ABT-CHANGHUA will produce sample PA bio-absorbable miniscrews and plates for research and animal test; GDPU Hospital will conduct research and animal testing, and a Phase II clinical trial for this new indication. The program will provide safety and efficacy data and provide further validation for the application of PA bio-degradable miniscrews and plates in Cranio-Maxillofacial Fracture Treatment, Craniofacial Restoration and Cosmetic Surgery.
The Company intends to apply to the SFDA (State FDA of China) for Phase III clinical testing upon successful completion of its Phase II program. Under the agreement, both parties will contribute funding for the project but ABT-CHANGHUA has first right to file patent applications.
“The Company’s bio-degradable, bio-absorbable materials are currently being applied to orthopaedic trauma treatment, and the Company has been seeking opportunities and cooperative partners to expand its potential use for a number of new medical procedures. The cooperation with GDPU Hospital indicates that our PA products and technologies are being recognized by Doctors and Specialists from other medical fields. This has created another dimension in the application of our PA bio-absorbable products and technologies. The Company and the Hospital are working closely to ensure the tests are conducted according to the SFDA guidelines and procedures so we can rapidly advance into these new clinical trials,” said Ms. Wang Hui, CEO of Advanced BioMedical Technologies Inc.