CytoSorbents Awarded $203K Phase I SBIR Contract from NHLBI/NIH for HemoDefend(TM)
CytoSorbents Awarded $203K Phase I SBIR Contract from NHLBI/NIH for HemoDefend(TM)
MONMOUTH JUNCTION, NJ -- (Marketwired) -- 09/09/13 -- CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company specializing in blood purification, announced today that the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), awarded the Company a Phase I SBIR (Small Business Innovation Research) contract to further advance its HemoDefend(TM) blood purification technology for packed red blood cell (pRBC) transfusions. The project, entitled "Elimination of blood contaminants from pRBCs using HemoDefend hemocompatible porous polymer beads," is valued at $203,351 over 6 months, with funding to start immediately.
The overall goal of this new program is to reduce the risk of potential side effects of blood transfusions, and help to extend the useful life of pRBCs. The HemoDefend(TM) platform is based upon CytoSorbents' proprietary hemocompatible porous polymer bead technology and already removes many blood contaminants that can potentially cause transfusion reactions such as free hemoglobin, antibodies, and cytokines. Funding will expand the platform to remove an even broader range of blood contaminants, assess the quality of the blood after treatment, and facilitate the parallel development of the HemoDefend(TM) In-line filter, designed to be used at the patient bedside to purify existing blood products, and the unique HemoDefend(TM) "Beads-in-a-Bag" blood treatment bag, intended to replace current simple blood storage bags.
As part of this program, CytoSorbents will be collaborating with Dr. Larry J. Dumont, MBA, PhD, Director of the Center for Transfusion Medicine Research and Associate Professor of Pathology at the Geisel School of Medicine at Dartmouth.
Dr. Dumont stated, "Transfusion medicine has made great strides in improving the quality and safety of the blood supply, though many risks remain. CytoSorbents' innovative HemoDefend(TM) technology could represent a significant advance in reducing contaminants in blood transfusion products that may lead to transfusion reactions and adverse clinical events. We look forward to working closely with CytoSorbents in further developing this exciting new technology."
Chief Executive Officer, Dr. Phillip Chan, MD, PhD stated, "We thank NHLBI and Dr. Dumont for their support of our HemoDefend(TM) platform. Success of this Phase I program may accelerate commercialization of our HemoDefend products, facilitate ongoing discussions with potential partners, and lead to further funding and development via larger Phase II and III SBIR awards. With an estimated 85 million pRBC transfusions worldwide each year, hundreds of thousands of related adverse events, and ongoing clinical studies such as RECESS and ABLE that may show the risk of older blood, we believe that HemoDefend(TM) has significant commercial potential."
HemoDefend(TM) is under advanced development and is not yet approved in the U.S. or elsewhere. This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN268201300044C.
About the National Heart, Lung, and Blood Institute
The NHLBI provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI supports research on the use, safety, and availability of blood and blood components for transfusion and cellular therapies. The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide.
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused therapeutic device company that specializes in blood and biological fluid purification. 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. Some of the Company's products include:
-- CytoSorb(R) - The Company's flagship product is approved and sold in the European Union as a safe and effective cytokine blood filter, with the goal of preventing or treating organ failure -- the leading cause of death in the intensive care unit with no effective therapies -- in life threatening illnesses such as sepsis, burn injury, trauma, lung injury, pancreatitis, and many others. A major unmet medical need, organ failure costs millions of lives, and billions of dollars each year. Development of the next generation of CytoSorb(R) is being partially funded by DARPA and the US Army. -- HemoDefend(TM) - Currently under advanced development, this technology is designed to remove non-infectious contaminants in blood transfusion products, such as free hemoglobin, cytokines, bioactive lipids, and antibodies, which may significantly contribute to the transfusion reactions and adverse outcomes of blood transfusions. -- ContrastSorb - A development-stage technology designed to rapidly remove intravenous (IV) imaging contrast from blood that could otherwise cause kidney failure, or contrast-induced nephropathy, in high risk patients undergoing the millions of interventional radiology procedures, such as cardiac catheterizations, and imaging CT scans with IV contrast each year. -- DrugSorb - Is a development-stage product designed to remove drugs, chemotherapy agents, and other chemicals from blood in drug overdose, high dose regional chemotherapy, chemical poisoning, and other applications.
Additional information is available on the Company's website: http://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 regulatory approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of 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 April 3, 2013, which is available at http://www.sec.gov
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