CytoSorbents Corporation Reports Second Quarter 2011 Financial Results Print
By Marketwire - Medical and Healthcare   
Tuesday, 16 August 2011 09:31

SOURCE: CytoSorbents Corporation

CytoSorbents Corporation Reports Second Quarter 2011 Financial Results

MONMOUTH JUNCTION, NJ--(Marketwire - Aug 16, 2011) - CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to treat life-threatening illnesses, announced its financial results for the second quarter of fiscal 2011.

The Company's research and development costs were $854,827 and $352,888 for the three months ended June 30, 2011 and 2010, respectively. The Company had losses of $1,341,182 and $676,278 for the three months ended June 30, 2011 and 2010, respectively. Historically, the Company's losses have resulted principally from costs incurred in the research and development of its polymer technology, and general and administrative expenses, which together were $1,046,629 and $546,931 for the three month periods ended June 30, 2011 and 2010, respectively. The Company has incurred additional expenses related to the ramp in manufacturing of CytoSorb cartridges under the CE Mark for clinical use. Cash and cash equivalents were $3,416,525 as of June 30, 2011.

For additional information and full financial results, please see our Form 10-Q filed with the SEC on August 15, 2011, which is available at www.sec.gov.

Dr. Phillip Chan, Chief Executive Officer, stated, "We are on track to begin our controlled market release of CytoSorb™ in Germany next month as we discussed in our shareholder letter in June. We expect this phase to take 3-6 months and currently plan an official launch in Germany in early 2012. The Company is executing well on a multi-prong strategy that is coordinating manufacturing, reimbursement, marketing, hiring of key personnel, and creating market awareness of CytoSorb™. Manufacturing of CytoSorb™ under the CE Mark is progressing well, with an outstanding, fully-trained team capable of producing enough product to supply our near-term needs. We also recently passed our annual ISO 13485:2003 certification site audit, confirming that our manufacturing and

quality systems conform to international standards. Based on a reimbursement analysis completed by a third-party expert team in Germany, there is a clear path for reimbursement for CytoSorb as we enter the German market. Our search for a head of Sales and

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Marketing in Germany has also gone well, and look to finalize that position soon. We have a busy conference schedule in September where we look to formally introduce CytoSorb™ to clinicians in Europe. Lastly, after reporting the achievement of our primary endpoint of IL-6 reduction in our European Sepsis Trial, we are nearing completion of our analysis of secondary and
exploratory clinical endpoints of the trial and will be discussing those results shortly. Overall, we are excited to finally begin commercializing CytoSorb™ and getting it in the hands of critical care physicians for real-world usage in life-threatening illnesses."

About CytoSorbents and CytoSorb™

CytoSorbents Corporation is a development stage, critical care focused therapeutic device company using blood purification to treat life threatening illnesses such as severe sepsis, the end result of "overwhelming infection," with a novel blood purification device called CytoSorb™. Severe sepsis afflicts more than 1 million people in the United States (U.S.), 1.5 million people in the European Union (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. Severe sepsis is typically triggered by bacterial infections like pneumonia, or viral infections like influenza. However, it is the body's abnormal immune response to the trigger that leads to severe inflammation and the unregulated, massive production of cytokines, often called "cytokine storm," that then causes multi-organ failure and often death. CytoSorb™ is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. 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. The Company is finalizing its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using CytoSorb™ and has achieved its targeted enrollment with 100 patients with severe sepsis or septic shock in the setting of respiratory failure. Importantly, cytokine reduction via CytoSorb™ has broad applicability to a number of other critical care diseases where cytokine storm plays a detrimental role, including burn and smoke inhalation injury, trauma, acute respiratory distress syndrome, advanced influenza, acute pancreatitis and others. In March 2011, the Company successfully achieved CE Mark approval to market its CytoSorb™ device as an extracorporeal cytokine filter to be used in clinical situations where excessive cytokine levels exist. CytoSorbents has also achieved 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 begin commercializing its product in Europe and then seek to commence clinical trials in the U.S. for 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

Forward-Looking Statements

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.

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