Trinity Biotech plc announced that its next‑generation high‑capacity HbA1c column system, designed for the Premier Hb9210 analyzer, has received regulatory clearances in more than ten countries, including the United States. The approvals allow the company to launch the product in new markets and expand its presence in the growing global HbA1c testing market, which is projected to rise from $2 billion to $3.5 billion by 2030.
The new column can deliver up to four times the testing throughput of the existing product, reducing instrument downtime and improving laboratory workflow. The higher‑capacity system also incorporates the company’s patented boronate‑affinity HPLC technology, which provides high specificity and minimal interference from hemoglobin variants. By increasing capacity and reliability, the system is positioned to capture a larger share of the diabetes‑care laboratory segment and support Trinity’s broader turnaround strategy.
Despite the product launch, Trinity Biotech remains in a challenging financial position. The company has not been profitable over the last twelve months, carries more than $100 million in debt, and reported a negative earnings‑per‑share figure in its most recent quarterly report. Management has highlighted that the new column’s market potential will help offset these headwinds, but the company must continue to manage costs and accelerate adoption to achieve profitability.
John Gillard, CEO and President, said the approvals “position Trinity Biotech to capture further growth opportunities in the global diabetes care segment.” He added that the combination of higher capacity, reduced downtime, and automation “creates a compelling value proposition for laboratories, and we expect strong adoption in key markets to drive long-term shareholder value.”
The regulatory clearances are a key milestone for Trinity Biotech, as they unlock new revenue streams and strengthen the company’s competitive moat in a market that is expanding rapidly. However, the company’s ongoing financial challenges underscore the need for disciplined execution and continued investment in product development to sustain long‑term growth.
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