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Humacyte Announces Six Presentations Scheduled for the Upcoming 52nd Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITHsymposium)
Globenewswire· 2025-11-13 13:00
Core Insights - Humacyte, Inc. is set to present six studies on its acellular tissue engineered vessel (ATEV™) at the upcoming VEITHsymposium, a key event for vascular specialists [1][2][3] Presentation Details - The presentations will cover various applications of ATEV™, including its effectiveness in combat vascular trauma, torso arterial trauma, dialysis access, and long-term clinical use [2][3] - Notable presentations include outcomes from the War in Ukraine, case reports from clinical trials, and a review of published outcomes across multiple vascular indications [2][3] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable bioengineered human tissues and advanced tissue constructs [3] - The FDA approved Humacyte's Biologics License Application for ATEV in December 2024, specifically for vascular trauma [3] - ATEV is currently in late-stage clinical trials for other vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3] - The 6mm ATEV for AV access in hemodialysis was the first to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation [3]
Humacyte Announces Publication of New Data Comparing Symvess™ to Autologous Vein in Extremity Arterial Trauma
Globenewswire· 2025-10-30 12:00
Core Insights - Humacyte, Inc. announced the publication of a study comparing the clinical outcomes of its product Symvess to autologous vein in treating extremity arterial trauma, showing similar short-term outcomes [1][2][4] Company Overview - Humacyte, Inc. is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][13] - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for vascular trauma indications [13][14] Study Findings - The study published in the AAST's Trauma Surgery & Acute Care Open Journal indicated that Symvess achieved comparable outcomes to autologous vein in terms of primary patency (86.6% for Symvess vs. 91.8% for autologous vein), secondary patency (91.0% vs. 97.7%), amputation rates (7.5% vs. 8.2%), conduit infection (1.5% vs. 0%), and mortality (4.5% for both) [2][3] - The analysis utilized data from Humacyte's Phase 2/3 V005 study and the Humanitarian V017 study, matched against the PROOVIT registry [2][3] Product Indication - Symvess is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed and autologous vein graft is not feasible [5][13] Market Context - Autologous vein has been the gold standard for treating extremity arterial trauma due to its resistance to infection and maintenance of patency, but may not always be available [2][3] - Symvess offers an off-the-shelf solution that can save critical surgical time in traumatic situations [3][4] Leadership Perspective - Humacyte's CEO emphasized the need for innovative alternatives to autologous vein grafts, highlighting Symvess as a safe and effective option for complex trauma cases [4][13]
Humacyte Clinical Results in High-Risk Dialysis Patients from V007 Pivotal Phase 3
GlobeNewswire News Room· 2025-06-02 12:00
Core Insights - Humacyte, Inc. announced that its abstract on the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) has been accepted for oral presentation at the Society for Vascular Surgery Vascular Annual Meeting (VAM25) [1] - The presentation will highlight that the ATEV outperforms arteriovenous fistula in high-risk patients undergoing hemodialysis, based on results from the CLN-PRO-V007 randomized controlled trial [1][2] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable bioengineered human tissues and advanced tissue constructs aimed at improving patient outcomes and transforming medical practices [3] - The company has received FDA approval for its Biologics License Application for the ATEV in the vascular trauma indication as of December 2024, and is conducting late-stage clinical trials for other vascular applications [3] - The ATEV has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, indicating its potential in treating various vascular conditions [3] Presentation Details - The presentation titled "Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial" will be delivered by Dr. Mohamad A. Hussain at the VAM25 meeting [2] - The session is scheduled for June 6, 2025, at 10:50 a.m. CT [2]