DUBLIN, Ireland, Feb. 23, 2015 (GLOBE NEWSWIRE) -- 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 late last week it shipped Meritas Troponin I product to the USA for the immediate recommencement of US clinical trials on its Troponin I point-of-care product.
The product is now demonstrating the identical clinical performance witnessed in our European CE marking trials early in 2014 and in the independent clinical evaluation carried out at Hennepin County Medical Centre, Minneapolis and published at the AACC meeting in July 2014.
With the clinical trial restarted, management estimate that the entire trial process, consisting of patient sampling, data collection, cardiologist adjudication and statistical analysis, will be completed by the end of July, 2015 with FDA submission planned for August, 2015.
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.
CONTACT: Trinity Biotech plc Kevin Tansley 353)-1-2769800 firstname.lastname@example.org Lytham Partners LLC Joe Diaz, Joe Dorame & Robert Blum 602-889-9700
Source:Trinity Biotech plc