Arbios Commences Process to Seek European Marketing Approval for SEPET(TM)
April 15 2008 - 10:07AM
PR Newswire (US)
WALTHAM, Mass., April 15 /PRNewswire-FirstCall/ -- Arbios Systems,
Inc. (OTC:ABOS) (BULLETIN BOARD: ABOS) today announced that it has
commenced the marketing authorization process in the European Union
to pursue CE Marking the SEPET(TM) Liver Assist Device. The Company
has engaged the British Standards Institute (BSI), one of the
leading notified bodies in Europe, to assist the Company in its
effort to obtain a CE Mark for SEPET, which is a sterile,
disposable cartridge with proprietary membrane permeability
characteristics for use in treating patients with chronic liver
failure. CE Marking indicates that the product complies with the
essential requirements of the relevant European health, safety and
environmental protection legislation and allows sale of the product
within the European Union (28 countries) and the European Free
Trade Association (3 countries). "We are pleased to announce this
arrangement with BSI, and look forward to advancing our market
approval and product acceptance strategy for SEPET in Europe,"
commented Shawn Cain, President and Chief Executive Officer of
Arbios. "Importantly, based on guidance from BSI, we will seek
approval of SEPET using data from our recently completed
feasibility trial. If no additional clinical data are necessary,
and if we meet all the requirements for CE Marking, we believe that
our CE Mark filing for SEPET will be completed by the beginning of
2009. We are also seeking a European distribution, marketing, and
sales partner to assist us in introducing SEPET into the European
market," Mr. Cain added. 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 is designed for use with standard
blood dialysis systems available in hospital intensive care units.
According to the American Liver Foundation, liver disease is among
the top seven causes of death in adults in the United States
between the ages of 25 and 64. In fact, one out of every 10
Americans has some form of liver disease. 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 is designed to provide
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/ . All statements in this press release that
are not historical are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements regarding: the Company's intention to seek
approval of SEPET using data from its recently completed
feasibility trial and the Company's belief that SEPET could
possibly be available for sale in Europe by early 2009. Such
statements represent the judgment of the Company's management as of
this date are subject to the risks and uncertainties that could
cause actual results to differ materially from those projected,
including, but not limited to, uncertainties relating to the
ability of the Company to successfully and timely obtain a CE Mark
for SEPET, 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 the Company's ability to
successfully market its products and technologies. These risks and
other additional factors affecting these statements and the
Company's business are discussed in the Company's Annual Report on
Form 10-KSB for the fiscal year ended December 31, 2007, and to our
subsequent Quarterly Reports on Form 10-Q, all as filed with the
Securities and Exchange Commission, and in other filings made by
the Company with the Securities and Exchange Commission from time
to time. The Company expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in the Company's expectations with regard thereto or any change in
events, conditions, or circumstances on which any such statements
are based, except as may be required by law. SEPET(TM) and
HepatAssist(TM) are trademarks of Arbios Systems, Inc. CONTACT AT
ARBIOS: Shawn Cain, President and CEO, 1-781-839-7292 Scott
Hayashi, CFO, 1-626-356-3105 CONTACT FOR INVESTOR RELATIONS: Lisa
Wilson, 1-212-759-3929 CONTACT FOR MEDIA RELATIONS: Doug MacDougall
& Kari Watson, 1-781-235-3060 DATASOURCE: Arbios Systems, Inc.
CONTACT: Shawn Cain, President and CEO, +1-781-839-7292, or Scott
Hayashi, CFO, +1-626-356-3105, both of Arbios Systems, Inc.; or
Investors, Lisa Wilson, +1-212-759-3929, or Media, Doug MacDougall
& Kari Watson, +1-781-235-3060, all for Arbios Systems, Inc.
Web site: http://www.arbios.com/
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