Trinity Biotech PLC
NASDAQ : TRIB

Trinity Biotech PLC

May 04, 2011 08:51 ET

Trinity Biotech Announces CE Marking of Premier Hb9210

DUBLIN, IRELAND--(Marketwire - May 4, 2011) -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 is has obtained CE Marking (European regulatory approval) for the Premier Hb9210 (Premier).

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.

CE marking enables the instrument to be launched and sold in Europe. Trinity 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.

Commenting on the announcement, Trinity Biotech's CEO, Mr Ronan O'Caoimh said, "We are delighted to announce this key milestone which represents regulatory approval for the Premier instrument in Europe. Submissions will be made to the FDA and other regulatory authorities in key markets such as China in the next few weeks. The Premier analyser is a best in class instrument with the following key advantages:

  • Patented boronate affinity technology, therefore eliminating interference from haemoglobin variants;
  • Results available in 59 seconds enabling fastest patient result turnaround times;
  • State of the art software using touch screen technology to facilitate ease of use with operators; and
  • Modular instrument which will significantly reduce the cost of on-site maintenance.

The instrument will be formally launched and demonstrated at the IFCC WorldLab conference in Berlin from 15 to 19 May, 2011 after which sales will commence."

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.

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