USFDAJun 25, 2026, 09:32 AM
Cytosorbents Schedules FDA Pre-Submission Meetings for DrugSorb-ATR
AI Summary
Cytosorbents Corp announced it has scheduled two pre-submission meetings with the FDA in August 2026 to discuss its ticagrelor and DOAC programs for the DrugSorb-ATR device. The company expects to file a new De Novo submission for ticagrelor removal in late 2026 or early 2027. Financially, Cytosorbents reported Q1 2026 sales of $8.9M, a 2% increase year-over-year, and anticipates achieving operating cash flow breakeven in the second half of 2026.
Key Highlights
- Scheduled two pre-submission meetings with the FDA in August 2026 for ticagrelor and DOAC programs.
- DrugSorb-ATR is an investigational device designed to reduce perioperative bleeding in cardiac surgery.
- New De Novo submission for ticagrelor removal expected late 2026 or early 2027.
- Q1 2026 sales were $8.9M, representing a 2% increase year-over-year.
- Trailing 12-month sales reached $37.3M.
- Anticipating operating cash flow breakeven in the second half of 2026.
- Ended Q1 2026 with $6.4M in cash, cash equivalents, and restricted cash.
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