Arbios Announces It Has Suspended Operations
August 05 2008 - 4:49PM
PR Newswire (US)
Action taken to conserve cash while seeking financing/strategic
alternatives WALTHAM, Mass., Aug. 5 /PRNewswire-FirstCall/ --
Arbios Systems, Inc. (OTC:ABOS) (BULLETIN BOARD: ABOS) announced
today that the Company is focusing its day-to-day operations
exclusively on obtaining financing or consummating a strategic
transaction. In order to preserve the Company's remaining cash
resources, the Company's employees were released from employment,
except for Shawn Cain, the Company's President and CEO, and Scott
Hayashi, the Company's CFO, who will continue to provide services
to the Company as part-time consultants on a month-to-month basis
while they seek funding and strategic alternatives. The Company
does not expect to publicly disclose any developments with respect
to any financing transactions or strategic alternatives unless and
until its Board of Directors has approved a transaction. There can
be no assurances that the Company will be able to obtain financing
and/or enter into a strategic transaction, or as to the timing or
terms of any such transaction. As the Company has previously
disclosed, the Company needs to either raise additional funds or
enter into a strategic relationship in order to fund the completion
of clinical trials for its SEPET(TM) Liver Assist Device, the
preparation and submission of applications to the FDA and other
competent authorities for marketing in Europe, and the maintenance
of its intellectual property portfolio. If a financing or strategic
transaction is not consummated, or near consummation, by August 31,
2008 the Company will then need to consider other options,
including liquidation of the Company. "We have spent the past
several months seeking financing and strategic opportunities to
maintain the momentum we have achieved towards the clinical
validation and market approval of SEPET(TM). SEPET(TM) is our
extracorporeal (outside the body) liver assist device for blood
purification of patients suffering from cirrhosis due to chronic
liver disease and who are hospitalized with acute complications due
to worsening liver dysfunction and portal hypertension," commented
Shawn Cain. "Unfortunately, despite our recent accomplishments, in
the current financial environment, we have not been able to obtain
any funding." These accomplishments include: -- Completing and
reporting positive safety results from our Phase 1 clinical study.
In addition, signs of clinical efficacy were observed with 79% of
the patients meeting the primary endpoint of a two-grade
improvement in hepatic encephalopathy, with an average of only two
treatments. -- Establishing exclusive manufacturing agreements with
recognized and well-respected manufacturers of medical products,
allowing commercial scale production and economics. -- Securing FDA
approval to commence a pivotal clinical trial of the SEPET(TM)
device in the US and Europe. -- Securing the required European
approvals to begin the first segment of the SEPET(TM) pivotal trial
in Rostock, Germany. -- Commencing work towards approval to market
SEPET(TM) in the European Union (through a CE Mark). "We remain
confident in the benefits that SEPET(TM) may offer patients with
chronic liver disease," noted Dr. John Vierling, M.D., FACP,
Chairman of Arbios and Professor of Medicine and Surgery and Chief
of Hepatology at the Baylor College of Medicine. "Hepatic
encephalopathy represents one of the most frequent complications of
cirrhosis necessitating hospitalization, and SEPET's rapid time to
a sustained two-stage improvement of hepatic encephalopathy
observed in the SEPET(TM) Phase 1 FDA trial exceeded our
expectations, providing us with much hope for the clinical success
of SEPET's pivotal trial," further commented Dr. Vierling.
"Unfortunately, unless in the near future we are able obtain
additional operating funds, or unless we are able to otherwise
enter into a strategic transaction, Arbios will not realize a
return on its investment in this company's important and valuable
assets and technologies." 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, liver
disease is among the top seven causes of death in adults in the
United States between the ages of 25 - 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 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 belief that, the pivotal trial,
if successful, should support approval of SEPET(TM) in the United
States and marketing efforts in the United States and the European
Union, the Company's expectations with respect to the timing,
design and implementation of the pivotal trial, including the
Company's plans with respect to seeking approvals for sites to
conduct the pivotal trial, and the Company's goals regarding its
financing and strategic alternatives. 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 risks or uncertainties
related to the Company's ability to timely and successfully raise
capital, the goals and results of clinical trials, compliance with
regulatory requirements, the likelihood of obtaining marketing
approval, 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, 2007, and to our subsequent Quarterly
Reports on Form 10-Q, 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: ARBIOS: Shawn Cain, +1-781-839-7292,
or Scott Hayashi, +1-626-356-3105, or MEDIA RELATIONS: Doug
MacDougall, +1-781-235-3060 Web site: http://www.arbios.com/
Copyright