MONMOUTH JUNCTION, NJ--(Marketwire - October 17, 2011) - CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company working to save lives through blood purification, announced the launch of its HemoDefend purification technology platform for use in blood transfusion applications. The development-stage technology is designed to safeguard the quality and safety of the blood supply by removing substances in whole blood, packed red blood cells, and platelets that can cause transfusion reactions such as life-threatening Transfusion Related Acute Lung Injury (TRALI), and disease. The technology is potentially applicable to the majority of the approximately 30 million blood component transfusions that occur each year in the United States, as well as an even greater number of transfusions that take place each year worldwide. The HemoDefend system is based on CytoSorbents’ highly biocompatible, porous polymer bead technology that captures substances based on size and surface adsorption and specifically targets antibodies, foreign antigens, cytokines, inflammatory mediators, toxins, free hemoglobin, and bioactive lipids that can trigger adverse events. The same technology may also be capable of removing prions, the infectious agent responsible for Creutzfeldt-Jakob disease, commonly known as “mad-cow” disease.
In addition to the proprietary bead technology, the HemoDefend system also includes the unique, patent-pending “Beads in a Bag” treatment configuration where the beads are placed directly into a blood storage bag. Blood or separated blood components are then simply added to the bag and purification begins instantly and continues throughout the duration of storage, maximizing removal efficiency. Because the beads are neutrally buoyant, no mixing is required, which greatly simplifies the purification process, and is compatible with current blood storage conditions. An integrated filter in the bag prevents beads from leaving the bag during the transfusion process. The polymer beads meet ISO 10993 standards for biocompatibility, hemocompatibility, genotoxicity, cytotoxicity, acute sensitivity and complement activation and can therefore directly contact blood for extended periods of time. In addition, the beads are inert and stable at a wide range of temperatures, and do not contain any antibodies, biologics, ligands, or drugs. Because of this, they have a very long shelf life that is consistent with blood storage bag manufacturing standards. No special equipment or handling is required, making it ideal for mainstream and military applications, as well as for use in less developed countries.
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents, stated, “Our new HemoDefend purification technology platform represents a unique, easy to use, robust solution to potentially improve the quality and safety of blood by reducing transfusion reactions, extending its useful life, and preventing adverse consequences sometimes associated with administration of older blood.” Dr. Chan continued, “For example, the incidence of adverse events in blood transfusion is estimated at 5-10% of the 30 million transfusions performed in the US each year. One of the most serious of these reactions is TRALI, the rapid development of acute respiratory distress following blood transfusion that occurs in approximately 1 in every 2,000-5,000 transfusions and has a mortality of approximately 10%. TRALI is associated with the transfusion of donor antibodies to the recipient, the removal of which may reduce its incidence. Another example is the growing number of studies that have suggested that administration of aged blood can lead to adverse outcome, including increased mortality. This risk is greatly increased in patients receiving multiple transfusions. Older blood accumulates many substances during storage such as free hemoglobin, bioactive lipids, cytokines, and others that can increase the risk of adverse outcome. HemoDefend targets the removal of these substances to improve the quality and safety of blood.” Dr. Chan concluded, “HemoDefend is yet another high volume, high value application for our blood purification technology that is completely distinct from our flagship product, CytoSorb™. Our goal is to out-license this technology for blood transfusion applications. We continue to invest in our R&D pipeline and have other exciting opportunities under development.”
CytoSorbents will exhibit its HemoDefend technology platform at the AABB (formerly known as the American Association of Blood Banks) conference CTTXPO exhibition in Booth #1239 from October 22-25, 2011 at the San Diego Convention Center in California. http://www.aabb.org/events/annualmeeting/esa/Pages/exhibitor.aspx#snapshot
The HemoDefend purification technology platform is a development stage product that is not yet FDA approved, but is currently available for out-licensing.
About CytoSorbents
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 cases 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. 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. 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
Forward-Looking Statements
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.
Contact:
CytoSorbents Corporation
David Lamadrid
Chief Financial Officer
(732) 329-8885 ext. 816
DavidL@cytosorbents.com
