Humacyte at ASN Kidney Week: Phase 3 Trial Built for Women Shows ATEV Advantage Over Fistula, Getting Patients Off Catheters Months Sooner
Key Highlights
- ➤V012 women averaged 220.4 catheter-free days versus 129.3 with AV fistula
- ➤ATEV achieved functional access in 1.7 months versus 5.3 months for AV fistula
- ➤Approximately 65% of AV fistulas reached functional maturation by Month 12
- ➤ATEV infections were approximately 6 versus 23 per 100 patient-years with AV fistula
- ➤Humacyte targets FDA submission this quarter for Symvess AV-access label expansion
Expert Statements
Prabir Roy-Chaudhury, M.D., Ph.D., FASN; 2025 President of the American Society of Nephrology and Co-Director of the University of North Carolina Kidney Center
“Every woman in this study was judged by her surgeon to be a candidate for a fistula, but more than a third of those fistulas failed to mature within a year in this study”
Prabir Roy-Chaudhury, M.D., Ph.D., FASN; 2025 President of the American Society of Nephrology and Co-Director of the University of North Carolina Kidney Center
“That tells us that even in the right patients, we cannot count on a fistula to work, or to work in time.”
Prabir Roy-Chaudhury, M.D., Ph.D., FASN; 2025 President of the American Society of Nephrology and Co-Director of the University of North Carolina Kidney Center
“In V012, women with the ATEV reached usable access months sooner and spent significantly less time on a catheter.”
Prabir Roy-Chaudhury, M.D., Ph.D., FASN; 2025 President of the American Society of Nephrology and Co-Director of the University of North Carolina Kidney Center
“These results give the nephrology community a strong reason to rethink our approach to access decisions for women and, once approved by the FDA, to consider the ATEV as a meaningful new option for the patients who need it most.”
Mohamad A. Hussain, M.D., Ph.D.; vascular and endovascular surgeon-scientist at the Heart and Vascular Institute, Mass General Brigham, and Associate Professor of Surgery at Harvard Medical School
“Prolonged catheter dependence is one of the most serious problems a surgeon encounters in dialysis care.”
Mohamad A. Hussain, M.D., Ph.D.; vascular and endovascular surgeon-scientist at the Heart and Vascular Institute, Mass General Brigham, and Associate Professor of Surgery at Harvard Medical School
“A bioengineered vessel that women can use sooner, and that keeps them off a catheter longer, could make a real difference,”
Charmaine Lok, M.D.; Professor of Medicine at the Faculty of Medicine, University of Toronto and Senior Scientist at the Toronto General Hospital Research Institute
“For a woman receiving maintenance hemodialysis, it’s important to have vascular access options that can be individualized to meet their needs.”
Charmaine Lok, M.D.; Professor of Medicine at the Faculty of Medicine, University of Toronto and Senior Scientist at the Toronto General Hospital Research Institute
“Less is more when it comes to getting women to usable access sooner - less catheter time is more time to enjoy non dialysis activities without having to worry about the risks of catheter-related infection, hospital visits, and uncertainty.”
- The presenter, Dr. Roy-Chaudhury said, “These results give the nephrology community a strong reason to rethink our approach to access decisions for women and, once approved by the FDA, to consider the ATEV as a meaningful new option.”
– In a planned interim analysis, women implanted with the ATEV averaged 220 catheter-free days in the first year compared to 129 days with arteriovenous fistula, meeting the trial’s primary endpoint of superiority.
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