CytoSorbents Inc. (NASDAQ: CTSO) stock gained by 7% at last close whereas the CTSO stock price declines by 5.53% in the after-hours trading. CytoSorbents Corporation is a pioneer in the use of blood purification to address life-threatening diseases in critical care and heart surgery.
CTSO stock’ Recent Past Development
The United States Food and Drug Administration has given CytoSorbents Corporation a second Breakthrough Device designation for their DrugSorb-ATR Antithrombotic Removal System (FDA). The withdrawal of the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban from a cardiopulmonary bypass circuit to minimize the risk of severe perioperative bleed in urgent cardiothoracic surgery is covered by this Breakthrough Device designation. It comes after the Breakthrough Designation in April 2020, which allowed ticagrelor to be removed from the same application.
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Dr. David Cox, Vice President of Global Regulatory Affairs of CTSO stock stated,
The United States Prescribing Information for apixaban and rivaroxaban, two popular DOACs used to prevent blood clots and their consequences, specifically states that dosage should be discontinued prior to surgery to avoid bleeding. Unfortunately, in emergency cardiothoracic surgery, this is frequently not achievable, putting these patients at danger of life-threatening hemorrhage. They are happy that the FDA has identified the possibility of their DrugSorb-ATR Antithrombotic Removal System to lower medication levels in a patient’s blood, thereby minimizing the chances of life-threatening perioperative bleeding.
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents commented,
With this accomplishment, they are moving on with their multi-phase approach in the United States to possibly establish DrugSorb-ATR as an easy-to-use, new standard of care for removing antithrombotic medicines during cardiothoracic surgery. The crucial randomized, controlled research study for the STAR-T in the United States is already underway, and they hope to work with the FDA to get the next IDE approval for the research on DOAC removal during cardiothoracic surgery in the United States. They estimate that the entire addressable market for DrugSorb-ATR to eliminate ticagrelor, apixaban, and rivaroxaban during cardiothoracic surgery in the United States is more than $500 million today, with a considerable rise predicted in the future.