Trinity Biotech plummets after withdrawing heart attack device from FDA

Shares in healthcare manufacturer Trinity Biotech plunged after it withdrew the application for its heart attack diagnosis device with the US Food and Drug Administration on the regulator’s guidance.

The FDA raised concerns over the Meritas point-of-care analyzer and the Meritas Troponin-I detector's temperature range and consistency of its performance in comparison to the recently cleared laboratory based Troponin device.

The company said: “Over the coming weeks we will engage with the FDA to gain a better understanding of the nature of their concern.

“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.”

Meanwhile, Trinity Biotech said they will move the technology from its Swedish facility in Uppsala to its base in Bray, Ireland where it will be incorporated into the company’s existing research and development programme, which will result in the closure of the facility and 40 redundancies.

This will also reduce the company’s expenditure to about $1.5m from $9m, excluding closure costs and severance to Swedish employees, and more than $50m of costs incurred on the project will be written off.

Shares in Trinity Biotech were down 48.28% to $6.77 at 0956 ET.