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About CytoSorbents Corporation

CytoSorbents Corporation (NASDAQ: CTSO; Monmouth Junction, NJ) is a publicly-traded, critical care immunotherapy company using blood purification to treat life-threatening illnesses. With its flagship product, CytoSorb®, approved in the European Union and distributed in 32 countries worldwide, CytoSorbents is committed to helping save the lives and improve the outcomes of critically-ill and cardiac surgery patients around the world.

CytoSorbents’ blood purification technology is 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. Each polymer bead, approximately the size of a grain of salt, contains millions of pores and channels that can be modified to remove substances as small as drugs, to substances as large as antibodies from blood. These beads are synthesized at CytoSorbents' ISO 13485 certified manufacturing facility in New Jersey. The technology is protected by 32 issued U.S. patents and multiple patent applications pending.

CytoSorb®

CytoSorb® is approved for sale in all 28 countries of the European Union (E.U.) as an extracorporeal cytokine adsorber, and can be used with standard hemodialysis or heart-lung machines in any situation where cytokines are elevated. This includes a diverse range of conditions where cytokines are driving a potentially dangerous inflammatory response, including acute critical illnesses such as sepsis and infection, burn injury, trauma, acute respiratory distress syndrome, severe acute pancreatitis, liver failure, influenza, and complications of cardiac surgery, as well as in other more chronic diseases such as cancer, cancer cachexia, autoimmune diseases, and others.

With registration, CytoSorb® can also be sold outside of the E.U. in countries that accept European medical device approval. CytoSorb® is being sold directly in Germany, Austria and Switzerland, and marketed through distributors in the United Kingdom, Italy, Ireland, the Netherlands, Israel, the Middle East (including Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Bahrain, Oman, Yemen, Iraq and Jordan), Turkey, Vietnam, Australia, New Zealand, Romania, Moldova, and Russia. One of our strategic partners, Fresenius Medical Care, the largest dialysis company in the world, is currently distributing CytoSorb® in France, Norway, Finland, Sweden, Denmark, and Poland. CytoSorb® is currently also being sold in India, Sri Lanka, and select emerging markets through our strategic partner, Biocon Ltd, Asia's largest biotechnology company, and is part of an initial partnership in France with one of the world’s largest cardiac surgery companies.

The goal of CytoSorb® is to modulate the immune system by removing excessive cytokines, often called "cytokine storm", and other inflammatory toxins in critically-ill patients that can lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death. CytoSorb® therapy has been associated with statistically significant reductions in mortality in septic patients at high risk of death in a small study. There are now more than 50-investigator initiated studies and multiple company-sponsored studies to help generate more data using CytoSorb® in a variety of applications.

HemoDefend

HemoDefend™ is a development-stage blood purification technology platform for the blood transfusion industry intended to reduce transfusion reactions and safeguard the quality and safety of blood products. The HemoDefend technology utilizes the Company's polymer bead technology to remove many substances, such as antibodies, free hemoglobin and inflammatory mediators that can cause potentially serious and sometimes fatal transfusion reactions. CytoSorbents was recently awarded a $1.5M Phase 2 SBIR contract to develop HemoDefend towards commercialization.


CytoSorb® and HemoDefend™ are just two of a number of different resins the Company has designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy drugs during treatment of cancer with high dose regional chemotherapy, removal of IV contrast, drug detoxification, and others. Additional information is available in the Investor Relations section.

CytoSorbents and its technology have garnered more than $17 million in support from the U.S. Government. DARPA, or the Defense Advanced Research Projects Agency, as part of its "Dialysis-Like Therapeutics" program to treat sepsis, awarded CytoSorbents a $3.8 million five year contract to develop cytokine and toxin binders for the program. CytoSorbents collaborates with groups such as Battelle Laboratories, Harvard's Wyss Institute, NxStage Medical (NASDAQ: NXTM), Massachusetts Institute of Technology, and others in this program.

CytoSorbents was also awarded $1.15 million by the U.S. Army in a Phase I and Phase II SBIR contract to develop its blood purification technologies to treat burn injury and trauma. The U.S. Air Force is also funding an FDA-approved, 30-patient randomized controlled human pilot study using CytoSorb® to treat trauma patients with rhabdomyolysis that has begun. CytoSorbents was also recently awarded a $203,000 Phase I SBIR contract from the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), to further develop its HemoDefend™ technology for blood transfusions.

CytoSorbents operates through its wholly-owned subsidiary, CytoSorbents Medical Inc. (fka CytoSorbents Inc.), and conducts its European business through its wholly-owned subsidiary, CytoSorbents Europe GmbH. CytoSorbents Corporation is a publicly-traded Delaware corporation trading on NASDAQ under stock ticker symbol: CTSO



 
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