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Pluristem Therapeutics, Inc., a leading developer of placenta-based cell therapies, today announced it is submitting its application to the United Stated Food and Drug Administration requesting the Company to be granted Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells in the treatment of severe preeclampsia.

Pluristem Therapeutics, Inc., a leading developer of placenta-based cell therapies, today announced it has formed a Preeclampsia Steering Committee to advance its PLacental eXpanded (PLX) cell therapies for the treatment of preeclampsia.

Pluristem Therapeutics, Inc., a leading developer of placenta-based cell therapies, today announced the appointments of two of its senior executives. These executive appointments support the Company’s growth and opportunities both on the clinical development front and with its big-pharma corporate partnerships. This comes at a time when Pluristem is advancing its cell therapies for numerous indications through global clinical trials.

Pluristem Therapeutics, Inc., a leading developer of placenta-based cell therapies, today announced that the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), will commence a mechanism-of-action study of Pluristem’s PLacental eXpanded RAD (PLX-RAD) cells for the treatment of acute radiation syndrome (ARS). The study aims to investigate the effect of PLX-RAD cells on body weight, blood count parameters, cytokine concentrations and bone marrow or spleen cellularity at various time points following the administration of PLX-RAD cells to animals receiving total body irradiation. The study is scheduled to begin in February 2014.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, today announced top-line results from its Phase I/II clinical trial testing the safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury. The trial indicated PLX-PAD cells were safe and statistical significance was reached (p=0.0067) for the primary efficacy endpoint of the study, the change in maximal voluntary isometric contraction force of the gluteal muscle at six months after total hip replacement. Patients treated with PLX-PAD had a greater improved change of maximal voluntary muscle contraction force than the placebo group. These results provide evidence that PLX cells may be efficacious in the treatment of orthopedic injuries including muscles and tendons.

Pluristem Therapeutics Inc., today announced that the results of the company’s Phase I/II clinical trial testing the safety and efficacy of PLacental Expanded (PLX-PAD) cells for the treatment of muscle injury will be presented on January 21, 2014.

Pluristem Therapeutics, Inc., a leading developer of placenta-based cell therapies, today announced it has been granted a new patent in Australia. Patent #2008300185, titled "Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced thereby for Therapy," covers the use of adherent placental cells for the treatment of ischemia, which is a restriction of blood supply to tissues, and for treatments of conditions requiring connective tissue repair or regeneration.

Pluristem Therapeutics Inc. today announced that pursuant to the previously announced exclusive out-license and strategic partnership agreement between Pluristem Ltd. and South Korea-based CHA Bio&Diostech, the details of which were announced on June 26, 2013. Pluristem and CHA entered into investment agreements pursuant to which Pluristem has issued to CHA 2,500,000 shares of its common stock in consideration for the issuance to Pluristem of 1,011,504 shares of CHA. This reflects a total consideration of $10.4 million, at a price of $4.16 per Pluristem common share, a premium of 26% over the closing price on December 16, 2013. The shares are subject to a lock up period of one year.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA), has approved Pluristem's Investigational New Drug (IND) Application to conduct a Phase II study using PLX-PAD cells for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapies, announced today that its PLacental eXpanded (PLX) cells proved to be safe in an animal study assessing maternal and fetal toxicity. The study was conducted at the Charles River Laboratories, one of the world's leading contract research organizations. The results showed that the intramuscular administration of PLX-PAD cells to pregnant rats did not result in any maternal or fetal toxicity. Pluristem will pursue the clinical development of PLX-PAD cells for the indication of preeclampsia based on these results and earlier evidence that the cells were efficacious in preeclamptic animal models.