India, Oct. 23 -- Humacyte, Inc. (HUMA) announced positive interim results from the Phase 3 V012 trial evaluating its investigational acellular tissue engineered vessel (ATEV) against arteriovenous (AV) fistula for hemodialysis access in female patients with end-stage kidney disease.
In the prespecified interim analysis of the first 80 patients, women receiving ATEV averaged 220.4 catheter-free days during the first 12 months, compared with 129.3 days for those receiving an AV fistula, meeting the trial's primary endpoint of superiority (p<0.001).
ATEV recipients also achieved functional access faster, with a median time of 1.7 months compared with 5.3 months for AV fistula recipients.
Approximately 65% of fistulas achieved functional ma...