Pluristem’s goal is to provide patients, physicians and healthcare systems around the globe with standardized, easy to use, and highly effective PLX cell products that need no genetic or tissue matching prior to administration. We are active with many respectful regulatory agencies worldwide to advance our clinical programs towards marketing. Part of our clinical development strategy is to achieve product approval through rapid regulatory pathways wherever possible. So far, our clinical development program for PLX-PAD in Critical Limb Ischemia (CLI) is progressing via advanced regulatory pathways in Europe and Japan.
Our leading clinical programs in Critical Limb Ischemia (CLI), Femoral Neck Fracture (FNF) and Acute Radiation Syndrome (ARS) are in the final stages of development and we anticipate positive data from our 170 patients phase II study in the coming months.
More about advanced regulatory pathways in Europe and Japan
Pluristem is one of only a handful of companies in the world that have been selected to develop a product using the Adaptive Pathways pilot project in Europe, and Japan’s rapid regulatory pathway for regenerative medicines. As a result, we have a significant opportunity to bring PLX-PAD more quickly to patients suffering from CLI, a severe, life-threatening condition with poor treatment options.