-- Securing FDA approval to commence a pivotal clinical trial of the SEPET(TM) device in the US and Europe.

-- Securing the required European approvals to begin the first segment of the SEPET(TM) pivotal trial in Rostock, Germany.


-- Commencing work towards approval to market SEPET(TM) in the European Union (through a CE Mark).

"We remain confident in the benefits that SEPET(TM) may offer patients with chronic liver disease," noted Dr. John Vierling, M.D., FACP, Chairman of Arbios and Professor of Medicine and Surgery and Chief of Hepatology at the Baylor College of Medicine. "Hepatic encephalopathy represents one of the most frequent complications of cirrhosis necessitating hospitalization, and SEPET's rapid time to a sustained two-stage improvement of hepatic encephalopathy observed in the SEPET(TM) Phase 1 FDA trial exceeded our expectations, providing us with much hope for the clinical success of SEPET's pivotal trial," further commented Dr. Vierling. "Unfortunately, unless in the near future we are able obtain additional operating funds, or unless we are able to otherwise enter into a strategic transaction, Arbios will not realize a return on its investment in this company's important and valuable assets and technologies."

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.

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 provides 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, visit http://www.arbios.com.


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