other material
confidence high
sentiment negative
materiality 0.70
CytoSorbents STAR-T trial misses primary effectiveness endpoint in overall population; positive trend in CABG subgroup
Cytosorbents Corp
- 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.