SOURCE: Trinity Biotech

Trinity Biotech

February 15, 2011 08:40 ET

Trinity Biotech Announces Distribution Agreement for Premier Hb9210 Instrument With Menarini Diagnostics

DUBLIN, IRELAND--(Marketwire - February 15, 2011) - Trinity Biotech plc (NASDAQ: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced an agreement to exclusively supply Menarini Diagnostics with the new Premier Hb9210 (PDx) instrument for distribution in European territories. The Premier Hb9210 instrument is a fully automated system that measures HbA1c in high and low throughput clinical laboratories. HbA1c, also known as glycated hemoglobin, is a measure of a patient's average blood sugar control over the last two to three months. 

As one of Europe's leading pharmaceutical and diagnostics companies, Menarini, with a turnover of EUR 2.6billion and 12,000 employees, is the market leader in HbA1c measurement in Europe. Menarini have a market share of 40% in the European HbA1c market, a large installed base of equipment and over 20 years experience in HbA1c measurement.

HbA1c testing is one of the fastest growing markets in the diagnostics industry. Diabetes is the fourth leading cause of death by disease in the world and the number of diabetic patients is expected to reach 370 million in 2030. In the U.S. alone some 20.8 million Americans (7 percent of the population) have the disease with a full 54 million Americans considered to be pre-diabetic. The total laboratory HbA1c market worldwide is expected to reach $272 million by 2012. 

The Premier Hb9210 analyser is a best in class instrument with the following key advantages;

  • Patented boronate affinity technology, therefore eliminating interference from haemoglobin variants,
  • Results available in 59 seconds enabling fastest patient result turnaround times,
  • State of the art software using touch screen technology to facilitate ease of use with operators,
  • Modular instrument which will significantly reduce the cost of on-site maintenance.

The new Premier Hb9210 instrument is currently undergoing external clinical trials which will be completed by April 2011 at which point the instrument will be CE marked and launched by Menarini. The instrument will be simultaneously submitted to the FDA for 510k clearance. 

Commenting on the announcement, Trinity Biotech's CEO, Mr. Ronan O'Caoimh said, "We are delighted to announce this exclusive distribution agreement with Menarini who are number one in Europe with a 40% market share. The launch of the Premier Hb9210 instrument through Menarini will secure a significant market share for Trinity Biotech in the European market in the short term. The launch of this instrument in April will allow us to target a rapidly growing global market estimated to be worth $272 million by 2012 with a best in class product. We will file a U.S. FDA submission in April and simultaneously we will file for authorisation in China, Brazil and other significant markets."

Share Buy-Back

Trinity is also pleased to announce that the Irish High Court has approved the reduction of share premium and creation of distributable reserves thus clearing the final legal hurdle for a share buyback program.

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.

Contact Information

  • Contact:
    Trinity Biotech plc
    Ronan O'Caoimh
    (353)-1-2769800
    E-mail: Email Contact

    Lytham Partners LLC
    Joe Diaz, Joe Dorame & Robert Blum
    602-889-9700