PRINCETON, N.J., March 29, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, highlights the recently published study entitled, “CytoSorb hemoperfusion markedly attenuates circulating cytokine concentrations during systemic inflammation in humans in vivo” in the renowned medical journal “Critical Care.” In this landmark publication, leading sepsis researchers in the group of Prof. Dr. Peter Pickkers from Radboud University Medical Center, Nijmegen, Netherlands convincingly demonstrate the robust ability of CytoSorb® to rapidly reduce cytokine storm during systemic hyperinflammation in a well-controlled and well-established human experimental sepsis model.
In this clinical study, Jensen, et al., intravenously administered bacterial lipopolysaccharide endotoxin - a dangerous toxin found on the surface of most Gram-negative bacteria such as E. coli, Pseudomonas, and Klebsiella - to twenty-four healthy male volunteers (age 18-35). Endotoxin is a common culprit in sepsis that potently activates the immune system, triggering the high production of cytokines, often called a “cytokine storm,” and severe inflammation. Extracorporeal blood purification with CytoSorb was then used to treat half of the volunteers for a total of 6 hours. Baseline demographic characteristics between those that received CytoSorb therapy and those that did not (control) were similar. All other interventions between the two groups were identical. Cytokine measurements were taken every hour or half-hour throughout the experiment.
Intravenous administration of endotoxin resulted in impressive transient increases in cytokine concentrations in the control group, characteristic of levels seen in a true cytokine storm. Meanwhile, the CytoSorb group had significantly lower plasma levels of cytokines, including TNF (median AUC: -58%, p<0.0001), IL-6 (-71%, p=0.003), IL-8 (-48%, p=0.02), IL-10 (-26%, p=0.03), MCP-1 (-34%, p=0.02) and MIP-1a (-39%, p=0.006), showing that CytoSorb profoundly attenuates the increase in circulating cytokine concentrations during endotoxin-induced systemic inflammation in humans. This result is very clinically relevant, as the severity and duration of cytokine storm and inflammation in sepsis are directly correlated with life-threatening complications such as shock, respiratory failure, and other organ failure, and the risk of death. Importantly, following endotoxin re-challenge seven days later (without blood purification), no differences in cytokine response were observed between the two groups, demonstrating that use of CytoSorb a week earlier did not affect long-term immune function.
Dr. Christian Steiner, Executive Vice President of Sales & Marketing of CytoSorbents, stated, “We are pleased to highlight this most recent publication from Professor Pickkers and colleagues, and were excited to invite Prof. Pickkers to speak on these results at our symposium at last week’s International Symposium on Intensive Care & Emergency Medicine in Brussels, Belgium. The response from current and prospective users has been extremely positive, and has helped to refocus our discussions on how to optimize the way CytoSorb is used to have the strongest effect, such as treating early, as seen in this study. We are very excited by this development and will continue to strive to make CytoSorb Therapy accessible to all patients in need.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, added, “The beauty of this study is its simplicity and elegance, demonstrating definitively that CytoSorb reduces cytokine storm in a well-controlled and balanced study that eliminates the heterogeneity and confounding variables that plague clinical trials in critically ill patients. This study corroborates the well-established literature on CytoSorb and cytokine reduction across many different fields over the past decade, and we strongly believe closes any debate on the utility of CytoSorb for this purpose. No other blood purification technology has amassed this level of evidence, helping to establish CytoSorb as the de facto standard for extracorporeal control of cytokine storm and hyperinflammation. Importantly, the use of CytoSorb for this purpose has been directly associated with positive clinical outcomes, such as high 74% survival in 100 critically ill COVID-19 patients when used with ECMO under FDA Emergency Use Authorization, as we reported from our U.S. CytoSorb Therapy in COVID-19 (CTC) Registry, or the reduction in sepsis-related mortality when used intraoperatively in patients with Staph. aureus endocarditis, for example. This is the heart of why CytoSorb has been used across 75 countries in more than 200,000 human treatments around the world to date.”
About CytoSorbents Corporation (NASDAQ: CTSO)
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 2022, more than 195,000 CytoSorb devices have 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 is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 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.
CytoSorbents’ 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 $48 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™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, statements about potential exposures resulting from our cash positions, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report 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 press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
kbloch@cytosorbents.com
