MONMOUTH JUNCTION, N.J. and BERLIN, April 24, 2019 /PRNewswire/ -- CytoSorbents Corporation (CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, shares highlights from the recent 6th International CytoSorb Users' Meeting and the Satellite Symposium at the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels, Belgium, and the 8th Annual EuroELSO 2019 Conference held recently in Barcelona, Spain.
CytoSorbents was a major sponsor at the 8th EuroELSO 2019 Congress held recently in Barcelona, Spain that brought together more than 1,500 intensivists, cardiac surgeons, cardiologists, pediatric and neonatology specialists, perfusionists, and ICU nurses from around the world, to obtain vital updates in the use of extracorporeal membrane oxygenation (ECMO) and other extracorporeal support technologies to help treat critically ill patients.
EuroELSO is the European Chapter of the Extracorporeal Life Support Organization (ELSO), an international non-profit consortium of health care institutions dedicated to the development and evaluation of novel therapies for support of failing organ systems. Established in Ann Arbor, MI, USA in 1989, ELSO initially grew from the work of our former Chief Medical Officer, Dr. Robert Bartlett, the pioneer of ECMO, and the 2019 Recipient of the Lifetime Achievement Award from the Society of Critical Care Medicine (SCCM). Please click on this link to see an inspirational keynote speech delivered by Dr. Bartlett on the history of ECMO at the 48th Critical Care Congress of SCCM this year.
Dr. Bartlett commented, "The combination of ECMO and systemic inflammatory mediator reduction with CytoSorb has the potential to be an exciting new innovation in treating lung injury, shock and other complications. The data combining the two therapies are very encouraging, especially in sepsis. I look forward to seeing the story strengthen as we gain greater clinical experience."
CytoSorbents offered a two-day live presentation workshop during the conference, which was attended by approximately 100 medical specialists and led by top perfusionists from Switzerland and Italy with experts from CytoSorbents, to discuss and demonstrate the use of ECMO and CytoSorb as a life-saving therapy.
The ISICEM is one of Europe's largest critical care conferences, attracting over six thousand specialists from 100 countries, with 237 speakers delivering 1,161 presentations in 195 sessions. The 6th International CytoSorb Users' Meeting was held at the beginning of the conference, with videotaped sessions here, and pictures of the event here, and included:
- Welcome address – Prof. Jean-Louis Vincent, Chairman of the ISICEM, Brussels, Belgium
- Opening lecture: Past, present and future of CytoSorb – Prof. Claudio Ronco, Vicenza, Italy
- Speakers and panel discussions
Some of the highlighted topics and presentations included:
- CytoSorb as an Immunomodulating Therapy: Prof. Claudio Ronco, St. Bortolo Hospital, Vicenza, Italy summarized the current knowledge supporting the use of CytoSorb to treat sepsis, including its role in reducing inflammation, cytokines, toxins, capillary leak syndrome, and restoring immune homeostasis. He concluded that the treatment of sepsis may benefit from a combined therapeutic approach involving antibiotics and various blood purification technologies, including CytoSorb.
- Reversal of Septic Shock: Dr. Yatin Mehta, Delhi, India, presented data supporting the use of CytoSorb to improve hemodynamic stability and reduce vasopressor usage in a large cohort of 100 septic shock patients from India, especially when the therapy was started within the first 48 hours after the development of septic shock.
- Post-Cardiac Arrest Resuscitation: eCPR (extracorporeal cardio-pulmonary resuscitation with veno-arterial extra-corporeal membrane oxygenation or VA-ECMO) is a vitally important new innovation to restore blood flow in patients whose hearts suddenly stop and often die. However, even when blood flow is restored, massive inflammation and cytokine storm can destabilize and potentially kill the patient. Prof. Daniel Dürschmied, Freiburg-Bad Krozingen, Germany presented data on the first 25 patients treated with both CytoSorb and eCPR at his institution, demonstrating a more than doubling of survival compared to that predicted. Setup was easy, there were no severe complications, and there was a rapid decrease in IL-6 and lactate. He also announced the start of a new 30-patient randomized controlled pilot study evaluating eCPR with or without CytoSorb.
- Transplant Organ Rehabilitation: Dr. Ilker Iskender, Zurich, Switzerland demonstrated that cytokine reduction with CytoSorb in an ex vivo porcine lung perfusion model improved lung function and decreased pulmonary edema and electrolyte imbalances, supporting a potential role of the therapy in lung and other organ transplant.
