HemoDefend™ is an extension of CytoSorbents’ powerful bead-based blood purification technology and is designed to improve the safety and quality of the blood supply. Each year, there are an estimated 100 million transfusions of blood products worldwide, each with a 1-5% risk of a transfusion reaction. These reactions can be as mild as fever or shortness of breath, to potentially life-threatening transfusion related acute lung injury (TRALI) and anaphylaxis. These reactions are linked to antibodies, cytokines, toxins, bioactive lipids, free hemoglobin, and other inflammatory mediators from either the blood donor, or from de novo generation during blood storage. HemoDefend™ is capable of removing many of these contaminants from packed red blood cells (pRBCs), the major transfused blood product, potentially reducing the risk of transfusion reactions. This is expected to be especially important in critically-ill patients, trauma patients, and high risk surgery patients that receive many units of blood where the risk of transfusion reactions is cumulative.
HemoDefend™ beads can be implemented in a number of ways. The first is an in-line filter between the blood bag and the patient, used at the time of transfusion. This is the initial focus of the development effort. The second is a more innovative patent-pending approach called “Beads in a Bag”, which allows purification of blood during the entire refrigerated storage period. This configuration takes advantage of the high biocompatibility of the HemoDefend beads, allowing the beads to have extended contact with blood without causing damage to the cells. Also, because the beads are neutrally buoyant and are suspended in the blood, the blood storage bag does not need to be mixed. An integrated bead filter retains the beads in the blood bag during transfusion. This low cost purification technology requires no machines, no electricity, no energy source, or other manipulation. Because of this, it is an ideal blood purification strategy for not only mainstream blood treatment applications, but also for military and developing nation applications where simple and robust are operative words.
In 2013, the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), awarded CytoSorbents a $203,000 Phase I SBIR contract to help develop HemoDefend™ for the purification of blood products. In October 2015, CytoSorbents was awarded a $1.5M Phase II SBIR contract by NHLBI and U.S. Special Operations Command (USSOCOM) to further advance HemoDefend™ towards commercialization. CytoSorbents is collaborating with Dr. Larry J. Dumont, Associate Director of Blood Systems Research Institute – Denver, internationally respected for its work to advance blood safety worldwide, and was the immediate past chair of BEST, the international Biomedical Excellence for Safer Transfusion Collaborative.
In June 2016, the U.S. Army Medical Research Acquisition Activity (USAMRAA) awarded CytoSorbents a $150,000 Phase I Small Business Technology Transfer contract to develop blood purification technologies to enable universal plasma. Plasma is a core whole blood component that contains many essential proteins such as albumin and coagulation factors. It is often used to expand blood volume and restore the ability of blood to clot in many serious illnesses such as trauma and massive hemorrhage, shock, liver disease, severe burn injury, sepsis, and other conditions. It is also used in plasma exchange procedures to treat autoimmune diseases. More than 10,000 units of fresh frozen plasma are administered each day, or more than 3.6 million units per year, in the United States alone. With the exception of Type AB plasma, plasma typically requires blood-type matching with the patient to prevent incompatibilities and reduce the risk of major transfusion reactions. Because Type AB plasma lacks blood type-specific antibodies, it is called ‘universal plasma’ and can be readily administered to patients in emergency situations, making logistics fairly straightforward for both military and civilian applications. However, there are not enough Type AB plasma donors to supply current demand. Under this Phase I STTR program, HemoDefend™ is being modified to remove these blood-type specific antibodies from all blood-type plasmas to demonstrate the proof-of-concept production of a true ‘universal plasma’. In doing so, it may enable the relief of a major bottleneck in the availability of plasma to help address these major unmet medical needs.