
HepaLife™ Acquires Liver Support Technology, Tested in
America's Largest-Ever Human Clinical Trial for Bioartificial Liver
Assist Devices
HepaLife bolsters development and strengthens its IP portfolio
through acquisition of bioartificial liver technology: clinically
evaluated in over 170 human patients, with 12 additional patents
and licenses, and FDA's 'orphan drug' and 'fast-track' designation.
Boston, MA – October 7, 2008 – HepaLife
Technologies, Inc. (OTCBB: HPLF)
(FWB: HL1) (WKN: 500625) developers of the first-of-its-kind bioartificial
liver device intended for the treatment of human liver failure, announced
that the Company has acquired a liver support technology formerly
known as “HepatAssist”, along with numerous related patents,
licenses, clinical protocols, and important fast-track and orphan
drug designations by the United States Food and Drug Administration
(FDA).
“The complexion of our Company has changed dramatically as
a result of this acquisition, and the prospects for substantially
cutting our time-to-market for a commercial bioartificial liver device
have become very real,” stated Mr. Frank Menzler, President,
CEO and Chairman of HepaLife Technologies, Inc. “This move
significantly improves our market position, and marks a very important
milestone in the research and development of our bioartificial liver.”
In ongoing efforts to enhance and strengthen its patented PICM-19
porcine liver cell line-supported bioartificial liver technology,
HepaLife has purchased certain assets of Waltham, MA-based Arbios
Systems, Inc., relating to the company’s pig cell-reliant liver
device technology, HepatAssist. HepatAssist was evaluated in the
largest-ever Phase II/III clinical study (prospective randomized
trial involving over 170 patients) to test safety and efficacy of
a bioartificial liver assist device, with the resultant clinical
data published in 2004.
Among the assets acquired by HepaLife, included are: over 12 patents
and patent licenses; miscellaneous equipment; FDA Investigative New
Drug Application, including important orphan drug and fast track
designation; Phase I and Phase II/III clinical protocols; clinical
data from human patient trials; and standard operating procedures
for manufacturing and quality control.
The purchase price of the acquired assets consisted of cash and
warrants to purchase shares of the Company’s common stock.
As a result of the successful acquisition of the HepatAssist technology,
HepaLife also announced today plans to deploy an enhanced product
development program, and immediate re-organization of the Company’s
bioartificial liver device development activities. The Company has
notified the U.S. Department of Agriculture, Agricultural Research
Service (USDA, ARS) that it has elected to terminate the Cooperative
Research and Development Agreement (the “CRADA”) between
the Company and the USDA, ARS effective November 30, 2008.
The exclusive license agreement for the PICM-19 liver cell line
with the USDA, ARS for the use of patented liver cell lines in artificial
liver devices and in-vitro toxicological testing platforms remains
in force and effect. Last month, HepaLife announced expansion of
this license, allowing for the additional use of PICM-19 cells as
an in-vitro infection host system for viral and protozoan agents
such as malaria.
Please see press release from October 1, 2008.
(http://www.hepalife.com/press_releases/20081001.html.php).
The Company also announced the appointment of Mr. Frank J. Fabio
as HepaLife’s Chief Financial Officer. Mr. Fabio received a
BBA in Accounting from Pace University in June 1973, and has been
a Certified Public Accountant since 1976. Mr. Fabio earned his MS
in Taxation from Long Island University in June 1989, and was employed
by Ernst & Ernst from 1973 to 1980. Since 1980, Mr. Fabio has
maintained a private accountancy practice in New York.
ABOUT HEPALIFE TECHNOLOGIES, INC.
Based in Boston, Massachusetts, HepaLife Technologies, Inc. (OTCBB: HPLF
- News) (FWB: HL1) (WKN: 500625) is a developer of cell-based
medical technologies addressing prevalent human health concerns.
Any statements contained in this press release regarding our ongoing
research and development and the results attained by us to-date have
not been evaluated by the Food and Drug Administration.
For additional information, please visit www.hepalife.com.
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http://www.hepalife.com/investor-alerts.php
To view the full HTML text of this release, please visit:
http://www.hepalife.com/press_releases/20081007.html.php
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be no assurance that further research and development, and /or whether
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or that HepaLife will be able to develop commercially viable products
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