CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.
Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.
The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.
The prospective, randomized trial looked to evaluate the safety and feasibility of the CytoSorb in treating deadly inflammation in critically-ill and cardiac surgery patients between 18 and 80 years.
Results from the study indicate that valve replacement surgery was the highest risk procedure for peak plasma free hemoglobin, and that treatment with the CytoSorb increased reductions in peak pfHb levels by 26% at 3.5 hours and 38% at 4 hours. Treatment also resulted in statistically significant decreases in activated complement C3a and C5a during surgery, according to CytoSorbents
The company said that the trial achieved its primary safety endpoint with a favorable adjudication of all serious adverse events, and no significant differences in the rate of adverse events or serious adverse events at 30 days. No unanticipated adverse device effects were reported.
“We are pleased to report on this first multi-center U.S. trial demonstrating the safe and easily implemented use of CytoSorb during high risk complex cardiac surgery. Inflammation and toxic injury from excessive plasma free hemoglobin and activated complement are well-known insults that are associated with organ injury such as acute kidney injury, stroke, lung injury, and other complications. The finding that complex valve replacement procedures generate high levels of pfHb, and that CytoSorb can significantly reduce pfHb and activated complement in this population, represents a potentially important advance in the field. In a future larger study, we plan to correlate the reduction of pfHb and activated complement in this enriched at-risk population with reduced organ dysfunction and injury, while confirming the risk/benefit of the therapy,” principal investigator Dr. Joseph Zwischenberge of the University of Kentucky College of Medicine said in a press release.
In January, CytoSorbents and Fresenius Medical Care (NYSE:FMS) said that they expanded the terms of their partnership and added a co-marketing agreement for the CytoSorb blood absorber in countries where the therapy is available.
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