WARSAW, IN and ST. LOUIS, MO – Zimmer
Holdings, Inc., 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
“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.