Xvivo Perfusion: FDA panel recommends approval for TransMedic's OCS lung system2017-05-19 12:47, Edited at: 2017-05-19 13:02
An FDA advisory panel has recommended market approval for TransMedic’s device used to perfuse lungs prior to transplantation. Xvivo Perfusion has previously been the sole actor in the market for warm perfusion of lungs in the United States, but will now face competition. We believe that Xvivo Perfusion has a stronger product offering and see no reason to revise our estimates due to the event.
A majority of the FDA’s Gastroenterology & Urology Devices panel voted that the OCS lung system was safe, effective and that its benefits outweigh its risks. The device will be in direct competition with the XPS, but unlike Xvivo Perfusion, TransMedic's does not offer a proprietary solution, with both a solution (STEEN Solution) and a machine. We also recognise that Xvivo Perfusion already has an installed base at many of the larger clinics in the United States and that TransMedic's sales have been modest on the markets where the company currently holds market approval. We will not perform any changes to our estimates due to the event.
TransMedics device for warm perfusion of lungs is commercially available in Europe and Australia. The company has a market approved device for heart perfusion in Europe and Australia, which is currently under review by the FDA. Since February 2016, the company is also performing a pivotal study of its OCS liver device.
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