Trinity Biotech Announces FDA Approval of Premier Hb9210
07 December 2011 - 12:00AM
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 it has obtained
FDA approval for the Premier Hb9210.
The Premier instrument is a fully automated system that measures
HbA1c in high and low throughput clinical laboratories. HbA1c, also
known as glycated hemoglobin, is a measure of a patient's average
blood sugar control over the last two to three months and is a key
tool in the diagnosis and monitoring of diabetes. The current
worldwide prevalence of diabetes is estimated to be 250 million and
it is expected to reach 380 million people by 2025. Within the USA
it is estimated that 12.9% of persons over the age of 20 have
diabetes, 40% of whom are undiagnosed. The worldwide costs of
diabetes in 2007 were approximately $232 billion and this is
expected to increase to $302 billion by 2025.
FDA approval enables the instrument to be launched and sold in
the United States and will greatly facilitate sales in other
international jurisdictions. The instrument has already been
CE marked for sale in Europe and was formally launched in Quarter
2, 2011.
In the USA, Trinity will market and sell the Premier through a
combination of direct selling through our existing US salesforce
and through Fisher Healthcare's extensive distribution network.
Fisher Healthcare is one of the leading distributors of HbA1c
products in the USA with an installed base of approximately 1,000
A1c instruments. Fisher has recently signed a distribution
agreement with Trinity and will be exclusively selling the Premier
instrument in the USA.
Trinity also recently announced an agreement to exclusively
supply Menarini Diagnostics with the new Premier instrument for
distribution in European territories. As one of Europe's leading
pharmaceutical and diagnostics companies, Menarini, with a turnover
of €2.6 billion and 12,000 employees, is the market leader in HbA1c
measurement in Europe. Menarini has a market share of 40% in the
European HbA1c market, a large installed base of equipment and over
20 years experience in HbA1c measurement.
We are also making significant progress in obtaining the
necessary approvals in other key markets. In June we submitted our
application to the Chinese regulatory authorities and we expect to
receive approval by the end of 2012. This will represent an
excellent opportunity to build on our existing installed base in
China.
The Premier analyser is a best in class instrument with the
following key advantages :
- Results available in 1 minute, making it the fastest test in
the market;
- State of the art software using touchscreen technology to
facilitate ease of use for operators;
- Patented exclusive boronate affinity technology, therefore
eliminating interference from hemoglobin variants;
- Modular instrument which will significantly reduce the cost of
on-site maintenance.
Commenting on the announcement, Trinity Biotech's CEO, Mr Ronan
O'Caoimh, said, "HbA1c testing is already a US$300 million global
market with enormous growth potential. We have now the fastest,
most user friendly and state of the art HbA1c analyser in the
world. FDA approval of the instrument, in conjunction with its
recent CE marking, now gives us access to the US and European
markets, the two most important individual markets in the world,
and will accelerate the approval process in other key markets such
as Brazil and China. Together with our partners, Menarini in Europe
and Fisher in the USA, we are ideally positioned to become a
significant and serious player in the global HbA1c market in the
coming years."
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.
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 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.
The Trinity Biotech PLC logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=10602
CONTACT: Trinity Biotech plc
Kevin Tansley
(353)-1-2769800
E-mail: kevin.tansley@trinitybiotech.com
Lytham Partners LLC
Joe Diaz, Joe Dorame & Robert Blum
602-889-9700
Trinity Biotech (NASDAQ:TRIB)
Historical Stock Chart
From Apr 2024 to May 2024
Trinity Biotech (NASDAQ:TRIB)
Historical Stock Chart
From May 2023 to May 2024