FDA approves Pluristem’s Buerger’s disease stem cell treatment


FDA approves Pluristem’s Buerger’s disease stem cell treatment

The company has received orphan drug status for its treatment for the rare blood disease of the limbs, which can lead to amputation.

25 August 11 14:52, Globes’ correspondent

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has obtained US Food and Drug Administration (FDA) orphan status approval to use its PLX stem cells for the treatment of thromboangiitis obliterans (Buerger’s disease), a rare and severe disease affecting the blood vessels in the limbs, which can lead to amputation.
Pluristem has also applied for orphan drug status for treatment with the European Medicines Agency (EMEA).

Buerger’s Disease cause inflammation and clotting of the blood vessels resulting in reduced blood flow, severe pain and ulcers or necrosis can occur, which may lead to amputation. Buerger’s Disease affects 50,000 people in the US and Europe. There is no current treatment. The company says that various sources estimate the market for a cure at $2.5 billion.

Pluristem’s share price rose 1.8% by mid-afternoon to NIS 9.34, and rose 5.6% to $2.61 in premarket trading on Nasdaq, giving a market cap of $104 million.

Published by Globes [online], Israel business news – www.globes-online.com – on August 25, 2011





  1. Using an inflammatory stem cell to fight Buerger’s, an inflammatory disease, is fighting fire with fire. It won’t work. I have no investment in T2Cure- a privately held Franfkurt company, but their therapy- autologous bone marrow cells, which received Orphan designation by the FDA and the Euopean agency Last Year, has a better chance of successfully treating Buergers. So does smoking cessation.

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