CYTOSORBENTS CORP · Data as of 2026-09-08
Nov 2026
Following the new De Novo submission, a regulatory decision would be expected following a typical 150-day review process but may be accelerated or extended depending on interactive discussions with the FDA related to submission questions.Source filing
early 2027
Once finalized, we anticipate completing the required testing and submitting a new De Novo application in early 2027.Source filing
2026
Initial data outputs from the STAR Registry have already been presented at the EuroPCR and at the European Association of Cardiothoracic Surgery conferences in previous years with new analyses expected to be presented on an ongoing basis at international conferences and published in peer-reviewed journals in 2026 and beyond.Source filing
Oct 7–Oct 10
Looking ahead, we have submitted multiple original analyses for presentation at the 2026 European Society of Cardiology (ESC) Congress in Munich this coming August and the 2026 EACTS Annual Meeting in Barcelona this coming October.Source filing