Company Press Releases Back
CytoSorbents Announces New Statistical Analysis and Confirms Statistical Significance in 28-Day Mortality
Tuesday September 13, 2011
MONMOUTH JUNCTION, NJ--(September 13, 2011) - CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to treat life-threatening illnesses, commented on new data presented yesterday by Dr. Phillip Chan, Chief Executive Officer, at its investor presentation at the Rodman & Renshaw Global Investment Conference.
In a post-hoc analysis of patients with highly elevated IL-6 ( ≥ 1,000 pg/mL) or IL-1ra ( ≥ 16,000 pg/mL) levels from the Company's European Sepsis Trial, CytoSorb™ treatment resulted in a statistically significant reduction in 28-day all-cause mortality (0.0% treatment versus 62.5% control, p=0.03, n=6 treatment, 8 control). In addition, 60-day all-cause mortality also demonstrated a positive trend to benefit in CytoSorb™ treated patients (16.7% treatment versus 62.5% control, p=0.14, n=6 treatment, 8 control).
Dr. Chan stated, "We are pleased to announce that our third party bio-statistician just completed further analysis of our results and confirmed that those patients treated with CytoSorb™ in our trial with elevated IL-6 and IL-1ra achieved statistical significance for 28-day all-cause mortality. We look forward to confirming these very promising data in a small, prospective, randomized, controlled trial in sepsis patients with very high levels of either IL-6 or IL-1ra, where 28-day mortality is the primary endpoint."
An audio webcast and slides of the presentation can be found at: http://www.wsw.com/webcast/rrshq20/ctso
About CytoSorbents and CytoSorb™
CytoSorbents Corporation is a development stage, critical care-focused therapeutic device company using blood purification to treat life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption. In March 2011, CytoSorb™, the Company's flagship product, achieved European regulatory approval as an extracorporeal cytokine filter, and can now be sold throughout the European Union (E.U.) under the CE Mark to be used in cases where cytokines are elevated. To the Company's knowledge, this is the first E.U approved medical device to have the specific indication as a cytokine filter. The goal of CytoSorb™ is to modulate the immune system by removing excessive cytokines, often called "cytokine storm," in critically-ill patients that can lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death. Cytokine storm frequently occurs in fatal diseases commonly seen in medical and surgical intensive care units, such as severe sepsis and septic shock, acute respiratory distress syndrome, serious burn and smoke inhalation injury, trauma and pancreatitis. Current standard of care therapies are mainly supportive and do little to hasten disease recovery. CytoSorb™ represents a new generation of "active" therapies, designed to counter cytokine storm and prevent or mitigate organ failure, potentially helping patients to heal and recover faster, leading to better patient outcome and reduced overall treatment costs. In the Company's recently completed European Sepsis Trial, CytoSorb™ treatment resulted in a statistically significant reduction of a number of key cytokines in patients with severe sepsis or septic shock, and respiratory failure. This was associated with positive clinical improvements in high risk patients. Severe sepsis and septic shock afflicts more than 1 million people in the United States (U.S.), 1.5 million people in the E.U., and an estimated 18 million people worldwide each year, killing one in every three patients despite the best medical treatment. In the U.S., more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. CytoSorb™ therapy is simple yet elegant. As blood is pumped repeatedly through the CytoSorb™ cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. CytoSorb™ is currently manufactured under ISO 13485:2003 Full Quality Systems certification, an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive management systems in place to safely design, develop, manufacture and distribute medical devices in the E.U. Assuming availability of adequate and timely funding, and continued positive results from our clinical studies, the Company intends to commercialize CytoSorb™ in Europe and then seek to commence U.S.-based clinical trials to obtain U.S. regulatory approval. CytoSorb™ is one of a number of different resins the Company has designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy drugs during treatment of cancer with high dose regional chemotherapy, drug detoxification, and others. Additional information is available for download on the Company's website: www.cytosorbents.com http://www.cytosorbents.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. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and additional CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate and timely financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on March 31, 2011, which is available at http://www.sec.gov.
Chief Financial Officer
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Source: CytoSorbents Corporation