DUBLIN, IRELAND -- 11/29/07 --
Trinity Biotech plc (NASDAQ: TRIB), a
leading developer and manufacturer of diagnostic products for the
point-of-care and clinical laboratory markets, today announced that the US
Food and Drug Administration has given clearance to market the rapid,
point-of-care TRIstat(TM) HbA1c system.
The TRIstat(TM) point-of-care platform is designed to measure HbA1c, also
known as glycated hemoglobin, which is a measure of a patient's blood sugar
control over the previous two to three months. The availability of the
TRIstat(TM) system will improve overall efficiency of diabetes care by
delivering HbA1c values during patient's visits to their physicians and
outpatient clinics. Utilizing a patented Affinity Two-Phase Optical
system, together with a simple, fully automated, or plug-and-play design,
TRIstat(TM) offers highly accurate results within minutes while eliminating
complex, hands-on operator requirements found with other
point-of-care technologies.
Diabetes is the fourth leading cause of death by disease in the world.
According to the International Diabetes Federation, the number of people
diagnosed with Type 2 diabetes worldwide has increased from 30 million to
more than 246 million over the last two decades. This figure is projected
to increase further to 380 million by 2025. In the USA, 20.8 million
people (7 percent of the population) have the disease with a further 54
million considered to be pre-diabetic, according to the Centers for Disease
Control and Prevention (CDC) and the American Diabetes Association (ADA).
The ADA strongly recommends that patients be tested for HbA1c at least 4
times a year. Testing should also be performed during treatment changes or
after periods of elevated blood glucose levels. The ADA added a
recommendation for point-of-care HbA1c monitoring to their 2006
professional practice guidelines emphasizing the importance of routine
real-time HbA1c monitoring of persons with diabetes.
Commenting on the news, Brendan Farrell, CEO, said, "FDA Clearance of the
TRIstat(TM) product is an extremely exciting development for Trinity
Biotech and enables us to compete in the high growth point-of-care segment
of the HbA1c market. As TRIstat(TM) provides test results within 10
minutes, patients will know their HbA1c status during their visit to their
physician or diabetic clinic. This will assist the physician and patient
to make immediate diabetes management decisions and ultimately improve
outcomes."
"Our Ultra2(TM)and PDQ(TM) systems already address the $700m clinical lab
market for HbA1c and the launch of TRIstat(TM) means that Trinity will now
have a presence in the point-of-care segment which is estimated at $300m
world wide. Discussions with distribution partners in the USA and Europe
are well advanced and will be concluded shortly."
Trinity Biotech develops, acquires, manufactures and markets diagnostic
systems, including both reagents and instrumentation, for the point-of-care
and clinical laboratory segments of the diagnostic market. The products are
used to detect infectious diseases and blood coagulation disorders, and to
quantify the level of Haemoglobin A1c and other chemistry parameters in
serum, plasma and whole blood. Trinity Biotech sells direct in the United
States, Germany, France and the U.K. and through a network of international
distributors and strategic partners in over 75 countries worldwide. For
further information please see the Company's website:
www.trinitybiotech.com.
Forward-looking statements in this release are made pursuant to the "safe
harbor" provision of the Private Securities Litigation Reform Act of 1995.
Investors are cautioned that such forward-looking statements involve risks
and uncertainties including, but not limited to, the results of research
and development efforts, the effect of regulation by the United States Food
and Drug Administration and other agencies, the impact of competitive
products, product development commercialisation and technological
difficulties, and other risks detailed in the Company's periodic reports
filed with the Securities and Exchange Commission.
Contact :
Trinity Biotech plc
Brendan Farrell
CEO
(353)-1-2769800
E-mail: Email Contact
