Enables a new powerful combined therapy to treat respiratory failure and shock
MONMOUTH JUNCTION, N.J., Sept. 26, 2017 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using CytoSorb® blood purification to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announced the launch and immediate availability of its CytoSorb Therapeutic ECMO™ Kit, at the 30th Annual European Society of Intensive Care Medicine (ESICM) Congress in Vienna, Austria (September 23-27, 2017).
The CytoSorb Therapeutic ECMO™ Kit combines the market leading CytoSorb blood purification cartridge – the only specifically approved extracorporeal cytokine adsorber in the European Union – with an innovative, patent-pending tubing connector set that allows the easy integration of CytoSorb into the blood circuit of most commercial ECMO machines. The connector set also enables the safe and convenient daily exchange of the CytoSorb cartridge while minimizing the risk of air emboli and blood leakage.
Extracorporeal membrane oxygenation, or ECMO, is a life-support technology that oxygenates blood outside of the body when the lungs become so damaged that traditional mechanical ventilation fails. Originally pioneered by CytoSorbents’ former Chief Medical Officer, Dr. Robert H. Bartlett, ECMO is currently used in intensive care units throughout the world and has been credited with saving the lives of thousands of pediatric and adult patients. Veno-venous ECMO has gained popularity in the management of respiratory failure as a way to provide gas exchange in blood, while reducing the need for harmful mechanical ventilation that can further damage the lungs via oxygen toxicity, and pressure and volume trauma. Veno-arterial ECMO adds hemodynamic support to gas exchange, and has been useful as a supportive care therapy in shock.
The limitation of ECMO and mechanical ventilation is that these technologies may keep the patient alive, but do not address or reverse the underlying inflammatory processes that cause and perpetuate lung and other organ injury, as well as circulatory collapse. CytoSorb Therapeutic ECMO™, or the combination of ECMO with CytoSorb, has been used to reduce cytokines, bacterial toxins, and other inflammatory mediators in more than 1,000 treatments in critically ill patients. Some observed benefits of the combined therapy include improved lung function, a reversal of shock with the weaning of harmful vasopressors, and a recovery of kidney function. Kit availability is expected to accelerate the adoption and usage of CytoSorb Therapeutic ECMO in the treatment of a wide range of critical illnesses.
Today, CytoSorbents will host a research symposium at the ESICM Congress (12:30-2:00PM CET) entitled “CytoSorb Therapy – Enhance your Therapeutic Options in Systemic Hyperinflammation“. In a session chaired by Dr. Marlies Ostermann (London, UK) and Dr. Claudio Ronco (Vincenza, Italy), Prof. Dr. med Karl Träger, one of the pioneers of CytoSorb therapy, will give a presentation entitled, “CytoSorb and ECMO – Supporting Life Support”, highlighting the rationale and use of this novel therapy. The agenda is as follows:
- Update on blood purification – Why CytoSorb is the most promising approach in sepsis? Dr. Patrick Honoré (Brussels, Belgium)
- CytoSorb in liver failure – New chances to reduce hepatic encephalopathy
- Dr. Andrea De Gasperi (Milan, Italy)
- CytoSorb and ECMO – Supporting life support
Prof. Dr. med Karl Träger (Ulm, Germany)
About the European Society of Intensive Care Medicine (ESICM)
The European Society of Intensive Care Medicine (ESICM) is an international association of more than 7,000 doctors, nurses, physiotherapists, and other allied health professionals. Founded in 1982, ESICM focuses on the support and promotion of the advancement of knowledge in intensive care medicine, in particular in fostering the highest standards of multidisciplinary care of critically ill patients and their families through education, research and professional development. ESICM LIVES 2017 is one of the leading critical care congresses in Europe, offering a unique, multidisciplinary approach to caring for the critically ill. www.esicm.org
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 44 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial – a multi-center, randomized controlled study that has demonstrated the safety and efficacy of free hemoglobin reduction with intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery. In 2017, the Company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval. CytoSorb® has been used safely in more than 27,000 human treatments to date.
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 $20 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), and others. The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued U.S. patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com, and 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, 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 3, 2017, 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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