Company Press Releases Back
CytoSorbents Corporation Achieves ISO 13485 Certification
Monday September 27, 2010
Monmouth Junction, NJ – (September 27, 2010) – CytoSorbents Corporation (OTCBB:CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, announced the achievement of ISO 13485:2003 Full Quality Systems certification, a major milestone. ISO 13485 is 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 European Union (E.U.) It is a regulatory requirement of the E.U.’s Medical Device Directive and an important step toward attaining European CE Mark approval.
Dr. Phillip Chan, Chief Executive Officer, stated “We are very pleased to have attained this key milestone. ISO 13485 certification confirms that our manufacturing and quality systems meet the same high standards required of other major US medical device companies selling into Europe. Of the possible options, Full Quality Systems certification is the most stringent and efficient route to CE Mark approval for CytoSorb™ and other future CytoSorbents products. When coupled with CE Mark approval, ISO 13485 certification will allow CytoSorbents to commercialize its products in the E.U. market and other countries that recognize the ISO 13485 and CE Mark standards.”
About CytoSorbents and CytoSorb™
CytoSorbents Corporation, and its operating subsidiary CytoSorbents, Inc., is a critical care focused therapeutic device company in clinical trials to treat severe sepsis, often called “overwhelming infection”, with a novel blood purification device called CytoSorb™. Severe sepsis afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, 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 currently conducting its European Sepsis Trial – a multi-center, randomized, controlled clinical trial using CytoSorb™ to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Pending a successful trial, the Company will seek CE Mark approval and commercialization of CytoSorb™ in the European Union. 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 other. CytoSorb™ is one of a number of different resins designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others. Additional information is available for download on the Company's website: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 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 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 April 9, 2010, which is available at http://www.sec.gov.
(732) 329-8885 ext. 816
Source: CytoSorbents Corporation (fka MedaSorb Technologies Corporation)