Zimmer Holdings, Inc. (NYSE and SIX: ZMH), a global leader in musculoskeletal health, and ISTO Technologies, Inc., an orthobiologics company focused on developing breakthrough products to regenerate and restore function to damaged cartilage and bone, today 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 DeNovo ET Graft program represents a natural extension to our early intervention and joint preservation portfolio," said Cheryl R. Blanchard, Ph.D., Senior Vice President and Chief Scientific Officer at Zimmer. "This Phase III study will generate meaningful data on the potential of this novel biological solution for treatment of cartilage lesions earlier in the continuum of care."
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. Recognizing and harnessing the significant regenerative capacity differences between adult and juvenile cells is an underlying principle of ISTO's platform for cartilage repair. In addition, through a proprietary scalable manufacturing process, ISTO has developed a platform technology for cartilage regeneration using juvenile cartilage cells.
"It is gratifying for our team to see our breakthrough cartilage repair technology advancing from research into a late stage clinical trial for what is clearly a large unmet medical need," said Mitchell Seyedin, Ph.D., President and CEO of ISTO.
More information about the Phase III clinical study is available at http://www.repairmyknee.com/ .