CAMBRIDGE, Mass., March 1, 2011 /PRNewswire/ — Pervasis
Therapeutics, Inc. announced today that the European Commission
(EC) has granted Orphan Drug Designation for Vascugel® for the
prevention of hemodialysis vascular access failure in patients with
end stage renal disease (ESRD). The designation follows a positive
opinion from The Committee for Orphan Medicinal Products (COMP)
within the European Medicines Agency (EMA) earlier this year.
Vascugel is a novel endothelial cell-based therapy that aims to
regulate the body’s healing response following surgical
interventions to create vascular access which are necessary for
ESRD patients undergoing hemodialysis. By promoting and enhancing
vascular repair, Vascugel reduces the need for repeat surgical
interventions and improves overall patient outcomes.
ESRD is an advanced and irreversible condition treated mainly by
hemodialysis or kidney transplantation. It is estimated that more
than 250,000 ESRD patients in the EU receive hemodialysis, a blood
purification therapy designed to replace critical kidney functions
– such as filtering waste.
Orphan Drug Designation by the EC provides regulatory and
financial incentives for companies to develop and market therapies
that treat a life-threatening or chronically debilitating condition
affecting no more than five in 10,000 persons in the European Union
(EU). In addition to a 10-year period of marketing exclusivity in
the EU after product approval, Orphan Drug Designation provides
companies with scientific advice and regulatory assistance from the
EMA during the product development phase, direct access to
centralized marketing authorization, as well as reductions in
certain fees.
“We are committed to bringing Vascugel to patients with end
stage renal disease who currently must endure serious complications
and repeat surgical procedures so they can continue to receive
life-saving hemodialysis treatment,” Frederic Chereau, president
and
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