获批创新器械！含镁可降解高分子骨修复材料

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].