HepaLife(TM) Achieves 20-Fold Increase in Cell Production for
Bioartificial Liver While Reducing Labor 4-FoldBOSTONMA-
TECHNOLOGIES
BOSTON--(BUSINESS WIRE)--
HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625),
developing the first-of-its-
for the treatment of liver failure announced today significant
process improvements for cell manufacturing and storage, important
factors in cost-efficiently producing enough cell-based liver devices
for in-vivo trials, and ultimately, clinical application.
Efficient large-scale manufacturing of HepaLife's patented PICM-19
liver stem cells is a key consideration in the operation of the
Company's bioartificial liver, since scientists anticipate that tens
of billions of cells will be needed inside the device's bioreactor
system.
'Efficient cell manufacturing protocols in combination with improved
storage capabilities provide us with important tools in moving us
towards clinical and commercial success,' explained Mr. Frank
Menzler, President and CEO of HepaLife Technologies, Inc. 'We are
very pleased with the enhanced production of our patented PICM-19
cells, an especially important achievement as we move towards in vivo
studies.'
HepaLife researchers have achieved important cell-production
improvements including a 20-fold increase in output, and a concurrent
reduction in labor intensive cell maintenance by four-fold. The
improved cell growth process make use of FDA cGMP (U.S. Food and Drug
Administration'
technology, an important factor in allowing the Company to readily
transfer the manufacturing of its PICM-19 cells to third-party
contract manufacturers.
Using the new cell production technology, HepaLife researchers
initiated pilot production of PICM-19 cells, which showed desirable
liver function characteristics such as ammonia utilization, urea
production rates and drug detoxification activities. HepaLife
researchers hope to further optimize cryopreservation protocols for
these cells in order to provide for better storage and improved
viability when thawed for use in liver support treatment.
In ongoing tests, HepaLife's proprietary PICM-19 liver stem cells
inside the bioartificial liver have been perfused with cell culture
media, blood plasma and whole blood, an environment designed to
better mimic natural conditions for animal and human clinical trials
in preparation for anticipated in vivo studies.
Intended for the treatment of liver failure, the HepaLife'
Bioartificial Liver device consists of three basic components: (1) a
plasma filter, separating the patient's blood into blood plasma and
blood cells; (2) the bioreactor, a unit filled with the patented PICM-
19 liver stem cell line which biologically mimics 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.
ABOUT HEPALIFE TECHNOLOGIES, INC.
Based in Boston, Massachusetts, HepaLife Technologies, Inc. (OTCBB:
HPLF) (FWB: HL1) (WKN: 500625) is a developer of cell-based medical
technologies addressing prevalent human health concerns.
HepaLife is developing the first-of-its-
device intended for the treatment of liver failure using the
Company's patented PICM-19 liver stem cell line. The HepaLife'
bioartificial liver, currently under development, is designed to
serve as a supportive device, either allowing the liver to regenerate
upon acute liver failure, or to bridge the patient's liver functions
until a transplant is available.
Utilizing its patented liver stem cell line PICM-19, HepaLife is
designing testing platforms to improve the pharmaceutical industry's
capability to evaluate drug toxicity and possible side-effects before
pharmaceutical compounds are commercially distributed.
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.
To receive future press releases via email, please visit:
http://www.hepalife
To view the full HTML text of this release, please visit:
http://www.hepalife
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,
ate,' '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.
Company undertakes no obligation 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.
Ad-Hoc-News.
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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