CytoSorbents Corp. (NASDAQ: CTSO) stock gained by 0.29% at last close whereas the CTSO stock price plunges by 7.22% in the after-hours trading session. CytoSorbents Corporation is a pioneer in the use of blood purification to treat life-threatening diseases in critical care and heart surgery.
CTSO stock’ Current Update
The FDA has given complete clearance to CytoSorbents Corporation’s Investigational Device Exemption application to perform the key STAR–D double-blind, randomized, and controlled study in the US to support FDA marketing approval. The DrugSorb–ATR Antithrombotic Removal System was previously given FDA Breakthrough Device Designation for the removal of apixaban and rivaroxaban in a cardiopulmonary bypass circuit to minimize the probability of severe perioperative bleeding in urgent cardiothoracic surgery.
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents commented,
They are happy to obtain a second IDE clearance for the antithrombotic removal application for the randomized, controlled, double-blind STAR-D study, which will help the FDA approve DrugSorb–ATR for intraoperative apixaban and rivaroxaban removal in cardiothoracic surgery. The next stage of their STAR development program is STAR–D. The STAR-D trial design and operational structure are identical to the STAR-T trial for ticagrelor elimination that is now under progress and are projected to provide significant scientific, operational, and budgetary savings.
Drs. Michael Mack and C. Michael Gibson, Co-Principal Investigators, and an Executive Committee consisting of well-known cardiac surgeons, interventional cardiologists, and thrombosis/hemostasis experts will lead STAR–D. It is anticipated to enroll up to 120 patients across 25 U.S. clinical sites – many of which are already playing an active role in STAR-T. Trial preparations are ongoing, and the research is expected to begin in the first quarter of 2022.
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents, stated,
The STAR-D protocol now has complete IDE approval, allowing them to move on with their DrugSorb-ATR market development approach. With this additional approval, they will have two randomized, controlled pivotal trials underway in the United States to help U.S. FDA marketing authorization for the intraoperative removal of the important antithrombotic drugs Brilinta, Eliquis, and Xarelto during open-heart surgery to minimize the risk of perioperative bleeding.