Benzinga | Apr 19, 2021 12:24PM EDT

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 (NASDAQ: 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 (NASDAQ: 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.