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Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device
Date:5/12/2008

ate the pivotal trial may enable us to raise the capital needed to implement our clinical and regulatory plans for SEPET."

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(TM) 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 - 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 purificatio
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SOURCE Arbios Systems, Inc.
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