secwatch.observer — SEC 8-K summary
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Issuer:     Cytosorbents Corp (CTSO)
CIK:        0001175151
Form:       8-K
Filed at:   2023-12-28T23:59:59+00:00
Accession:  0001104659-23-130093
Event type: other_material
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CytoSorbents STAR-T trial misses primary effectiveness endpoint in overall population; positive trend in CABG subgroup
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- STAR-T trial did not meet primary composite effectiveness endpoint in overall 140-patient population.
- Safety endpoint met; DSMB found no safety issues with DrugSorb-ATR device.
- In isolated CABG subgroup (over 90% of patients), reduced bleeding complications observed, including serious events.
- Company expects to complete full data analysis in weeks and may submit to FDA/Health Canada.
- Full results to be presented at ACC 2024 in Atlanta next April if accepted.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1175151/000110465923130093/0001104659-23-130093-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1175151/000110465923130093/tm2333824d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-130093

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