SOURCE: CytoSorbents Corporation
MONMOUTH JUNCTION, NJ--(Marketwire - Jun 29, 2012) - CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to modulate the immune system, reduce severe inflammation, and prevent or treat organ failure caused by life-threatening illnesses, announced promising large animal data from a research collaboration with Dr. David Rabkin, Assistant Professor of Surgery, Division of Cardiothoracic Surgery at the University of Washington Medical Center in Seattle, Washington. In a presentation today entitled "Effect of Cytokine Hemoadsorption on Brain Death Induced Ventricular Dysfunction in a Porcine Model" at the Annual Meeting of the Western Thoracic Surgical Association in Hawaii, Dr. Rabkin will present animal data supporting the potential future use of CytoSorb® blood purification to protect the viability of organs donated by patients whose organs still function, but who have been declared officially dead from irreversible brain injury.
Dr. Rabkin commented, "While the vast majority of organ transplants rely on cadaveric donors, it's long been appreciated that brain death creates an environment hostile to organ function. This effect is particularly pronounced in the heart where estimates suggest that about 20% of potential organ donors are excluded from cardiac donation due to the effects of brain death on cardiac function. One of the components of the body's reaction to brain death is a surge in inflammatory cytokines which have been shown in other contexts to importantly depress heart function. Using the CytoSorb® hemoadsorption technology in a porcine model we demonstrated that cytokine filtration significantly improves heart function after brain death compared to brain dead animals that did not undergo cytokine filtration. This may have important implications for expanding the cardiac donor pool and reducing the increasing disparity between the supply and demand of hearts for transplantation and warrants further study."
This follows a human pilot study, funded by the U.S. Department of Health and Human Services, published previously in the scientific journal Critical Care Medicine, entitled, "Feasibility study of cytokine removal by hemoadsorption in brain-dead humans," by Dr. John Kellum, Professor of Critical Care Medicine at the University of Pittsburgh. In this paper, Dr. Kellum, also an advisor on the current work, and his colleagues demonstrated the ability to temporarily reduce cytokines in human potential organ donors who had previously suffered irreversible brain death.
Dr. Phillip Chan, Chief Executive Officer, noted, "Although early, this initial body of research demonstrates the potential use of CytoSorb® in protecting organ function in solid organ transplant. These surgeries mean life or death for patients, and are extremely expensive -- costing hundreds of thousands of dollars or more -- and there is every incentive to make sure that the organ that is being transplanted is as healthy as it can be."
For costs relating to transplant, please see:
Dr. Chan continued, "The data also again demonstrate the detrimental effect of excessive cytokines, or 'cytokine storm,' on vital organs such as the heart, and highlights the use of CytoSorb® to protect organ function in yet another potentially important clinical application. Given that CytoSorb® is approved to treat excessive levels of cytokines in the European Union today, we hope to translate this early data into real world use, both to protect organs before transplant, but also to reduce cytokines and inflammation during and after the surgery."
About CytoSorbents, CytoSorb®, and HemoDefend
CytoSorbents Corporation is a critical care-focused therapeutic device company using blood purification to modulate the immune system and fight multi-organ failure in life-threatening illnesses. Its 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 adsorption. In March 2011, CytoSorb®, the Company's flagship product, achieved European regulatory approval as an extracorporeal cytokine filter, and can now be sold throughout the European Union (E.U.) under the CE Mark to be used in clinical situations where cytokines are elevated. The goal of CytoSorb® is to modulate the immune system by removing excessive cytokines, often called "cytokine storm," in critically ill patients that can lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death in common illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome, and pancreatitis. CytoSorb® has demonstrated statistically significant reductions in mortality in septic patients at high risk of death and is now available for sale in Germany for the treatment of critical care illnesses, with availability in other E.U. countries planned in the future, assuming adequate and timely funding, and continued positive results from our clinical studies. 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. CytoSorb® and HemoDefend are just two of a number of different polymers the Company has designed for various medical applications, including improved dialysis, reduction of post-surgical complications, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, drug detoxification, and others. Additional information is available for download on the Company's website: www.cytosorbents.com
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and additional CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate and timely financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on March 30, 2012, which is available at http://www.sec.gov.
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