JCMED - Bongolle®

Description du produit

Structure Composition: Poly(lactide-co-glycolide) (PLGA), β-tricalcium phosphate (β-TCP), metallic magnesium (Mg). Scope of Application: Suitable for filling and repairing limb bone defects that do not affect the stability of the bone structure. Through an innovative ternary composite design of degradable polymer (PLGA), bioceramic (β-TCP), and degradable metallic magnesium (Mg), the material is prepared using ultra-low-temperature 3D printing technology. This process allows flexible, precise, and controlled regulation of pore size, porosity, three-dimensional interconnected pore structure, and the individual shape of the scaffold. The material features a three-dimensional biomimetic structure similar to human cancellous bone, forming an ideal osteoconductive environment histologically, effectively enhancing the adhesion, proliferation, and migration of bone cells, and comprehensively promoting bone tissue growth. The main body of Bongolle® Magnesium-Containing Biodegradable Polymer Bone Repair Materials consist of interconnected macropores with a pore size range of 100–900 μm; the walls of the macropores are distributed with fine micropores, with a micropore size of ≤50 μm. Dynamic Mechanical Adaptation: Bongolle® offers a mechanical strength >2.0 MPa, closely matching that of human cancellous bone. It provides mechanical support in the early stages of osteogenesis while achieving dynamic adaptation between material degradation and new bone formation rates. The material possesses a certain degree of toughness, allowing for free shaping during surgery without fragmentation when penetrated by internal fixation screws; it adapts to complex bone defect morphologies, meeting the clinical needs of various scenarios. Bongolle® Magnesium-Containing Biodegradable Polymer Bone Repair Materials can be completely degraded and metabolized in the body within 6–9 months. Bongolle® Magnesium-Containing Biodegradable Polymer Bone Repair Materials have completed multi-center clinical trials at eight major research hospitals in China, including Beijing Jishuitan Hospital (leading unit) and Shanghai Sixth People's Hospital. The clinical trial summary report indicates no rejection reactions, with a bone fusion rate of 100% at 24 weeks. It demonstrates excellent safety and clinical efficacy in regenerative repair of bone defects caused by pathological or traumatic conditions. Typical Case: Female, 66 years old, diagnosed with a typical Schatzker II tibial plateau fracture, with a defect size of 18 mm × 20 mm × 15 mm. X-ray follow-ups were conducted preoperatively and at 1 week, 12 weeks, 24 weeks, and 36 weeks postoperatively. At 24 weeks after implantation of the Bongolle® product, the lateral left knee showed good wound healing. No exudate or swelling was observed, and the left lower limb exhibited good flexion and extension without discomfort. X-ray images showed good local bone graft fusion, blurred fracture lines, visible bone graft shadows, and stable internal fixation. The local alkaline environment generated during the degradation of metallic magnesium can inhibit the formation of bacterial biofilms, effectively preventing postoperative infections. Experimental evidence demonstrates that, under near-infrared laser irradiation, metallic magnesium particles exhibit excellent near-infrared photothermal effects. The magnesium composite multifunctional scaffold can rapidly ablate residual tumors under near-infrared light-responsive conditions, effectively suppressing bone tumor recurrence.