
Internationally Renowned Artificial Organs
Expert Joins HepaLife™.
HepaLife’s patented PICM-19 cell line,
bioreactor, and HepaDrive™ perfusion system demonstrate success
as an integrated artificial liver device system..
Boston, MA – August 21, 2007 - HepaLife Technologies,
Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625), developing the first-of-its-kind
artificial liver device, is pleased to announce the addition of Aly
El-Banayosy, MD, to the Company’s Scientific Advisory Board.
With over 20 years of experience on the forefront of artificial
organs and circulatory care, and heading the world’s most active
ventricular assist device program (VAD), Dr. Banayosy is a widely-published,
internationally renowned expert and lecturer in the treatment of
heart and organ failure.
“I’m honored to welcome Dr. Banayosy to the HepaLife
team,” stated Mr. Frank Menzler, President and CEO of HepaLife
Technologies, Inc. “Dr. Banayosy brings us extensive
patient management experience in artificial organ-related technologies
and intensive care medicine. His expertise in treating patients with
heart, liver and kidney problems with artificial organs, implantable
and extracorporeal, is extremely valuable for the development process
of our bioartificial liver.”
“Despite advances in medical therapy and technology, the prognosis
of patients with persistent multiple organ failure, often following
a cardiogenic shock remains poor. Mortality rates are as high as
80%. Patients with hypoxic liver failure after such cardiogenic shock
after cardiac surgery are expected to benefit significantly from
artificial liver support,” explained
Dr. Banayosy. “The HepaLife bioartificial liver is an exciting
and promising approach to a huge clinical need. I am very happy to
assist in making this technology available to patients.”
In the United States, liver diseases and cirrhosis rank as the seventh
leading cause of death among adults between the ages of 25 and 64,
and an estimated 30 million Americans - one in every 10 - are or
have been afflicted by liver diseases, according to the American
Liver Foundation. 18,000 people are on the waiting list for a liver
transplant in the USA, 1,300 have died while waiting.
In response, HepaLife is working to develop the world’s first-of-its-kind
bioartificial liver device, an actively rising market expected to
achieve record growth, second only to artificial kidney support and
more than double the expected $1.31 billion artificial heart market.
Forecast data from a newly issued study on the worldwide market
for artificial organs projects the artificial liver device market
to exceed $2.7 billion in the upcoming 36 months.
Despite a promising commercial outlook, current artificial liver
technologies have not yet lived up to their full potential as a consequence
of problems relating to their inability to grow liver cells quickly
and safely, and with inconsistent results from filtering devices.
Culturing and maintaining their cell systems has proven difficult;
once removed from the body, their cells soon lose normal functionality.
In contrast, HepaLife's patented PICM-19 cells can survive at room
temperature, retain their desired properties even after years in
continuous culture, and unlike other cells, are not tumor-causing,
a feature critical to nutrient metabolism research.
In early tests, HepaLife’s patented PICM-19 cell line, bioreactor,
and HepaDrive™ perfusion system have demonstrated early success
as an integrated system, successfully replicating the liver’s
key function – removal of toxic ammonia and synthesis of urea.
Researchers have also demonstrated that HepaLife's PICM-19 cells
mimic other key liver responses such as expressing high levels of
CYP-450 enzymes. Most impressively, HepaLife's PICM-19 liver cells
have outperformed the world's most widely used human liver cell line
(HepG2-C3A), and are the only cells of their kind in the world able
to produce substantial amounts of urea in an in-vitro system, a highly-important
function in the removal of toxic ammonia from the bloodstream.
The HepaLife™ Bioartificial Liver device consists of three
basic components: (1) a plasma filter, separating the patients blood
into blood plasma and blood cells; (2) the bioreactor, a unit filled
with PICM-19 cells which biologically mimic the liver’s function;
and (3), the HepaDrive™, a perfusion system for pumping the
patient's plasma through the bioreactor while controlling gas supply
and temperature for best possible performance of the cells.
Aly El-Banayosy, MD: Physician, Clinical Researcher and
Artificial Organs Expert
Aly El-Banayosy, MD, is an internationally renowned authority in
artificial organ support. With more than 20 years of clinical expertise
of managing patients with cutting-edge circulatory support systems,
his research focus is mechanical circulatory support, cell therapy
and liver replacement therapy.
