CytoSorbents Gets FDA Approval To Conduct Trial

 CytoSorbents Corp. said it received Food and Drug Administration approval of its investigational device exemption to conduct the Safe and Timely Antithrombotic Removal -- Ticagrelor trial in the U.S., sending shares higher in premarket trade.

The company said it is performing this under the FDA breakthrough designation granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent and emergent cardiothoracic surgery with CytoSorbents' proprietary polymer adsorption technology.

The primary objective of the study will evaluate if the use of DrugSorb-ATR with standard of care in patients on ticagrelor undergoing cardiothoracic surgery reduces the risk of peri-operative bleeding complications compared to standard of care alone.

CytoSorbents said it believes the study can be completed in 2022 "based on the high level of excitement and engagement we are seeing from participating sites."

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