FDA and the Paul Ehrlich Institute (Germany) Approve Pluristem's Regulatory Submissions in Support of a Phase I/II Clinical Trial Utilizing PLX-PAD for Peripheral Artery Disease

Pluristem Therapeutics Inc. (NASDAQ:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that the Paul Ehrlich Institute (PEI) in Germany has approved the pre-clinical study synopsis to support a Phase I/II clinical trials in Germany and that the Center for Biologics Evaluation and Research (CBER), a division of the US Food and Drug Administration (FDA), has approved the synopsis to conduct a Phase I clinical trial in the US utilizing PLX-PAD for the treatment of limb ischemia associated with peripheral artery disease (PAD). The PEI is the German federal authority granting clinical trial approvals. PLX-PAD are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem’s proprietary 3D PluriX™ technology The regulatory and scientific package submitted to both authorities contains detailed information on the clinical indication, product properties, the Good Manufacturing Practices (GMP) manufacturing process for the production of PLX-PAD, and the clinical protocol synopsis for the planned Phase I/II clinical trial. The package also contains information on the safety and biodistribution study designs required to file an investigational new drug (IND) application. Mr. Zami Aberman, Pluristem’s President & CEO, stated: "I am proud that our team has accomplished this important milestone in achieving the FDA and PEI approval of our clinical route. We believe that this now paves the way to submit an IND using PLX-PAD for limb ischemia this summer and hopefully begin our Phase I/II clinical trials in 2008.” About Limb Ischemia In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with peripheral artery disease (PAD). The disease is characterized by narrowing and hardening of the arteries in the patient’s limb(s) caused and/or aggravated by conditions such as diabetes, Buerger's Disease and smoking. With decreased blood flow to the affected extremity, patients can suffer a host of complications, including nerve and tissue damage. In advanced stages, limb ischemia can lead to gangrene, which often requires treatment with amputation. The current market for therapeutics and other interventions to treat limb ischemia is estimated to be approximately $1.2 billion. About Pluristem Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from the human placenta, a non-controversial, non-embryonic, adult stem cell source. These placental mesenchymal stromal cells (MSCs) are expanded in the Company’s proprietary PluriX™ 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes the resultant PLX (PLacental eXpanded) cells are multi-potent and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and have immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations. Pluristem’s first product in development, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company’s products in development also include PLX-I, targeting the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; PLX-STROKE, targeting ischemic stroke victims; and PLX–MS, targeting Multiple Sclerosis. Pluristem has offices in the USA with research and manufacturing facilities in Israel. See our product animation on YouTube: http://www.youtube.com/watch?v=OFhWXyJT6Us 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 we believe that this now paves the way to submit an IND using PLX-PAD for limb ischemia this summer and hopefully begin our Phase I/II clinical trials in 2008, we believe that this now paves the way to submit an IND using PLX-PAD for limb ischemia this summer and hopefully begin our Phase I/II clinical trial in 2008, 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; 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; 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 risk 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.