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Arbios Announces Positive Preclinical Data for SEPET -- An Extracorporeal Blood Purification Device for Treatment of Patients in Liver Failure.


LOS ANGELES -- Arbios Systems Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:ABOS ABOS American Board of Orthopaedic Surgery ), a biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 device company engaged in the development of proprietary liver assist technologies useful in the treatment of acute liver failure Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease (such as jaundice), and indicates that the liver has sustained severe damage (loss of function of 80-90% of liver cells). , announced today the results of two preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
 using its proprietary SEPET SEPET System Electrical Performance and Evaluation Test (TM) device. The SEPET(TM) device is a single-use hollow-fiber cartridge designed to provide extracorporeal extracorporeal /ex·tra·cor·po·re·al/ (-kor-por´e-al) situated or occurring outside the body.

ex·tra·cor·po·re·al
adj.
Situated or occurring outside the body.
 blood purification therapy for patients with acute liver failure. SEPET(TM) is designed to work with standard kidney dialysis machines for removal of the plasma fraction in blood containing toxins of hepatic failure.

One of the pre-clinical studies was designed to examine the effect of SEPET(TM) therapy on safety profile, survival time and blood chemistries in pigs with end-stage liver failure due to liver ischemia and necrosis (liver cell death). Sixteen hours after induction of liver necrosis, six pigs underwent treatment with SEPET(TM) and six control animals underwent control therapy without SEPET(TM) (i.e., plasma separation and re-infusion of the separated plasma back to the treated animals without the SEPET(TM) cartridge). A standard PRISMA PRISMA Probing Rotation and Interior of Stars: Microvariability and Activity
PRISMA Preparation of Regional Industry for the Single Market (EU) 
 kidney dialysis system (Gambro GmbH, Germany) was used as the platform for both arms of the study.

The results of this study indicate that treatment of pigs with acute liver failure with the SEPET(TM) device is safe and effective in prolonging survival. All treatments with SEPET(TM) were well tolerated and completed as scheduled. Pigs treated with SEPET(TM) remained hemodynamically stable throughout the treatment period and showed no abnormal changes in routine hematological hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 tests. Most noteworthy, however, was the statistically significant survival time of the pigs treated with SEPET(TM). The survival time was prolonged with the SEPET(TM) therapy even though certain blood chemistry data indicated that pigs to be treated with SEPET(TM) were in a worse condition than the control animals at the start of the study. The statistically significant increase in survival time (P less than 0.039) was associated with beneficial therapeutic effects of SEPET(TM) on blood pressure, brain swelling and the removal of ammonia.

A second study of the SEPET(TM) cartridge involving treatment of six normal pigs to determine safety (blood and biological compatibility) indicated that SEPET(TM) is bio-and blood compatible.

Commenting on the study, Dr. Jacek Rozga, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Arbios Systems, stated, "Based on the pre-clinical data we have received to date, there is strong experimental evidence that SEPET(TM) therapy has an important clinical potential in the treatment of patients with liver failure. To date, a device such as SEPET(TM) has not been developed for patients suffering from this debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 and ultimately fatal disease. We now plan on discussing with the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 the regulatory approach to be followed to gain approval to bring SEPET(TM) therapy to the marketplace."

About Arbios

Arbios Systems Inc. is a biomedical device company that, through its wholly-owned subsidiary, Arbios Technologies Inc., is engaged in the discovery, acquisition and development of proprietary liver assist devices and new technologies useful in the diagnosis and treatment of acute liver failure. Arbios' products in development include; SEPET(TM), a novel blood purification therapy employing selective plasma filtration therapy; BAL (1) (Basic Assembly Language) The assembly language for the IBM 370/3000/4000 mainframe series.

(2) (Branch And Link) An instruction used to transfer control to another part of the program.

BAL - Basic Assembly Language
 2004, a first-generation bioartificial liver (BAL) recently acquired from Circe Biomedical Inc. and LIVERAID(TM), a second-generation BAL in which liver cell therapy and sorbent-based hemodiafiltration are integrated in the company's proprietary three-compartment cartridge with fiber-in-fiber geometry.

At present no effective direct treatment for liver failure is available, and patients must receive a liver transplant or endure prolonged hospitalization with a significant mortality rate. However, only a small percentage of liver failure patients receive a transplant due to shortage of donor livers. Further, many patients cannot be transplanted because of alcohol or drug abuse, infection, cancer, cardiovascular disease, etc. There is, therefore, an urgent need for artificial means of liver assistance to facilitate recovery from liver failure without a transplant.

This press release contains forward-looking statements that 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 ability of Arbios to complete the development of SEPET(TM), the need for subsequent substantial additional financing to complete clinical development of SEPET(TM) and Arbios' ability to successfully market its SEPET(TM) products and technologies. These statements represent the judgment of Arbios' management as of this date and are subject to risks and uncertainties that could materially affect the company. The company does not undertake any obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. SEPET(TM) and LIVERAID are trademarks of Arbios Technologies Inc., the subsidiary of Arbios Systems Inc.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 21, 2004
Words:793
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