Orthovita submits new Cortoss clinical data to FDA

By Associated Press
September 16, 2008 | Comments (0)

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Orthovita Inc., an orthopedic and surgical products maker, said Tuesday it submitted additional clinical data about its Cortoss synthetic bone to the Food and Drug Administration.

Orthovita submitted two-year follow-up data from clinical trials of Cortoss Bone Augmentation Material. The company seeks 510(k) marketing approval for the product for use in vertebral augmentation.

Vertebral augmentation is a procedure in which material is added to a vertebra that has fractured due to injury or osteoporosis.

The company said the FDA asked for more data on Cortoss in March. The product has already been approved for use in the European Union.

Orthovita shares rose 15 cents, or 5.5 percent, to close at $2.90.

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