"Shire's vision of bringing new regenerative medicine therapies to patients with chronic diseases was a critical factor in our decision to proceed with this transaction," said Frederic Chereau, President and Chief Executive Officer at Pervasis. "I am excited to be partnering with Shire, which has demonstrated both the capability and commitment to bringing this promising cell-based technology to the patients with end stage renal disease who need it."
The closing of the acquisition is subject to ancillary conditions.
Vascugel is an endothelial cell-based therapy in development for enhancing blood vessel repair and improving hemodialysis access for patients with end-stage renal disease. Vascugel utilizes adult allogeneic endothelial cells embedded into a polymer matrix, and is placed on the outside of the blood vessel at the arteriovenous (AV) access site during the surgical intervention to create the access. Vascugel has received Orphan Product designation from the U.S. Food and Drug Administration and the European Medical Agency.About Arteriovenous (AV) Access for Hemodialysis End-stage renal disease (ESRD) is an advanced and irreversible kidney disease, treated mainly by hemodialysis or kidney transplantation. It is estimated that each year, there are more than 570,000 patients with ESRD treated in the U.S. and more than 250,000 patients in the EU [ i,iii]. Approximately 70% of these patients receive hemodialysis [ i ]. Before patients can undergo hemodialysis, an arteriovenous (AV) access site must be created where blood can be removed, filtered and returned to the body. The majority of AV access is achieved through either an AV fistula, where the vein is connected directly to the artery, or an AV graft, where the vein and artery are connected via a tube. There are an estimated 100,000 AV fistulas and 60,000 AV grafts occurring annually in the U.S. [iv,v] Unfortunately, complications following AV access procedures are common and can include infection, blood clots, and narrowing of the vessel, which frequently lead to AV access failure. An estimated 60% of AV grafts fail after one year, requiring a procedure to restore flow or to create another AV access site [vi,vii]. Notes to editors
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