Advanced BioMedical Technologies Inc. Completes Human Clinical Tests of PA Absorbable Orthopedic Implant Screw Required by the C
October 21 2009 - 6:39AM
Marketwired
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.
Contact£º TRACY MOTT TEL£º914-213-5252
EMAIL£ºtracy.mott@abtbiomedical.com INVESTOR RELATIONS£º CHIMING YU
TEL£º718-766-7898 EMAIL£ºchiming.yu@abtbiomedical.com KAI GUI
TEL£º(US) 845-746-4343 / (UK) +44-20-7100 4288
EMAIL£ºkai.gui@abtbiomedical.com
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