US Army Grants CytoSorbents $1 Million Phase II SBIR Trauma and Burn Injury Award
MONMOUTH JUNCTION, N.J., Sept. 24, 2012 /PRNewswire/ -- CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses such as sepsis, trauma, and burn injury, announced that, after a competitive process, the US Army Medical Research and Materiel Command has selected the Company's Phase II SBIR (Small Business Innovation Research) proposal for funding. This follows the successful completion of a previously funded $100,000 Phase I US Army SBIR award. The current one year program is valued up to $1 million, with an additional option for a $50,000 Phase I extension, and is contingent upon finalizing the award contract, continued availability of federal funding, and achievement of certain milestones. The Phase II SBIR award is a pre-requisite to apply for a Phase III SBIR award that would help to fund and accelerate human clinical testing in the area of burn injury and/or trauma.
Dr. Phillip Chan, Chief Executive Officer, stated "We are delighted to have the opportunity to continue our collaboration with the US Army, and have now also garnered interest from the US Air Force. As part of this Phase II SBIR program, we have expanded the scope of the project to evaluate the use of CytoSorb® and newly developed technologies to treat both trauma and burn and smoke inhalation injury in large animal models. These potentially life-threatening conditions are some of the most common injuries across all branches of the military as well as the general population. They involve a massive whole body inflammatory response that puts the patient at high risk of developing serious complications such as lung injury, kidney failure, other organ dysfunction, infection and death. Existing therapies are predominantly supportive care, and do little to prevent or treat these dangerous complications. CytoSorb®, and other products built around our blood purification platform technology, are well-suited to address these issues directly and may hopefully play a significant role in improving clinical outcome for our warfighters and civilians in the future."
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 surface 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 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 the blood supply. 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 in cardiac surgery, treatment of inflammatory and autoimmune disorders, radioimaging contrast removal in imaging and interventional radiology procedures, and the treatment of rhabdomyolysis, drug overdose, 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.
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1985309
Dr. Phillip Chan
Chief Executive Officer
(732) 329-8885 ext. *823
SOURCE CytoSorbents Corporation