Benzinga | Aug 12, 2021 07:09AM EDT

Second U.S. FDA Breakthrough Device Designation Granted to CytoSorbents' DrugSorb-ATR Antithrombotic Removal System Adding the Removal of Market-Leading Direct Oral Anticoagulants During Urgent Cardiothoracic Surgery

CytoSorbents Corporation (NASDAQ:CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Company has been granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System by the U.S. Food and Drug Administration (FDA). This Breakthrough Device designation covers the removal of the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery. It follows the Breakthrough Designation received in April 2020 to remove ticagrelor for the same application.

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DrugSorb-ATR Granted FDA Breakthrough Designation For Removal of Apixaban & Rivaroxaban In Urgent Cardiothoracic Surgery

Dr. David Cox, Vice President of Global Regulatory Affairs of CytoSorbents remarked, "The U.S. Prescribing Information for apixaban and rivaroxaban, two leading DOACs taken to reduce the risk of blood clots and associated complications, clearly warns that dosing should be stopped prior to a surgical procedure to reduce the risk of bleeding. Unfortunately, in unexpected urgent cardiothoracic surgery, this is often not possible, posing the risk of life-threatening bleeding in these patients. We are pleased that the FDA has recognized the potential of our DrugSorb-ATR Antithrombotic Removal System to reduce levels of these drugs in a patient's blood, potentially decreasing the risk of life-threatening perioperative bleeding. The achievement of two Breakthrough Designations in these situations where no approved or cleared alternatives exist is a major Company milestone that is expected to expedite our regulatory and clinical goals."

Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, "We are pleased that the DrugSorb-ATR Antithrombotic Removal System has been granted a second Breakthrough Device designation by the FDA. With this achievement, we continue to execute upon our multi-phase U.S. strategy to potentially establish DrugSorb-ATR as an easy-to-implement, new standard of care to remove antithrombotic drugs during cardiothoracic surgery. The U.S. STAR-T (Safe and Timely Antithrombotic Removal - Ticagrelor) pivotal randomized, controlled clinical trial is now underway and we look forward to working with the FDA in pursuit of the next IDE approval for the U.S. study on DOAC removal during cardiothoracic surgery. We estimate the total addressable market for DrugSorb-ATR to remove ticagrelor, apixaban, and rivaroxaban during cardiothoracic surgery is more than $500 million in the U.S. alone today, which is expected to significantly increase based on prescribing trends and generic availability of these drugs."

Apixaban (Eliquis(r), Bristol Myers Squibb/Pfizer) and rivaroxaban (Xarelto(r), Jansen/Johnson & Johnson) are two of the most commonly prescribed anticoagulants worldwide, including more than 5 million patients1 annually in the United States who are chronically on these medications to reduce the risk of deadly blood clots due to atrial fibrillation, prior history of heart attack or stroke, deep vein thrombosis, pulmonary embolism, and peripheral artery disease. We expect the number of patients prescribed these drugs to continue to climb based on the superior performance of these agents compared to older alternatives, underlying demographic trends in the aging baby boomer population, improved disease detection rates, and other factors. When patients on various "blood thinners", like apixaban or rivaroxaban, require urgent cardiothoracic surgery, the risk of serious or life-threatening bleeding and complications is very high. Based on our estimates, at least 1% of patients in the U.S. on apixaban or rivaroxaban may require urgent cardiothoracic surgery on an annual basis. Today there are no approved or cleared alternatives in the U.S. to reduce bleeding risks during cardiothoracic surgery caused by direct oral anticoagulants. DrugSorb-ATR has the potential to address this major unmet medical need.