Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Ass... (n therapy that providesenhanced liver d...)

Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device

Date:5/12/2008

n 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, please visit http://www.arbios.com.

This press release contains forward-looking statements, including, but not limited to, statements regarding the Company's belief that, the pivotal trial, if successful, should support approval of SEPET in the United States and marketing efforts in the United States and the European Union, the Company's expectations with respect to the timing, design and implementation of the pivotal trial, including the Company's plans with respect to seeking approvals for sites to conduct the pivotal trial, and the Company's hope that the FDA's approval to initiate the pivotal trial, may enable us to raise the capital needed to implement our clinical and regulatory plans for SEPET. The forward- looking statements contained in this press release involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the Company's ability to timely and successfully raise capital, the goals and results of clinical trials, compliance with regulatory requirements, the likelihood of obtaining marketing approval, 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 Arbios' ability to successfully market its products and technologies. These statements represent the judgment of Arbios' management as of this date and are subject to risks and uncertainties that could adversely affect the Company. Arbios cautio
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SOURCE Arbios Systems, Inc.
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Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Ass...(n therapy that providesenhanced liver d...),Health