News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter

Advanced BioMedical Technologies Inc. (ABMT) Completes Human Clinical Tests of PA Absorbable Orthopedic Implant Screw Required by the China SFDA

10/21/2009 11:25:46 AM

SHENZHEN, CHINA and MIDDLETOWN, NY--(Marketwire - October 21, 2009) -

Advanced BioMedical Technologies Inc. (OTCBB: ABMT) announced that it has completed all 60 human clinical test cases of its PA Absorbable Orthopaedic Implant Screw according to the regulations set out by the China State Food and Drug Administration (SFDA). The actual number of test cases that have been taken in is 63. The Company is compiling trial reports and has entered the last stage of its clinical trial. The Company will apply for the SFDA final approval of this product as soon as the Comparison Data are prepared.

"The successful taking in of 63 clinical test cases that were conducted at SFDA appointed hospitals is a milestone in our company's history. It symbolizes the approval of our technology by hospitals and doctors, and the acknowledgement and acceptance of our product by patients. We will commence production and marketing of our product as soon as we receive SFDA approval," said Ms Hui Wang, CEO of Advanced BioMedical Technologies Inc.

A Post Clinical Test Summary Conference for Advanced BioMedical Technologies Inc.'s PA Orthopaedic Implant Screw and Wire was held in Teng Chun City, Yunnan Province, China during September 9 to 12. Twenty-five medical specialists and doctors from eight SFDA appointed GCP (Good Clinical Practice) hospitals attended this meeting. Speakers from each hospital presented their clinical test summary reports to the audience. Advanced BioMedical Technologies Inc. also had in depth discussion with the attendees on the following topics:

1) The performances of the Company's PA Screw and PA Wire during clinical test

-- Feedback from hospital directors and doctors; -- Performances of the Company's products, tools and areas of improvement; -- Suggestions for improvements on appearances, packaging and literature of the Company's products.

2) Marketing forecast and service requirement

-- Potential regional market size and service requirement; -- Acceptance of absorbable products; Problems of existing absorbable products in the market;

3) Advice and recommendations from medical specialists on the forthcoming SFDA application for the Company's PA Screw

The feedback from attendees will help the Company in its marketing planning and price strategy. The Company's sales and services teams have also acquired valuable knowledge from their potential customers.

Advanced BioMedical Technologies Inc. anticipates the final SFDA application process for its PA Screw to start in the first quarter of 2010. The Company will continuously perform on clinical test exceeding the requirement of 60 cases in order to gather more accurate statistic data.

Meanwhile, the human clinical test of the Company's PA Absorbable Orthopaedic Wire has been carried out according to schedules. A total of 47 test cases have been completed as of today.

About Advanced BioMedical Technologies Inc. (OTCBB: ABMT)

ADVANCED BIOMEDICAL TECHNOLOGIES INC. specializes in the development and marketing of innovative biotech technologies. The company's cutting edge orthopedic internal fixation devices consist of surgical pins and screws which dissipate during the healing process while stimulating new bone growth. The result is stronger bone and increased resistance to recurring damage. These products provide an alternative to metal implants and overcome the limitations of other re-absorbable fixation devices.

Forward-Looking Statements

This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities and Exchange Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, and such forward-looking statements are intended to be covered by the safe harbors created thereby. Investors are cautioned that all forward-looking statements involve risks and uncertainties.

All statements other than statements of historical fact in this announcement are forward-looking statements, including but not limited to the viability of the company's business plans, the effectiveness, profitability, and the marketability of the Company's products; the Company's ability to protect its proprietary information; general economic and business conditions; the volatility of the company's operating results and financial condition; and other risks detailed in the Company's filings with the Securities and Exchange Commission.

These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the company and the industry. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in its expectations, except as may be required by law. Although the company believes that the expectations expressed in these forward-looking statements are reasonable, management cannot assure the public that their expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results.

TEL: 914-213-5252

TEL: 718-766-7898

TEL:(US) 845-746-4343 / (UK) +44-20-7100 4288

Read at

comments powered by Disqus