Recently, the controllable degradation magnesium alloy bone screw developed by Suzhou Innoco Medical Technology Co., Ltd. (hereinafter referred to as Innoco) has been awarded the Breakthrough Device qualification by the US Food and Drug Administration (FDA).

It is understood that this is the first biodegradable magnesium alloy orthopedic product in China to pass this certification. Moreover, as the only authoritative certified absorbable orthopedic implant technology enterprise in China, InnoTech has filled this technological gap in the domestic market and broken through the limitations of international similar products in terms of indications.

Integrating pioneering technology to solve neck problems
Innoco was founded in 2022 and is a high-tech enterprise with innovative technology and independent intellectual property rights. It is committed to the research and industrial transformation of absorbable magnesium alloy materials and advanced orthopedic instruments, and has multiple core technologies such as high-performance magnesium alloy synthesis, controllable degradation composite coating preparation, and scientific structural design. Currently, more than 20 independent intellectual property rights have been applied for or authorized.

At present, Innoco's products start with orthopedic medical equipment, covering multiple fields such as trauma orthopedics, sports medicine, spinal surgery, and plastic surgery. The innovative three types of medical equipment products under development include magnesium alloy bone screws, magnesium alloy wire anchors, and magnesium alloy craniofacial micro nail plate systems.

In addition, Innoco has established long-term and in-depth cooperation with many universities and research institutions at home and abroad, jointly expanding the application of high-tech materials such as absorbable magnesium alloys in various orthopedic fields, and creating a forward-looking orthopedic materials and research platform that deeply integrates clinical medicine, materials science, engineering and other disciplines.

It is understood that magnesium alloys have good application prospects in the field of orthopedic implants. However, magnesium is a chemically active metal element, and its rapid degradation in the human body is often accompanied by the accumulation of hydrogen gas at the implantation site. At the same time, the uncontrollable degradation rate leads to unstable mechanical properties, which in turn can cause fracture internal fixation failure.

The controllable degradation magnesium alloy bone screw, which has been granted breakthrough device certification by the FDA, uses Innoco's pioneering controllable degradation coating technology to successfully solve the problem of rapid degradation commonly found in magnesium alloy products, ensuring that magnesium alloys can maintain a stable degradation rate during the critical period of bone healing.

Moreover, the coating has good biocompatibility, uniform coating, safety and integrity, and can accurately control the degradation cycle of magnesium alloy products after implantation in the body, thereby matching its cycle with bone healing, ensuring that the implant remains stable during bone healing and reducing the risk of treatment failure.

In addition to surface modification technology, the controllable degradation magnesium alloy bone screw has also optimized the material, improving both mechanical properties and biocompatibility. Innoco uses exclusive patented formula magnesium alloy and advanced production technology to further optimize the mechanical properties and biocompatibility of magnesium alloy. The tensile strength of its material is significantly higher than that of traditional degradable implants, which can meet the fixation requirements of complex fractures. It is close to the elastic modulus of bone tissue and effectively reduces stress shielding. Magnesium alloy material is highly compatible with human tissue and does not interfere with the regeneration of bone and surrounding soft tissue.

In September 2024, Innoco absorbable magnesium alloy bone screws were clinically enrolled. It is reported that nearly 190 patients were included in this registered clinical trial, which also means that the controllable degradation magnesium alloy bone screw has officially entered a new stage of clinical application in trauma orthopedics, marking a milestone in the commercialization process of controllable degradation magnesium alloy implants. At the same time, it marks that China's medical magnesium alloy orthopedic implant devices have reached the international advanced level.

Market share growth, domestic orthopedic equipment enterprises are rising in strength
Orthopedic implants mainly include osseointegration implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal fixation implants, artificial joints, etc; According to different usage areas, it can be divided into trauma, spinal, joint, sports medicine, and others.
The global market size of orthopedic implantable medical devices will reach 45.8 billion US dollars in 2023, with a five-year compound growth rate of 4.08%. Preliminary estimates suggest that the global market size of orthopedic implantable medical devices will reach 48.6 billion US dollars by 2024.

At present, in the global orthopedic implant market, overseas giants still occupy the majority of market share, such as Johnson&Johnson Orthopedics, Jiemai Bangmei, Medtronic, Stryker and other enterprises. However, with the further improvement of China's technological level, new domestic forces are gradually rising, and a number of emerging enterprises have emerged, such as Weigao Orthopedics, Dabo Medical, Chunli Medical, Sanyou Medical and other enterprises.
Although the government has implemented a policy of quantity based procurement for high-value orthopedic consumables since 2021, the impact of centralized procurement on many medical equipment companies has been significant, leading to a significant decline in the performance of some enterprises. But as we enter 2024, many companies have reversed the situation, gradually emerged from the painful period, and achieved a recovery in performance growth.

Taking Weigao Orthopedics as an example, the company's revenue and net profit have significantly declined for two consecutive years in 2022 and 2023, especially in 2023, where revenue dropped to 1.284 billion yuan, a year-on-year decrease of 37.63%; The net profit attributable to the parent company sharply decreased by 81.3% to 112 million yuan. Despite two consecutive setbacks, in mid-2024, Weigao Orthopedics still failed to shake off the downward trend and even submitted its worst mid year report since going public. This series of financial reports has also raised doubts about Weigao Orthopedics.

On October 31st, Weigao Orthopedics released its third quarter 2024 financial report, which showed that its revenue in the third quarter was 330 million yuan, a year-on-year increase of 20%; The net profit was 71.16 million yuan, a year-on-year increase of 594.2%. Among them, Weigao Orthopedics has seen significant growth in multiple businesses, and its performance has returned to the trend of double growth, defending its position as the top domestic orthopedic surgeon.

And in the next step, Weigao Orthopedics has also clearly stated that it will continue to consolidate its existing market share, continuously build a highly collaborative and specialized sales team, adjust its product structure, and increase the proportion of high gross profit product sales; Continuously expanding the field of orthopedic innovation and improving product lines through various means such as mergers and acquisitions and cooperation; Accelerate the development of foreign markets, increase the international influence of the brand, and continuously expand market share; Further enhance refined management capabilities, reduce production costs, and optimize expense control to continuously improve the overall profitability of the company.

Conclusion
With the good news of Innoco's controllable degradation magnesium alloy bone screws, it also indicates that China's innovation level is moving forward with greater courage. I believe that in the future, with the maturity of technology and further expansion of indications, controllable degradation implants will become an important development direction in the field of orthopedics, meeting a wider range of clinical needs.

Source: https://news.yaozh.com/archive/44785.html