DONGGUAN, China, November 28, 2014 /PRNewswire/ — Chinese magnesium alloy maker DongGuan Eontec Co., Ltd (SHE: 300328, "Eontec") announced that its biodegradable magnesium alloy bone fixation screw has received Chinese regulatory inspection approval as an innovative medical apparatus and instrument and that the company acknowledges receipt of the approval notification. Eontec said in an interview with Science and Technology Daily journalists Wang Xiangming and Yang Tao, that the company chairman and founder, Professor Li Yangde, has been a pioneer in the research of the application of high purity magnesium into bone implants and, after many years of cooperation with likeminded experts at institutions around the world, the in vivo and in vitro studies led by Professor Li have resulted in a number of positive outcomes. Eontec plans to conduct a clinical trial of the product starting next year and the trial is expected to take from 12 to 18 months.
China-based DongGuan Eontec Chairman Li Yangde
Medial magnesium alloy bone fixation screw on track to be available for clinical trial next year
The China Food and Drug Administration (CFDA) recently released the Announcement on the Results of Special Inspection Approval of Innovative Medical Equipment (No.6, 2014), revealing that Eontec’s degradable magnesium alloy bone fixation screw is now included in the list of approved innovative medical equipment.
A spokesperson for Eontec said that the company’s application with the National Institutes for Food and Drug Control (NIFDC), a subordinate agency of the CFDA, represented a major breakthrough in its biodegradable medical magnesium alloy project. Eontec plans to apply for permission to run a clinical trial of the product with the CFDA once it passes the NIFDC’s sample inspection and standard review and receives a registration inspection report. The product is expected to be available for clinical trial in the first half of 2015 and the subsequent clinical trial will take from 12 to 18 months to complete, according to the spokesperson.
Eontec is currently the sole Chinese company engaged in the research and development of biodegradable medical magnesium alloy bone screws and plates. The company’s R&D team is the second such team to focus on biodegradable magnesium alloy and related implantable devices in Guangdong province. In May of 2011, with the support of the China Industry-University-Research Institute Collaboration Association, Eontec led the establishment of the Strategic Alliance for Technology Innovation of the Medical Magnesium Alloy Industry in Songshanhu, Dongguan. As the first Chinese alliance in the field of applied medical research on magnesium alloy materials, the group now comprises 29 members, including well-known Chinese companies, universities, research institutions and hospitals, among them Peking University, Tsinghua University, Shanghai Jiao Tong University, Beijing Institute of Technology, Institute of Metal Research, Chinese Academy of Sciences, Northwest Institute for Non-ferrous Metal Research, the general hospital of Chinese People’s Liberation Army and Chongqing Three Gorges Central Hospital.
China, Germany team up to promote industrialization of medical magnesium alloy
China and Germany are the two countries worldwide that have been recognized for their outcomes in the research and development as well as industrialization of medical magnesium alloy. Eontec has played a vital role in leading the development of the necessary technologies in China and internationally.
On January 5th, 2013, the Strategic Alliance for Technology Innovation of the Medical Magnesium Alloy Industry led by Eontec and the biodegradable magnesium alloy team of Germany-based AAP Implantate AG held a Sino-German seminar focusing on pre-clinical research in connection with biodegradable magnesium alloy bone implants at the China Hall of Science and Technology in Beijing. Fan Yubo, director of Chinese Society of Biomedical Engineering and professor of Beihang University, and AAP Implantate AG Vice President of R&D Dr. Daniel Zukowski participated in the seminar as featured speakers. This marks the beginning of the cooperation between China and Germany in the research and development as well as industrialization of biodegradable magnesium alloy bone implants.
German high-tech medical equipment company AAP Implantate is forward-thinking in its approach to medical magnesium alloy technology and its world-class portfolio includes bone cement, bone graft substitutes, antibiotic carriers and implants used for bone fracture healing and joint replacement. The Alliance has expressed the opinion that the collaboration between China and Germany in medical magnesium alloy technology demonstrates that the medical magnesium alloy industry is on track for industrialization within three years.
As a novel medical implant, magnesium alloy can degrade and be absorbed into the bodies of patients completely after the fulfillment of its role. The implant has been recognized as a revolutionary metal biomaterial as it eliminates a second surgical operation and the subsequent mental anguish and physical discomfort for patients while significantly reducing the associated economic burden. With the increasing replacement of steel bone screws with degradable magnesium alloy materials, the value of the medical magnesium alloy material market is set to reach 12 billion yuan (approx. US$1.9 billion). Industry analysts have predicted that China will soon enter a period of peak demand for the research and development and industrialization of medical magnesium alloy.
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