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Regenerative Medicine

 News Release - September 10, 2009

Pluristem Begins Enrollment in U.S. With Unmatched Placenta-Derived Stem Cell Product PLX-PAD in a Phase I Clinical Trial for Treatment of Peripheral Artery Disease

HAIFA, Israel--(HSMN NewsFeed)--Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

Enrollment began at the Center for Therapeutic Angiogenesis in Birmingham, Ala., one of two clinical sites in the U.S. Duke University Medical Center will also be screening patients for the trial. The initiation of this study follows the approval of the Company’s Investigational New Drug (IND) application to begin clinical trials with PLX-PAD by the U.S. Food & Drug Administration (FDA). The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to 12 adults with the disease will be included in this dose escalating trial.

“Initiation of the clinical trial in the U.S. with our unmatched placenta-derived stem cell therapy product signifies another major milestone for Pluristem,” said Zami Aberman, chairman, president and CEO of Pluristem. “This significant development, together with the beginning of dosing in Europe in July of this year, demonstrates our commitment to advancing our product pipeline and our strong position in the stem cell space.”

About Pluristem

Pluristem Therapeutics Inc. is a clinical development bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. Pluristem's first product, PLX-PAD (for the treatment of Peripheral Artery Disease), a “First-In-Human” placental-derived mesenchymal-like stromal cell product, has received both the FDA and Paul Erlich Institute (PEI) clearance and is being investigated in Phase I clinical trials. The Company is developing a pipeline of products derived from human placenta, a non-controversial, non-embryonic, adult stem cell source. The (PLacental eXpanded) cell products are stored off-the-shelf, ready-to-use, and require no histocompatibility matching.

The Company's additional product candidates include PLX-IBD, targeting Inflammatory Bowel Disease, which includes Crohn’s disease and Ulcerative Colitis; PLX-MS, targeting Multiple Sclerosis; PLX-BMT, targeting the global shortfall of matched tissue for bone marrow transplantation by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke.

Pluristem has offices in the USA with research and manufacturing facilities in Israel.

See our product animation on YouTube, the content of which is not part of this press release.

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 say that the initiation of the clinical trial in the U.S. with our unmatched placenta-derived stem cell therapy signifies another major milestone for us, or that this development, together with the beginning of dosing in Europe in July of this year, demonstrates our commitment to advancing our product pipeline and our strong position in the stem cell space, or when we discuss the number of adults that will be included in this dose escalating trial, we are using forward-looking statements. These forward-looking statements 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 our clinical trials; 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; 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.

For more information visit our website at www.pluristem.com, the content of which is not part of this press release.


Source: Pluristem Therapeutics

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