pRBC Contaminant Removal with Hemocompatible Porous Polymer Beads

Packed red blood cell (pRBC) transfusions save lives. However, hundreds of thousands of non-hemolytic
transfusion reactions occur each year worldwide, ranging from mild fever and pruritis, to serious life-
threatening reactions such as severe hyperkalemia, anaphylaxis, and transfusion-related acute lung injury
(TRALI). Mild-moderate reactions drive patient discomfort, documentation, and testing costs while
serious reactions can result in expensive intensive care, patient injury, and even death, driving increased
healthcare utilization and cost. Currently, there is no easy solution to purify contaminants that cause
these reactions from pRBCs. Therefore, CytoSorbents is developing HemoDefend-RBC™, an easy-to-use,
in-line filter, that removes extracellular potassium (K+) plus a broad spectrum of other substances from
pRBCs that may potentially harm transfusion recipients, including free hemoglobin, bioactive lipids,
cytokines, reactive enzymes, and antibodies. These contaminants are either residual components from
donor blood, or are generated during blood storage due to RBC deterioration and hemolysis.
Hyperkalemia from excessive K+ is particularly a risk in patients requiring transfusion of large numbers of
pRBC units due to trauma and high-risk surgery, those with renal insufficiency, as well as in pediatric
patients. In the U.S., the only currently available means to address these contaminants is to wash units
of blood. However, this takes considerable time, logistics and expense. HemoDefend-RBC is designed to
filter pRBCs via gravity flow and requires no additional equipment or energy source. Filtration is
compatible with current transfusion practices, including any of the standard anti-coagulants and additive
solutions. The shelf-stable device is made of inert materials with no perishable or leachable biological
components and can be readily gamma-sterilized.
The HemoDefend-RBC filter leverages and extends CytoSorbents’ proprietary adsorptive porous polymer
bead technology platform for medical filtration. The initial focus of our U.S. regulatory strategy for
HemoDefend-RBC will be the approval of a point-of-transfusion filter to remove extracellular K+ from pRBC
units in order to reduce the risk of transfusion-associated hyperkalemia. Potassium can reach extremely
high levels during cold storage due to the dysregulation of cell surface ion pumps and hemolysis that
causes K+ to be released from red cells. The proposed Phase IIB bridge program provides funding, with
matching funds from the company, for additional research, clinical development, and manufacturing
scale-up activities, to drive U.S. and E.U. regulatory approval and international commercialization of
HemoDefend-RBC. Availability of the HemoDefend-RBC filter will provide an easy-to-use, low cost
solution to safely and effectively “wash blood” of a broad range of contaminants without the expense,
logistics, and time currently required to physically wash blood.CytoSorbents Project Narrative:
There are more than 13 million red blood cell (RBC) transfusions in the US every year
and despite advances, there remains a vital need for improved solutions to prevent
transfusion-related adverse events mediated by excessive extracellular potassium, free
hemoglobin, bioactive lipids, antibodies, inflammatory cytokines and other substances
that accumulate in stored blood products. To address this unmet medical need,
CytoSorbents Inc. is developing the HemoDefend-RBC in-line filter, composed of
hemocompatible, highly porous polymer beads to removes the extracellular potassium
plus a broad range of other offending substances with the hope that this simple, low cost
approach will improve the safety of the blood supply and save lives across the world.