The orphan drug designation is granted for the prevention of arteriovenous fistula or arteriovenous graft failure in patients with end-stage renal disease receiving hemodialysis or preparing for hemodialysis.
Frederic Chereau, president and CEO of Pervasis, said: “We are very pleased to receive orphan drug designation from the FDA for Vascugel. The designation is for a broad array of vascular accesses for patients with end-stage renal disease, including placement of an arteriovenous graft or arteriovenous fistula for hemodialysis and revisions to existing accesses.
“Vascugel is a potential new treatment option that may improve outcomes for these patients, and the first in a portfolio of novel cell-based therapeutics we are developing to treat vascular injury by harnessing the body’s natural healing process. We are working closely with the FDA as we move forward with plans for a Phase III trial for Vascugel, and are in active discussions with potential partners to bring this product to market.”