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ARBIOS ANNOUNCES POSITIVE PRECLINICAL DATA FOR SEPET.


Arbios Systems, Inc. (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 BB: ABOS ABOS American Board of Orthopaedic Surgery ), Los Angeles, Calif., 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). , has announced the results of two preclinical studies using its proprietary SEPETTM device. The SEPETTM 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. SEPETTM 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 SEPETTM 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 SEPETTM and six control animals underwent control therapy without SEPETTM (i.e. plasma separation and re-infusion of the separated plasma back to the treated animals without the SEPETTM 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 SEPETTM device is safe and effective in prolonging survival. All treatments with SEPETTM were well tolerated and completed as scheduled. Pigs treated with SEPETTM 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 SEPETTM. The survival time was prolonged with the SEPETTM therapy even though certain blood chemistry data indicated that pigs to be treated with SEPETTM were in a worse condition than the control animals at the start of the study. The statistically significant increase in survival time (P<0.039) was associated with beneficial therapeutic effects of SEPETTM on blood pressure, brain swelling and the removal of ammonia.

A second study of the SEPETTM cartridge involving treatment of six normal pigs to determine safety (blood and biological compatibility) indicated that SEPETTM 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 SEPETTM therapy has an important clinical potential in the treatment of patients with liver failure. To date, a device such as SEPETTM 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 SEPETTM 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 SEPETTM, 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 LIVERAIDTM, 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.

For more information, call 212-370-4500, ext. 26.
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Publication:Biotech Equipment Update
Date:Sep 1, 2004
Words:624
Previous Article:BLOOD TEST CAN HELP RULE OUT CARDIAC CAUSE OF CHEST PAIN.
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