ADDED
As of March 20, 2026, there were approximately 62.7 million outstanding shares of the registrant s common stock.
CytoSorbents lead product, CytoSorb , is approved in the European Union and distributed in more than 70 countries worldwide, with more than 300,000 devices used cumulatively to date.
CytoSorb is not yet approved, authorized, or cleared in the United States.
The Company is actively pursuing regulatory approval of DrugSorb-ATR with the FDA and will pursue regulatory approval with Health Canada with better visibility from the FDA.
DrugSorb-ATR is not yet granted or approved in either the United States or Canada.
and Canada to address this large unmet medical need, with an initial estimated total addressable market of $300 million today to over $1 billion over time as we pursue additional indications for DrugSorb-ATR to remove additional classes of blood thinners and expansion of the antithrombotic drug removal application beyond cardiac surgery and across other surgical specialties.
Our Products and Applications CytoSorbents technology platform centers on hemocompatible, highly porous polymer beads that act like tiny sponges to remove harmful substances from blood by pore capture and concentration-dependent adsorption, without the need for ligands, antibodies, cells or biologics.
Based on numerous published studies, we believe treating the right patient, at the right time, with the right therapy of CytoSorb can lead to improved clinical outcomes.
and Canada, where approximately 60,000 patients on this medication will need urgent cardiovascular surgery annually in those two markets each year.
and Canadian prescribing trends that favor Brilinta over its competitors, Plavix (clopidogrel, BMS, Sanofi) and Effient (prasugrel, Daiichi Sankyo, Eli Lilly), and the recent availability of generic ticagrelor in the U.S.
REMOVED
As of March 31, 2025, there were approximately 62.5 million outstanding shares of the registrant s common stock.
This Annual Report contains our audited consolidated financial statements for the year ended December 31, 2024, and restates certain sections of the 2023 consolidated financial statements to correct misstatements related to inventory and stock-based compensation expense for restricted stock units.
Refer to Note 12 - Restatement of Previously Issued Financial Information, in the accompanying Consolidated Financial Statements included in Part II, Item 8 for additional information, including the impact on the specific financial statement line items.
Upon filing of this 2024 Annual Report, including the restated consolidated financial statements contained herein, the above referenced consolidated financial statements may be relied upon.
Impact on Internal Controls over Financial Reporting See Item 9A, Controls and Procedures, for information related to identified material weaknesses in internal control over financial reporting and the related remedial measures.
CytoSorbents lead product, CytoSorb , is approved in the European Union and distributed in dozens of countries worldwide, with more than 270,000 devices used cumulatively to date.
In September 2024, the Company submitted a De Novo medical device application to the FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024.
On November 1, 2024 we received Medical Device Single Audit Program (MDSAP) certification, a key regulatory milestone that certifies compliance of our quality management system with the standard regulatory requirements of Canada, the United States, Brazil, Japan and Australia; and then promptly submitted our Medical Device License (MDL) marketing application to Health Canada on November 1, 2024, with MDSAP certification a requirement for the submission.
Our applications with FDA and Health Canada continue to be in substantive and interactive review, and we continue to expect regulatory decisions from both agencies in 2025.
and Canada to address this large unmet medical need, with an initial estimated total addressable market of $300 million to $600 million that is anticipated to grow to $1-2 billion over time as we pursue additional indications for DrugSorb-ATR to remove additional classes of blood thinners and expansion of the antithrombotic removal application beyond cardiac surgery and across other surgical specialties.