FDA Lifts Clinical Hold of Pluristem's Phase II Intermittent Claudication Study

FDA Lifts Clinical Hold of Pluristem's Phase II Intermittent Claudication
Study

HAIFA, Israel, Sept. 16, 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 lifted the clinical hold previously placed on the Company's U.S. Phase II
Intermittent Claudication (IC) study (IND 15038) on June 4, 2013.

In its letter to Pluristem, the FDA indicated Pluristem had satisfactorily
addressed all the clinical hold issues and the Company may proceed with the
study.

Zami Aberman, Pluristem's Chairman and CEO commented, "Pluristem applauds the
FDA's vigor to resolve this clinical hold as quickly as possible. We look
forward to resuming this important study that addresses the growing, costly
and potential serious indication of intermittent claudication."

About Pluristem's Phase II Intermittent Claudication (IC) Clinical Trial

Pluristem's Phase II Intermittent Claudication (IC) study uses the Company's
PLX-PAD cells. Up to 150 patients will be enrolled in this dose escalation,
randomized, double blind, multicenter, multinational, placebo-controlled trial
whose primary endpoints at 12 months will be safety and maximal walking
distance relative to baseline. The study protocol will be modified by
tightening patient's eligibility criteria and by adding oral anti-histamines
and a safety follow-up period for 24 hours post study treatment.

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 intellectual property position, 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, when we discuss the PLX-PAD
Phase II Intermittent Claudication (IC) study, we are using forward-looking
statements. 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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