Arbios Announces SEPET(TM) Manufacturing Agreement With NxStage Medical
October 23 2007 - 7:00AM
PR Newswire (US)
WALTHAM, Mass., Oct. 23 /PRNewswire-FirstCall/ -- Arbios Systems,
Inc. (OTC:ABOS) today announced that it has entered into an
exclusive manufacturing agreement with NxStage Medical, Inc.,
whereby NxStage will manufacture the SEPET(TM) Liver Assist Device
developed by Arbios for use in treating liver failure. Arbios is
currently seeking permission from the US Food and Drug
Administration to begin a controlled pivotal clinical trial for
SEPET(TM). Under the terms of the agreement, NxStage, a marketer of
innovative systems for the treatment of end-stage renal disease and
acute kidney failure, will manufacture the devices for the pivotal
trial and subsequent product commercialization, upon receipt of FDA
approval. The SEPET(TM) device will be comprised of commercially
used NxStage components and will include a proprietary synthetic
microporous fiber, supplied by Membrana, GmbH. Arbios, a developer
of medical devices and cell-based therapies, recently announced an
exclusive supply relationship with Membrana, which is the world's
largest independent membrane producer. "We are pleased to announce
this exclusive arrangement with NxStage, as it signals another step
in bringing SEPET(TM) to the marketplace," commented Shawn Cain,
Interim President and Chief Executive Officer of Arbios. "This
joint effort with NxStage, similar to the agreement recently
entered into with Membrana, signifies another important alliance
with an established and well- respected manufacturer of medical
products." "We are pleased to help bring innovative solutions to
clinically challenging patients that need them," said Jeffrey H.
Burbank, President and Chief Executive Officer of NxStage Medical.
"We believe that our technology and capabilities will enhance
Arbios' opportunity and look forward to being a part of making them
a success." The exclusive manufacturing agreement stipulates that
Arbios will purchase from NxStage all commercial requirements of
the SEPET(TM) device, and that in turn NxStage will not market a
competing product for a specified time. About Arbios' SEPET(TM)
Liver Assist Device The SEPET(TM) Liver Assist Device is a sterile,
disposable cartridge containing microporous hollow fibers with
proprietary permeability characteristics. When a patient's blood is
passed through these fibers, blood plasma components of specific
molecular weights are expressed through the micropores, thereby
cleansing the blood of harmful impurities (e.g., hepatic failure
toxins as well as various mediators of inflammation and inhibitors
of liver regeneration). These substances would otherwise
progressively accumulate in the patient's bloodstream during liver
failure, causing hypotension, increasing risk of sepsis development
and accelerating damage to the liver, lungs and other organs,
including the brain and kidneys, and suppressing the function and
regeneration of the liver. SEPET(TM) is designed for use with
standard blood dialysis systems available in hospital intensive
care units. According to the American Liver Foundation, chronic
liver disease is the tenth leading cause of death in the United
States, resulting in approximately $10 billion in annual healthcare
costs. There is currently no satisfactory therapy available to
treat patients in liver failure, other than maintenance and
monitoring of vital functions and keeping patients stable through
provision of intravenous fluids and blood products, administration
of antibiotics and support of vital functions, such as respiration.
About Arbios Systems Arbios Systems, Inc. is developing proprietary
medical devices and cell- based therapies to enhance the survival
of millions of patients each year who experience, or are at risk
for, life-threatening episodes of liver failure. The Arbios product
candidate portfolio includes the SEPET(TM) Liver Assist Device, a
novel blood purification 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 expectations with respect to
SEPET(TM) and the belief that NxStage's technology and capabilities
will enhance Arbios' opportunity. 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, but not limited to, risks or uncertainties related to
the continued and successful relationships between the Company and
both NxStage and Membrana, the goals and results of clinical
trials, compliance with regulatory requirements, 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 cautions investors that there
can be no assurance that actual results or business conditions will
not differ materially from those projected or suggested in such
forward-looking statements. Please refer to our Annual Report on
Form 10-KSB for the fiscal year ended December 31, 2006, and to our
subsequent Quarterly Reports on Form 10-QSB, for a description of
risks that may affect our results or business conditions. 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 except as
required by law. SEPET(TM) and HepatAssist(TM) are trademarks of
Arbios Systems, Inc. DATASOURCE: Arbios Systems, Inc. CONTACT:
Shawn Cain, Interim President and CEO, +1-781-839-7292, Scott
Hayashi, CFO, +1-626-356-3105, both of Arbios Systems, Inc.;
Investors, Lisa Wilson, +1-212-759-3929; Media Relations, Doug
MacDougall, +1-508-647-0209 Web site: http://www.arbios.com/
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