Prnewswire·2025-06-24 11:00Core Viewpoint - CytoSorbents Corporation has filed a request for supervisory review with the FDA regarding the De Novo Denial Letter for its DrugSorb-ATR Device, which aims to reduce bleeding severity in CABG surgery patients on Brilinta® [1][2][7] Group 1: Company Overview - CytoSorbents Corporation specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery [5] - The company's proprietary technologies utilize biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios including sepsis and organ failure [5][6] - CytoSorbents' lead product, CytoSorb®, is CE Marked in the EU and has been used over 270,000 times globally [6] Group 2: Regulatory Developments - The FDA issued a De Novo Denial Letter on April 25, 2025, citing deficiencies that must be resolved before the DrugSorb-ATR can be authorized for U.S. commercialization [2][7] - The company has engaged with the FDA to clarify these deficiencies and believes that the supervisory review process will effectively address the concerns [2][4] - The appeals process typically results in a final decision approximately 60 days after filing, with the company optimistic about receiving a regulatory decision in 2025 [3][7] Group 3: Market Context - DrugSorb-ATR is designed to mitigate perioperative bleeding in patients undergoing high-risk surgeries while on antithrombotic medications [7] - The application for DrugSorb-ATR is also under advanced review by Health Canada, with the agency committed to issuing a decision despite current delays [4][7]