Ticagrelor

The BMJ investigation reveals data reporting issues in the PLATO trial, which supported ticagrelor's approval. FDA initially rejected due to higher US deaths, but later approved. Subsequent studies failed to replicate PLATO's positive results, raising questions about its validity and ticagrelor's guidelines.

CytoSorbents submits DrugSorb-ATR MDL application to Health Canada, targeting CABG-related bleeding reduction with ticagrelor. MDSAP certification received, regulatory decisions expected in 2025.

CytoSorbents announced FDA acceptance of its De Novo application for DrugSorb-ATR, aiming to reduce perioperative bleeding in ticagrelor-treated patients undergoing CABG surgery. The FDA Breakthrough Device Designation accelerates the review, with a decision expected in 2025. DrugSorb-ATR is also planned for submission to Health Canada.

CytoSorbents announces FDA acceptance of De Novo application for DrugSorb™-ATR, aiming to reduce perioperative bleeding in CABG patients on ticagrelor, with a 2025 FDA decision anticipated.

CytoSorbents announces FDA acceptance of its De Novo application for DrugSorb-ATR, aiming to reduce perioperative bleeding in CABG patients on ticagrelor, with a 2025 decision expected. The device targets urgent CABG surgery, reducing the need for ticagrelor washout periods, and aligns with FDA's Breakthrough Device Designation. CytoSorbents also plans to submit for Health Canada approval.

CytoSorbents submitted DrugSorb-ATR De Novo marketing application to FDA for reducing perioperative bleeding in CABG surgery patients on ticagrelor. The FDA granted Breakthrough Device Designation. CytoSorbents also completed its Health Canada MDL application. Third quarter 2024 product sales are estimated at $8.3-$8.5 million, with expected regulatory decisions in 2025. The company anticipates normalized production levels and product gross margins in Q4 2024. Valuation estimates for 2024 and 2025 reflect cost controls and potential revenue growth.

CytoSorbents submitted a De Novo marketing application for DrugSorb™-ATR to the FDA on Sept 27, 2024, for reducing perioperative bleeding in CABG patients on ticagrelor. The FDA previously granted Breakthrough Device Designation, making it eligible for priority review. A Health Canada Medical Device License application is also ready for submission, pending MDSAP certification. Final regulatory decisions are expected in 2025.

CytoSorbents submits DrugSorb™-ATR De Novo application to FDA for priority review as a Breakthrough Device, aiming to reduce perioperative bleeding in CABG patients on ticagrelor. Health Canada MDL application pending MDSAP certification. Regulatory decisions expected in 2025.

CytoSorbents submits DrugSorb™-ATR De Novo marketing application to FDA for priority review as a Breakthrough Device, aiming to reduce perioperative bleeding in CABG patients on ticagrelor. Health Canada MDL application pending MDSAP certification. Regulatory decisions expected in 2025.