Our vision at Pluristem Therapeutics is to leverage our position as a global leader in placenta-based cell science to develop and manufacture safe and effective cell therapy products. We believe our cutting edge technology can produce therapies that will help people affected by inflammation, ischemia, hematological disorders, and acute radiation syndrome, and establish us as a leading company in the cell therapy arena. We also believe that in cell therapy “the process is the product”, and precise control of the entire process, from obtaining cells from the source, to delivery to the patient, is vital to the success of a cell therapy. Our fully automated process, proprietary 3D cell expansion technology and increasing knowledge of the placental cell drive us to continue developing additional candidates for our product portfolio.
Recently we have made significant progress in the execution of our strategy to shorten the time to commercialization of our PLX cells.
The PLX cell program in critical limb ischemia has been selected for the European Medicines Agency’s Adaptive Pathways pilot project, which potentially allows for early marketing authorization of a therapy in a restricted patient population, and the possibility of later approval for use in broader patient populations. In Japan, we have applied to the Accelerated Pathway for Regenerative Medicine for our PLX cells in critical limb ischemia. Japan’s Pharmaceuticals and Medical Devices Agency just validated the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials there. We are hopeful that these rapid pathways will allow us to shorten the time it will take to bring our advanced cell therapies to patients in need of innovative treatments.