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Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
Date:9/25/2007

treatment with standard medical care alone, with 1:1 randomization between the two groups. An adaptive design feature, increasingly common in FDA product approval trials, would permit the size of the trial to be increased after enrollment of the first 80 patients if the primary efficacy endpoint has not yet reached statistical significance but has shown a positive trend. A further and final potential extension of the trial would also be permitted to achieve statistical significance of one or more secondary endpoints of the trial relating to clinical, functional, and reimbursement advantages for SEPET(TM)-treated patients.

In parallel with the US-oriented pivotal clinical trial of the SEPET(TM) Liver Assist Device, Arbios intends to advance the product toward European market approval under the CE Mark. Arbios believes that such registration of SEPET(TM) could be accomplished significantly earlier than registration in the US, because a randomized, controlled trial is customarily not required under the European Medical Device Directives. Arbios plans to involve several leading European medical centers in the pivotal trial, so that the results of the trial will be relevant to both US and European patients and may be used to support medical payor (both private sector and government) coverage in both regions.

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
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SOURCE Arbios Systems, Inc.
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