
HepaLife Achieves Major Milestone in Development
of Artificial Liver Device
HepaLife’s proprietary Bioreactor system achieves
early success using Company’s patented PICM-19 liver cells;
successfully replicates vital human liver functions
Boston, MA – April 30, 2007 - HepaLife Technologies, Inc.
(OTCBB: HPLF) (FWB: HL1) (WKN: 500625), developing the first-of-its-kind
artificial liver device, today announced favorable early test results
of the Company’s proprietary bioreactor system, the main mechanical
component of an artificial liver device, which successfully replicated
the human liver’s key function – removal of toxic ammonia
and synthesis of urea.
In early tests of HepaLife’s proprietary bioreactor, the Company’s
patented PICM-19 liver cells were seeded inside the system. Over
a 14-day period, the PICM-19 cells successfully remained contact-inhibited,
an important indicator of normal cell growth. The cells further
differentiated into hepatocytes (liver cells) with normal structure
and morphology. Most importantly, HepaLife’s proprietary
bioreactor and PICM-19 cell line system was able to remove toxic
ammonia and synthesize urea. This ability is vital to successfully
replicating the human liver’s function in an artificial liver
device.
In contrast, conventional cell systems may not remain contact-inhibited,
and as such, become tumorigenic or cancerous. Additionally,
unlike PICM-19 liver cells inside the bioreactor system, other traditional
cell lines may not differentiate into liver cells, or retain normal
morphology after growth. Notably, distinct from other cell
lines, HepaLife's PICM-19 cell line is the only known, embryonic
liver stem cell line of its kind with the ability to produce substantial
amounts of urea, in an in vitro system.
“These successful test results serve as early validation of
our bioreactor system and cell line, which earlier this month, significantly
outperformed the world’s most widely-used human liver cell
line,” explained Mr. Frank Menzler, President and CEO of HepaLife
Technologies, Inc.
(View HepaLife’s April 10, 2007 press release, announcing
Company’s PICM-19 cells mimic human liver’s responses,
and significantly outperform world’s most widely-used liver
cell line:
http://www.hepalife.com/20070410-1.html.php )
“Together, the strong performance of our PICM-19 liver cells,
and early success of our bioreactor system, clearly mark significant
strides in our development of a bioartificial liver device, able
to replicate human liver functions and support patients with acute
liver failure.”
The need for an artificial liver device able to remove toxins and
improve immediate and long-term survival results is more critical
today than ever before. Limited treatment options, a low number of
donor organs, the high price of transplants and follow up costs,
a growing base of hepatitis, alcohol abuse, drug overdoses, and other
factors that result in liver disease all clearly indicate a strong
need for an artificial liver device.
The World Health Organization estimates that 10% of the world’s
population has chronic liver disease, including 25 million Americans.
In China alone, half a million die of the disease each year. Currently
17,000 Americans are awaiting liver transplants, approximately six
times greater than the number of patients awaiting heart transplantation.
Last year, only 30% of those in need of liver transplantation were
transplanted due to a severe lack of donor livers available.
In response, the National Institutes of Health has issued its formal
Action Plan for Liver Disease Research, stating in part, “In
the area of acute liver failure, the primary goals of research should
be in developing means to prevent acute liver failure and ameliorate
its course….Most helpful would be an artificial or bioartificial
liver assist device that could be used to sustain patients and serve
as a bridge to liver transplantation, which is the only effective
treatment that is currently available for fulminant hepatic failure.”
HepaLife’s patented artificial liver device, currently under
development, is designed to operate outside the patient’s body
(extracorporeal). The machine mimics important functions of
the human liver by circulating the patient’s blood inside the
artificial liver device where it is exposed to HepaLife’s patented
PICM-19 liver cells inside the bioreactor unit.
Once inside the bioreactor unit, researchers anticipate HepaLife’s
artificial liver device will process the patient’s blood-plasma
using the Company’s PICM-19 liver cells, removing toxins, enhancing
metabolic function, and ultimately, imitating the liver’s function. In
contrast to HepaLife’s biological process, conventional filtration
or dialysis systems rely on mechanical methods, limited to merely
filtering toxins from the blood.
ABOUT HEPALIFE TECHNOLOGIES, INC.
HepaLife Technologies, Inc. (OTCBB: HPLF - News; FWB: HL1) (WKN:
500625) is a biotechnology company focused on the identification
and development of cell-based technologies and products.
Current cell-based technologies under development by HepaLife include
1) the first-of-its-kind artificial liver device, 2) proprietary
in-vitro toxicology and pre-clinical drug testing platforms, and
3) novel cell-culture based vaccine production to protect against
the spread of influenza viruses among humans, including potentially
the high pathogenicity H5N1 virus.
For additional information, please visit www.hepalife.com.
To receive future press releases via email, please visit:
http://www.hepalife.com/investor-alerts.php
To view the full HTML text of this release, please visit:
http://www.hepalife.com/20070430-1.html.php
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