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

Period of Performance: 08/15/2016 - 05/31/2017

$991K

Phase 2 SBIR

Recipient Firm

NEW Health Sciences, Inc.
BETHESDA, MD 20817
Principal Investigator
Principal Investigator

Abstract

? DESCRIPTION (provided by applicant): The objective of this project is to commercialize the Hemanext Storage System to deliver red blood cells (RBC) of significantly improved quality by establishing and maintaining an anaerobic environment for refrigerated RBC storage. The higher quality red blood cell product will exhibit bioequivalence vs. conventionally prepared RBC with lower doses by virtue of higher RBC recovery, superior microvascular perfusion and oxygen delivery and a reduction in agents implicated in adverse events. The design of the Hemanext Storage System has been informed by detailed study of existing blood bank operating practices to maximize compatibility with existing procedures, equipment use, and cost. The Phase IIB work described below will build on the outcomes achieved in an ongoing Phase II contract. Supported by the Phase II contract, a 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 clearance. The four aims of this Phase II Bridge proposal are: First, to conduct a pre-pivotal, dual-arm clinical study with 6 subjects under 2 processing conditions. A first generation, IDE-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 parameters. Second, to conduct the pivotal clinical study to support the FDA regulatory submission of the Hemanext Storage System. Hoxworth Blood Center and the American Red Cross Mid-Atlantic Region Research Center in Norfolk are the planned pivotal clinical study sites. Third, to 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 irradiation. Fourth, to apply systems biology analytics of red blood cell metabolomics, lipidomics, biomechanics, and vascular bioactivity to identify novel biomarkers that are predictive of in vivo recovery. All studies will be performed, where required, under the authorization of an FDA-compliant IRB.