Full Press Release Details
Announces Positive REFRESH I Trial Results
Achieved the goals of this safety and
feasibility study with demonstration of safe and significant reduction of toxic inflammatory mediators during complex open heart
MONMOUTH JUNCTION, N.J., May 5, 2017 - Positive
results from the REFRESH (REduction in FREe Hemoglobin) I trial were
presented on Monday, May 1, 2017 at the American Association for Thoracic Surgery (AATS) Centennial Conference in Boston, MA. REFRESH
I was a prospective, randomized, controlled trial in eight major U.S. cardiac surgery centers evaluating the safety and
feasibility of CytoSorb , a blood purification
technology designed to treat deadly inflammation in critically-ill and cardiac surgery patients aged 18-80 years of age,
where cardiopulmonary bypass (CPB) was expected to exceed 3 hours. Complex cardiac surgery generates high levels of plasma free
hemoglobin (pfHb), activated complement, and other inflammatory mediators that can trigger severe post-operative inflammation and
complications such as organ dysfunction and organ failure. The CytoSorb therapy, developed by CytoSorbents
Corporation (CTSO), a leader in critical care immunotherapy, is designed to reduce the risk of these sequelae.
Key findings of the study were:
Joseph B. Zwischenberger, M.D., Chairman and Johnston-Wright Professor of Surgery at University of Kentucky College of Medicine
and Principal Investigator of the REFRESH I trial stated, "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 investigators of the study have submitted
a manuscript containing these and additional data for publication. As customary, more data will be made available upon potential
information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or
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our Annual Report on Form 10-K, filed with the SEC on March 3, 2017, as updated by the risks reported in our Quarterly Reports
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Public Relations Contact:
Pascale Communications