Pluristem Therapeutics Inc was incorporated in the state of Nevada on May 11, 2001. The Company is a wholly owned research and development subsidiary in Israel called Pluristem Ltd. The Company operates in one segment, namely, the research, development and commercialization of cell therapeutics and related technologies The Company is developing a standardized cell therapy product from human placenta for the treatment of multiple disorders. The Company develops cell therapy production technologies and products that are derived from the human placenta. PluriX Bioreactor system, was invented at the Technion - Israel Institute of Technology's Rappaport Faculty of Medicine, in collaboration with researchers from the Weizmann Institute of Science. The Company's patented PLX (PLacental eXpanded) cells function as a drug delivery platform that releases a number of therapeutic proteins in response to various local and systemic inflammatory and ischemic signals generated by the patient. PLX cells are grown using its proprietary 3D micro-environment technology that produces an 'off-the-shelf' product that requires no tissue matching prior to administration. The Company faces competition from both allogeneic and autologous cell therapy companies, academic, commercial and research institutions, pharmaceutical companies, biopharmaceutical companies and governmental agencies. Its competitors include Athersys, Inc., Capricor Therapeutics, Inc., Celgene Corporation and Mesoblast LTD. The development, manufacturing and marketing of cell therapy product candidates are subject to the laws and regulations of governmental authorities in the United States and the European Union as well as other countries in which its products will be marketed in the future. Specifically, the FDA in the United States and the EMA in Europe must approve the product for marketing. Furthermore, various governmental statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage and record keeping related to such products and their marketing.
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