Humacyte has announced the publication of one-year results from the V007 phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for haemodialysis patients in The Lancet Digital Health.
In a press release, the company says that the publication demonstrates the positive findings from Humacyte’s V007 trial, previously presented at major medical conferences, showing the superiority of the ATEV over autogenous arteriovenous fistula (AVF) for haemodialysis vascular access after one year of follow up, particularly for all female patients and male patients with obesity and diabetes, groups that often face higher rates of AVF failure.
“Reliable haemodialysis access is critical for patients with end-stage kidney disease, yet remains a challenge for many, especially those with higher risk profiles,” said Mohamad A Hussain, lead author of the publication and vascular and endovascular surgeon at the Heart and Vascular Institute, Mass General Brigham and associate professor of surgery at Harvard Medical School (Boston, USA). “This publication in The Lancet Digital Health provides additional validation of these results and highlights the potential of ATEV as an alternative for patients who may be less likely to benefit from AV fistulas.”
“Publication in The Lancet Digital Health is a significant milestone for Humacyte and an important validation of our phase 3 dialysis data. These results demonstrate that the ATEV can offer a better option for the patients who need it most, particularly all women and men with obesity and diabetes, who too often face poor outcomes with traditional fistulas,” said Laura Niklason, founder and CEO of Humacyte. “With the V007 and V012 results we believe we have built a compelling case to bring this technology to the patients who stand to benefit most.”
Positive two-year results from the V007 phase 3 trial, announced in November 2025 at Kidney Week 2025, the American Society of Nephrology (ASN) annual meeting (5–9 November, Houston, USA), further demonstrated the durability of ATEV’s benefits over time.
Additionally, Humacyte reported top-line interim results from its V012 phase 3 study at the Society of Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM; 10–13 June, Boston, USA). V012 is specifically focused on female patients with end-stage renal disease (ESRD) needing haemodialysis—a population in which the V007 one-year data already showed meaningful advantages for ATEV over traditional fistulas.
Aa a result of meeting the primary superiority endpoint in V012, Humacyte plans to submit a supplemental Biologics License Application (sBLA) to expand the Symvess label to include a second indication in AV access for haemodialysis in the second half of 2026.
For uses other than the Food and Drug Administration (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.
