Announcement • Jun 11

Humacyte Announces Positive Interim Results for V012 Phase 3 Clinical Trial of Acellular Tissue Engineered Vessel in Female Dialysis Access Patients

Humacyte, Inc. announced positive top-line interim results from its Phase 3 clinical trial (V012) of the acellular tissue engineered vessel (ATEV) in arteriovenous access for female patients with end-stage renal disease requiring hemodialysis. The ATEV met V012's primary endpoint and was observed to have superior catheter-free days (p=0.00070) compared to autologous arteriovenous (AV) fistula, the current standard of care. The ATEV's ability to reduce time on catheter has the potential to improve patient outcomes and lower the burden of dialysis costs on the healthcare system. In a prespecified interim analysis conducted in the first 80 patients enrolled in the study, the V012 trial's primary endpoint was met with the ATEV observed to have an average of 91 more catheter-free days compared to autologous arteriovenous (AV) fistula, the current standard of care. In accordance with the study protocol, as a result of meeting the primary endpoint, study enrollment will terminate and existing patients will continue to be followed as per protocol. Humacyte plans to file a supplemental Biologic License Application (BLA) with the Food and Drug Administration (FDA) during the second half of 2026. The currently planned target indication is focused on adult patients with end-stage kidney disease who are at increased risk of AV fistula maturation failure. The V012 clinical study is designed to demonstrate the efficacy and safety of the ATEV as a dialysis access method compared to autologous AV fistula in female dialysis patients, a high-unmet-need population. V012 is a Phase 3, prospective, multi-center, open label, randomized, two-arm comparative study conducted in the United States in up to 150 patients, with 120 patients are currently enrolled. The primary measure of efficacy is total days free from in-dwelling catheter ("catheter-free days") until 365 days after access placement, or until access abandonment, whichever occurs first. A prespecified interim analysis was conducted after the first 80 patients enrolled had completed 12 months of follow-up. In this analysis, patients implanted with the ATEV achieved an average of 220 catheter-free days compared to 129 catheter-free days for patients who received an AV fistula. The result was statistically significant (p=0.00070), meeting the primary endpoint of the study. The primary safety measure in the V012 study is the number and severity of infections related to all accesses (including catheters) from the date of access creation until 365 days thereafter. Patients receiving the ATEV incurred infections at a rate of six per 100 patient years, as compared to 23 per 100 patient years for patients receiving an AV fistula procedure. There were no study access-associated infections reported in the ATEV patients, while there were three among the AV fistula patients. There were no spontaneous ruptures reported in either of the treatment groups. The overall benefit risk profile of the ATEV was observed to be favorable, with no new or unexpected safety signals identified. Humacyte's Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular injury indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). 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 injury and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. Results from the V012 Phase 3 study will be presented the evening of June 11, 2026 at the Society for Vascular Surgery's (SVS's) Vascular Annual Meeting (VAM) in Boston in the Women's Health seminar. For uses other than the FDA approval in the extremity vascular injury indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. The ATEV met V012s primary endpoint by demonstrating superior catheter-free days compared to arteriovenous fistula (AVF), the standard of care 91 more catheter-free days for ATEV versus AVF. ATEV patients incurred 17 fewer dialysis access infections than AVF per 100 patient-years, the primary safety measure for the study. The ATEV was observed to have consistent advantages over AVF in multiple secondary endpoints. Overall benefit-risk safety profile of ATEV was favorable with no new or unexpected safety concerns identified. Statistically Significant p=0.0007 Pre-specified superiority threshold met Interim analysis: ATEV (N=40) vs AVF (N=40). Humacyte plans to file a supplemental BLA with the FDA during the second half of 2026 (target indication is in adult patients with end-stage kidney disease (ESKD) who are at increased risk of AV fistula maturation failure). The ATEV met V012s primary endpoint by demonstrating superior catheter-free days compared to AVF, the current standard of care 91 more catheter-free days than AVF (p=0.0007). ATEV patients incurred 17 fewer dialysis access infections than AVF per 100 patient years, the primary safety measure for the study. The ATEV was observed to demonstrate consistent advantages over AVF in multiple secondary endpoints. Overall benefit-risk safety profile of ATEV is favorable with no new or unexpected safety concerns identified. In accordance with the study protocol, as a result of meeting the primary endpoint, study enrollment will terminate. Humacyte plans to file a supplemental BLA with the FDA during the second half of 2026 (target indication is in adult patients with ESKD who are at increased risk of AV fistula maturation failure).

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