MONMOUTH JUNCTION, NJ--(Marketwire -08/06/12)- CytoSorbents Corporation (CTSO), a pioneer in the use of blood purification to treat life-threatening illnesses such as sepsis, trauma, burn injury, lung injury and pancreatitis, announced that the Defense Advanced Research Projects Agency, or DARPA, has awarded the Company a technology development contract worth up to $3.8 million as part of its Dialysis-Like Therapeutics (DLT) program to treat sepsis, pending satisfactory achievement of key milestones. Sepsis is characterized by an overzealous immune response to a serious infection that leads to severe inflammation, organ failure and death in many cases. Sepsis is one of the leading causes of death in the world, killing millions of people each year and costing tens of billions of dollars to treat.
DARPA, the U.S. Department of Defense agency responsible for funding cutting-edge programs such as the internet, the global positioning satellite system (GPS), and robotic surgery, is funding the development of a portable, artificially intelligent blood purification system that can detect and remove, in real time, substances that can contribute to sepsis, including cytokines, toxins, biowarfare agents, pathogens, and activated cells. The goal is to save the lives of injured warfighters and civilians afflicted with sepsis, where approximately one in every three patients die today, even with the best medical treatment.
Under the terms of this contract, CytoSorbents will develop next-generation broad-spectrum, porous polymers capable of removing cytokines, toxins and certain biowarfare agents from whole blood, with $1.5 million in funding designated for the first of five years, based upon the achievement of pre-determined milestones.
Dr. Phillip Chan, Chief Executive Officer, stated, "We are delighted to officially begin working with DARPA on this exciting project and are honored to have had our unique core blood purification technology selected for funding. We are one of the industry leaders in the area of blood purification to treat sepsis and other critical care illnesses, with our first-in-class CytoSorb® cytokine filter currently approved and commercialized in the European Union. That being said, under this DARPA program, we are looking to significantly advance our polymer technologies to not only remove cytokines, but also a wide variety of toxins, and do so with little to no anti-coagulation in both high flow and microfluidic systems. The excessive production of cytokines, or 'cytokine storm,' is common in the worst forms of sepsis, and triggers massive inflammation that can lead to organ failure and infection -- the two leading causes of death in the ICU. Meanwhile, toxins produced by bacteria, viruses and other pathogens play an additional devastating role on the body, poisoning or killing cells, leading to widespread tissue destruction and worsened inflammation and sepsis. And the threat of a biowarfare attack with toxins such as ricin and botulinum remains a perennial concern. Our porous polymers are ideally suited to achieve the broad spectrum removal that is needed to counter most of these agents."
Dr. Chan continued, "Because of the maturity of our technology, we are confident in our ability to meet DARPA's timetable for technology development and strict performance metrics. Over the past several months, we have also collaborated with some of the leading potential systems integrators, to include our technologies into their integration proposals, under a separately funded DARPA DLT solicitation. The role of the systems integrator is to put together the best detection, separation and predictive modeling technologies into a single blood purification system and guide it to human clinical trials within 4 to 5 years. These partnerships are mutually beneficial and will help to contribute to the success of the overall program."
Dr. Chan concluded, "Just within the recent past, we have seen many high-profile cases of sepsis here in the U.S. including a young woman injured from a fall from a broken homemade zip-line who developed sepsis from a 'flesh-eating' bacterial infection, and a 12-year-old boy who died of unrecognized sepsis after cutting his arm during a basketball game. Unfortunately, these cases are not unusual, with thousands of patients dying silently from sepsis every day in hospitals around the world. The number of sepsis cases in the U.S. alone has doubled in the past decade, and continues to climb due to increased antibiotic resistance, a high rate of hospital-acquired infections, and an aging baby boomer population that is prone to infection due to age, diseases such as diabetes and cancer, and the use of implantable medical devices such as artificial hips and knees. There are currently no approved therapies to treat sepsis in the U.S. or in the European Union. Therapies like CytoSorb® and the device being proposed by DARPA are sorely needed and we are proud to be part of this worthy effort."
This material is based upon work supported by DARPA and SSC Pacific under Contract No. N66001-12-C-4199. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of DARPA and SSC Pacific.
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 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 reducing "cytokine storm" in critically ill patients that could otherwise 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 in early studies and is now being sold 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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Dr. Phillip Chan
Chief Executive Officer
(732) 329-8885 ext. *823