STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic

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, announces the full approval of its Investigational Device Exemption (IDE) application by the FDA to conduct the pivotal STAR–D (Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants [DOAC]) double-blind, randomized, controlled trial in the United States to support FDA marketing approval. This is being performed under the previously announced FDA Breakthrough Device Designation granted to the DrugSorb–ATR™ Antithrombotic Removal System for the removal of apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Janssen/Bayer) in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery.

Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are pleased to receive a second IDE approval for the antithrombotic removal application for the randomized, controlled, double-blind STAR-D trial designed to support FDA marketing approval of DrugSorb–ATR™ for intraoperative apixaban and rivaroxaban removal during cardiothoracic surgery. STAR–D is the next milestone of our STAR development program. The STAR-D trial design and operational framework are identical to the actively screening STAR-T trial for ticagrelor removal, and are expected to yield extensive scientific, operational, and financial efficiencies. STAR–D is expected to enroll up to 120 patients across 25 U.S. clinical sites – of which many are already actively participating in STAR-T, and will be led once again by Co-Principal Investigators Drs. Michael Mack and C. Michael Gibson and an Executive Committee comprised of world–renowned cardiac surgeons, interventional cardiologists, and thrombosis/hemostasis experts. Trial start-up activities are underway and we expect the study to start in the first quarter of 2022.

Full FDA IDE Approval Received to Begin U.S. STAR-D Trial on DOAC Removal During Urgent Cardiothoracic Surgery

Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents, stated, “The full IDE approval of the STAR-D protocol now positions us to execute the next step in our DrugSorb-ATR market development strategy. With this additional approval, we will have two U.S. randomized, controlled pivotal trials ongoing to support U.S. FDA marketing approval for the intraoperative removal of the key blockbuster antithrombotic drugs Brilinta®, Eliquis® and Xarelto® during open heart sur.gery to reduce the risk of perioperative bleeding. If successful, we intend to estab.lish DrugSorb-ATR as the go-to, easy-to-use, potential standard of care single treatment for this application in the U.S., targeting an estimated total addressable market in this country of approximately $1 billion. In doing so, our goal is to address this major unmet medical need for patients and surgeons, while establishing a new, potentially significant driver of future company growth.

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 bleeding during 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 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. 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.

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