CytoSorbents Announces DrugSorb-ATR De Novo Submission To FDA - Quick Facts

(RTTNews) - CytoSorbents (CTSO) announced the submission of DrugSorb-ATR medical device De Novo marketing application to the FDA 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. Final regulatory decisions on DrugSorb-ATR are expected in 2025.

CytoSorbents said it estimates that third quarter Product Sales excluding grant income will be in the range of approximately $8.3 million to $8.5 million, representing growth of 7% to 10%, from $7.8 million, a year ago. Also, the company noted that a planned temporary slowdown in production to rebalance inventory levels coupled with a short-term manufacturing issue resulted in a significantly lower number of CytoSorb devices produced in the quarter. As a result, the company estimates that product gross margins for third quarter will be in the range of approximately 50% - 60%, compared to 71%, prior year.

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