Health & Fitness
Health and Fitness
Health and Fitness
Mon, December 29, 2008
Wed, December 24, 2008
Tue, December 23, 2008 Trinity Biotech: Trinity Biotech Files 510k for Destiny Max With FDA
DUBLIN, IRELAND--(Marketwire - December 23, 2008) - Trinity Biotech plc (
Trinity recently obtained CE marking which enables it to sell the Destiny Max in Europe and has now filed its 510k submission with the FDA seeking permission to sell the instrument in the United States. The target market for the instrument in both markets includes university hospitals, high throughput general hospitals, high volume commercial laboratories and reference laboratories.
Commenting on the filing Ronan O' Caoimh, CEO, said, "Filing the 510k with the FDA is the last step in the launch of our new high throughput coagulation platform, the Destiny Max. 2008 has been an eventful year for our coagulation business and we have now rationalised our three coagulation brands (Biopool, Amax and bioMerieux) into the new Trini brand, we have successfully completed the integration of the bioMerieux business from North Carolina to our coagulation manufacturing facility in Ireland, and we have now launched the Destiny Max. Our goal is to have the Max approved by the FDA during quarter 2 of 2009. In the meantime we are actively demonstrating the instrument to potential customers in the USA and are receiving excellent feedback from all customers. Sales outside the USA have already begun with the first instruments being shipped to Japan, Italy and Ireland this month and with initial sales to the UK expected in January. We are extremely confident that we now have all the tools in place to seriously challenge the competition in this US$1 billion market."
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 over 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The broad line of test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases. Trinity Biotech sells worldwide in over 80 countries through its own salesforce and a network of international distributors and strategic partners. For further information please see the Company's website: [ www.trinitybiotech.com ].
