Take
a step towards
the possibility of a better quality of life.
The Company initiated patient enrollment in a
pivotal study in North America to assess the safety and efficacy of
Augment™ Injectable Bone Graft as a substitute for autograft
in foot and ankle fusion procedures. This randomized, controlled
study is intended to support Augment™ Injectable product registration in
the United States and Canada. The study will incorporate
approximately 300 patients. Up to 20 clinical centers in North
America will be involved, with five sites already approved for
enrollment in Canada.
We have already begun
enrolling patients in centers throughout Canada. Further, we
have submitted an Investigational Device Exemption (IDE) to the Food
& Drug Administration (FDA) for this study and are currently
finalizing the statistical plan. Based on the most
recent discussions with the FDA regarding the Augment Injectable
study, we expect to begin enrolling patients at our U.S. study sites
in the first quarter of 2010 and hope to have the study fully
enrolled by the end of the year.
If you have questions regarding the Foot and Ankle Fusion
Study, or would like information regarding clinical trial site locations in your area,
please
contact us.
Foot Fact: 40% of adults
experience foot pain at some point in their lives.
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Getting back on
your feet again
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