Zimmer Holdings, Inc (WARSAW, Indiana), an orthopaedic leader in reconstructive and spinal implants, trauma, and related orthopaedic surgical products, and ISTO Technologies, Inc (ST. LOUIS, Missouri), a clinical-stage orthobiologic company that focuses on cell-based technology for the repair and regeneration of damaged cartilage in joints and spinal discs, announced the initiation of a clinical trial for Neocartilage, a living tissue-engineered graft. Neocartilage is 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® ET Engineered Tissue Graft.

In June 2006, the US FDA approved ISTO's investigational new drug (IND) application, allowing the companies to move forward with clinical trials. Three additional study sites for the clinical trial include OrthoIndy (Indianapolis, Indiana), Jordan-Young Institute (Virginia Beach, Virginia), and Rush University Medical Center (Chicago, Illinois).

Zimmer and ISTO entered into a codevelopment agreement in 2002 granting Zimmer exclusive worldwide commercial distribution rights to the Neocartilage technology. The two companies have since collaborated on further development and preclinical testing. In preclinical studies, DeNovo ET has demonstrated the ability to resurface cartilage defects.

According to Zimmer, the company has made biologics the centerpiece of their investment strategy and intends to play a leadership role in the generation of biologic repair and regeneration technologies for the orthopaedic market.  

DeNovo ET is a living tissue graft grown from juvenile chondrocytes using ISTO's proprietary cell-based platform technology. Studies have demonstrated that juvenile chondrocytes produce cartilage significantly better than their adult counterparts. Zimmer, in conjunction with ISTO, is also developing another cartilage repair product intended to support the surgical repair of damaged articular cartilage. The DeNovo NT Natural Tissue Graft also consists of juvenile chondrocytes in the form of minced cartilage tissue.

—A. Techman

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