CytoSorbents Reports Preliminary Unaudited Fourth Quarter and Full-Year 2024 Product Revenue

Core Insights - CytoSorbents Corporation reported preliminary fourth quarter product revenue growth estimated at 22% to 25% year-over-year, with gross margin expected to improve to approximately 70% [1][7] - The company is preparing to enter the North American market with its investigational product DrugSorb-ATR, pending FDA and Health Canada approvals [4][10] Financial Performance - Fourth quarter product revenue (excluding grant income) is estimated to be between $9.0 million and$9.2 million, compared to $7.35 million in the fourth quarter of 2023, reflecting a growth of approximately 22$35.4 million to $35.6 million, representing about 14$31.1 million in 2023 [7] - Fourth quarter product gross margin is estimated at approximately 70%, an improvement from 61% in the prior quarter and 72% in the fourth quarter of 2023 [7] Business Updates - The company will host in-person investor meetings during the J.P. Morgan Healthcare Conference in San Francisco from January 13-16, 2025 [5] - CytoSorbents is developing DrugSorb-ATR, an investigational device aimed at reducing perioperative bleeding in patients on Brilinta during CABG surgery, with regulatory reviews currently underway [7][10] - The company commenced a rights offering on December 23, 2024, with a subscription period ending on January 10, 2025 [7] Product Information - CytoSorb, the company's flagship product, is approved in the European Union and distributed in 76 countries, with over a quarter million devices used cumulatively [9] - The company has received FDA Emergency Use Authorization for CytoSorb for critically ill COVID-19 patients [9] - DrugSorb-ATR has received two FDA Breakthrough Device Designations for the removal of ticagrelor and direct oral anticoagulants during urgent cardiothoracic procedures [10]