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NEW YORK--(BUSINESS WIRE)--Pluristem Life Systems, Inc.
(OTCBB:PLRS -
News), a cell
therapy Company dedicated to the commercialization of cell therapy
products for a variety of indications, has announced it will upgrade and
enlarge its existing manufacturing facility to Support $200 Million in
Production Capacity for PLX - I. The additional 6,900 square foot will
double in size the Company's facilities and is expected to be ready this
summer. This facility will manufacture PLX-BMT, the Company's introductory
product to address the bone marrow transplant market, for Phase I
clinical trials and large scale commercial production.
Zami Aberman, Pluristem CEO, stated: "We continue to execute our
strategy of controlling the entire commercialization process, from
harvesting placenta cells and umbilical cord blood to product
development and expansion, and product sales. We anticipate completion
of the new facilities and GMP (Good Manufacturing Practice)
certification prior to the initiation of Phase I clinical trials,
planned to begin during 2007." The Company intends to commercialize PLX-BMT
and several prospective cell therapy products in the United States as
well as the rest of the world.
Once complete, Pluristem's initial annual production capacity for its
proprietary PLX (PLacenta eXpanded) cells will be approximately 14,000
doses of PLX-BMT per year with an estimated value of $200 million.
Pluristem is spending about $500,000 to lease additional space adjacent
to its current facilities, adding bioreactors, support equipment and
other infrastructure improvements.
Mr. Aberman added, "We are able to increase the production capability
of this new facility by another 300% very quickly. This enables us to
scale our production as we gain market share and still keep our expenses
under control."
Pluristem is in the process of implementing GMP controls to provide a
reliable quality assurance environment per US Food and Drug
Administration (FDA) requirements. These requirements call for process
and organizational controls to ensure authenticity, integrity and
confidentiality for all product records from design, manufacture,
testing, packing, storage and other product development processes.
About Pluristem
Pluristem Life Systems, Inc. is life sciences driven Company that is
developing and commercializing stem cell expansion technology products
for the potential treatment of a variety of disorders. The Company is
discovering and developing cell-based therapeutics that utilizes adult
stem cells expanded in a three-dimensional proprietary bioreactor termed
the PluriX(TM) that mimics different naturally occurring physiological
environments. Pluristem expects its first product, PLX-BMT, will be
involved as an efficient and superior alternative to the standard
procedure of bone marrow transplantation (BMT). PLX-BMT is intended to
target a critical global shortfall of matched tissue for BMT since BMT
is often the only cure for patients suffering from leukemia, lymphoma,
myeloma and many other hematological diseases. The Company has made a
strategic decision to work only with adult stem cells since the
practical use of embryonic stem cells is severely restricted by various
religious, ethical and legal considerations.
www.pluristem.com
Safe Harbor Statement
This press release contains statements, which may constitute
"forward-looking statements" regarding our intent, belief or current
expectations. Forward-looking statements in this release, include that
we are upgrading and doubling our manufacturing facility to support $200
million in production capacity for PLX - I; that we expect to complete
the expansion of the production area as well as the implementation of
the GMP controls before the initiation of the Phase I clinical trials
which we are expecting to start during 2007; that we are able to
increase the production capability of this new facility by another 300%
very quickly; That this enables us to scale our production as we gain
market share and still keep our expenses under control. Factors that
could prevent our forward looking statements from being achieved include
that we may be unable to get regulatory approval for our products; we
may be unsuccessful in developing any products; our technology may not
be validated as we progress further and our methods may not be accepted
by the scientific community; we may be unable to retain or attract key
employees whose knowledge is essential to the development of our
products; unforeseen scientific difficulties may develop with our
process; results in the laboratory may not translate to equally good
results in real surgical settings; our patents may not be sufficient to
protect essential aspects of our technology; competitors may invent
better technology; our products may not work as well as hoped or worse,
our products may harm recipients; and we may not be able raise funds for
development or working capital when we require it. As well, our products
may never develop into useful products and even if they do, they may not
be approved for sale to the public. For further risk factors see the
Company's latest 10-KSB filed with the SEC.
For more information visit our website at
www.pluristem.com
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