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pRBC Contaminant Removal with Hemocompatible Porous Polymer Beads

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL141928-03
Agency Tracking Number: R44HL141928
Amount: $995,984.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: HL16-009
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-20
Award End Date (Contract End Date): 2021-07-31
Small Business Information
Monmouth Junction, NJ 08852-1977
United States
DUNS: 830014077
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (732) 398-5426
Business Contact
Phone: (732) 398-5404
Research Institution

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

* Information listed above is at the time of submission. *

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