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.
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