Pluristem's PLX Cells Receive Orphan Drug Status for Treatment of Buerger's Disease

Pluristem Therapeutics, Inc. PSTI today announced that on August 22, 2011, the U.S. Food and Drug Administration (FDA) designated Pluristem's PLX cells orphan status for the treatment of thromboangiitis obliterans (Buerger's disease). The Company also announced that a concurrent application in Europe at the EMA's Committee for Orphan Medicinal Products is pending. Buerger's Disease, or thromboangiitis obliterans, is a rare and severe disease affecting the blood vessels of the extremities. It is characterized by inflammation and clotting of the vessels that result in a reduced blood flow to these areas. Severe pain and ulcers or necrosis of the extremities may occur, which may lead to amputation. Buerger's Disease affects approximately 50,000 patients in the United States and Europe. As there are no established treatments available, there is a strong medical need for the development of drugs for this indication. Various sources estimate the market for the treatment of Buerger's disease to be approximately $2.5 billion.