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 today that the first patient has been enrolled in the Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D) double-blind, randomized, controlled clinical trial designed to support FDA marketing approval of the DrugSorb™-ATR Antithrombotic Removal System for intraoperative removal of apixaban and rivaroxaban during cardiothoracic surgery. The STAR-D trial is being performed under the auspices of an FDA Breakthrough Device Designation and is expected to enroll up to 120 patients across 30 sites in the United States. The first patient was enrolled at Virginia Commonwealth University's Pauley Heart Center by Principal Investigator Dr. Patricia A. Nicolato, D.O, Cardiothoracic Surgeon and Associate Professor in the Department of Surgery, Division of Cardiothoracic Surgery, Director of the Extracorporeal Life Support Program.
CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents' flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)" src="https://mma.prnewswire.com/media/1096384/CytoSorbents_Working_To_Save_Lives_Logo.jpg" />
CytoSorbents Enrolls First Patient in U.S. STAR-D Pivotal Trial
Dr. Nicolato stated, "We frequently encounter patients on direct oral anticoagulants, such as apixaban and rivaroxaban, who need urgent cardiac surgery and are at very high risk for serious bleeding complications. Currently, there are no available solutions to help our team manage this complex clinical scenario and reduce the significant associated morbidity and excess costs. We are pleased to enroll the first patient in the pivotal STAR-D trial investigating the ability of DrugSorb™-ATR to remove apixaban or rivaroxaban during urgent cardiac surgery. If the results of STAR-D are positive, then DrugSorb™-ATR can be a safe and easy to implement solution to help cardiac surgeons around the world effectively address this important unmet medical need."
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, "The successful enrollment of the first patient in STAR-D represents another major executional milestone in our strategy to obtain FDA approval for antithrombotic drug removal during cardiac surgery. We continue to observe very high levels of interest from U.S. sites to participate in our STAR-T and STAR-D trials, and as such we obtained FDA approval to expand each study to 30 sites. We anticipate most of the study sites to participate in both trials, as they routinely operate on patients on ticagrelor, apixaban, or rivaroxaban, who all face an equally high risk of serious perioperative bleeding. DrugSorb-ATR is potentially a "one-stop-shop" solution to allow cardiac surgeons to operate on patients taking any of these drugs in a safe and timely manner. Importantly, we expect the total addressable market for this application to continue to grow globally, supported by the increasing usage of these latest generation antithrombotic agents worldwide and their upcoming generic availability in the future."
In August 2021, the FDA granted CytoSorbents Breakthrough Device Designation to remove the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban to reduce the risk of serious perioperative bleeding from urgent cardiothoracic surgery, recognizing this major unmet medical need. Apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Janssen/Bayer) are two of the most commonly prescribed anticoagulants worldwide, including more than 5 million patients 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. With the appropriate U.S. marketing approvals for removal of ticagrelor and the two leading DOACs during cardiothoracic surgery, DrugSorb-ATR has the potential to address these major unmet medical needs, while targeting an estimated U.S. total addressable market of one billion dollars.