Singapore, March 20, 2008: The Industrial Technology Research Institute (ITRI), the largest non-profit R&D organization in Taiwan and National Taiwan University (NTU) Hospital which have co developed biphasic osteochondral repair for articular cartilage regeneration technology (ACRT) announced licensing agreement with Exactech Taiwan, one of the leading manufacturer of orthopaedic implant devices in the world.

 

Human clinical trials employing osteochondral repair technology will be initiated at NTU Hospital and throughout the world. It is expected that the product will be formally marketed in the United States, the European Union and other nations in the future. This autologous articular cartilage repair technology has the characteristics of short procedure, small wound, and quick recovery.

 

Dr. Johnsee Lee, president, ITRI said,” The biphasic osteochondral repair for articular cartilage regeneration technology marks the significance on Taiwan in which NTU Hospital’s physicians expressed their need for a solution to a clinical problem and proposed a design for the medical equipment needed. ITRI cooperated by helping to develop the innovative technology required and it is transferring the technology to Exactech Taiwan.”

 

He further said, “These breakthroughs, which were entirely developed locally, exhibited that research in this field on Taiwan had reached world-class standards. Exactech was brought into the effort to make best use of its product development experience and international marketing network and carry out clinical trials and commercialize products. This will mark an important step in bringing together medical device industry in Taiwan.”

 

This research project was jointly led by Prof Ching-Chuan Jiang, Chairman of the Department of Orthopaedic Surgery of the National Taiwan University Hospital, and Dr. Dr Chun-Jen Liao, the lead researcher of biomaterial applications of the Biomedical Engineering Research Laboratories at ITRI.

 

Mr Lin Fang-yue, Superintendent, NTU Hospital said that Prof Ching-Chuan Jiang led a team in carrying out stem cell and tissue engineering research, and then applied the research to stage breakthroughs in cartilage regeneration. Over a five-year period, the team released six research papers in international medical journals announcing the state-of-the-art technology they had developed.

 

Prof Ching-Chuan Jiang said that during surgery, physicians only need to extract small amounts of healthy cartilage from the damaged area. This material is then soaked in a special enzyme solution to release the cartilage cells. A biphasic porous scaffold is then implanted into the damaged area, enabling the cartilage to regenerate on its own in a short period. What makes this technology special is that there is no need to cultivate cartilage cells outside the body and that the patient needs to undergo only one surgery. This short surgery only leaves a small wound, and it offers the advantage of quick recovery.

 

Presently, the most advanced osteochondral procedures only address repairing damaged cartilage. This new technology will both repair cartilage and the bone below it. This technology will be particularly beneficial to young people who suffer cartilage damage from sports or other external injuries. Middle-aged and older people who suffer from arthritis or whose joints or bones have been damaged due to poor blood flow will also be candidates for this procedure.

 

Dr. Chung-cheng Liu, General Director, Biomedical Engineering Research Laboratories ITRI said, “The ITRI research team has paid special attention to various processes and instruments to aid surgeons and promote the use of this technology in clinical applications. For instance, ITRI developed disposable devices that will treat autologous tissue in minimal time. It has also developed bio-absorbent bone materials and instruments enabling minimally invasive surgery. In addition, ITRI’s GMP-certified biomedical products factory carries out production of implants and kits of pilot scale.”

 

Dr. Chun-Jen Liao, the lead researcher of biomaterial applications of the Biomedical Engineering Research Laboratories at ITRI, said, “This technology has already passed large-scale trials on adult pigs in preparation for human clinical trials. The results of the trials on the pigs has confirmed the effectiveness in repairing osteochondral defects to the full thickness. ” 

 

Mr Bruce Thompson, chief of the Ecaxtech Taiwan said, “This technology license agreement allows Exactech to enter a field of treatment that is on the frontier of orthopaedics. Since this technology also concerns metallic instruments and resorbable biopolymers, Exactech intends to coordinate the development of related product technology among Taiwan’s GMP-certified orthopaedic medical products factories.