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Arbios Systems Appoints Shawn Cain Vice President Operations; Company Establishes Liver Cell Manufacturing Facility.


LOS ANGELES -- Arbios Systems, Inc. (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
: 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 developing proprietary liver assist devices for the treatment of liver failure liver failure Clinical medicine Liver insufficiency that results in death, requires a liver transplant, or is characterized by recovery after encephalopathy, or while awaiting a transplant; also defined as a condition with ≥ 3 of following: albumin < 3. , today announced the appointment of Shawn Cain to the position of Vice President Operations, effective April 25, 2005. Reporting directly to the Chief Executive Officer of Arbios, Mr. Cain's primary responsibilities will include establishing Arbios' cell manufacturing for its bioartificial liver ("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
") program, as well as ensuring the continued quality and integrity of Arbios' manufacturing process for the cartridges used in its liver assist devices.

Mr. Cain, 38, joins Arbios from Becton Dickinson & Company, where he was responsible for the operation of two manufacturing facilities that produced over 900 biologics. While there, Mr. Cain supervised a staff of 80 associates supporting manufacturing, quality control, shipping and receiving, continuous improvement, inventory control, planning/logistics and purchasing.

Mr. Cain began his career with W.R. Grace & Co.'s Research Division, and its wholly-owned subsidiary, Circe Biomedical, Inc. ("Circe"), where he was involved in early development work on BAL technology, including HepatAssist, a bioartificial liver currently being developed by Arbios. Mr. Cain's accomplishments while at W.R. Grace and Circe included:

--co-developing a novel hepatocyte hepatocyte /hep·a·to·cyte/ (hep´ah-to-sit?) a hepatic cell.

hep·a·to·cyte
n.
A parenchymal liver cell.


Hepatocyte
A liver cell.
 isolation technique, which consistently produced three times the cell yield as conventional isolation techniques

--developing and validating functionally closed systems for all of the cell processing steps, from cell isolation and cryopreservation cryopreservation /cryo·pres·er·va·tion/ (-prez?er-va´shun) maintenance of the viability of excised tissue or organs by storing at very low temperatures.

cry·o·pres·er·va·tion
n.
, to clinical thaw and elution elution /elu·tion/ (e-loo´shun) in chemistry, separation of material by washing; the process of pulverizing substances and mixing them with water in order to separate the heavier constituents, which settle out in solution, from the  

--establishing quality control and quality assurance protocols for the manufacturing, storage and shipment of cryopreserved liver cells for bioartificial liver use

--authoring a significant portion of the initial IND and BLA BLA
abbr.
Bachelor of Liberal Arts
 for HepatAssist

--authoring six patents and two additional invention disclosures, and managing Circe's intellectual property portfolio and patent strategy

Mr. Cain earned a Bachelors of Science degree in Biological Sciences from Northeastern University and a Masters of Science degree in Biological Sciences from the University of Massachusetts The system includes UMass Amherst, UMass Boston, UMass Dartmouth (affiliated with Cape Cod Community College), UMass Lowell, and the UMass Medical School. It also has an online school called UMassOnline. .

Commenting on today's news, Amy Factor, Chief Executive Officer of Arbios, stated, "We are delighted to welcome Shawn to the Arbios team. His proven experience in operations and manufacturing, as well as his intimate knowledge of HepatAssist, the first generation of our BAL device -- currently known as HepatAssist-2(TM) -- will be invaluable as we move forward with the continued development of each of our proprietary liver assist products."

Concurrent with this appointment, Arbios announced that it has entered into a multi-year lease with American Integrated Biologics, Inc. ("AIB AIB n abbr (BRIT) (= Accident Investigation Bureau) → oficina de investigación de accidentes

AIB n abbr (Brit) (= Accident Investigation Bureau) →
") for a high-health, biosecure facility in Bellwether Farm, Woodstock, CT, for the manufacturing of liver cells to be used in the Company's BAL devices currently under development. Mr. Cain will have oversight responsibility for this facility.

Ms. Factor continued, "The newly signed lease agreement with AIB represents a critical component of our plan to establish cell manufacturing capabilities in support of our BAL program and related clinical trials. By hiring Shawn and executing the lease agreement, Arbios has begun to put into place the infrastructure necessary for the development and eventual commercialization of our liver assist devices."

Among other products, Arbios is currently developing HepatAssist-2(TM), a second generation BAL combining liver cell therapy and sorbent-based detoxification Detoxification Definition

Detoxification is one of the more widely used treatments and concepts in alternative medicine. It is based on the principle that illnesses can be caused by the accumulation of toxic substances (toxins) in the body.
. In contrast to the first generation HepatAssist device developed by Circe, which used 5 billion viable pig liver cells, Arbios' HepatAssist-2(TM) will utilize 15 billion viable pig liver cells, and be placed in a new, user-friendly platform.

In April 2004, Arbios acquired certain assets of Circe, including its rights to HepatAssist and its intellectual property portfolio related to large-scale production and cryopreservation of mammalian (pig) liver cells for bioartificial liver use.

About HepatAssist-2(TM)

HepatAssist-2(TM) is an 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.
 liver failure therapy device, in which the function of porcine porcine /por·cine/ (por´sin) pertaining to swine.

porcine

pertaining to pig. See also hog (1), swine.


porcine circovirus 1
a nonpathogenic virus.
 liver cells is supplemented by a detoxification column filled with charcoal particles. During therapy using HepatAssist-2(TM), the patient's blood is first separated into plasma and cellular components using membrane plasmapheresis plasmapheresis, see apheresis. . The plasma first goes through the charcoal filter, which removes small molecular weight toxins. After this initial detoxification, the plasma runs through the hollow fiber column lined with cryopreserved porcine liver cells that provide liver specific functions. The plasma that has been cleaned and processed by the liver cells is then reunited with the blood cellular components and returned to the patient.

About Liver Failure

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.

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 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). . Arbios' products in development include SEPET SEPET System Electrical Performance and Evaluation Test (TM), a novel blood purification therapy, HepatAssist-2(TM), and LIVERAID(TM), bioartificial livers combining liver cell therapy and sorbent-based detoxification.

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 its products, the uncertainty related to the results of the clinical tests to be conducted by the company, the need for subsequent substantial additional financing to complete clinical development of its 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 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 HepatAssist-2(TM) are trademarks of Arbios Technologies, Inc., the subsidiary of Arbios Systems, Inc.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 8, 2005
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