secwatch.observer — SEC 8-K summary
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Issuer:     Cytosorbents Corp (CTSO)
CIK:        0001175151
Form:       8-K
Filed at:   2024-10-01T23:59:59+00:00
Accession:  0001104659-24-104669
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1175151/000110465924104669/0001104659-24-104669-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1175151/000110465924104669/tm2425307d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-104669

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