fase 3 confrontando l'efficacia e la sicurezza del suo vaso ingegnerizzato acellulare (ATEV™) con le fistole AV autologhe nei pazienti con malattia renale cronica allo stadio terminale. La presentazione sarà effettuata dal Dr. Charles Keith Ozaki al 51° Simposio Annuale VEITH a New York il 23 novembre 2024. Il Dr. Ozaki è il Direttore della Ricerca in Chirurgia Vascolare presso il Brigham and Women's Hospital e Professore di Chirurgia alla Harvard Medical School. L'ATEV rimane un prodotto in fase investigativa in attesa di approvazione da parte della FDA.
Humacyte (Nasdaq: HUMA) anunció que presentará los resultados de la Fase 3 que comparan la eficacia y seguridad de su vaso tejido acelular (ATEV™) con fístulas AV autógenas en pacientes con enfermedad renal en etapa terminal. La presentación será realizada por el Dr. Charles Keith Ozaki en el 51º Simposio Anual VEITH en Nueva York el 23 de noviembre de 2024. El Dr. Ozaki es el Director de Investigación en Cirugía Vascular en el Brigham and Women's Hospital y Profesor de Cirugía en la Escuela de Medicina de Harvard. El ATEV sigue siendo un producto de investigación a la espera de la aprobación de la FDA.
휴메이시트(Humacyte, Nasdaq: HUMA)는 말기 신장 질환 환자에서 자가 혈관 조정 AV 누공과 비교하여 세포 없는 조직 공학 혈관(ATEV™)의 효능과 안전성을 비교하는 3상 결과를 발표할 예정이라고 발표했습니다. 발표는 2024년 11월 23일 뉴욕에서 열리는 제51회 연례 VEITH 심포지엄에서 찰스 키스 오자키 박사에 의해 진행될 것입니다. 오자키 박사는 브리검 여성 병원의 혈관 수술 연구 소장이며 하버드 의대 외과 교수입니다. ATEV는 FDA 승인을 기다리고 있는 조사 제품입니다.
Humacyte (Nasdaq: HUMA) a annoncé qu'elle présentera les résultats de la Phase 3 comparant l'efficacité et la sécurité de son vaisseau en tissu acellulaire (ATEV™) avec des fistules AV autologues chez des patients atteints de maladie rénale terminale. La présentation sera faite par le Dr Charles Keith Ozaki lors du 51ème Symposium Annuel VEITH à New York le 23 novembre 2024. Le Dr Ozaki est directeur de la recherche en chirurgie vasculaire au Brigham and Women's Hospital et professeur de chirurgie à la Harvard Medical School. L'ATEV reste un produit expérimental en attente d'approbation par la FDA.
Humacyte (Nasdaq: HUMA) gab bekannt, dass es die Ergebnisse der Phase 3 vorstellen wird, in denen die Wirksamkeit und Sicherheit seines acellulären, gewebekonstruierten Gefäßes (ATEV™) mit autologen AV-Fisteln bei Patienten mit terminaler Nierenkrankheit verglichen werden. Die Präsentation wird von Dr. Charles Keith Ozaki auf dem 51. jährlichen VEITH-Symposium in New York am 23. November 2024 gehalten. Dr. Ozaki ist der Forschungsdirektor für Gefäßchirurgie am Brigham and Women's Hospital und John A. Mannick Professor für Chirurgie an der Harvard Medical School. Das ATEV ist ein Forschungsprodukt, das auf die Genehmigung durch die FDA wartet.
- Phase 3 clinical trial results ready for presentation
- Study compares company's ATEV with current standard of care (AV fistulas)
- Presentation by prominent medical expert from Harvard Medical School
- ATEV still pending FDA approval
- No efficacy or safety data disclosed in advance of presentation
DURHAM, N.C., Nov. 22, 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 present Phase 3 results from a clinical study comparing efficacy and safety of Humacyte's acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in patients with end stage renal disease at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH) in New York, NY on November 23, 2024.
Details of the presentation are as follows:
Presentation Title: Results of a Phase 3 Study Comparing Efficacy and Safety of Humacyte Tissue-Engineered Vessel with Autologous AV Fistulas in Patients with End Stage Renal Disease
Presenter: Dr. Charles Keith Ozaki, MD, Vascular Surgeon and Director of Vascular Surgery Research at Brigham and Women’s Hospital; John A. Mannick Professor of Surgery at Harvard Medical School
Session Title: Novel Technologies in Hemodialysis Access
Session Date/Time: Saturday, November 23, 2024, 2:15 – 2:22 PM ET
For more information on the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH), please click here.
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 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. The ATEV is an investigational product and has not been approved for sale by the Food and Drug Administration or any international regulatory agency.
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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