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TheStreet Open House

Pluristem's CEO Letter To Shareholders

HAIFA, Israel, Jan. 7, 2013 (GLOBE NEWSWIRE) --

Dear Pluristem Shareholders,

In 2012 we have made great progress and moved closer to fulfilling our vision of being a leader in developing and manufacturing cell therapies. We have had significant achievements in many areas including:

  1. Clinical trials development activity
  2. Exploring new potential product candidates
  3. Enhancing our IP position
  4. Insured financial soundness and joining the Tel Aviv 75 and 100 indexes
  5. Constructing a new state of the art manufacturing facility for our PLX Cells

Clinical trials development activity

Achievements in clinically developing our products attest to the hard work, dedication and ingenuity that our team demonstrates on a daily basis. In 2012 our milestones included:

  1. The initiation of an FDA-approved Phase II clinical trial using PLX cells for the treatment of Intermittent Claudication (IC), a form of Peripheral Artery Disease (PAD)
  2. The approval by the Paul Erhlich Institute (PEI), the German medical regulatory body, to commence a Phase I/II clinical trial for the rehabilitation of injured gluteal muscles following a total hip replacement
  3. The filing with the FDA for Orphan Drug Status in using our PLX cells in the treatment of Aplastic Anemia (a disease involving bone marrow failure)
  4. The successful treatment of critically ill patients under a compassionate use program at the Hadassah Medical Center in Jerusalem
  5. The development of a Point-of-Care thawing device for our PLX Cells
  6. The invitation by the U.S. National Institutes of Health (NIH) to submit our PLX cells to their scientific teams to evaluate them in animal models of acute radiation syndrome (ARS)
  7. The formation of a Peripheral Artery Disease Steering Committee and a Hematological Diseases Clinical Advisory Board (CAB)

Exploring new potential product candidates

We have conducted several preclinical studies this year and the results of these studies demonstrate that our PLX cells may be effective in a number of indications. Because we can produce specific PLX products tailored towards the mechanism of a disease, this allows us to expand these indications. We discovered and developed a dedicated composition of PLX cells tailored to possess unique characteristics found to be beneficial in the treatment of Acute Radiation Syndrome and bone marrow illness.

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