WALTHAM, Mass., April 15 /PRNewswire-FirstCall/ -- Arbios Systems, Inc.
(OTC 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
SOURCE Arbios Systems, Inc.
 back to top
Related links:
http://www.arbios.com
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.
|
