Trinity Biotech plc announced that it received regulatory approval for Destiny Max. The company is launching the instrument in the US market with immediate effect. The target market for the Destiny Max includes university hospitals, high throughput general hospitals, high volume commercial laboratories and reference laboratories. As part of its US launch Trinity will be showcasing the Destiny Max at the AACC Clinical Lab Expo in Chicago on 21-23 July, 2009 and at the ISTH Congress in Boston on 11-16 July, 2009.

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

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.