Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Pervasis Therapeutics, a biotechnology company, has received orphan drug designation from the FDA for Vascugel, a novel allogeneic cell therapy product that may restore natural repair and regeneration pathways in the vasculature.
Subscribe to our email newsletter
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.”