secwatch.observer — SEC 8-K summary
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Issuer:     Cytosorbents Corp (CTSO)
CIK:        0001175151
Form:       8-K
Filed at:   2025-06-24T23:59:59+00:00
Accession:  0001104659-25-062097
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CytoSorbents appeals FDA denial of DrugSorb-ATR De Novo request; decision expected ~60 days
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- Appeal filed June 18, 2025 under 21 CFR 10.75; FDA denial letter dated April 25, 2025.
- DrugSorb-ATR designed to reduce bleeding risk in CABG patients on Brilinta; had Breakthrough Device Designation.
- Supervisory review includes formal hearing with CDRH senior management; final decision typical within 60 days.
- Health Canada review remains ongoing; company expects a regulatory decision in 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1175151/000110465925062097/0001104659-25-062097-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1175151/000110465925062097/tm2518791d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-062097

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