Regulatory Approval & Commercialization of an RBC Processing and Storage System to Improve Transfusion Therapy by Minimizing Oxidative Damage to RBC during Storage

DESCRIPTIONprovided by applicantThe objective of this project is to commercialize the Hemanext Storage System to deliver red blood cellsRBCof significantly improved quality by establishing and maintaining an anaerobic environment for refrigerated RBC storageThe higher quality red blood cell product will exhibit bioequivalence vsconventionally prepared RBC with lower doses by virtue of higher RBC recoverysuperior microvascular perfusion and oxygen delivery and a reduction in agents implicated in adverse eventsThe design of the Hemanext Storage System has been informed by detailed study of existing blood bank operating practices to maximize compatibility with existing proceduresequipment useand costThe Phase IIB work described below will build on the outcomes achieved in an ongoing Phase II contractSupported by the Phase II contracta first generation disposable oxygen reduction and anaerobic storage system was designed and fabricated with the objective of performing the required pivotal clinical studies to achieve FDA clearanceThe four aims of this Phase II Bridge proposal areFirstto conduct a pre pivotaldual arm clinical study withsubjects underprocessing conditionsA first generationIDE ready commercial device will be tested at Hoxworth Blood Center to both verify the fit of the Hemanext Storage System into pre storage component processing operations at a blood center and to measure the impact deoxygenation and anaerobic storage have on in vivo recovery and in vitro blood quality parametersSecondto conduct the pivotal clinical study to support the FDA regulatory submission of the Hemanext Storage SystemHoxworth Blood Center and the American Red Cross Mid Atlantic Region Research Center in Norfolk are the planned pivotal clinical study sitesThirdto conduct an in vivo recovery study at Columbia University to demonstrate how establishing and maintaining an anaerobic environment mitigates the damage done to red blood cells by irradiationFourthto apply systems biology analytics of red blood cell metabolomicslipidomicsbiomechanicsand vascular bioactivity to identify novel biomarkers that are predictive of in vivo recoveryAll studies will be performedwhere requiredunder the authorization of an FDA compliant IRB