A Material Revolution in Bone Surgery
While traditional bone repair materials remain bound by cumbersome on-site mixing procedures, Medgen Life Science's independently developed BoneSwift™ — China's first hydroxyapatite pre-filled bone repair material — has officially received market approval, obtaining NMPA Class III medical device registration (Registration No. 20243132567).
This innovative product delivers a leapfrog upgrade in both material performance and clinical usability, providing surgeons and patients with an entirely new treatment option.
Innovative Technology Redefining the Industry
BoneSwift™ is indicated for filling bone defects and gaps in low-load-bearing extremities. The product mimics autologous bone (the gold standard) by providing mechanical support at the micrometer scale, promoting cell recruitment, and guiding mesenchymal stem cell differentiation into osteoblasts. Clinical applications have demonstrated excellent osteoinductive properties comparable to autologous bone.
Medgen selected natural porcine bone as the hydroxyapatite source for its superior biocompatibility and tissue integration capabilities, enabling more effective, faster, and more stable bone defect repair. The pre-filled syringe design eliminates on-site mixing — ready to use right out of the package — significantly reducing surgical time and minimizing infection risks from handling errors.
Three Core Advantages
Natural Biomimetic Technology
- Natural bone composition simulates the human skeletal microenvironment with high biocompatibility
- Superior osteoinductive properties accelerate bone healing
- Excellent osteoconductive performance facilitates cell migration and growth
Safety and Efficacy
- Resistant to liquid-phase collapse with high stability
- Freely moldable with excellent extensibility
- Pre-filled design for convenient, immediate use
- Fully resorbable with complete remodeling
Broad Clinical Coverage
Suitable for various bone defects, delayed union, osteoporotic fractures, comminuted fractures, joint fusion, and nonunion.
Experimental Validation
In a rat calvaria critical-size defect model, BoneSwift™ demonstrated outstanding osteogenic efficiency:
| Timepoint | Imported Injectable Active Bone Material | β-TCP | BoneSwift™ | |-----------|------------------------------------------|-------|------------| | 6 weeks post-op | ~6% | ~6% | ~14% | | 12 weeks post-op | ~20% | ~17% | ~25% |
Relative bone tissue volume growth (BVI/TV%) comparison
Results demonstrate that BoneSwift™ significantly outperforms comparable imported products and conventional β-TCP materials in bone tissue regeneration.
Looking Forward
The launch of China's first pre-filled bone repair material makes every surgery more precise and every healing process more efficient. The Medgen team will continue to push technological boundaries, bringing biomaterials from the laboratory to the clinic, and from China to the world.