Full Press Release Details
Groundbreaking Randomized Controlled Trial Reports
Excellent Clinical Outcomes Using CytoSorb Intraoperatively in Heart Transplant Patients
CytoSorb Blood Purification Results in Statistically
Significant Reductions in Multiple Organ Failure and Dysfunction
PRINCETON, N.J., January 17, 2024 - CytoSorbents
Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using
blood purification via its proprietary polymer adsorption technology, reports on excellent outcomes from a groundbreaking randomized
controlled trial (RCT) using CytoSorb blood purification during heart transplant, recently published in the European Society
of Cardiology journal, ESC Heart Failure.
As co-lead authors Drs. Endre N meth and
Adam Soltesz from the Heart and Vascular Center at Semmelweis University, Budapest, Hungary explain, as more complex and higher risk
patients become eligible for heart transplant, so does the risk of serious complications such as multiple organ failure, that not only
is the second leading cause of death following heart transplant, but results in high costs due to protracted ICU and hospital stays.
In particular, vasoplegic syndrome (VS), a form of circulatory failure or shock, is routinely seen in these patients and can cause worsened
organ failure. In a prior observational study, CytoSorb was associated with the reduced severity of vasoplegia in heart transplant
patients, in addition to other clinical benefits.
In this prospective, single-center, open-label
RCT, 60 heart transplant recipients were randomly assigned to either receive intraoperative CytoSorb hemoadsorption or standard of care.
Key statistically significant findings of the study were that the CytoSorb group, compared to the control group, had:
Dr. Daniel Wendt, Vice President Medical -
Cardiovascular at CytoSorbents stated, "Over the years, cardiothoracic surgeons have repeatedly
observed the benefits of intraoperative CytoSorb blood purification in improved hemodynamic stability, reduced incidence and severity
of vasoplegic shock, decreased incidence of organ dysfunction, reduced inflammatory responses, and favorable post-operative outcomes.
Now, Nemeth, Soltesz, and colleagues have confirmed many of these observations in this rigorous and well-designed groundbreaking
randomized controlled trial in orthotopic heart transplant patients. These vital and statistically significant clinical outcomes highlight
the critical importance of CytoSorb in cardiothoracic surgery and are expected to be a catalyst for continued adoption, usage, and reimbursement
in this arena. Also, on the heels of recent positive data in lung transplant using CytoSorb, these results continue to advance
our pioneering role in the field of solid organ transplant in general."
About CytoSorbents Corporation
CytoSorbents Corporation is a leader
in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead
product, CytoSorb , is approved in the European Union and distributed in 75 countries worldwide. It is an
extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical
illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely
high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic
drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure.
At the end of Q3 2023, more than 221,000 CytoSorb devices had been used cumulatively. CytoSorb was originally launched in the European
Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in
clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal
in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States
for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb -ATR antithrombotic
removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations,
one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban
and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company has completed the FDA-approved,
randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at approximately 30 centers in
U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving
ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval
for DrugSorb-ATR in this application.
purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood
and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other
funding of approximately $50 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes
of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command
(SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development
based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks,
and multiple patent applications pending, including ECOS-300CY , CytoSorb-XL , HemoDefend-RBC , HemoDefend-BGA ,
VetResQ , K+ontrol , DrugSorb , ContrastSorb, and others. For
more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or
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on Form 10-K, filed with the SEC on March 9, 2023, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the
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