Zimmer
Holdings, Inc. (NYSE: ZMH; SWX: ZMH), a leader in the orthopaedics
industry, and ISTO Technologies, Inc., an innovative orthobiologic company,
today announced that the clinical trial is now underway for Neocartilage, a
living tissue-engineered graft under investigation for the restoration of
cartilage defects, reestablishment of joint function and relief of pain in
the knee. Zimmer plans to market the product as DeNovo(R) ET Engineered
Tissue Graft.
In June 2006, the U.S. Food and Drug Administration (FDA) approved
ISTO's Investigational New Drug (IND) application, allowing the companies
to move forward with human clinical trials of the novel cartilage
regeneration treatment.
Jack Farr II, M.D., an orthopaedic surgeon with OrthoIndy,
Indianapolis, performed the surgery on the first patient in November 2006.
"I have participated in a variety of projects involving cartilage repair
and regeneration, and I find the science behind DeNovo ET very compelling,"
said Dr. Farr. "The initial surgery went as we had hoped, and we look
forward to enrolling more patients into the study and serially assessing
their progress with the implant."
Kevin F. Bonner, M.D., an orthopaedic surgeon with Jordan-Young
Institute in Virginia Beach, Virginia, has also enrolled patients into the
study. "In pre-clinical studies, DeNovo ET has demonstrated the ability to
resurface cartilage defects," said Dr. Bonner. "The procedure is
straightforward and builds on earlier cartilage repair techniques."
Additional study sites for the clinical trial are being added.
Recently, Rush University Medical Center in Chicago was added; Dr. Brian
Cole, the head of Rush's Cartilage Restoration Center, will serve as the
principal investigator for the Rush location.
Zimmer and ISTO entered into a co-development agreement in 2002
granting Zimmer exclusive worldwide commercial distribution rights to the
Neocartilage technology. The two companies have since collaborated on
further development and pre-clinical testing. The potential market for
DeNovo ET is large, as each year in the United States alone approximately
500,000 cartilage lesions are treated in knee joints.
"We are delighted both to advance the Neocartilage technology into
human clinical trials, and to be collaborating with the world's leading
orthopaedic company to achieve this significant milestone," said Mitchell
Seyedin Ph.D., President and Chief Executive Officer of ISTO.
"Zimmer has made biologics the centerpiece of our innovative investment
strategy and we are pleased to have reached this very concrete milestone in
the development of our plans," said Ray Elliott, Chairman, President and
Chief Executive Officer of Zimmer Holdings. "With our investments in other
biologic repair and regeneration technologies, we intend to play a
leadership role in the next generation of treatments to address the needs
of patients with arthritis and other orthopaedic issues."
DeNovo ET is a living tissue graft grown from juvenile chondrocytes
(cartilage cells) using ISTO's proprietary cell-based platform technology.
Studies have demonstrated that juvenile chondrocytes produce cartilage
significantly better than their adult counterparts. Cartilage works as a
low friction articulating surface to protect joints from wear and tear
experienced during motion. Articular cartilage can be damaged as a result
of injury, or can simply deteriorate over time leading to osteoarthritis.
Cartilage is known to have limited capacity to heal on its own. Most joint
replacements are performed as a result of the effects of osteoarthritis.
Zimmer is also developing another cartilage repair product in
conjunction with ISTO. The DeNovo NT Natural Tissue Graft also consists of
juvenile chondrocytes in the form of minced cartilage tissue. This living
tissue graft is also intended to support the surgical repair of damaged
articular cartilage.
About Zimmer
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer is the
worldwide #1 pure-play orthopaedic leader in designing, developing,
manufacturing and marketing reconstructive and spinal implants, trauma and
related orthopaedic surgical products. Zimmer has operations in more than
24 countries around the world and sells products in more than 100
countries. Zimmer's 2006 sales were approximately $3.5 billion. The Company
is supported by the efforts of nearly 7,000 employees worldwide.
About ISTO Technologies, Inc.
ISTO Technologies, Inc. is an orthobiologic company focused on
developing differentiated products for sports medicine and spinal therapy.
ISTO's products are intended for repair and regeneration of damaged
cartilage in joints and spinal discs.
Visit Zimmer on the worldwide web at zimmer
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