Trinity Biotech Expands Global Rollout of High-Capacity Column System for FDA-Cleared HbA1c Testing Solution After Securing Regulatory Clearances

Rhea-AI Summary

Trinity Biotech (Nasdaq: TRIB) announced expanded regulatory clearances and a wider rollout of its next‑generation high‑capacity HbA1c column system for the Premier Hb9210 analyzer, now available in more than 10 countries, including the United States.

The upgraded column offers up to 4x testing capacity, improved stability, reduced maintenance and a software update that automates routine tasks, which the company says supports higher throughput, recurring revenue potential and margin expansion in a global HbA1c market currently > $2B and forecast to exceed $3.5B by 2030.

Positive

• Availability in >10 countries including the United States
• Column system delivers up to 4x testing capacity
• Targets recurring revenue and potential margin expansion
• Software update adds automation to reduce operator workload

Negative

• None.

News Market Reaction

-12.15% 5.2x vol

11 alerts

-12.15% News Effect

+3.4% Peak Tracked

-26.1% Trough Tracked

-$3M Valuation Impact

$20M Market Cap

5.2x Rel. Volume

On the day this news was published, TRIB declined 12.15%, reflecting a significant negative market reaction. Argus tracked a peak move of +3.4% during that session. Argus tracked a trough of -26.1% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $20M at that time. Trading volume was exceptionally heavy at 5.2x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Current HbA1c market size: over $2 billion annually Projected HbA1c market: exceed $3.5 billion HbA1c market reference: $2B+ +3 more

6 metrics

Current HbA1c market size over $2 billion annually Global laboratory HbA1c market

Projected HbA1c market exceed $3.5 billion Global laboratory HbA1c market by 2030

HbA1c market reference $2B+ HbA1c market referenced in headline

Countries available more than 10 countries Availability of upgraded HbA1c column system including U.S.

Testing capacity increase up to four times New column system vs existing column system

Market growth horizon 2030 Projection year for HbA1c market exceeding $3.5 billion

Market Reality Check

Price: $0.8161 Vol: Volume 121,471 vs 20-day ...

normal vol

$0.8161 Last Close

Volume Volume 121,471 vs 20-day average 83,484 (relative volume 1.46) ahead of the news. normal

Technical Shares at $1.07, trading above the 200-day MA $0.88 and well below the $3.44 52-week high.

Peers on Argus

Peers show mixed moves: ADGM +11.48%, AIMD +2.25%, NSYS +1.24%, while IRIX -5.07...

1 Down

Peers show mixed moves: ADGM +11.48%, AIMD +2.25%, NSYS +1.24%, while IRIX -5.07% and PTHL -1.49%. Momentum scanner only flagged ADGM earlier with a -4.88% move, suggesting stock-specific rather than broad sector dynamics.

Historical Context

5 past events · Latest: Nov 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 18	Manufacturing approval	Positive	+0.5%	WHO approval to outsource Uni-Gold HIV test manufacturing for margin improvement.
Nov 14	R&D collaboration	Positive	+3.1%	Collaboration to enhance epigenetic analysis for late-stage EpiCapture test.
Oct 27	Capital structure update	Positive	+2.0%	Indicated proposal for partial debt-to-equity conversion with largest lender.
Sep 02	Listing compliance	Positive	-4.1%	Regained Nasdaq minimum bid price and MVPHS listing requirements.
Aug 21	Board change	Positive	-10.3%	Appointment of experienced non-executive director with capital markets background.

Pattern Detected

Recent positive operational and strategic updates often saw modest positive reactions, but some constructive corporate developments drew negative responses, indicating inconsistent alignment between news tone and price moves.

Recent Company History

Over the last six months, Trinity Biotech reported several milestones, including WHO approval for outsourced Uni-Gold HIV test manufacturing on Nov 18, 2025, a collaboration to advance EpiCapture prostate cancer testing on Nov 14, 2025, and a proposed debt-to-equity conversion with Perceptive Advisors on Oct 27, 2025. The company also regained Nasdaq compliance on Sep 2, 2025 and refreshed its board on Aug 21, 2025. The current HbA1c system rollout continues this operational and strategic transformation.

Market Pulse Summary

The stock dropped -12.2% in the session following this news. A negative reaction despite expanded ro...

Analysis

The stock dropped -12.2% in the session following this news. A negative reaction despite expanded rollout of the upgraded HbA1c system would fit prior instances where constructive news, such as Nasdaq compliance or board enhancements, coincided with price declines. With exposure to a market estimated at over $2 billion and projected above $3.5 billion by 2030, future sentiment may remain sensitive to delivery on recurring revenue and margin expansion goals.

