Clinical Follow-Up Successfully Completed
Medgen's independently developed innovative product — China's first pre-filled injectable artificial bone (indicated for non-weight-bearing and low-weight-bearing bone filling in the extremities) — has successfully completed all subject follow-ups in its clinical trial. The clinical trial was led by the Third Hospital of Hebei Medical University, consistently ranked among China's top ten orthopedic centers, in collaboration with multiple renowned tertiary clinical centers.
According to clinical investigators and follow-up results: the product is convenient to use, requires no on-site mixing, and can be freely shaped, significantly reducing surgical operating time. Subjects demonstrated outstanding treatment outcomes with no adverse reactions, fully validating the product's safety and efficacy in the human body.
The successful completion of clinical follow-up provides strong data support for the product's subsequent clinical registration and indication expansion. Building on this success, by August 2023, the clinical trial for the product's spinal fusion indication also exceeded expectations by completing enrollment of all subjects ahead of schedule.
Product Advantages
BoneSwift™ — the pre-filled injectable artificial bone used in this trial — was independently designed and developed by Medgen using internationally leading patented technology. Designed with a focus on surgical convenience and improved patient experience, it is China's first pre-filled injectable artificial bone.
The product uses animal bone as its raw material, which shares the same composition and structure as human bone, preserving its natural porous architecture that provides essential scaffolding in the tissue microenvironment. Compared to mainstream artificially-pored hydroxyapatite on the market, its natural porous structure increases the specific surface area of the particles, better promoting cell ingrowth and cell adhesion. When cells adhere to the material surface, the inherent calcium and magnesium ions help induce bone and soft tissue regeneration. Animal-derived hydroxyapatite possesses excellent biocompatibility and bioactivity, and undergoes specialized processing to effectively remove all organic components, preventing immune reactions.
Product Pipeline
While actively advancing the pre-filled injectable artificial bone, the company has also developed an interbody fusion cage for use with the injectable bone in spinal fusion surgery, which successfully obtained its registration certificate in September 2022 (NMPA Registration No. 20223131203).
Through careful refinement of key milestones across different product registration processes, Medgen has established and refined its R&D, manufacturing, registration, and quality systems in compliance with regulatory and strategic requirements. This solid foundation supports the company's future pipeline of orthopedic, sports medicine, medical aesthetics, and oral surgery products based on natural porous hydroxyapatite and active collagen materials.