CYTOSORBENTS CORPORATION (NASDAQ:CTSO) Files An 8-K Other Events
Item 8.01 Other Events.

In June 2013, CytoSorbents Corporation, a Delaware corporation (the “Company”), announced that the U.S. Air Force was funding a Company-sponsored, 30 patient, single site, randomized controlled human pilot study of the Company’s CytoSorb® product to evaluate patients with severe trauma and rhabdomyolysis (the “Study”). The primary endpoint for the Study was myoglobin removal. Though the Company did not expect to receive material direct funding from this $3.0 million budgeted program, it was hoped that the Study would generate valuable data that could be used commercially by the Company or in the Company’s future trauma studies.

However, because of the stringency of the inclusion criteria, and because of the patient mix seen at the single clinical trial site, the Study experienced difficulty in enrolling patients. In an effort to increase enrollment, in 2015 the Company amended the applicable Study protocol to modify the key inclusion criteria and expand the number of clinical trial sites. Unfortunately, these amendments did not result in increased enrollment. In December 2016, the Company contacted the Contracting Officer’s Representative for the Study to discuss potential options and alternatives, including closing the Study. Due to the continued difficulty in enrolling patients in this Study and likelihood this would continue without significant modification to the protocol, the Company and U.S. Air Force determined to close the Study. This included notification of the San Antonio Military Medical Center (primary Study site) Ethics Committee, that occurred and was acknowledged on January 4, 2017. In addition, the Company is in the process of notifying the U.S. Food and Drug Administration that it will officially close the Study.

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.

CYTOSORBENTS CORPORATION (NASDAQ:CTSO) Recent Trading Information

CYTOSORBENTS CORPORATION (NASDAQ:CTSO) closed its last trading session up +0.10 at 6.30 with 277,337 shares trading hands.