Pluristem Receives FDA Orphan Drug Status Designation for Treatment of Aplastic Anemia

Pluristem Receives FDA Orphan Drug Status Designation for Treatment of
Aplastic Anemia

HAIFA, Israel, Feb. 21, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc.
(Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell
therapies, announced today that the U.S. Food and Drug Administration (FDA)
has designated Pluristem's PLacental eXpanded (PLX) cells orphan drug status
for the treatment of aplastic anemia.

Orphan drug designation qualifies a company for several benefits under the
Orphan Drug Act of 1983 (ODA), as amended. These benefits include a 7-year
period of orphan drug exclusivity upon product approval, a tax credit for
certain clinical testing expenses for the orphan drug, written guidance on the
non-clinical and clinical studies needed to obtain marketing approval of an
orphan drug, and orphan drug grants.

This is Pluristem's second orphan drug designation from the FDA. The company
also received orphan drug status from the FDA for its PLX cells for the
treatment of Buerger's disease in August of 2011.

Aplastic anemia is a rare but serious disorder with a prevalence of less than
200,000 in the U.S. The disease is caused by the failure of hematopoietic stem
cells (HSCs) contained within the bone marrow to produce red blood cells,
white blood cells and platelets. The disease is considered an emergency and
patients are supported with blood products in anticipation of a bone marrow
transplant (BMT) or drugs that suppress the immune system.

"Receiving orphan drug designation for aplastic anemia is an important event
for Pluristem as it open pathways for using our PLX cells for additional
indications in the field of hematology," stated Zami Aberman, Chairman and CEO
of Pluristem.

Pluristem has established clinical advisory board made up of key opinion
leaders in the area of bone marrow transplantation from the United States,
Europe and Israel to provide the company with valuable insight towards
expanding its activities in the treatment of the bone marrow diseases and
transplantations.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell
therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug
delivery platform that releases a cocktail of therapeutic proteins in response
to a host of local and systemic inflammatory and ischemic diseases. PLX cells
are grown using the company's proprietary 3D micro-environmental technology
and are an "off-the-shelf" product that requires no tissue matching prior to
administration.

Pluristem has a strong patent and patent applications portfolio, company-owned
GMP certified manufacturing and research facilities, strategic relationships
with major research institutions and a seasoned management team. For more
information visit www.pluristem.com, the content of which is not part of this
press release.

The Pluristem Therapeutics Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6882

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995 and federal securities laws. For example, we are using forward-looking
statements when we discuss that this indication may open pathways for the use
of PLX cells in additional indications in the field of hematology, or when we
discuss the expansion of our activities in the treatment of the bone marrow
diseases and transplantations. These forward-looking statements and their
implications are based on the current expectations of the management of
Pluristem only, and are subject to a number of factors and uncertainties that
could cause actual results to differ materially from those described in the
forward-looking statements. The following factors, among others, could cause
actual results to differ materially from those described in the
forward-looking statements: changes in technology and market requirements; we
may encounter delays or obstacles in launching and/or successfully completing
our clinical trials; our products may not be approved by regulatory agencies,
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; our
products may wind up being more expensive than we anticipate; results in the
laboratory may not translate to equally good results in real surgical
settings; results of preclinical studies may not correlate with the results of
human clinical trials; our patents may not be sufficient; our products may
harm recipients; changes in legislation; inability to timely develop and
introduce new technologies, products and applications; loss of market share
and pressure on pricing resulting from competition, which could cause the
actual results or performance of Pluristem to differ materially from those
contemplated in such forward-looking statements. Except as otherwise required
by law, Pluristem undertakes no obligation to publicly release any revisions
to these forward-looking statements to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated events. For a
more detailed description of the risks and uncertainties affecting Pluristem,
reference is made to Pluristem's reports filed from time to time with the
Securities and Exchange Commission.

CONTACT: Pluristem Therapeutics Inc.:
        
         William Prather R.Ph., M.D. Sr. VP Corporate Development
         1-303-883-4954
         William.PratherMD@pluristem.com
        
         Daya Lettvin
         Investor & Media Relations Director
         +972-54-674-5580
         daya@pluristem.com

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