Pluristem Therapeutics Inc. shares surged 5.4% in premarket trade Tuesday, after the company said the U.S. Food and Drug Administration has granted approval for a late-stage trial of PLX-PAD cells in the treatment of critical limb ischemia, or CLI. CLI is a condition in which fatty deposits block arteries in the leg, reducing blood flow and causing pain, non-healing ulcers, and gangrene. Patients suffering from CLI often require limb amputation. Pluristem, an Israeli developer of placenta-based cell therapy products, said it will use the Phase III study of its PLX-PAD cells to support an application for a marketing approval for the treatment. The company is aiming to start enrolling patients in the U.s. and Europe in the first half of 2017. Shares have gained 47% in the last 18 months, while the S&P 500 has gained 18%.
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