Advanced Biomedical Technologies Receives Chinese CFDA Approval of Polymer Fixation Screws

Advanced Biomedical Technologies Inc., a developer and manufacturer of orthopedic internal fixation devices, announced that it has received approval from the China Food and Drug Administration (“CFDA”) for its polymer orthopedic internal fixation screws.
 
Company CEO Hui Wang said, “Today is a momentous day for our company and biomaterial technologies as our orthopedic internal fixation screws, based on our unique innovative composite material, gain approval from the CFDA. The revolutionary composite material developed by our company is the only biomaterial of its kind in the current market of human internal fixation devices. It consists of PA6-P(MMA-CO-NVP)-HA and is distinctively fiber-reinforced. The CFDA approval presents our company with great clinical and financial potential, and advances our mission to provide innovative products to patients that address the full continuum of orthopedic care. The signification of this regulatory approval also means that we can bring a series of products based on the same PA biomaterial to the market much quicker. Our series of products include Binding Wires, Micromodule Screws & Plates, Maxillofacial & Craniofacial Plates and Rib Pins. We are working closely with medical institutions and the CFDA to expedite future clinical programs.”
 
“Polymer PA is the first of its kind among all polymer-based implantations and has no competitors due to the sophisticated manufacturing technologies and technique needed for its production. Not only is it biologically stable and easily accepted by the human body, it is also very versatile and therefore has a great market potential. This is an astounding accomplishment for our company and an imperative progression in the field of orthopaedic research and treatment” Wang added.
 
“The annual growth rate of Chinese orthopedic medical devices market has been over 15 percent for the past 10 years and it will continue to grow at this rate for the next 10-15 years due to China’s ageing population. There are estimated over 4M surgical procedures in China each year. With superior technologies and competitive pricing, we believe that we can capture a significant segment of this thriving market. Our first CFDA approval is a milestone for the company. Our objectives are to reach 3,000 hospitals out of a total of 30,000 hospitals in China and to bring a series of products to the market. We thank all our investors and everyone involved for their support over the last decade and look forward to sharing further success in the new chapter of our company.” Added Kai Gui, company CFO.