WALTHAM, Mass., April 15 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. today announced that it has commenced the marketing authorization process in the European Union to pursue CE Marking the SEPET(TM) Liver Assist Device. The Company has engaged the British Standards Institute (BSI), one of the leading notified bodies in Europe, to assist the Company in its effort to obtain a CE Mark for SEPET, which is a sterile, disposable cartridge with proprietary membrane permeability characteristics for use in treating patients with chronic liver failure. CE Marking indicates that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation and allows sale of the product within the European Union (28 countries) and the European Free Trade Association (3 countries).
"We are pleased to announce this arrangement with BSI, and look forward to advancing our market approval and product acceptance strategy for SEPET in Europe," commented Shawn Cain, President and Chief Executive Officer of Arbios. "Importantly, based on guidance from BSI, we will seek approval of SEPET using data from our recently completed feasibility trial. If no additional clinical data are necessary, and if we meet all the requirements for CE Marking, we believe that our CE Mark filing for SEPET will be completed by the beginning of 2009. We are also seeking a European distribution, marketing, and sales partner to assist us in introducing SEPET into the European market," Mr. Cain added.
About Arbios' SEPET(TM) Liver Assist Device
The SEPET(TM) Liver Assist Device is a sterile, disposable cartridge containing microporous hollow fibers with proprietary permeability characteristics. When a patient's blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (e.g., hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration). These substances would otherwise progressively accumulate in the patient's bloodstream during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver, lungs and other organs, including the brain and kidneys, and suppressing the function and regeneration of the liver. SEPET is designed for use with standard blood dialysis systems available in hospital intensive care units.
According to the American Liver Foundation, liver disease is among the top seven causes of death in adults in the United States between the ages of 25 and 64. In fact, one out of every 10 Americans has some form of liver disease. There is currently no satisfactory therapy available to treat patients in liver failure, other than maintenance and monitoring of vital functions and keeping patients stable through provision of intravenous fluids and blood products, administration of antibiotics and support of vital functions, such as respiration.
About Arbios Systems
Arbios Systems, Inc. is developing proprietary medical devices and cell-based therapies to enhance the survival of millions of patients each year who experience, or are at risk for, life-threatening episodes of liver failure. The Arbios product candidate portfolio includes the SEPET(TM) Liver Assist Device, a novel blood purification therapy that is designed to provide enhanced "liver dialysis," and the HepatAssist(TM) Cell-Based Liver Support System, a bio-artificial liver that combines blood detoxification with liver cell therapy to replace whole liver function in patients with the most severe forms of liver failure. For more information on the Company, please visit http://www.arbios.com .
All statements in this press release that are not historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding: the Company's intention to seek approval of SEPET using data from its recently completed feasibility trial and the Company's belief that SEPET could possibly be available for sale in Europe by early 2009. Such statements represent the judgment of the Company's management as of this date are subject to the risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to the ability of the Company to successfully and timely obtain a CE Mark for SEPET, the goals and results of clinical trials, compliance with regulatory requirements, labeling of the Company's products, the need for subsequent substantial additional financing to complete clinical development of its products, future markets and demand for the Company's products, and the Company's ability to successfully market its products and technologies. These risks and other additional factors affecting these statements and the Company's business are discussed in the Company's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2007, and to our subsequent Quarterly Reports on Form 10-Q, all as filed with the Securities and Exchange Commission, and in other filings made by the Company with the Securities and Exchange Commission from time to time. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based, except as may be required by law. SEPET(TM) and HepatAssist(TM) are trademarks of Arbios Systems, Inc.
CONTACT: Shawn Cain, President and CEO, +1-781-839-7292, or Scott Hayashi,
CFO, +1-626-356-3105, both of Arbios Systems, Inc.; or Investors, Lisa
Wilson, +1-212-759-3929, or Media, Doug MacDougall & Kari Watson,
+1-781-235-3060, all for Arbios Systems, Inc.
Web site: http://www.arbios.com/