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Zimmer and ISTO Technologies Announce Phase III Clinical Study to Evaluate the Effectiveness of Engineered Juvenile Cartilage to Repair Damaged Knees

Tue, 02/07/2012 - 11:45am
The Associated Press

/FROM PR NEWSWIRE DALLAS 888-776-3971/

STK NYSE:ZMH Swiss:ZMH

IN MTC MEQ

SU TRI

TO BUSINESS, AND MEDICAL EDITORS:

Zimmer and ISTO Technologies Announce Phase III Clinical Study to

Evaluate the Effectiveness of Engineered Juvenile Cartilage to Repair

Damaged Knees

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/.

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.

About ISTO

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.

-0- 02/07/2012

/CONTACT: CONTACT: Media, Garry R. Clark, +1-574-372-4493, garry.clark@zimmer.com, Investors, Robert J. Marshall Jr., +1-574-371-8042, robert.marshall@zimmer.com

/Web Site: http://www.zimmer.com

(NYSE:ZMH /

Swiss:ZMH) /

CO: Zimmer Holdings, Inc.; ISTO

ST: California Indiana

IN: MTC MEQ

SU: TRI

PRN

-- DE49322 --

0000 02/07/2012 21:30:00 EDT http://www.prnewswire.com

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