Core Viewpoint - The article highlights the innovative development of magnesium-based biodegradable polymer bone repair materials by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd., which addresses significant challenges in orthopedic surgery and has shown promising clinical results [1][19]. Group 1: Product Development and Features - The magnesium-based biodegradable polymer bone repair material is composed of PLGA, β-TCP, and magnesium, utilizing low-temperature additive manufacturing technology [1][4]. - This material is designed to fill and repair bone defects without compromising bone structural stability, making it suitable for various orthopedic applications [1][4]. - The product has received special approval from NMPA and is recognized as an international innovation [3][19]. Group 2: Clinical Applications and Efficacy - The material has been tested in clinical trials across eight major hospitals in China, with a bone fusion rate exceeding 98% among 176 patients, demonstrating excellent biocompatibility [13][14]. - Micro-CT analysis indicated significant improvements in new bone trabecular thickness and bone mineral density compared to control groups [14]. - The material is particularly effective for non-weight-bearing bone defects and can be shaped during surgery to fit complex defect geometries [14] . Group 3: Market Dynamics - The global bone repair materials market is projected to reach approximately $15 billion by 2025, with a CAGR of about 6.5%, driven by aging populations and increasing orthopedic diseases [19]. - The Chinese market for bone repair materials is expected to exceed 5 billion RMB by 2024, with a CAGR of over 18%, indicating substantial growth potential [19]. - The domestic market is primarily dominated by imported products, with a local market share of about 30%, but increasing support for domestic innovation is expected to enhance local market presence [19]. Group 4: Competitive Landscape - Key competitors in the bone repair materials market include Stryker's Vitoss, Geistlich's Bio-Oss and Bio-Gide, Zimmer Biomet's RegenerOss, and Medtronic's INFUSE, each offering unique materials and technologies for bone repair [20][22][23][24]. Group 5: Company Overview - Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. was established in 2013 and focuses on the R&D, production, and sales of high-tech medical devices in orthopedics, neurosurgery, and dentistry [25]. - The company is recognized as a national high-tech enterprise and has a core technology team from the Shenzhen Institute of Advanced Technology and the Chinese University of Hong Kong [25].

Core Viewpoint - The "magnesium-containing biodegradable polymer bone repair material" developed by the Shenzhen Institute of Advanced Technology has received approval for clinical use, addressing the challenge of clinical bone defect repair after 15 years of research [1][2]. Group 1: Product Development and Innovation - The innovative "magnesium-containing biodegradable polymer bone repair material" fills a gap in the industry and is developed by a team from the Shenzhen Institute of Advanced Technology, in collaboration with Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. [2] - The material was created using a low-temperature 3D printing method, overcoming multiple technical challenges in orthopedic device manufacturing, achieving precise shaping and a biomimetic structure with suitable strength [2]. - The material exhibits mechanical strength comparable to human cancellous bone, providing stable support during surgical procedures and avoiding disintegration or fragmentation [2]. Group 2: Clinical Trials and Efficacy - The clinical trials involved 176 patients with bone defects across eight major research hospitals in Beijing and Shanghai, showing a bone fusion rate of over 98% at 24 weeks without any rejection reactions [3]. - The material can be shaped during surgery, allowing it to adapt to complex bone defect shapes, which is a significant advantage over traditional bone repair methods [3]. Group 3: Future Directions and Market Potential - The research team plans to expand the clinical applications of the "magnesium-containing biodegradable polymer bone repair material" to improve precision and efficiency in bone repair, addressing complex bone defects and challenging bone diseases [5]. - The material is positioned as a safe and effective solution for bone repair, significantly enhancing the success rate of bone repair procedures and improving patient recovery and quality of life [5].

Core Viewpoint - The "magnesium-containing biodegradable polymer bone repair material" developed by the Shenzhen Advanced Institute of Technology has received approval from the National Medical Products Administration, marking a significant advancement in bone defect repair technology and filling a gap in the industry [1][2]. Group 1: Product Development - The product was developed over 15 years by a team led by Qin Ling and Lai Yuxiao at the Translational Medicine Research and Development Center [1]. - The material utilizes a low-temperature 3D printing method, overcoming multiple technical challenges in orthopedic device manufacturing [1]. - The inclusion of magnesium allows the material to achieve mechanical strength comparable to human cancellous bone, providing stable mechanical support during surgical procedures [1]. Group 2: Clinical Trials - A multicenter clinical trial involving 176 patients with bone defects was conducted across eight major research hospitals in China, including Beijing Jishuitan Hospital and Shanghai Sixth People's Hospital [2]. - The results indicated a bone fusion rate exceeding 98% at 24 weeks, with no reported adverse reactions, demonstrating excellent biocompatibility of the material [2]. - Currently, there are no magnesium-related bone repair materials approved for clinical use as medical devices according to public data from the National Medical Products Administration and the U.S. Food and Drug Administration [2].

Group 1: Innovative Medical Devices - Beijing Bairen Medical Technology Co., Ltd. received approval for its "Transcatheter Valve-in-Valve System," which is designed for patients with symptomatic heart disease due to the failure of previously implanted surgical bioprosthetic mitral valves [5][6] - The system includes components such as a biological valve, delivery system, balloon dilation catheter, catheter sheath kit, gripping device, and inflation pump, utilizing materials like bovine pericardial leaflets and cobalt-chromium alloy [5][6] - As of now, there are a total of 351 innovative medical devices approved for market in China [6] Group 2: Biodegradable Bone Repair Materials - Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. has received approval for its "Magnesium-based Biodegradable Polymer Bone Repair Material," which is suitable for filling and repairing bone defects in limbs without compromising structural stability [10] - The material is composed of PLGA, β-TCP, and magnesium, manufactured using low-temperature additive manufacturing technology [10] - The company was established in 2013 and focuses on the research and production of new orthopedic implants, cardiovascular stents, and high-tech medical products [10]