Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials announced today it has initiated a prospective, randomized, multi-center, clinical trial to evaluate the safety and effectiveness of a new cartilage repair technology.
“This is the first time a one-step, single-surgery system has allowed transplantation of a patient's own cartilage processed to facilitate regeneration of focal defects”
The first of 92 surgeries planned for the study was successfully performed December 1, 2011, by Professor Ching-Chuan Jiang, M.D., and Dr. Hong-Sen Chiang, at the National Taiwan University Hospital (NTUH) in Taipei, Taiwan. The study will include one-year follow-up of patients treated for focal chondral or osteochondral lesions of the knee, and will provide the basis for a premarket approval application to the Taiwan Food and Drug Administration upon its completion.
The new technology incorporates a novel tissue processing system that allows for preparation of a patient's own cartilage for delivery to the site of a cartilage defect in a single-stage procedure. The system uses both mechanical and chemical processing to increase the potential for cartilage regeneration.
"Cartilage repair has become a strategic focus of Exactech's biologic research and development efforts," said Bruce Thompson, senior vice president and general manager of Exactech's Spine and Biologics Division. "Exactech believes cartilage repair can offer an early intervention, regenerative approach to treating patients who present with cartilage defects, which is often a precursor to osteoarthritis."
"This is the first time a one-step, single-surgery system has allowed transplantation of a patient's own cartilage processed to facilitate regeneration of focal defects," said Professor Jiang. "It is our hope that this clinical trial will prove our implant technique to be effective in regenerating native cartilage."
Exactech licensed the technology in 2008 from Industrial Technology and Research Institute of Taiwan (ITRI) and NTUH and has spent three years conducting research and development.
Initiation of this clinical trial represents a major milestone in Exactech's plan for commercialization of its cartilage regeneration technology in multiple global markets, including the United States and Europe. Exactech will follow the particular regulatory requirements of the intended markets to assure the most timely introduction of the technology for the benefit of patients in these markets.
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