MONMOUTH JUNCTION, N.J., Oct. 27, 2015 - CytoSorbents Corporation (CTSO), a critical care immunotherapy 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 II SBIR (Small Business Innovation Research) contract, that will help advance the Company's HemoDefend™ blood purification technology towards commercialization for the purification of packed red blood cell (pRBC) transfusions. The project, entitled "pRBCs Contaminant Removal with Porous Polymer Beads", is valued at $1,521,671 over 2 years, with funding to start immediately.
The HemoDefend™ platform is based upon CytoSorbents' proprietary hemocompatible porous polymer bead technology that can reduce a broad range of contaminants such as cytokines, free hemoglobin, bioactive lipids, potassium, and antibodies from blood transfusion products by pore capture and surface adsorption. This contract follows the successful completion of a $203K Phase I SBIR contract for HemoDefend™ awarded in September 2013, and is designed to bring the HemoDefend™ in-line blood filter to human testing, a required major step towards commercialization. In addition, the contract will also fund development of new polymers that could enable safer whole blood transfusions, a potentially life-saving advance in the treatment of trauma and military combat casualty victims.
CytoSorbents will again collaborate 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, "The HemoDefend technology was easy to use and performed well in the Phase I SBIR program, removing a wide range of contaminants from packed red blood cells that are implicated in transfusion reactions and adverse clinical events. We plan to work with CytoSorbents in this Phase II SBIR to further optimize the technology and advance it to the next phases of human testing and potential commercialization."
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "We are very appreciative of NHLBI's continued support of our HemoDefend™ platform. This non-dilutive funding will accelerate our product development efforts to potentially help bring our in-line filter closer to the market. We believe that HemoDefend™ can play a significant role in improving the quality and safety of blood transfusions worldwide."
Separately, a poster abstract entitled, "Removal of Free Hemoglobin, Potassium, Cytokines, Bioactive Lipids and Immunoglobulins from Red Blood Cells with Hemocompatible Porous Polymer Beads" was selected by the American Association of Blood Banks (AABB) Selection of Abstracts Program Unit as a Top Poster at the AABB 2015 Annual Meeting, the main national conference for the blood transfusion industry that concluded yesterday in Anaheim, California and attracted more than 4,000 attendees. Less than 8% of the accepted posters have this designation and were presented in a special area for Top Posters. CytoSorbents was also selected to present a poster at the upcoming NHLBI Innovation Conference-West to be held in Irvine, CA on November 17, 2015. Dr. Maryann Gruda, PhD, Associate Director of Biology at CytoSorbents, will make both presentations.
HemoDefend™ 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. HHSN268201600006C.
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 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 immunotherapy 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® - The Company's flagship product is E.U. approved and distributed in more than 30 countries around the world, with the goal of reducing deadly inflammation thereby 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, complications of cardiac surgery, and many others. A major unmet medical need, organ failure costs millions of lives, and billions of dollars each year. CytoSorb® has been used safely in more than 8,000 human treatments.
HemoDefend™ - 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 significantly contribute to the millions of transfusion reactions and adverse outcomes, including death, each year from 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 for download on the Company's websites: http://www.cytosorbents.com and http://www.cytosorb.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. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2015, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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