CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S.

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 surgery to reduce the risk of perioperative bleeding. If successful, we intend to establish 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.”

Leave a Reply