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Founded in 2004, ProFibrix leverages its expertise in fibrinogen technology to develop and market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen is a natural blood protein that plays a pivital role in blood clotting and tissue healing. FibrocapsTM, the proposed name of the company’s lead biologic, is being studied to help stop bleeding during surgery and after trauma injury. A Phase II clinical trial in the Netherlands has been completed and a large Phase II trial is currently underway in the U.S. and the Netherlands examining the use of Fibrocaps for mild and moderate bleeding during liver surgery. Final study results are expected in 2011. A dry powder mixture of fibrinogen and thrombin, Fibrocaps is a ready-to-use preparation designed to be stable at room temperature and applied in different formats, including sprays and bandages. ProFibrix is also developing a recombinant fibrinogen in mammalian cells in collaboration with a large-scale cGMP manufacturer. This platform is expected to go into production in 2010 and to help sustain the development of several pipeline products. |
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