- Necrotizing Fasciitis: Prof. Didier Payen, Paris, France emphasized the ability of CytoSorb to reduce a wide spectrum of cytokines, bacterial toxins, and other damage and pathogen associated inflammatory mediators, and how this could be beneficial in treating necrotizing fasciitis (commonly referred to as "flesh eating bacterial infection") and soft tissue infections caused by toxin-producing Staphylococcus and Streptococcus bacteria.
- International CytoSorb Registry Update: Prof. Frank Brunkhorst, Jena, Germany, provided an update on the 7th interim analysis of the International CytoSorb Registry covering 599 patients, of which 348 patients had sepsis or septic shock. Among these patients, CytoSorb use showed a decrease in observed mortality vs expected mortality amongst very sick patients, while those treated less than 12 hours after the diagnosis of septic shock had a higher survival rate than those treated after 12 hours.
- Effect on Coagulation Factors and Antibiotics: Dr. Antoine Schneider, Lausanne, Switzerland, presented data from a 30-patient randomized controlled pilot study in cardiac surgery, showing no significant change in the levels of the vast majority of coagulation factors – supporting the safety of CytoSorb during cardiac surgery. In addition, he presented important new experimental porcine data suggesting that the removal of a number of key antibiotics by CytoSorb was small compared to control pigs, and could be mitigated by increasing the antibiotic dose, further supporting the safety of CytoSorb in septic patients.
- Microcirculation: Prof. Can Ince, Amsterdam, Netherlands discussed the available data supporting the benefit of CytoSorb in improving microcirculation, a key factor in protecting and restoring organ function, and announced the initiation of a new trial to evaluate this.
- Risk Stratification CytoScoreTM: Dr. Klaus Kogelmann, Emden, Germany introduced a new risk stratification algorithm based on vasopressor use, and clinical and laboratory data, called the CytoScore™, designed to help clinicians decide when to start CytoSorb therapy and how long to continue treatment. He again reiterated the need to begin treatment early.
- Liver Failure: Prof. Dana Tomescu, Bucharest, Romania discussed her experience in using CytoSorb to treat acute exacerbations of chronic liver failure triggered by infection, with significant reductions in bilirubin and without bleeding complications.
- Rhabdomyolysis: Prof. Jacques Duranteau, Paris, France reviewed how high levels of myoglobin released by damaged muscle following severe trauma can lead rapidly to acute kidney injury, and how CytoSorb is used to help prevent this.
- Extracorporeal Membrane Oxygenation (ECMO): Prof. Federico Pappalardo, Milan, Italy recommended consideration of CytoSorb as a primary adjunct to ECMO therapy to help stabilize patients, particular those suffering from shock, hyperinflammation, and hemolysis generated by ECMO.
- Children: Dr. Andrey Rybalko, Moscow, Russia cited numerous successes when CytoSorb was used in adolescents and young children. He also presented two cases when CytoSorb was used on infants between 10-20 pounds, to treat acute liver failure, and to treat multiple organ failure and hemolysis during ECMO following a complicated post-operative recovery from heart surgery.
- Sepsis and Chronic Lupus: Dr. Axel Nierhaus, Hamburg, Germany presented a special case of a young woman with a long history of a serious autoimmune disease called lupus, on chronic immune suppression, who was admitted with septic shock and multiple organ failure due to an E. coli soft tissue groin and thigh infection. She was successfully treated with aggressive use of CytoSorb, and was again successfully treated with CytoSorb following a bout of Klebsiella pneumonia a week later, leading to her full recovery.
CytoSorbents also was a Platinum Sponsor and Exhibitor at ISICEM, and hosted a Satellite Symposium that attracted approximately 450 attendees from 25 countries, with the following agenda:
"Update on the Role of CytoSorb Hemoadsorption in Intensive Care and Emergency Medicine"
Chairs: Prof. Lui Forni, Surrey, UK and Prof. Claus Krenn, Vienna, Austria
- Rationale for hemoadsorption and review of latest scientific results
Prof. Herwig Gerlach, Berlin, Germany
- Impact on microvascular perfusion in septic shock
Prof. Abele Donati, Ancona, Italy
- Combination of ECMO with CytoSorb – Chances to improve outcome
Prof. Daniel Dürschmied, Freiburg, Germany
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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 55 countries around the world, as an 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. 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 that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 56,000 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 nearly $26 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 (USSOCOM), and others. The Company has numerous products under development based upon this unique patented blood purification technology 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 7, 2019, 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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