Health & Beauty

According to the Huacheng Import and Export Data Observation Report, on February 17, Dongguan Yi'an Technology Co., Ltd. (hereinafter referred to as Yi'an Technology) announced that the first biodegradable high-purity magnesium orthopedic implant product in China developed by the company, "biodegradable magnesium internal fixation screw", had completed the clinical trial, and held a press conference and a seminar on clinical conversion of medical magnesium alloy orthopedic implants.

According to the observation report of Huacheng Import and Export Data, the completion of clinical enrollment means that the biodegradable magnesium implants have been successfully used in batches in human body, marking that the industrialization of biodegradable metal implants has entered a new stage and is of milestone significance. At present, there is no degradable magnesium bone nail product in the domestic medical market.

The product can avoid secondary surgery

In the laboratory of Yi'an Technology R&D Headquarters, the magnesium bone nail product shows its true appearance: its appearance is similar to that of ordinary screws, silver white, with a length of several centimeters, and light weight.

In many orthopedic operations, steel nail and steel plate are common treatment methods. The disadvantage is that it needs to be removed by a second operation after rehabilitation, which will increase the burden on the patient.

The first domestic magnesium bone nail developed by Yian Technology can cure diseases without taking out. The product is made of magnesium with purity of 99.999%. Relevant experiments show that it not only has the medical function similar to steel nail, but also can dissolve automatically in human body, thus avoiding the trouble of secondary surgery.

According to the observation report of Huacheng Import and Export Data, in orthopedic surgery, bone nails are mainly used to fix bones and help heal damaged bones. At present, there are stainless steel nails, titanium alloy nails and polylactic acid nails, while magnesium bone nails will be the fourth new bone nail material.

"The magnesium bone nail is made of high-purity magnesium, which will corrode and degrade in the human environment and eventually form magnesium ions, which will be discharged from the body through urine." Li Weirong, chairman of the board of directors of Magnesia Medical Devices Co., Ltd., said that the degradation process of the magnesium bone nail in the body needs two or three years, and it plays the role of fixing the bone in the early stage. After the completion of "service", it will disappear automatically without taking out.

"In terms of safety, magnesium is an indispensable mineral element for the human body. Adults need to ingest hundreds of milligrams of magnesium every day, and the excess amount will be automatically discharged from the body without causing harm to the human body." Li Weirong said that the production cost of magnesium bone nails is relatively low, and the price will be lower than other bone nail products, and the need for secondary surgery is eliminated, which can help orthopedic patients reduce treatment costs and physiological trauma.

Extract "5 9s" in 2 years

For this day, Yi'an Technology has been waiting for 13 years.

In 2009, Li Yangde, the chairman of the company, accidentally learned from a material expert that magnesium will degrade in the human body and can be used for medical purposes, such as making bone nails. This statement aroused Li Yangde's curiosity. After that, he studied a large number of documents and found that magnesium bone nail is a valuable scientific research project. After careful consideration, he decided to dig into this field.

As a traditional industrial enterprise, it is conceivable that it has suddenly crossed into the field of highly specialized medical devices.

"At the beginning, many people were reading our jokes and thought that we could not succeed without medical professional foundation. Even if we succeed, once the medical device giant" killed "in, we would not have many market opportunities, and might eventually make a wedding dress for others." Li Weirong said that Huacheng's import and export data observation report.

In the face of doubt, the first action of Yi'an Technology is to introduce a team of experts to make up for professional weaknesses. Yi'an Technology has successively established the strategic alliance for technological innovation in the medical magnesium alloy industry and the alliance for clinical innovation of biodegradable magnesium implants, bringing together a group of industry experts from the Institute of Metals of the Chinese Academy of Sciences, the Zhongshan Hospital affiliated to Dalian University, the Chinese University of Hong Kong, Peking University and other institutions.

"The most challenging thing is the quality control of raw materials. Our product's raw materials are of high purity, commonly known as' five 9s', which is 99.999% purity of high-purity magnesium. The higher the purity, the more difficult it is to remove impurities." Dr. Yu Youlu, senior engineer in charge of the company's technology department, said that the company's research and development team spent two years extracting high-purity magnesium.

With the help of experts, the research and development project of magnesium bone nail was successfully promoted. Through the unremitting efforts of all parties, in February 2023, the "degradable magnesium internal fixation screw" completed the clinical enrollment of 184 cases. Huacheng Import and Export Data Observation Report.