Core Insights - Humacyte, Inc. announced positive two-year results from the V007 Phase 3 clinical trial of its acellular tissue engineered vessel (ATEV) for hemodialysis access, demonstrating superior performance compared to the current gold standard, autogenous fistula, particularly in high-need subgroups [1][2][5] Group 1: Clinical Trial Results - The V007 Phase 3 trial showed that ATEV had a superior duration of use over 24 months compared to autogenous fistula in female, obese, and diabetic patients, who typically have poor outcomes with AV fistula procedures [2][4] - In female patients (n=70), the average duration of ATEV usage was 15.8 months compared to 10.0 months for AV fistula (p<0.0137) [4] - In the target population of females and males with obesity and diabetes (n=110), ATEV had an average duration of access use of 14.8 months versus 9.1 months for AV fistula (p=0.0114) [4] Group 2: Clinical Significance - The ATEV provided a clinically meaningful advantage in early usability and functional patency, enabling faster and more reliable dialysis initiation, especially in high-risk patients [3][5] - The results indicate that ATEV could significantly reduce reliance on catheters for arteriovenous access, which is a major cause of complications and treatment costs in patient care [3][6] Group 3: Safety Profile - After 24 months of follow-up, no unexpected side effects were observed in patients implanted with the ATEV, showing a comparable safety profile to AV fistula with low rates of infection [7] - Although ATEV patients experienced more thrombosis and stenosis events requiring interventions, most cases were successfully treated [7] Group 4: Company Overview - Humacyte is developing a biotechnology platform for universally implantable bioengineered human tissues and has received FDA approval for the ATEV in vascular trauma [9] - The company is also conducting late-stage clinical trials for other vascular applications, including AV access for hemodialysis and peripheral artery disease [9]

Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q3 2025 on November 12, 2025, and will provide a corporate and financial update during a webcast and conference call [1][2]. Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at a commercial scale [1][3]. - The company manufactures acellular tissues aimed at treating various diseases, injuries, and chronic conditions [3]. - The FDA approved the Biologics License Application for Humacyte's acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 [3]. - ATEVs are currently in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3]. - Preclinical development is ongoing for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other novel cell and tissue applications [3]. - Humacyte's 6mm ATEV for AV access in hemodialysis is notable for being the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation [3]. - The ATEV has received priority designation for vascular trauma treatment from the U.S. Secretary of Defense [3]. Financial Results Announcement - The financial results for the quarter ending September 30, 2025, will be announced on November 12, 2025, at 8:00 AM ET [2]. - A conference call will be available for U.S. and international investors, with specific dial-in numbers provided [2]. - The webcast will be accessible 15 minutes prior to the call and will be available for replay for at least 30 days [2].

Core Insights - Humacyte, Inc. presented data from its V007 Pivotal Phase 3 clinical trial, demonstrating the superiority of its acellular tissue engineered vessel (ATEV™) over autologous arteriovenous fistula (AVF) in high-risk patients with end-stage kidney disease [1][2][3] Group 1: Clinical Trial Overview - The CLN-PRO-V007 trial was a multicenter, randomized controlled trial involving 242 end-stage kidney disease patients, focusing on the efficacy and safety of ATEV compared to AVF [3] - The trial specifically targeted high-risk patients, including women and individuals with obesity and diabetes, who are more likely to experience AVF maturation failure [3][4] - ATEV showed better functional patency and usability, with a comparable access-related complication profile to AVF in the high-risk subgroup [3][4] Group 2: Results and Implications - ATEV demonstrated a lower need for maturation and surgical revision procedures compared to AVF, indicating its potential as a more effective option for high-risk patients [3][4] - The safety profile of ATEV was comparable to AVF, with low rates of infections, although there were more thrombosis and stenosis events in the ATEV group, most of which were successfully treated [3][4] - The results highlight a significant unmet medical need in the dialysis access market, particularly for the high-risk demographic, which represents over half of the market [4] Group 3: Company Background and Future Outlook - Humacyte is focused on developing universally implantable bioengineered human tissues and has received FDA approval for ATEV in vascular trauma indications [6][7] - The company is advancing ATEV through late-stage clinical trials for various vascular applications, including hemodialysis access and peripheral artery disease [6][7] - Humacyte anticipates publishing the V007 trial results in a major peer-reviewed medical journal soon, which could further validate the findings and support market adoption [4]

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]

Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q1 2025 on May 13, 2025, and will provide a corporate and financial update during a webcast and conference call [1][2]. Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][3]. - The company manufactures acellular tissues aimed at treating various diseases, injuries, and chronic conditions [3]. - The FDA approved the Biologics License Application for Humacyte's acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 [3]. - ATEVs are currently in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3]. - Preclinical development is ongoing for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other novel cell and tissue applications [3]. - Humacyte's 6mm ATEV for AV access in hemodialysis is notable for being the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation [3]. - The ATEV has received priority designation for vascular trauma treatment from the U.S. Secretary of Defense [3]. Financial Results Announcement - The financial results for the quarter ended March 31, 2025, will be announced on May 13, 2025, at 8:30 AM ET [2]. - A conference call will be available for U.S. and international investors, with specific dial-in numbers provided [2]. - The webcast will be accessible 15 minutes prior to the call and will be available for replay for at least 30 days [2].