PRINCETON, N.J. and BERLIN, July 8, 2022 /PRNewswire/ — During the recent 2022 CytoSorb Users’ Meeting in Berlin, Germany hosted by CytoSorbents Corporation (NASDAQ: CTSO), leading critical care specialists, cardiac surgeons, and research scientists from around the world highlighted the use of CytoSorb® blood purification across a broad range of applications driven by major current trends in healthcare. Examples include diseases of the rapidly aging population such as sepsis and trauma, the high incidence and prevalence of chronic liver disease and acute liver failure, the growing global demand for solid organ transplants, the risk of bleeding caused by the widespread use of antithrombotic “blood thinning” medications, severe illness due to the COVID-19 pandemic, and many others.
Nearly 300 specialists from 40 countries attended the conference in-person with leading KOLs presenting updates on the latest scientific findings, clinical study results, and data from new case series in an expansive agenda (seen here). These presentations underscore CytoSorb® as a pioneering, interdisciplinary therapeutic approach for organ support that both builds upon, and extends beyond, its first approved indication of cytokine reduction when launched in Europe ten years ago. Among the many notable speakers:
- Prof. Jean-Louis Vincent, the past president of the World Federation of Societies of Intensive and Critical Care Medicine, emphasized that the growing use of therapies such as blood purification to support organ health and functioning is key to improved clinical outcomes, “To further align clinical benefits with patient needs, the importance of extracorporeal organ support is increasing. It serves patient well-being, conserves resources, and at the same time can lead to cost benefits.”
- Cardiovascular surgeon Prof. Carlos Mestres of University of the Free State, Bloemfontein, South Africa focused on the need to mitigate organ injury from uncontrolled inflammation in cardiac surgery and the role that CytoSorb is playing. “Hyperinflammation is understood as an indicator of deeper injury or organ failure and suggests a growing number of applications for hemoadsorption.”
- Dr. Endre Nemeth at the Semmelweis University in Budapest, Hungary presented compelling results from a randomized controlled study on intraoperative CytoSorb® use in heart transplantation that will be presented at the 36th Annual EACTS conference in Milano, Italy, from October 5-8, 2022
- Dr. Sandra Lindstedt from Lund University in Sweden, a pioneer in the use of cytokine adsorption in lung transplant, presented strong new data on the use of ex vivo organ perfusion with CytoSorbents’ cytokine reduction technology to improve lung function, expected to be available this fall
- Dr. Serdar Günaydin from Ankara City Hospital in Ankara, Turkey presented data from a clinical study on the impact of CytoSorb to prevent the progression of renal dysfunction in cardiac surgery patients with borderline renal disorders
This year’s discussions also focused on the combination of CytoSorb® and ECMO for the treatment of respiratory failure, the use of CytoSorb® to reverse septic shock and improve microcirculation, how CytoSorb® is helping to advance the treatment of acute liver failure, and other key topics.
“Once again this year, the CytoSorb World Users’ Meeting proved to be an exciting and authoritative interdisciplinary event where pioneers and power users from around the world shared first-hand insights into clinical results and experiences with CytoSorb®,” summarized Christian Steiner, EVP Marketing & Sales of CytoSorbents and Managing Director of CytoSorbents Europe. “CytoSorb® is the new dimension in blood purification that we believe is key to improving clinical outcomes in critically ill patients worldwide.”
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
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 more than $39.5 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.
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, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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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SOURCE CytoSorbents Corporation