Trinity Biotech Receives FDA Approval for Destiny Max in the USA

DUBLIN, IRELAND--(Marketwire - July 07, 2009) - Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced the FDA approval and US launch of its high throughput haemostasis analyzer, the Destiny Max.

Trinity has today obtained FDA approval of its Destiny Max analyzer and is now launching the instrument in the U.S. market with immediate effect. The target market for the instrument includes university hospitals, high throughput general hospitals, high volume commercial laboratories and reference laboratories.

Key features of the Destiny Max include:

-- being the only high throughput instrument on the worldwide market that allows simultaneous and automated measurement of mechanical and optical clot detection, chromogenic and immuno-turbidimetric assays; -- best in class graphical user interface and touch screen technology; -- the most reliable and novel cap piercing solution on the market. 

As part of its U.S. launch Trinity will be showcasing the Destiny Max at the ISTH Congress in Boston on 11-16 July, 2009 and at the AACC Clinical Lab Expo in Chicago on 21-23 July, 2009.

Commenting on the approval Ronan O’Caoimh, CEO said, “I am delighted to announce FDA approval of the Destiny Max analyzer for the U.S. market. This follows the successful launch of Destiny Max in Europe and other international markets, following CE mark approval in December, 2008. The FDA approval and U.S. launch of Destiny Max represents a key strategic milestone for Trinity. This completes the roll out of Destiny Max in all major worldwide markets thus providing Trinity with access to the high throughput haemostasis market, estimated to be US$500 million per annum.

This approval by the FDA significantly improves the marketability of the analyzer and represents a clear endorsement of Trinity’s ability to integrate hardware, software, reagents and consumables into a new state-of-the-art instrument platform that will exceed customer expectations. In the few short months since its international launch we have already enjoyed considerable success with the Destiny Max globally with sales in Japan, China, Italy, Ireland, the Netherlands, Germany, Australia, Turkey and the United Kingdom. Based on the market reaction we have received to date, I am more convinced than ever that we now have the best haemostasis instrument available on the market today.

The combination of Destiny Max with our mid-throughput Destiny Plus and other instruments, in conjunction with our comprehensive reagent portfolio and strong service commitment means that Trinity is now in a leading position to offer a complete and best in class heamostasis product range to all customers in the market. This will undoubtedly act as a key driver for the growth of our haemostasis business going forward, which we expect will result in a significant increase in our market share.”

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 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.