Trinity Biotech Announces Recommencement of US Clinical Trials on Its Point-of-Care, High Sensitivity Troponin I Product
February 23 2015 - 10:18AM
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
kevin.tansley@trinitybiotech.com
Lytham Partners LLC
Joe Diaz, Joe Dorame & Robert Blum
602-889-9700
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