Dr. Banayosy is a widely-published clinical researcher and investigator
of more than 20 clinical trials in the field of heart, liver and
kidney failure. Among his numerous publications and lectures he also
published on the first use of the molecular adsorbent recirculating
system technique on patients with hypoxic liver failure after cardiogenic
shock.
At the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen,
Germany,
Dr. Banayosy currently is the head of the world’s most-active
VAD program and Director of the Intensive Care Unit for Thoracic
and Cardiovascular Surgery.
The Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen,
Germany, is a world-leading institution in the fields of cardiac,
circulatory and metabolic diseases. With over 6,000 operations per
annum, the center is at the very forefront of its international peers
and is the leading university hospital in Europe. Facilities around
the world, including new heart centers in Japan and Russia, have
been modeled on clinical facilities at Bad Oeynhausen.
Dr. Aly El-Banayosy received his MD from the Ruhr University of
Bochum, Germany.
Dr. Banayosy is member of 11 medical societies including the American
and the European Society for Artificial Internal Organs and the Society
of Critical Care Medicine. He is Program Director of the joint EUMS
(European Mechanical Support Summit) with Pitié Salpêtrière,
Paris, France.
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/20070821-1.html.php
# # # #
Legal
Notice Regarding Forward-Looking Statements
No statement herein
should be considered an offer or a solicitation of an offer for
the purchase or sale of any securities. This release contains forward-looking
statements that are based upon current expectations or beliefs,
as well as a number of assumptions about future events. Although
the Company believes that the expectations reflected in the forward-looking
statements and the assumptions upon which they are based are reasonable,
it can give no assurance that such expectations and assumptions
will prove to have been correct. Forward-looking statements, which
involve assumptions and describe our future plans, strategies,
and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “could,” “expect,” “anticipate,”
“estimate,” “believe,” “intend,” or “project” or
the negative of these words or other variations on these words or
comparable terminology. The reader is cautioned not to put undue
reliance on these forward-looking statements, as these statements
are subject to numerous factors and uncertainties, including but
not limited to adverse economic conditions, intense competition,
lack of meaningful research results, entry of new competitors and
products, adverse federal, state and local government regulation,
inadequate capital, unexpected costs and operating deficits, increases
in general and administrative costs, termination of contracts or
agreements, technological obsolescence of the Company's products,
technical problems with the Company's research and products, price
increases for supplies and components, litigation and administrative
proceedings involving the Company, the possible acquisition of new
businesses or technologies that result in operating losses or that
do not perform as anticipated, unanticipated losses, the possible
fluctuation and volatility of the Company's operating results, financial
condition and stock price, losses incurred in litigating and settling
cases, dilution in the Company's ownership of its business, adverse
publicity and news coverage, inability to carry out research, development
and commercialization plans, loss or retirement of key executives
and research scientists, changes in interest rates, inflationary
factors, and other specific risks. We currently have no commercial
products intended to diagnose, treat, prevent or cure any disease.
The statements contained in this press release regarding our on going
research and development and the results attained by us to-date have
not been evaluated by the Food and Drug Administration. There can
be no assurance that further research and development, and /or whether
clinical trial results, if any, will validate and support the results
of our preliminary research and studies. Further, there can be no
assurance that the necessary regulatory approvals will be obtained
or that HepaLife will be able to develop commercially viable products
on the basis of its technologies. In addition, other factors that
could cause actual results to differ materially are discussed in
the Company's most recent Form 10-Q and Form 10-K filings with the
Securities and Exchange Commission. These reports and filings may
be inspected and copied at the Public Reference Room maintained by
the U.S. Securities & Exchange Commission at 100 F Street, N.E.,
Washington, D.C. 20549. You can obtain information about operation
of the Public Reference Room by calling the U.S. Securities & Exchange
Commission at 1-800-SEC-0330. The U.S. Securities & Exchange
Commission also maintains an Internet site that contains reports,
proxy and information statements, and other information regarding
issuers that file electronically with the U.S. Securities & Exchange
Commission at http://www.sec.gov.
The Company makes no commitment to publicly release the results of
any revisions to these forward looking statements that may be made
to reflect the events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events. |