Humacyte to Host In-Person and Virtual Investor Event in New York to Discuss Commercial Launch of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma on March 6, 2025
Humacyte (Nasdaq: HUMA) has announced an upcoming investor event, scheduled for March 6, 2025, at 12:00 PM ET in New York, available both in-person and virtually. The event will spotlight Symvess, their groundbreaking bioengineered human tissue product that received FDA approval in December 2024.
The presentation will feature vascular surgery experts Dr. Michael Curi from Rutgers New Jersey Medical School and Dr. Sammy Siada from UCSF Fresno, alongside company management. They will discuss commercial strategies and initial market performance of Symvess, a first-in-class universally implantable vascular conduit.
The FDA approved Symvess for adult use in extremity arterial injury cases requiring urgent revascularization to prevent limb loss, specifically when autologous vein grafts aren't viable. The event will conclude with a Q&A session, and a webcast replay will be available on Humacyte's investor relations website.
Humacyte (Nasdaq: HUMA) ha annunciato un prossimo evento per investitori, programmato per il 6 marzo 2025, alle 12:00 ET a New York, disponibile sia in presenza che virtualmente. L'evento metterà in evidenza Symvess, il loro innovativo prodotto di tessuto umano bioingegnerizzato che ha ricevuto l'approvazione della FDA nel dicembre 2024.
La presentazione vedrà la partecipazione di esperti di chirurgia vascolare, il Dr. Michael Curi della Rutgers New Jersey Medical School e il Dr. Sammy Siada della UCSF Fresno, insieme alla direzione aziendale. Discuteranno le strategie commerciali e le prestazioni iniziali di mercato di Symvess, un condotto vascolare di prima classe universalmente impiantabile.
La FDA ha approvato Symvess per l'uso negli adulti in casi di lesioni arteriose agli arti che richiedono una rivascolarizzazione urgente per prevenire la perdita dell'arto, specificamente quando i trapianti di vena autologa non sono praticabili. L'evento si concluderà con una sessione di domande e risposte, e una registrazione in webcast sarà disponibile sul sito web delle relazioni con gli investitori di Humacyte.
Humacyte (Nasdaq: HUMA) ha anunciado un próximo evento para inversores, programado para el 6 de marzo de 2025, a las 12:00 PM ET en Nueva York, disponible tanto en persona como virtualmente. El evento destacará Symvess, su innovador producto de tejido humano bioingenierizado que recibió la aprobación de la FDA en diciembre de 2024.
La presentación contará con expertos en cirugía vascular, el Dr. Michael Curi de la Rutgers New Jersey Medical School y el Dr. Sammy Siada de UCSF Fresno, junto con la dirección de la empresa. Discutirán las estrategias comerciales y el rendimiento inicial del mercado de Symvess, un conducto vascular de primera clase universalmente implantable.
La FDA aprobó Symvess para uso en adultos en casos de lesiones arteriales en extremidades que requieren revascularización urgente para prevenir la pérdida del miembro, específicamente cuando los injertos de vena autóloga no son viables. El evento concluirá con una sesión de preguntas y respuestas, y se dispondrá de una repetición del webcast en el sitio web de relaciones con inversores de Humacyte.
Humacyte (Nasdaq: HUMA)는 2025년 3월 6일 오후 12시(ET) 뉴욕에서 열리는 투자자 행사에 대해 발표했습니다. 이 행사는 대면 및 가상으로 진행됩니다. 이 행사에서는 2024년 12월 FDA 승인을 받은 혁신적인 생체 공학 인간 조직 제품인 Symvess가 조명될 것입니다.
발표에는 Rutgers New Jersey Medical School의 Michael Curi 박사와 UCSF Fresno의 Sammy Siada 박사가 참석하며, 회사 경영진과 함께합니다. 그들은 Symvess의 상업 전략과 초기 시장 성과에 대해 논의할 것입니다. Symvess는 최초의 범용 이식 가능한 혈관 도관입니다.
FDA는 Symvess를 성인 사용을 위해 승인했으며, 이는 사지 손실을 방지하기 위해 긴급 재혈관화가 필요한 사지 동맥 손상 사례에 적용됩니다. 자가 정맥 이식이 불가능할 때 특히 사용됩니다. 이 행사는 질의응답 세션으로 마무리되며, Humacyte의 투자자 관계 웹사이트에서 웹캐스트 재방송이 제공될 것입니다.
Humacyte (Nasdaq: HUMA) a annoncé un prochain événement pour investisseurs, prévu pour le 6 mars 2025 à 12h00 ET à New York, disponible à la fois en personne et virtuellement. L'événement mettra en lumière Symvess, leur produit de tissu humain bio-ingénierie révolutionnaire qui a reçu l'approbation de la FDA en décembre 2024.
La présentation mettra en vedette des experts en chirurgie vasculaire, le Dr. Michael Curi de la Rutgers New Jersey Medical School et le Dr. Sammy Siada de l'UCSF Fresno, aux côtés de la direction de l'entreprise. Ils discuteront des stratégies commerciales et des performances initiales sur le marché de Symvess, un conduit vasculaire de première classe universellement implantable.
