SBIR/STTR Award attributes
Packed red blood cellpRBCtransfusions save livesHoweverhundreds of thousands of non hemolytic transfusion reactions occur each year worldwideranging from mild fever and pruritisto serious lifethreatening reactions such as severe hyperkalemiaanaphylaxisand transfusion related acute lung injuryTRALIMild moderate reactions drive patient discomfortdocumentationand testing costs while serious reactions can result in expensive intensive carepatient injuryand even deathdriving increased healthcare utilization and costCurrentlythere is no easy solution to purify contaminants that cause these reactions from pRBCsThereforeCytoSorbents is developing HemoDefend RBCan easy to usein line filterthat removes extracellular potassiumKplus a broad spectrum of other substances from pRBCs that may potentially harm transfusion recipientsincluding free hemoglobinbioactive lipidscytokinesreactive enzymesand antibodiesThese contaminants are either residual components from donor bloodor are generated during blood storage due to RBC deterioration and hemolysisHyperkalemia from excessive Kis particularly a risk in patients requiring transfusion of large numbers of pRBC units due to trauma and high risk surgerythose with renal insufficiencyas well as in pediatric patientsIn the U Sthe only currently available means to address these contaminants is to wash units of bloodHoweverthis takes considerable timelogistics and expenseHemoDefend RBC is designed to filter pRBCs via gravity flow and requires no additional equipment or energy sourceFiltration is compatible with current transfusion practicesincluding any of the standard anti coagulants and additive solutionsThe shelf stable device is made of inert materials with no perishable or leachable biological components and can be readily gamma sterilizedThe HemoDefend RBC filter leverages and extends CytoSorbentsproprietary adsorptive porous polymer bead technology platform for medical filtrationThe initial focus of our U Sregulatory strategy for HemoDefend RBC will be the approval of a point of transfusion filter to remove extracellular Kfrom pRBC units in order to reduce the risk of transfusion associated hyperkalemiaPotassium can reach extremely high levels during cold storage due to the dysregulation of cell surface ion pumps and hemolysis that causes Kto be released from red cellsThe proposed Phase IIB bridge program provides fundingwith matching funds from the companyfor additional researchclinical developmentand manufacturing scale up activitiesto drive U Sand E Uregulatory approval and international commercialization of HemoDefend RBCAvailability of the HemoDefend RBC filter will provide an easy to uselow cost solution to safely and effectivelywash bloodof a broad range of contaminants without the expenselogisticsand time currently required to physically wash blood CytoSorbents Project NarrativeThere are more thanmillion red blood cellRBCtransfusions in the US every year and despite advancesthere remains a vital need for improved solutions to prevent transfusion related adverse events mediated by excessive extracellular potassiumfree hemoglobinbioactive lipidsantibodiesinflammatory cytokines and other substances that accumulate in stored blood productsTo address this unmet medical needCytoSorbents Incis developing the HemoDefend RBC in line filtercomposed of hemocompatiblehighly porous polymer beads to removes the extracellular potassium plus a broad range of other offending substances with the hope that this simplelow cost approach will improve the safety of the blood supply and save lives across the world
