Shares in Irish medical technology firm Trinity Biotech slump by over 50pc
Published 04/10/2016 | 15:47
Shares in Irish medical technology firm Trinity Biotech slumped by over 50pc today, slashing $150m from its market capitalisation in New York, after the US Food and Drug Administration (FDA) asked the company to withdraw an application for approval for a product aimed at detecting heart failure.
Trinity Biotech said that it’s also writing off $50m that was related to the project, as a non-cash charge.
Shares in the company, which is listed on New York’s Nasdaq and headed by chief executive and chairman Ronan O’Caoimh, plummeted after Trinity Biotech revealed the news.
The company has a range of diagnostic products for the point-of-care and clinical laboratory markets.
It said that during a meeting last week with the FDA, the watchdog asked Trinity Biotech to consider withdrawing its submission for premarket approval of its Meritas Troponin-I test, and Meritas Point-of-Care analyser.
“Their primary concerns relate to the device’s operating temperature range and that the Troponin-I clinical performance is not consistent with the clinical performance data presented by the most recently cleared laboratory Troponin device,” said Trinity Biotech.
The company said that while it believes the Meritas product demonstrates “excellent performance” for a point-of-care product, “we decided… to withdraw the submission”.
“Over the coming weeks we will engage with the FDA to gain a better understanding of the nature of their concerns,” it added.
“However, it is our understanding that in order for any new point-of-care Troponin product to obtain clearance, the FDA will require it to demonstrate performance equivalent to the most recently cleared laboratory based device,” it warned.
“Our decision to withdraw is based on the fact that, notwithstanding its excellent performance characteristics, we believe that there is no certainty that this level of performance can be achieved by the Meritas product even with the benefit of further development efforts.”