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 results from Fraunhofer Institute’s additional pre-clinical study utilizing the Company’s proprietary PLacental eXpanded (PLX) cells in treating ischemic stroke showed statistical significance utilizing functional as well as anatomical endpoints. PLX cells are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem’s proprietary 3D PluriX™ technology.

Fraunhofer Institute’s scientists systemically injected PLX cells into spontaneously hypertensive rats that had undergone middle cerebral artery occlusion, a commonly accepted ischemic stroke model. The functional endpoints of improvement in beam walking and neurological severity score and the anatomical endpoint of reduction in infarct size reached statistical significance versus controls.

Zami Aberman, Pluristem’s President and CEO said: “We are very excited about the results and believe that utilizing our PLX product may successfully treat millions of ischemic stroke patients and lead to a multi-billion dollar market. This independent study, together with the previously announced favorable pre-clinical results of PLX cells to treat limb ischemia and blood cancer, give us a robust pipe line for developing new therapeutic products.”

The trial was conducted under the supervision of Professor Frank Emmrich, Head of the Fraunhofer Institute for Cell Therapy and Immunology (IZI), Leipzig, Germany, a branch of the Fraunhofer Society.

Prof. Frank Emmrich stated, "PLX cells possibly show potential to become a new treatment for the functional recovery from a stroke. The data show that a double injection of PLX cells at two different time points significantly improve the functional recovery and reduce of size of the lesion compared to the control. However, these preliminary findings have to be confirmed and the running experimental series have to be completed before a final statement can be made. Additional optimization surrounding the administration of PLX cells will be required to supply clear evidence that PLX cells may help patients with ischemic stroke.”

About Ischemic stroke

Ischemic stroke accounts for approximately 90% of all stroke cases and is caused when an artery to the brain becomes blocked causing a sudden disruption of blood flow. Current estimates suggest ischemic stroke affects approximately 2 million patients annually worldwide with a large percentage dying or becoming permanently disabled. Industry leaders have estimated the potential market for treating ischemic stroke to be approximately $4 billion.

About Fraunhofer Institute for Cell Therapy and Immunology

The Fraunhofer Institute for Immunology and Cell Therapy (IZI) founded in April 2005 is member of the Fraunhofer Life Sciences Alliance. Its objective being to find solutions to specific problems at the interfaces between medicine, life sciences and engineering for partners active in medicine-related industries and businesses. The Institute’s core competencies are to be found in regenerative medicine, or more precisely in cell-therapeutic methods of regenerating non-functioning tissue and organs through to the biological substitution with tissue cultivated in vitro (tissue engineering). In order for the living organism to accept the tissues without any difficulty, it is necessary to study cellular and immunological defense and control mechanisms and take these into account during process and product development. These core competencies entail a multiplicity of tasks to be solved by new products and processes. The Institute works especially closely with hospital institutions, performing quality tests and clinical studies on their behalf. Additionally it also provides assistance in obtaining manufacturing licenses and certifications.