BRUSSELS, March 16, 2016 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in critical care immunotherapy commercializing its CytoSorb® blood filtration technology to reduce deadly uncontrolled inflammation in critically-ill and cardiac surgery patients around the world, announced the conclusion of its successful 3rd International CytoSorb Users Meeting in Brussels, Belgium. Held one day ahead of the International Symposium of Intensive Care and Emergency Medicine (ISICEM), one of the largest international critical care conferences, the Users Meeting brought together 107 members of the CytoSorb® community from a total of 23 countries, to share data from many new pre-clinical and clinical studies. To date, more than 10,000 CytoSorb® treatments have been performed in thousands of patients.
Some of the most important findings include:
- In addition to cytokines, CytoSorb® has been shown to remove a broad range of other inflammatory mediators called pathogen (PAMPs) and damage (DAMPs) associated molecular patterns, which play an important role in inducing systemic inflammation in a wide range of critical illnesses. PAMPs are toxins produced or released by bacteria, viruses and fungi that can cause tissue injury or inflammation. DAMPs originate from damaged or necrotic tissue, like HMGB-1, S100 protein, procalcitonin, and activated complement, and are also toxic in excessive quantities. DAMPs and PAMPs are a leading focus of international research on the uncontrolled systemic inflammatory response syndrome
- The intra-operative application of CytoSorb® in an ongoing three-arm randomized controlled open heart surgery study in Cologne, Germany was associated with a statistically significant decrease in sternal wound infections, a major complication of cardiac surgery with a total of 165 patients enrolled to date
- In a cardiac surgery evaluation performed at Angers, France, CytoSorb® was used intra-operatively on 10 patients undergoing a diverse set of complex cardiac surgery procedures, similar to patients in the U.S. REFRESH I trial. All ten patients did well, with CytoSorb® credited with helping to stabilize two hemodynamically unstable patients going into extensive and complicated surgery, and reducing the need for vasopressors and extensive, costly, and risky extracorporeal life support that would normally be required in the post-operative period in these patients
- Four different independent septic shock case series totaling more than 50 treated patients with severe or refractory shock, have all reported a consistent stabilization of the cardiovascular system following treatment, with a reduction in vasopressor support
- Several studies have suggested that early intervention with aggressive treatment is superior to late intervention in terms of clinical outcomes
- New systematic data, confirming previous observations, that CytoSorb® can effectively remove liver toxins such as bilirubin, in some cases better than established liver support therapies
- All of the presenters once again reiterated the safety of the device in all reported applications
- An update on the start of the PACIFICA trial, using CytoSorb to treat severe acute pancreatitis
- Reiteration that CytoSorb® is a useful therapy to reduce extensive myoglobinemia that occurs due to rhabdomyolysis due to trauma, burns, or infection
Dr. Phillip Chan, Chief Executive Officer, stated, “We are pleased to report this initial summary of the 3rd International CytoSorb® Users Meeting. The purpose of these meetings is to disseminate the lessons learned from experienced users so that we can ensure uniformity of treatment and that all users worldwide benefit from the latest information. Although there is always more to learn, we are pleased to see that when CytoSorb® is used in the right way, users continue to experience positive results with the treatment. As we have done in the past, a more detailed report of this meeting will be published in a proceedings booklet that will be available at our CytoSorb website.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorb® is approved in the European Union with distribution in 32 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. CytoSorb® has been used safely in more than 10,000 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. 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 HemoDefend™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company’s websites: https://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 9, 2016, 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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