The FDA granted breakthrough therapy designation to CytoSorbents‘ (NASDAQ:CTSO) CytoSorb blood purification technology for the removal of ticagrelor during emergency surgery.
Ticagrelor is an antiplatelet drug that is administered to patients to reduce the risk of blood clot formation. When patients on ticagrelor require emergency surgery, however, there is a very high risk of serious or life-threatening bleeding and complications.
“This breakthrough designation represents another constructive regulatory step forward on the heels of the recent emergency use authorization granted by [the] FDA for use of CytoSorb in critically-ill COVID-19 patients,” Mr. Vincent Capponi, CytoSorbent’s COO, said in a statement.
“We believe this represents an important step towards our goal of obtaining U.S. regulatory approval of CytoSorb for this indication,” he added.
