MONMOUTH JUNCTION, NJ -- (Marketwire) -- 12/14/11 -- CytoSorbents Corporation (OTCBB: CTSO), a critical care focused therapeutic device company using blood purification to treat life-threatening illnesses, announced today that it was awarded a Phase I SBIR (Small Business Innovation Research) grant by the US Army Medical Research and Materiel Command titled, "Investigation of CytoSorb Cytokine and Myoglobin Removal in the Treatment of Trauma." Valued at $100,000 over six months with the potential option for an additional $50,000, the recently finalized contract will allow CytoSorbents to plan and optimize its technological approach for a planned Phase II SBIR submission in 2012, valued at up to $1 million. The Phase I award is a pre-requisite for both Phase II and Phase III SBIR awards, which involve animal and human studies, respectively.
Dr. Phillip Chan, Chief Executive Officer, stated, "We are very excited that the US Army has selected to fund our Phase I program in trauma. Trauma is the number one cause of combat-related deaths in the military and is a leading cause of civilian mortality. Uncontrolled hemorrhage and head injury are typically responsible for early death in combat trauma, while multiple organ failure accounts for the majority of late deaths. Multiple organ failure has many causes. For example, trauma potently triggers a cytokine-driven, whole-body inflammatory reaction, often called SIRS, which can lead to the loss of function or death of vital organs like the lungs, heart or kidneys. Another significant cause is from crush injury to muscles, causing them to break down and release myoglobin, a toxin that can cause kidneys to fail. In one study*, researchers found that mortality was less than 5% with one failed organ system, but was 32% with two, 67% with three, and 90% when four organ systems failed. If we can reduce the incidence of organ failure in trauma patients using our blood purification technology to remove inflammatory mediators such as cytokines and myoglobin, we hope to improve clinical outcomes in trauma patients, not just in the military, but in hospitals worldwide."
This work is supported by the US Army Medical Research and Materiel Command under Contract No W81XWH-12-C-0038.
*Durham, R.M., et al. "Multiple Organ Failure in Trauma Patients" J Trauma, 2003. 55(4): p.608-16.
About CytoSorbents, CytoSorb, and HemoDefend
CytoSorbents Corporation is a critical care-focused therapeutic device company using blood purification to treat 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 under a controlled market release, with a planned broad product launch in Germany anticipated for the first half of 2012 and availability in other E.U. countries, 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 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, 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 31, 2011, which is available at http://www.sec.gov.
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