CytoSorbents to Report Second Quarter 2025 Financial Results and Recent Business Highlights

Core Insights - CytoSorbents Corporation will report its second quarter 2025 financial results and business highlights on August 7, 2025, with a live conference call scheduled for 4:30 PM ET [1][2] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [3] - The company's proprietary technology utilizes biocompatible, highly porous polymer beads to remove toxic substances from blood and bodily fluids [3] - CytoSorbents' lead product, CytoSorb®, is approved in the EU and distributed in over 70 countries, with more than 270,000 devices used to date [4] Product Development - The company is developing the DrugSorb™-ATR system to reduce perioperative bleeding in high-risk surgeries, which has received two FDA Breakthrough Device Designations [5] - A De Novo Request for DrugSorb-ATR was submitted to the FDA in September 2024, but was denied in April 2025 due to identified deficiencies [5][6] - The company plans to resolve these deficiencies through a formal appeals process, with an appeal hearing scheduled for late August 2025 [6] Regulatory Challenges - In Canada, the company faced a Notice of Refusal for its Medical Device License application, with plans to file a Request for Reconsideration [7] - DrugSorb-ATR has not yet been authorized for commercialization in the U.S. or Canada [8] Intellectual Property - CytoSorbents holds numerous patents and trademarks for its blood purification technologies, with multiple products under development [9]