Advanced BioMedical Technologies Inc. Completes GMP Certified Renovation Works
Published: Jun 28, 2012
NEW YORK, NY and SHENZHEN, CHINA--(Marketwire - June 26, 2012) - Advanced BioMedical Technologies Inc. (OTCQB: ABMT) (PINKSHEETS: ABMT), developer and manufacturer of orthopaedic internal fixation devices, is delighted to announce that the Company 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 Company's facilities now meet the new SFDA standard and exceed the GMP requirements in certain areas.
The completed renovation includes:
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.
Wang Hui, CEO of the Company, said: "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."
About Advanced Biomedical Technologies Inc. (OTCQB: ABMT)
Advanced Biomedical Technologies, Inc.'s primary product line includes internal fixation devices (bone screws, pins, wires, etc.) consisting of proprietary high grade polymers (polyamide - "PA") 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.
The products and materials that the Company has created differ from competing bio-degradable and metal based products being marketed today by:
- The ability to control the speed that the device degrades; therefore improving upon the healing time.
- Eliminating the need for a second surgery to replace device due to infection or other post-operative complications.
- The capability of being evenly absorbed from outer layer inwards, so that it gives enough restoration time for bone healing and re-growth.
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development or marketing of our products, government regulatory agencies may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop bone fixation devices may be unsuccessful, our common stock could be delisted from the over-the-counter market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.