Trinity Biotech Receives FDA Approval For Destiny Max In The USA

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 08 Jul 2009 - 4:00 PDT

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Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, 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."

Source
Trinity Biotech