CytoSorbents Achieves Key Milestone with FDA Approval of the U.S. REFRESH 2 Pivotal Cardiac Surgery Trial IDE Application

Achieves Key Milestone with FDA Approval of the U.S. REFRESH 2 Pivotal Cardiac Surgery Trial IDE Application

NJ, December 21, 2017 - CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing

its flagship CytoSorb blood filter to treat deadly inflammation in critically-ill and cardiac surgery patients

around the world, announced that the U.S. Food and Drug Administration (FDA) has granted approval of its REFRESH 2 Investigational

Device Exemption (IDE) application, with conditions. These conditions relate to requested clarifications and changes to the patient

consent form and Instructions for Use document, which have now been modified. Based on FDA guidance, study initiation and patient

enrollment can now begin at each clinical center with site institutional review board (IRB) approval and the revised documentation.

Chief Medical Officer of CytoSorbents stated, "The FDA approval of our REFRESH 2 trial IDE application is a major milestone

for our clinical program. This pivotal trial is designed to provide the key safety and efficacy data needed to support United

States regulatory approval for the use of CytoSorb in cardiac surgery. The IDE approval allows us to aggressively move forward

with our clinical trial sites to complete the final steps prior to the official start of the study, which is expected shortly."

continued, "The REFRESH 2 pivotal study will assess the effectiveness of intraoperative CytoSorb blood treatment on postoperative

acute kidney injury (AKI), the primary endpoint of the study and one of the most common adverse events in patients undergoing

complex cardiac surgery. Studies have demonstrated that even mild postoperative AKI increases the risk of patient death in the

years after surgery, while also increasing the risk of progressive chronic kidney disease in survivors. CytoSorb has the potential

to decrease kidney injury by reducing a broad range of inflammatory nephrotoxins that are generated during surgery and can damage

the kidneys, such as plasma free hemoglobin and activated complement. This could have significant global clinical importance,

particularly since heart disease remains the leading cause of death worldwide and the incidence of open heart surgery is rising

due to the obesity pandemic and the aging baby boomer generation."

2 trial is a randomized, controlled, multi-center, clinical trial designed to evaluate intraoperative CytoSorb use as a therapy

to reduce AKI, as measured by Kidney Disease Improving Global Outcomes (KDIGO) criteria, following complex cardiac surgery. The

trial will enroll up to 400 patients undergoing elective, non-emergent open heart surgery for either valve replacement, or aortic

reconstruction with hypothermic cardiac arrest. Control patients will receive standard of care during surgery, while Treatment

patients will receive standard of care with dual parallel CytoSorb cartridges in a heart-lung machine bypass circuit that are

intended to reduce toxic inflammatory mediators and renal toxins such as plasma free hemoglobin and activated complement, during

surgery. Other secondary and exploratory endpoints include time on mechanical ventilation, the use of vasopressors or other hemodynamic

support, days in the intensive care unit, reduction in inflammatory mediators, and mortality at 30 days, for example. A synopsis

of the trial protocol will be available in the near future at www.clinicaltrials.gov.

Corporation (NASDAQ: CTSO)

Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb is

approved in the European Union with distribution in 44 countries around the world, as an extracorporeal cytokine adsorber designed

to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation,

organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective

treatments exist. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators

that can lead to post-operative complications, including multiple organ failure. CytoSorbents has completed its REFRESH (REduction

in FREe Hemoglobin) 1 trial - a multi-center, randomized controlled safety and feasibility study that has demonstrated that

intra-operative CytoSorb use in a heart-lung machine during complex cardiac surgery can significantly reduce plasma

free hemoglobin and activated complement. The company expects to shortly initiate the pivotal REFRESH 2 trial intended to

support U.S. FDA approval. CytoSorb has been used in more than 31,000 human treatments to date.

purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from

blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract,

and other funding of nearly $22 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM)

and others. The Company has numerous products under development based upon this unique blood purification technology, protected

by 32 issued U.S. patents and multiple applications pending, including CytoSorb-XL , HemoDefend , VetResQ ,

K+ontrol , ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites

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