La FDA a approuvé Symvess pour un usage adulte dans les cas de blessures artérielles aux extrémités nécessitant une revascularisation urgente pour prévenir la perte de membre, en particulier lorsque les greffes de veine autologue ne sont pas viables. L'événement se terminera par une session de questions-réponses, et une rediffusion du webcast sera disponible sur le site Web des relations avec les investisseurs de Humacyte.
Humacyte (Nasdaq: HUMA) hat eine bevorstehende Investorenveranstaltung angekündigt, die für den 6. März 2025 um 12:00 Uhr ET in New York geplant ist und sowohl persönlich als auch virtuell verfügbar sein wird. Die Veranstaltung wird Symvess in den Mittelpunkt stellen, ihr bahnbrechendes bioengineering menschliches Gewebeprodukt, das im Dezember 2024 von der FDA genehmigt wurde.
Die Präsentation wird Experten für Gefäßchirurgie, Dr. Michael Curi von der Rutgers New Jersey Medical School und Dr. Sammy Siada von UCSF Fresno, zusammen mit dem Management des Unternehmens, umfassen. Sie werden über kommerzielle Strategien und die anfängliche Marktleistung von Symvess, einem erstklassigen universell implantierbaren Gefäßleitungsprodukt, diskutieren.
Die FDA hat Symvess für den Einsatz bei Erwachsenen in Fällen von arteriellen Verletzungen der Extremitäten genehmigt, die eine dringende Revaskularisierung erfordern, um den Verlust von Gliedmaßen zu verhindern, insbesondere wenn autologe Venenverpflanzungen nicht möglich sind. Die Veranstaltung wird mit einer Frage- und Antwortsitzung enden, und eine Wiederholung des Webcasts wird auf der Investor-Relations-Website von Humacyte verfügbar sein.
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DURHAM, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced it will host an in-person and virtual investor event in New York on Thursday, March 6, 2025 at 12:00 PM ET. To register as an in-person or virtual attendee, please click here.
The event will feature vascular surgery key opinion leaders (KOLs) Michael Curi, MD, MPA (Rutgers New Jersey Medical School) and Sammy Siada, DO, FACS, RPVI (UCSF Fresno), who will join company management to discuss the commercial plans and early market-launch success of Symvess (acellular tissue engineered vessel-tyod) for extremity arterial injury.
Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair. The U.S. Food and Drug Administration (FDA) granted a full approval for Symvess in December 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. Please see full Prescribing Information, including Boxed Warning, for SYMVESS at www.symvess.com.
A live question and answer session will follow the formal presentations. A replay of the webcast will be available for a limited time on the Events & Presentations page within the Investors portion of the Humacyte website.
About Michael Curi, MD, MPA
Michael Curi, MD, MPA is Associate Professor of Surgery and Chief of Division of Vascular Surgery at Rutgers New Jersey Medical School. Dr. Curi is a proud graduate of New Jersey Medical School and received his undergraduate degree from Lafayette College. Prior to medical school he obtained a Master’s Degree in Public Administration studying Health Policy & Management from New York University. He completed his surgical residency at University of Chicago where he spent an additional 2 years performing cutting-edge research into the treatment of vascular disease utilizing gene therapy and novel biological agents. He then completed an advanced fellowship in Vascular & Endovascular Surgery at Washington University in St. Louis, where he trained under Dr. Juan Parodi, inventor of the aortic stent graft. He has published many articles in leading vascular journals, authored chapters in surgical textbooks on aortic aneurysms, and has been nationally recognized for his work in vascular research. He is a member of the American College of Surgeons, Society of Vascular Surgery, Peripheral Vascular Surgical Society, and The Eastern Vascular Society and is an investigator on the V005 trial.
About Sammy Siada, DO, FACS, RPVI
Sammy Siada, DO, FACS, RPVI, specializes in vascular and endovascular surgery and is an Assistant Clinical Professor in the Department of Surgery at UCSF Fresno. Dr. Siada attended the University of Texas at Arlington where he earned his Bachelor of Science degree in biology. Upon completing his undergraduate education, Dr. Siada continued his medical education at the University of North Texas Health Science Center to complete his Doctor of Osteopathic Medicine in Fort Worth, TX. After medical school, he joined UCSF Fresno for his residency training in general surgery. Dr. Siada subsequently completed a two-year fellowship in vascular surgery at the University of Colorado School of Medicine. He is board certified in surgery and board eligible in vascular surgery. In addition to providing expert care to vascular surgery patients, Dr. Siada is very involved in the medical community. He is a member of the following organizations: American College of Surgeons, Society for Vascular Surgery, Society for Clinical Vascular Surgery, and the Vascular and Endovascular Surgery Society. Furthermore, Dr. Siada has also authored several research articles in the general and vascular surgery arenas.
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 acellular tissue engineered vessels (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 was approved by the FDA in December 2024. 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.
For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
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, our plans and ability to commercialize our ATEV in the United States under the brand name SYMVESS in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; 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, our quarterly report on Form 10-Q for the quarter ended September 30, 2024, each 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.
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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