Zimmer and ISTO Technologies, Inc. Announce Phase III Clinical Study to Evaluate the Effectiveness of Engineered Juvenile Cartilage to Repair Damaged Knees
Published: Feb 08, 2012
SAN FRANCISCO, Feb. 7, 2012 /PRNewswire/ -- 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/.
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.
Zimmer Safe Harbor Statement
This press release contains forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 based on current expectations, estimates, forecasts and projections about the orthopaedics industry, management's beliefs and assumptions made by management. Forward-looking statements may be identified by the use of forward-looking terms such as "may," "will," "expects," "believes," "anticipates," "plans," "estimates," "projects," "assumes," "guides," "targets," "forecasts," and "seeks" or the negative of such terms or other variations on such terms or comparable terminology. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that could cause actual outcomes and results to differ materially. For a list and description of such risks and uncertainties, see our periodic reports filed with the U.S. Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Readers of this document are cautioned not to place undue reliance on these forward-looking statements, since, while we believe the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this document.
SOURCE Zimmer Holdings, Inc.