CytoSorbents submits DrugSorb-ATR FDA De Novo for CABG bleeding; Q3 sales $8.3-8.5M

Cytosorbents Corp

DrugSorb-ATR De Novo application submitted to FDA on Sept 27, 2024 for reducing perioperative bleeding in CABG patients on ticagrelor.
FDA Breakthrough Device Designation, eligible for priority review; decision expected in 2025.
Health Canada MDL application complete, pending MDSAP certification for submission; decision also expected 2025.
Q3 2024 product sales estimated $8.3M-$8.5M, up 7-10% YoY from $7.8M.
Q3 product gross margin estimated 50-60% vs 71% due to production slowdown; issue resolved, normalized margins expected Q4.

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