Key Terms

hba1c, biosensors, fda-cleared, clinical laboratories

4 terms

hba1c medical

"high-capacity HbA1c column system for the Premier Hb9210 analyzer"

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

biosensors medical

"diabetes management solutions, including wearable biosensors, today announced"

Biosensors are devices that use a biological element (like an enzyme or antibody) combined with a detector to identify and measure molecules such as glucose, pathogens or biomarkers. Think of them as a smoke detector for specific chemicals or biological signals; they turn a biological reaction into a readable signal. Investors care because biosensors can drive recurring revenue from diagnostics, monitoring and wearable health devices, and their commercial value depends on accuracy, manufacturing scale and regulatory approval.

fda-cleared regulatory

"high-capacity Column System for FDA-Cleared HbA1c Testing Solution"

FDA-cleared means a medical product—typically a device or diagnostic—has passed a U.S. regulator’s review showing it is substantially similar to an existing approved product and is safe and effective for its intended use. For investors, clearance acts like an official safety stamp that lowers regulatory risk and can speed market access, comparable to getting a trusted roadworthy certificate before selling cars, which can make sales and adoption happen faster.

clinical laboratories medical

"These operational gains create a more efficient workflow for clinical laboratories"

Medical testing facilities where patient samples such as blood, urine or tissue are analyzed to diagnose illness, monitor treatment and support clinical decisions. For investors, they matter because these labs generate revenue from tests and contracts, face regulatory and reimbursement rules that affect profit, and act like a quality-control engine for healthcare products — reliable volume and accuracy can be a steady, predictable business driver.

AI-generated analysis. Not financial advice.

Company advances its mission to deliver next-generation diabetes management solutions and expand global market penetration

Next-generation column technology enhances efficiency, expands recurring revenue potential, and strengthens Trinity Biotech’s competitive position in the $2B+ HbA1c market

DUBLIN, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced that it has secured regulatory clearances in multiple countries,  enabling the expanded rollout of its next-generation high-capacity HbA1c column system for the Premier Hb9210 analyzer which is now available in more than 10 countries, including the United States. The upgraded system significantly increases testing throughput, improves operational efficiency, and supports greater recurring revenue opportunities and margin expansion as the company strengthens its leadership position in the growing global HbA1c market.

The global laboratory HbA1c market is estimated to be currently worth over $2 billion annually and is expected to grow to exceed $3.5 billion by 2030.  This expected rise in the HbA1c market is primarily driven by the increasing prevalence of diabetes¹.

Designed for Trinity Biotech’s Premier Hb9210 analyzer, the company’s dedicated laboratory HbA1c solution, the upgraded column system delivers up to four times the testing capacity compared to the existing column system and minimizes instrument downtime through improved stability and reduced maintenance requirements. These operational gains create a more efficient workflow for clinical laboratories and support broader adoption of the platform.

Key Highlights:

• Reduced downtime and improved operational efficiency, enabling higher throughput.
• Increased column stability, minimizing maintenance interruptions and reducing operator workload.
• The latest software update delivers additional automation of routine tasks enabling greater productivity and cost savings.

Trinity Biotech’s Premier Hb9210 solution continues to be recognized as a gold standard in HbA1c testing, with published peer-reviewed scientific comparative studies continuing to confirm the strong clinical performance of the company’s HbA1c analyzer system².  In addition, a recent article published by the Association for Diagnostics and Laboratory Medicine states “Still, BAC (Trinity Biotech) remains the method with the highest specificity for HbA1c currently on the market.”³

“Launching this advanced system in key markets, including the U.S., positions Trinity Biotech to capture further growth opportunities in the global diabetes care segment,” said John Gillard, CEO and President of Trinity Biotech. “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.”

Trinity Biotech continues to work closely with customers and regulatory authorities to expand availability into additional countries, reinforcing its commitment to global market penetration and innovation in diabetes care.

Forward-Looking Statements

This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

About Trinity Biotech
Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company's website: www.trinitybiotech.com.

Contact:	Trinity Biotech plc	RedChip Companies Inc.
	Gary Keating, Ph.D.   (353)-1-2769800	Dave Gentry, CEO   (1)-407-644-4256   (1)-800-RED-CHIP (733-2447)   TRIB@redchip.com

________________________
¹ https://www.maximizemarketresearch.com/market-report/global-hba1c-laboratory-tests-market/81466/
² https://doi.org/10.1080/00365513.2023.2281400 and https://doi.org/10.1080/03630269.2025.2524437 
³ https://myadlm.org/cln/articles/2025/septemberoctober/navigating-hemoglobin-a1c-measurements-for-diabetes-care?utm_campaign=september-cln-monthly-email&utm_medium=email&_hsenc=p2ANqtz--H-b8nqWXfE5QzwxN7g7ng4LhJzv0dDYVj2Cvg-NZlV7uT8_-w9cxM7lAzfzVYdEg1c2QDGQmD_hAXRIAHVcYtRVxNxLe4bPax9TWmCPC1IGjFkjQ&_hsmi=382763562&utm_content=382763562&utm_source=hs_email

FAQ

What did Trinity Biotech announce about the Premier Hb9210 column system (TRIB) on December 15, 2025?

Trinity Biotech announced regulatory clearances enabling expanded rollout of a next‑generation high‑capacity HbA1c column system for the Premier Hb9210, now in >10 countries including the U.S.

How much capacity improvement does the new TRIB column system provide?

The upgraded column system delivers up to four times the testing capacity versus the existing column system.

Will the TRIB Premier Hb9210 software change with the new column system?

Yes; a software update adds automation of routine tasks to improve productivity and reduce operator workload.

What market opportunity did Trinity Biotech cite for its HbA1c solution (TRIB)?

The company cited a global laboratory HbA1c market currently worth over $2 billion and forecast to exceed $3.5 billion by 2030.

Does Trinity Biotech claim clinical performance for the Premier Hb9210 (TRIB)?

Yes; the company referenced peer‑reviewed comparative studies and a published article noting high specificity for its HbA1c method.