secwatch.observer — SEC 8-K summary
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Issuer:     Cytosorbents Corp (CTSO)
CIK:        0001175151
Form:       8-K
Filed at:   2025-07-02T23:59:59+00:00
Accession:  0001104659-25-065280
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CytoSorbents: FDA appeal hearing set; Health Canada refuses DrugSorb-ATR license
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- FDA confirmed appeal hearing under 21 CFR 10.75; supervisory review expected to complete by end of August 2025.
- Health Canada issued Notice of Refusal for DrugSorb-ATR Medical Device License, citing non-compliance with regulations.
- Company intends to file Level 1 Request for Reconsideration with Health Canada by July 25, 2025.
- DrugSorb-ATR is an FDA Breakthrough Device to reduce bleeding in CABG surgery patients on Brilinta (ticagrelor).
- CEO states no approved therapies exist in U.S. or Canada; final regulatory decisions expected by end of 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1175151/000110465925065280/0001104659-25-065280-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1175151/000110465925065280/tm2519729d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-065280

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