CYTOSORBENTS CORPORATION (NASDAQ:CTSO) Files An 8-K Other Events
Item 8.01
On April 20, 2020, CytoSorbents Corporation (the “Company”) issued a press release to provide an update that the U.S. Food and Drug Administration has granted Breakthrough Designation to CytoSorb, the Company’s lead product, for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated herein by reference.
The Company also wishes to clarify a statement in its press release issued on April 15, 2020 and incorporated by reference into the Company\’s Current Report on Form 8-K, dated April 17, 2020 (the “Press Release”). In the Press Release, the Company reported that “up to 30% of COVID-19 patients also have septic shock.” The Company would like to clarify that various published case series have reported that a range of 30% to 70% of critically-ill COVID-19 patients have shock or septic shock.
(d) Exhibits
| 99.1 | Press Release of the Company, dated April 20, 2020 |
Cytosorbents Corp Exhibit
EX-99.1 2 tm2016346d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Development Update: U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery MONMOUTH JUNCTION,…
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About CYTOSORBENTS CORPORATION (NASDAQ:CTSO)
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.