Key insights
- Humacyte Inc. reported positive interim results from its Phase 3 V012 clinical trial for its acellular tissue engineered vessel (ATEV) for hemodialysis access. The ATEV demonstrated superiority over arteriovenous fistulas, achieving more catheter-free days and faster functional access. The trial met its primary endpoint, and enrollment was stopped. The safety profile was comparable, with fewer infections reported for the ATEV. Humacyte plans to submit a supplemental BLA to the FDA this quarter to expand the Symvess label.
DURHAM, N.C. - Humacyte Inc. (NASDAQ:HUMA) presented interim results from its V012 Phase 3 clinical trial evaluating an acellular tissue engineered vessel for hemodialysis access in women with end-stage kidney disease, according to a press release statement.
The results were presented Thursday at the American Society of Nephrology’s Kidney Week 2026 in Denver, Colorado. The trial compared the company’s ATEV device against arteriovenous fistula, the current standard of care for hemodialysis access.
In the interim analysis of the first 80 patients, women implanted with the ATEV averaged 220 catheter-free days in the first year compared to 129 days with arteriovenous fistula. The trial met its primary endpoint of superiority, and enrollment was stopped.
ATEV recipients achieved functional access with a median of 1.7 months compared to 5.3 months with an AV fistula. Approximately 65% of AV fistulas achieved functional maturation by month 12, leaving about one-third of women in the fistula arm without a functionally mature fistula at one year.
The V012 trial enrolled approximately 150 female hemodialysis patients, randomized 1:1 to receive either the ATEV or an AV fistula. All women enrolled were receiving hemodialysis through a catheter and were considered suitable candidates for AV fistula creation.
The safety profile of the ATEV was comparable to that of AV fistula. Dialysis access infections occurred at approximately 6 per 100 patient-years with the ATEV, compared to 23 per 100 patient-years with AV fistula. No spontaneous ruptures were reported in either group.
Humacyte stated it plans to submit a supplemental Biologics License Application to the FDA this quarter to expand the Symvess label to include AV access for hemodialysis. The company’s ATEV for vascular trauma was approved by the FDA in December 2024.
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