Zimmer and ISTO Technologies Announce Phase III Clinical Study to Evaluate the Effectiveness of Engineered Juvenile Cartilage to Repair Damaged Knees
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TO BUSINESS, AND MEDICAL EDITORS:
Zimmer and ISTO Technologies Announce Phase III Clinical Study to
Evaluate the Effectiveness of Engineered Juvenile Cartilage to Repair
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
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
About Zimmer 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
SOURCE Zimmer Holdings, Inc.
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CO: Zimmer Holdings, Inc.; ISTO
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