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CytoSorbents Reports on Successful 3rd International CytoSorb® Users Meeting

March 22, 2016

Continued Flow of Data Correlating Positive Clinical Improvements with CytoSorb® Usage

BRUSSELS, BELGIUM, March 16, 2016 – 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.

Proceedings 3rd International CytoSorb Users Meeting

proceedings

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.”

 

Proceedings 3rd International CytoSorb® Users Meeting

proceedings

Presentations

Introduction to the CytoSorb Therapy

John Kellum, Pittsburgh, USA

A comprehensive introduction on blood purification in general and on the CytoSorb therapy in particular, the underlying operating principle derived from preclinical data and its potential benefit in fighting life-threatening infections.

Early cytokine adsorption in septic shock: The ACCES trial

Zsolt Molnar, Szeged, Hungary

Overview on the evolution from a localized insult to life-threatening organ dysfunction caused by dysregulated host response, main conclusions from current CytoSorb evidence and data gained so far for the ACESS trial (Adsorbtion of Cytokines Early in Septic Shock)

Outcome observations in early vs late use in septic shock patients

M Drüner, Emden, Germany

Description of the clinical effects of CytoSorb therapy in septic shock and presentation of outcome observations in early vs. late use.

In Vitro Adsorption of a Broad Spectrum of Sepsis Inflammatory Mediators with CytoSorb

M Gruda, New Jersey, USA

Presentation of brand new in vitro data on the broad-spectrum removal capability of inflammatory mediators including PAMPS and DAMPS by CytoSorb

Quantification and kinetics of bilirubin removal with CytoSorb

S Faenza, Bologna, Italy

Presentation of in vitro results on bilirubin removal and clinical experience with CytoSorb in patients with liver transplantation and liver insufficiency.

Role of CytoSorb in the therapy of severe acute pancreatitis

A Faltlhauser, Weiden, Germany

Presentation of three cases of acute severe pancreatitis treated with CytoSorb and introduction of the upcoming PACIFIC trial investigating CytoSorb in these patients in a controlled fashion.

Treatment support of rhabdomyolysis patients by CytoSorb

D Fries, Innsbruck, Austria

Experience with CytoSorb in patients with severe myoglobinemia due to rhabdomyolysis.

Treatment experience with CytoSorb in severely burnt patients

C Calin, Bucharest, Romania

Experience with CytoSorb in three severely burnt patients after a fireworks accident at a Bucharest nightclub.

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