Recently, PLA/HA composite absorbable interface screw developed by SZLX Medical Technology Corporation was approved by the State Food and Drug Administration of China (NMPA) for listing. This product has complete independent intellectual property rights, marking another breakthrough of domestic innovative enterprises in the field of medical grade composite raw materials.
This product is the first heavy product launched by SZLX based on a new generation of high-performance degradable composite materials. It can be used to fix bone tendon bone or soft tissue graft to bone tissue in knee, shoulder, elbow, ankle and wrist joint surgery.
Orthopedic sports medicine is a branch of orthopedic medicine and sports medicine. Its goal is to achieve maximum functional repair with minimal trauma.
Among them, the interface screw is the basic product of internal fixation in orthopaedic sports medicine. Interfacial screws used in clinic need not only high strength, good biocompatibility, but also strong processability, so there is an intergenerational development relationship. It can be roughly divided into medical titanium materials, the first generation of absorbable materials, medical grade PEEK materials and new generation of absorbable materials.
With the change of clinical demand and market environment, domestic internal fixation products with high performance, absorbable and induced regeneration materials will become an inevitable choice.
SZLX adopts the customized polylactic acid raw materials developed and produced by itself and the original super dispersed composite technology to make HercuRegen absorbable interface screws have both strength and toughness.
The new generation of PLA-HA composites can achieve complete absorption and nail bone healing within 4 years
Among all kinds of interface screw materials, metal and PEEK materials have high strength but cannot be absorbed. After wound healing, they often need to be removed by a second operation; Although the pure polymer material can be absorbed, it is easy to form fibrous tissue after degradation, which is easy to cause acid inflammation, and does not have bone healing and bone inducing activity.
Therefore, many enterprises turn to the research and development of degradable composites, adding inorganic materials such as bioceramics to neutralize the acid and retain a certain bone inducing activity, but the activity and strength need to be improved.
The PLA/HA composite absorbable interface screw of SZLX adopts the fourth generation high-performance degradable composite material, which is composed of PLA (polylactic acid)/HA (hydroxyapatite), and has super fixation and high regeneration induction activity.
Generally, HA particles are easy to settle gradually in PLA solution, and it is difficult for HA to disperse uniformly in organic matrix, which limits the improvement of properties of PLA/HA composites.
In order to improve the interface compatibility between HA particles and PLA matrix, SZLX adopts a unique preparation process, which reduces the energy barrier at the PLA/HA interface, and obtains the dispersion effect of uniform and fine HA particles. In addition, it realizes the directional distribution of polymer materials through self reinforcement. Finally, the strength and toughness of the composite materials are significantly improved.
The bending strength of the previous generation of degradable composites can only reach about 70% of that of cortical bone, while the strength of the new generation of PLA/HA composite can reach twice that of cortical bone.
At the same time, the hyperdispersion technology realized by SZLX through overcoming the energy barrier can let the small and uniform HA particles contact and fuse with the cells, give full play to its osteoinductive activity, and effectively promote osteogenesis in the degradation process.
In the field of sports medicine, doctors generally focus on the treatment end point of tendon bone healing. At present, the absorbable interface screw on the market can meet the requirements of tendon bone healing in the short term, but the long-term effect is not ideal. The reason is that the degradation rate of nail material is too fast, while the osteogenesis rate is too slow, and the two cannot balance, which will easily lead to cavities in bone.
PLA/HA composite can not only complete tendon bone healing within 6 months after implantation, but also complete degradation and absorption within 3-4 years after implantation to achieve nail bone healing, and finally achieve regenerative repair.
In addition to absorbable internal fixation products, SZLX is based on the research and development of biomedical polymer degradable materials represented by polylactic acid, and has also formed a production line of bone filler products, oral cavity, medical and aesthetic absorbable polymers and other renewable implants.
SZLX's artificial bone product is the world's first absorbable artificial bone that can effectively meet the requirements of shaping, anti liquid phase collapse and efficient induction of regeneration. The first generation of product is currently in clinical trials in China, and has taken the lead in submitting to FDA certification and entered the stage of supplement. It is expected that it will be approved by FDA for listing in the first half of 2022, and will be submitted to the State Food and Drug Administration of China for registration at the same time.