Humacyte's V012 Trial Meets Primary Endpoint in Dialysis Access

Humacyte said Monday its engineered blood vessel, the ATEV, met the primary efficacy endpoint in the V012 study for dialysis access. The interim analysis, triggered after the first 80 patients reached one year of follow-up, showed that patients who received the ATEV had more catheter-free days than those who received an autogenous fistula, the current standard of care.

Laura Niklason, the company's founder and CEO, announced the results during a virtual investor event. She said the 80th patient reached one year in April and top-line data came in recently. The trial's primary endpoint at this interim analysis was the number of catheter-free days, a measure of how quickly and reliably the access site can be used for dialysis without a central venous catheter.

Dialysis access is a large and well-defined market. Fistulas often require weeks to months to mature before they can be used, and a significant fraction fail to mature at all. Patients who cannot use a fistula remain on catheters, which carry higher risks of infection and central vein stenosis. Humacyte's ATEV is a bioengineered vessel designed to be ready for cannulation without a maturation period, potentially reducing catheter dependence.