CytoSorbents To Start US Study With CytoSorb For Ticagrelor Removal

The FDA has signed off conditional approval for the STAR-T study to assess CytoSorbents Corporation's CTSO blood purification device, CytoSorb, to remove Ticagrelor.
The company can now initiate clinical trial agreement negotiations and institutional review board submissions.
The randomized, controlled clinical trial was designed to support U.S. marketing submission for CytoSorb, to remove AstraZeneca Plc's AZN Brilinta (ticagrelor) during the cardiothoracic surgery to reduce perioperative bleeding complications.
Ticagrelor is one of the most commonly used blood thinners to reduce the risk of cardiac death, heart attacks, and strokes in patients with the acute coronary syndrome.
It is also used to reduce the rate of stent thrombosis in patients who have been stented.
However, when patients on ticagrelor require emergent cardiac surgery, the risk of severe bleeding and complications is very high.
Last year in January, CytoSorb scored approval in the E.U. to remove ticagrelor during surgery requiring cardiopulmonary bypass.
In April 2020, CytoSorb received FDA Breakthrough Designation to remove ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
Price Action: CTSO shares are down 2.2% at $8.8 in market trading hours on the last check Monday.