Zimmer and ISTO Technologies Announce Phase III Clinical Study to Evaluate the Effectiveness of Engineered Juvenile Cartilage to Repair Damaged Knees
"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/.
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer's 2011 sales were approximately $4.5 billion. The Company is supported by the efforts of more than 8,500 employees worldwide. For more information about Zimmer, visit www.zimmer.com.
ISTO is a privately-held orthobiologics company dedicated to improving patient quality of life through the development of proprietary products for spinal therapies and sports medicine applications. ISTO's products are intended for the repair and regeneration of damaged or injured cartilage and bone. For additional information on ISTO, please visit our website at www.istotech.com.