CytoSorbents Corporation, a leader in blood purification therapies, has provided a regulatory update on its Breakthrough Device, DrugSorb-ATR. The device is designed to mitigate bleeding risks in patients undergoing coronary artery bypass grafting (CABG) surgery who have recently discontinued the blood thinner Brilinta®. The U.S. Food and Drug Administration (FDA) issued a denial letter for the De Novo Request, highlighting remaining deficiencies. CytoSorbents is actively engaging with the FDA to resolve these issues and, if necessary, plans to file a formal appeal within 60 days. The company remains committed to bringing DrugSorb-ATR to market to address this critical unmet medical need, aiming for a final regulatory decision in 2025.
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