Clinical Trial Milestone
Medgen Life Science's innovative project — China's first pre-filled injectable bone graft — has completed clinical trial follow-ups across three centers for the extremity non-load-bearing or low-load-bearing bone filling indication, including Hebei Medical University Third Hospital, Liaocheng People's Hospital, and Huanggang Central Hospital. This marks a major milestone for the company in the bone filling materials field and a significant step toward product commercialization.
The project is expected to complete all center follow-ups by the end of September and submit registration materials by the end of December. Additionally, the last subject for the product's spinal fusion clinical trial also completed enrollment in August 2023, with Wenzhou Medical University First Affiliated Hospital serving as the lead institution.
International-Leading Patented Technology
The pre-filled injectable bone graft product was independently designed and developed by Medgen using international-leading patented technology, making it the first of its kind in China.
The product uses porcine cancellous bone as raw material. Its unique natural porous structure provides superior scaffold support in the tissue microenvironment compared to the mainstream artificially synthesized single-pore materials on the market. The product demonstrates excellent biocompatibility, with a specialized process that effectively removes all organic components to prevent immune reactions.
As a particulate material, it provides increased surface area at the cellular scale, facilitating cell adhesion. When cells adhere to the material surface, the inherent calcium and magnesium ions support osteoinductive performance.
A New Phase of Industrialization
The completion of clinical follow-ups means the pre-filled injectable bone graft has been successfully used in batch clinical applications in the human body, marking a milestone as injectable bone graft materials enter a new industrialization phase. It also signifies another step for China's orthopedic implant technology toward international advanced standards.
Future Outlook
In accordance with clinical protocol requirements, upon completion of the six-month post-operative follow-up period for all subjects, the clinical trial report will be finalized and submitted to the National Medical Products Administration (NMPA). Following regulatory approval, the product will be available for commercial sale. Once launched, it will break the monopoly of imported bone filling materials, achieving a breakthrough in domestic bone graft material technology.
Looking ahead, Medgen will continue to pursue domestic replacement of imported products, maintaining a medical-engineering integrated R&D innovation model, continuously enriching its product portfolio, and providing accessible comprehensive solutions for patients.