CytoSorbents submits DrugSorb-ATR marketing application to FDA

CytoSorbents announces the submission of its DrugSorb-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration on September 27, 2024, to reduce the severity of perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft surgery. The FDA has previously granted Breakthrough Device Designation to DrugSorb-ATR to address this major unmet medical need, making it eligible for priority review. The U.S. FDA De Novo process for medical devices provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. Following application acceptance by FDA, De Novo submissions enter the substantive review phase where FDA Breakthrough Device designation and an associated interactive priority review, called “sprint discussions,” can accelerate the process. The Health Canada Medical Device License authorizes manufacturers to import or sell Class II, III, and IV medical devices in Canada. The license ensures that these devices meet the necessary safety, quality, and efficacy standards as per the Medical Devices Regulations. MDL requires MDSAP certification, which the Company expects to receive shortly, at which point it will file its MDL application. Final regulatory decisions on DrugSorb-ATR are expected from FDA and Health Canada in 2025. DrugSorb-ATR is not yet approved or cleared in the U.S. or Canada.