Pluristem Announces Agreement With Japan's PMDA on Design of Final Trial Needed to Apply for Conditional Approval of PLX-PAD

Pluristem Therapeutics Inc.

today announced that it has reached an agreement with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) on the design of the final trial needed to apply for conditional approval of PLX-PAD cells in the treatment of critical limb ischemia (CLI). The approval of the protocol for the 75-patient trial was part of a larger agreement on the development of PLX-PAD via Japan's new accelerated regulatory pathway for regenerative medicine. "With this achievement we have advanced our strategy to expedite commercialization of our cell products. Pluristem is now positioned favorably to accelerate negotiations with those Japanese pharma companies interested in becoming dominant players in the expanding regenerative medicine market in Japan," stated Pluristem Chairman and CEO Zami Aberman. The trial will collect data on 75 patients suffering from CLI. These patients will be randomized into three groups of 25. Group one will receive an initial 150 million PLX-PAD cell dose followed