ABMT completes GMP-certified renovation

NEW YORK, NY and SHENZHEN, China -- Advanced BioMedical Technologies Inc. (ABMT), a developer and manufacturer of orthopaedic internal fixation devices, said it has completed renovations at its GMP-certified facilities in Shenzhen, China.

The facilities were renovated to meet the newly adopted "SFDA Sterilized Medical Devices and Medical Implants Regulation." The completed renovation has been approved by the SFDA Guangzhou Medical Device Inspection Center.

The renovated facilities that now meet the new SFDA standard and exceed the GMP requirements in certain areas include:
1. Upgraded existing laboratory to higher level sterilized laboratory to meet the requirement of GMP standard -- 100 - 10,000 of < 5uM micro-dust per cube meter. Additional 16% capacity has been added to the central air control system. 
2. Upgraded water supply system which will provide the entire modification area with purified water for production, fully compliant with the new SFDA's guideline. 
3. Re-arranged part of the facilities to increase the production capacity.

"We are happy the renovations are completed on time and within budget. The renovated facility is fully validated and operational. We anticipate increased capability for our PA Screws and Wires production lines, as well as forthcoming new products for clinical trials," ABMT chief executive Wang Hui said.

Advanced Biomedical Technologies, Inc.'s primary product line includes internal fixation devices (bone screws, pins, wires, etc.) consisting of proprietary high grade polymers (polyamide) which allow the body to degrade the products during the healing process. During the healing process, the products stimulate new bone growth which replaces the degrading device, leaving newer, stronger bone in the exact location of the injury; thus making the site of the injury stronger and more resistant to recurring damage. These products provide an alternative to metal implants and overcome the limitations of other re-absorbable fixation devices.