October 19, 2016 – Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) has been investigating Trinity Biotech plc. ("Trinity” or the "Company") (NASDAQ: TRIB), a company developing medical diagnostics products, for potential violations of the federal securities laws. Investors who purchased Trinity’s American Depositary Receipts (“ADRs”) between December 17, 2015 and October 3, 2016 may be affected.
On December 17, 2015, Trinity announced that it had submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its Meritas Troponin-I Test and Meritas Point-Of-Care Analyzer for use in diagnosing myocardial infarction based on the detection of troponin in a patient’s blood.
On July 21, 2016, the Company stated that its “Meritas Troponin product may obtain FDA clearance even before the end of 2016” although the Company was still responding to comments and questions received from the FDA in April 2016.
Then, on October 4, 2016 before the market opened, Trinity announced that it was withdrawing its 501(k) submission for the Meritas Troponin-I Test and Meritas Point-of-Care Analyzer after being requested to do so by the FDA at a September 29, 2016 meeting. Trinity also announced a write-off in excess of $50 million for the costs incurred on the project and that it was closing its Swedish facility, eliminating 40 jobs.
On October 4, 2016 in a conference call that followed, Trinity also revealed that the FDA’s concerns include a concern that the performance of Trinity’s Meritas device is not consistent with clinical performance data for the most recently approved Troponin device, a Beckman Coulter device approved in 2013. The Company also disclosed that it had been in discussions for at least 18 months with the FDA over issues regarding which device Trinity should use as a point of comparison in the 501(k) submission. Moreover, the FDA had informed Trinity over the course of the 18-month discussions that the predicate for comparison should be “a recently approved predicate.”
On October 4, 2016, the price of Trinity’s ADRs declined by $6.53 per ADR, more than 50%, from a closing price of $12.99 on October 3, 2016 to close at $5.46 per ADR on October 4, 2016 on heavy trading volume.
If you purchased Trinity’s ADRs and would like to discuss our investigation, please contact us by e-mailing
or by calling 800-290-1952.
Attorneys: Laurence D. King, Jeffrey P. Campisi, Pamela A. Mayer