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.
