Humacyte Inc (NASDAQ:HUMA) announced five-year data from a Phase 2 trial of Human Acellular Vessel (HAV) for arteriovenous (AV) access in hemodialysis.
- In the Phase 2 long-term follow-up data, the HAV was observed to provide routine and functional hemodialysis access for patients with end-stage renal disease who require dialysis three times a week.
- At month 60, patency allowing for reliable dialysis access cannulation was estimated at 58.2% of evaluable patients after censoring for deaths and withdrawals.
- While there was no comparator in this Phase 2 trial, historical reports of arteriovenous fistula, currently the most prevalent method of providing hemodialysis access, indicate an approximately 30% functional patency of evaluable patients at five years.
- Related: After NASDAQ Debut, Humacyte's Investor Adds $25M Infusion.
- In addition, no infections of the HAV were reported during the five-year follow-up period, with the HAV being well-tolerated and non-immunogenic.
- The Company is currently conducting a Phase 3 trial in up to 240 dialysis patients to assess the usability of the HAV for dialysis at six and 12 months compared to autogenous fistulas.
- Human Acellular Vessels (HAV) are investigational engineered off-the-shelf replacement vessels under development for vascular repair, reconstruction, and replacement.
- Price Action: HUMA shares are trading 3.66% higher at $5.95 during the market session on the last check Monday.
