MONMOUTH JUNCTION, N.J., Oct. 5, 2015 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to reduce deadly uncontrolled inflammation in hospitalized patients around the world, reports on continued growth and adoption of CytoSorb® at its successful 2nd International CytoSorb Users Meeting held in Berlin, Germany on October 2, 2015.
This was one of the largest gatherings of worldwide CytoSorb® users, distributors and partners in the Company’s history, with 110 participants from 18 countries globally. The meeting was an excellent networking event and an opportunity for colleagues to present and discuss recent case reports, case studies and, for the first time, preliminary or interim results from several controlled pilot studies. This planned progression to increased levels of evidence-based medicine is part of the Company’s clinical development strategy.
Key findings of the symposium were:
- Continued and clear evidence of safety in now more than 8,000 human CytoSorb® treatments in thousands of patients
- These treatments have been in a broad range of serious conditions such as severe sepsis, septic shock, trauma, rhabdomyolysis, pancreatitis, lung injury, liver and kidney transplantation, liver failure, influenza, cardiac surgery, post-operative inflammation, toxic shock syndrome, necrotizing fasciitis, and many others
- CytoSorb® therapy has contributed to patients’ clinical stability in many ways including:
- Improved hemodynamic stability
- Less need for vasopressors
- Improvement of metabolic parameters
- New successful uses include the treatment of common tropical diseases such as Dengue Fever (50 to 100 million infections worldwide annually) and Scrub Typhus (1 million infections worldwide annually)
- Recent treatments using CytoSorb® in liver failure patients have confirmed previous reports of equivalent or superior removal of hepatic toxins from blood, compared with existing liver dialysis therapies. This opens up major new potential markets in the treatment of viral hepatitis, alcoholic liver disease, and others
- CytoSorb® is easy to implement and use without serious technical complications in a wide range of blood pump systems, including dialysis, continuous renal replacement therapy (CRRT), extracorporeal membrane oxygenation (ECMO), and cardiopulmonary bypass
- Preliminary results from two completed cardiac surgery randomized controlled pilot studies from University of Hamburg-Eppendorf (N=20) and Medical University of Vienna (N=37), where CytoSorb® was used intra-operatively in a heart-lung machine bypass circuit, in low-risk cardiac surgery patients, and interim data from 142 cardiac surgery patients in a 3-arm trial at University of Cologne, comparing inflammatory mediators in patients undergoing off-pump surgery (n=21), on-pump surgery without CytoSorb® (n=61), and on-pump surgery with CytoSorb® (N=60) demonstrate:
- Therapy was well-tolerated and safe without device-related issues, including no removal of heparin, no bleeding or coagulation issues, no device set-up concerns
- Preliminary initial cytokine data show that some cytokines are removed in CytoSorb® treated patients compared to control, but overall inflammation in these shorter, lower risk surgeries, was not high. Cytokine and other inflammatory mediator analysis is continuing. Similarly, the risk of adverse events and mortality were low in both treatment and control groups
- Now that safety has been determined, all three trial sites are interested in extending their treatment experience to complex cardiac surgery, where the risk of inflammation and adverse events are much higher
- The results support feasibility and safety in REFRESH I, a US based study that has begun to screen patients where CytoSorb® is being evaluated to safely reduce plasma free hemoglobin during complex cardiac surgery
- These clinical data on safety, ease of use, and feasibility are expected to increase the confidence of the cardiac surgery community to treat a wide range of open heart surgery patients in need with CytoSorb®
- CytoSorb® therapy is being used in “real-world” situations much earlier as an adjunctive therapy to control deadly inflammation and treat life-threatening illnesses, rather than as a therapy of “last resort”
Dr. Phillip Chan, CEO of CytoSorbents stated, “We are pleased with the expanding clinical experience with CytoSorb® around the world. We are currently seeking permission from our various investigators to make presentations and data public from the meeting, given that we did not sponsor these studies and do not own the data. Many are in the process of submitting their results for publication, so we hope in one way or another, data from these studies will be made available in the future.”
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused immunotherapy company using blood purification to control severe inflammation — with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome. CytoSorb®, the Company’s flagship product, is approved in the European Union with distribution in 31 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. 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’ 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. CytoSorbents has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company’s websites: http://www.cytosorbents.com and http://www.cytosorb.com
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 31, 2015, 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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