Cytosorbents Corp — Form 8-K

CytoSorbents reported Q2 2026 revenue of $9.6M (flat YoY), with gross margins improving to 73% and operating loss improving 27% to ($2.6M). The company achieved ~$200K operating cash burn (excluding restructuring), narrowing from prior quarters, and targets operating cash flow breakeven in H2 2026. Key milestone: DrugSorb-ATR's pivotal STAR-T trial met safety endpoints and showed 58% risk reduction in major bleeding (NNT=6) in cardiac surgery patients on blood thinners, but missed the primary efficacy composite endpoint. FDA denied the De Novo application but indicated no new trial needed and left door open for resubmission with additional mechanistic and real-world evidence data. HemoDefend-BGA (universal plasma via antibody removal) received FDA pre-IDE feedback for clinical pathway in July 2026, with $16M+ prior government funding.