Item 8.01

On November 25, 2019, CytoSorbents Corporation (the “Company”) issued a press release announcing that it is temporarily pausing enrollment of its REFRESH 2-AKI study at the recommendation of its Data Monitoring Committee the “DMC” as the Company transitions to a new contract research organization (a “CRO”) for the trial. The DMC recommended this pause following a blinded, interim, milestone review of clinical study data. The DMC requested that additional data analysis and clinical data, not pre-specified in the current version of the protocol, be provided by the Company and its newly appointed CRO, to improve the monitoring of patient safety endpoints. There were no specific adverse events of clinical outcomes cited in the DMC’s initial recommendations following this review. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.


 Exhibit No. Exhibit Name
99.1 Press Release dated November 25, 2019

Cytosorbents Corp Exhibit
EX-99.1 2 tm1923799d1_ex99-1.htm EXHIBIT 99.1   Exhibit 99.1 CytoSorbents Changes Contract Research Organizations and Temporarily Pauses Enrollment in REFRESH 2-AKI Study   MONMOUTH JUNCTION,…
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CytoSorbents Corporation is a critical care focused immunotherapy company. The Company is engaged in commercializing its product, CytoSorb, which is a blood purification technology with focus in preventing or treating multiple organ failure. The Company’s purification technologies are based on biocompatible, porous polymer beads that remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. The Company’s CytoSorb is an extracorporeal cytokine filter and is designed to reduce the cytokine storm that causes inflammation, organ failure and death in common critical illnesses, such as sepsis, burn injury, trauma, lung injury and pancreatitis. In addition, CytoSorb is used in other inflammatory conditions, such as cardiac surgery and autoimmune disease flares and cancer cachexia. It also has other products under development based upon its blood purification technology, including HemoDefend, ContrastSorb, DrugSorb, BetaSorb and others.

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