Advanced BioMedical Technologies (ABMT.OB) said its operating subsidiary, Shenzhen Changhua Biomedical Engineering Co. (ABT-Changhua), has signed a cooperative agreement to develop its Polyamide (PA) bio-absorbable material in new applications. Together with the First Affiliated Hospital of Guangdong Pharmaceutical University in Guangzhou, the company will conduct research and animal tests using PA for Cranio-Maxillofacial Fracture Treatment and Craniofacial Reconstruction.
ABT-Changhua will produce miniscrews and plates using its patented PA bio-absorbable material. GDPU Hospital will conduct research and animal testing on these medical devices, and it will also carry out a Phase II clinical trial for this new indication. The goals will be safety and efficacy data, which will support a request to the SFDA for a Phase III trial.
Both parties will contribute funding for the project but ABT-Changhua has first right to file patent applications.
Advanced BioMedical’s PA technology is also being used to make screws and wire that are being tested in orthopedic indications. Last month, the company reported its orthopedic implant screws completed their Phase III test, while the orthopedic wire is close to finishing its trial. So far, Advanced BioMedical has not filed for SFDA approval of either product. The company remains in development stage
Advanced BioMedical says its surgical screws, wires and rods, which dissipate over time, stimulate new bone growth, resulting in stronger bone and greater resistance to recurring damage.