Arbios Provides Clinical Strategy for SEPET(TM) Piv...( - Data Sufficient to Advanc...),Health

- Data Sufficient to Advance Product to Pivotal Phase -

WALTHAM, Mass., Sept. 25 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. (OTC Bulletin Board: ABOS), today provided its clinical trial strategy for the SEPET(TM) Liver Assist Device including information regarding a pre-pivotal phase meeting with the US Food and Drug Administration (FDA). In a meeting held between Arbios and the FDA's Office for Device Evaluation and Research (ODE), the FDA indicated that, pending receipt of a final report, SEPET(TM) has met the required feasibility trial objectives and Arbios may advance its clinical development program to the pivotal phase. In response to the presentation of a pivotal trial design, the FDA provided the Company with comment and further indicated that a single pivotal study may be acceptable to the FDA, subject to a submission of a full clinical protocol to include additional information required in an Investigational Device Exemption (IDE) application. Arbios intends to file this information for review in the coming weeks, as a potential final step toward FDA authorization of a pivotal clinical trial for SEPET(TM).

"We are pleased with the discussion at our recent meeting with the FDA regarding our SEPET(TM) Liver Assist Device," commented Shawn Cain, Interim President and Chief Executive Officer of Arbios. "Following the results of our feasibility clinical trial, the FDA review group said that SEPET(TM) could advance into a multicenter pivotal clinical trial. We appear to be on track for near-term initiation of a pivotal registration trial of SEPET(TM) in the US."

We expect the proposed pivotal clinical trial would enroll 80 patients in the principal randomized, controlled phase of the study, targeted to achieve the primary endpoint of the trial, which is a clinically significant reduction in hepatic encephalopathy. Patients receiving SEPET(TM) treatment plus standard medical care would be compared to control patients receiving
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