Zimmer Holdings (ZMH) and ISTO Technologies Announce Phase III Study for DeNovo ET Engineered Tissue Graft
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Zimmer Holdings, Inc. (NYSE: ZMH) and ISTO Technologies announced a Phase III clinical study to evaluate DeNovo ET Engineered Tissue Graft, an engineered cartilage implant intended to repair cartilage defects in the knee. DeNovo ET Graft is being developed under a collaborative relationship between ISTO and Zimmer.
The Phase III study will comprise a randomized, controlled clinical trial involving 225 patients at up to 25 centers in the United States. The program is designed to demonstrate superiority of DeNovo ET Graft over the current standard of care (microfracture) for articular cartilage defects.
In preclinical studies, cartilage cells derived from juvenile tissue demonstrated a significantly greater capacity for regenerating cartilage compared to cells derived from adult cartilage.
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The Phase III study will comprise a randomized, controlled clinical trial involving 225 patients at up to 25 centers in the United States. The program is designed to demonstrate superiority of DeNovo ET Graft over the current standard of care (microfracture) for articular cartilage defects.
In preclinical studies, cartilage cells derived from juvenile tissue demonstrated a significantly greater capacity for regenerating cartilage compared to cells derived from adult cartilage.
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