CytoSorbents Provides Update on the STAR-T Trial and Reports Final Independent Data and Safety Monitoring Board Recommendation - Seite 3

DrugSorb-ATR has been previously granted U.S. FDA Breakthrough Device Designation, acknowledging that perioperative bleeding in cardiac surgery due to ticagrelor is a major unmet medical need. There are currently no approved or cleared therapies for this unmet need in the U.S. or Canada. Outside of the U.S. and Canada, only CytoSorb is specifically approved for this indication. The Breakthrough Devices Program provides for more effective treatment of life-threatening or irreversibly debilitating diseases or conditions - in this case the need to reduce serious or life-threatening perioperative bleeding due to ticagrelor in emergent or urgent cardiac surgery. With Breakthrough Designation, CytoSorbents intends to work with FDA to facilitate the regulatory review of DrugSorb-ATR, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo 510(k), or premarket approval (PMA)) consistent with the Agency’s mission to protect and promote public health. 

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of Q3 2023, more than 221,000 CytoSorb devices had been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company has completed the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.