Trinity Biotech (Nasdaq: TRIB) gains IFCC Gold and HIV test manufacturing approval

Rhea-AI Filing Summary

Trinity Biotech plc filed a Form 6-K highlighting two operational milestones. The company’s Premier Hb9210™ HbA1c analyser, with its next‑generation Buffer A Plus column system, achieved IFCC Gold Classification for 2026, making it the only HbA1c system worldwide to receive this top‑tier certification.

The filing also notes full regulatory approval to begin upstream manufacturing of the Uni‑Gold™ HIV rapid test under an offshored and outsourced model. Management describes this as the final major regulatory milestone in its transformation plan and expects the new model to support gross margin expansion, better working capital efficiency, and improved long‑term scalability.

Insights

Healthcare diagnostics equity analyst

Trinity reports key product validation and manufacturing approval milestones.

Trinity Biotech emphasizes two developments: IFCC Gold Classification for the Premier Hb9210™ HbA1c analyser and final regulatory clearance to offshored upstream manufacturing of the Uni‑Gold™ HIV rapid test. Both relate to core franchises in diabetes monitoring and infectious disease diagnostics.

The IFCC Gold status, with the Premier Hb9210™ cited as the only HbA1c system worldwide at this level for 2026, reinforces technical credibility in a laboratory HbA1c testing market described as over $2 billion annually and projected above $3.5 billion by 2030. Management also notes cumulative investment in diabetes care technologies approaching approximately $100 million, underlining strategic focus on this area.

For Uni‑Gold™ HIV, the in‑country regulatory approval is presented as the final major milestone to implement an offshored and outsourced manufacturing model, which management expects will expand gross margins, enhance working capital efficiency, and increase scalability. Actual financial impact will depend on execution, production ramp‑up, and ongoing demand for HIV rapid testing, which may be detailed further in future periodic reports.

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

F O R M 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of February 2026

TRINITY BIOTECH PLC

(Name of Registrant)

IDA Business Park

Bray, Co. Wicklow, Ireland

(Address of Principal Executive Office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒    Form 40-F ☐

This Form 6-K is being incorporated by reference into our Registration Statements on Form S-8 (File Nos. 333-182279, 333-195232, 333-253070 and 333-292753).

 EXPLANATORY NOTE

On February 10, 2026, the Company issued two press releases: one announcing that the Premier Hb9210™ HbA1c Analyser achieved IFCC Gold Classification for 2026, and another announcing that the Company secured regulatory approval to commence upstream manufacturing of its Uni‑Gold™ HIV rapid test under its new offshored and outsourced model. Copies of the press releases are filed herewith as Exhibits 99.1 and 99.2.

EXHIBIT INDEX

Exhibit		Description
99.1		Trinity Biotech Glucose Monitoring Innovation Achieves Unique Global Recognition: Diabetes Care Premier Hb9210™ HbA1c Analyser Becomes the Only System Awarded Prestigious IFCC Gold Classification for 2026
99.2		Trinity Biotech Secures Regulatory Approval for Commencement of Upstream Manufacturing Activities of Uni-Gold™ HIV Rapid Test Under Its Offshored and Outsourced Model, Supporting Financial Performance Transformation

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	TRINITY BIOTECH PLC
		Trinity Biotech plc
		(Registrant)
	By:	/s/ Paul Murphy
		Paul Murphy
		Interim Chief Financial Officer

Date: February 13, 2026

Exhibit 99.1

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

Trinity Biotech Glucose Monitoring Innovation Achieves Unique

Global Recognition: Diabetes Care Premier Hb9210™ HbA1c

Analyser Becomes the Only System Awarded Prestigious IFCC

Gold Classification for 2026

- Reinforces Trinity Biotech’s growing position as a key player in diabetes care innovation

- Senior commercial executives of Trinity Biotech are attending the World Health Expo from February 10-12, 2026

DUBLIN, Ireland (February 10, 2026) - Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced that its Premier Hb9210™ HbA1c Analyser with its recently launched next-generation Buffer A Plus column system has achieved the prestigious Gold Classification from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for 2026. This marks a historic milestone as the Premier Hb9210™ HbA1c Analyser is the only HbA1c system worldwide to earn this highest level of HbA1c manufacturer's certification for 2026.

No system achieved Gold status in 2025, underscoring the significance of Trinity Biotech’s breakthrough. This achievement demonstrates the company’s ability to deliver industry-leading technology innovations that advance diabetes care worldwide.

The next-generation Premier Hb9210™ Buffer A Plus column system, which is used for laboratory testing, builds on a series of recent innovations and enhancements to the Premier Hb9210™ platform, designed to increase usability, minimize operator interaction, and reduce operating costs while continuing to support the highest levels of patient care.

The IFCC is the global authority that sets international standards for HbA1c measurement, a critical biomarker for blood glucose management in diabetes care. HbA1c reflects the average blood glucose level over the past 2–3 months.  The IFCC’s rigorous certification process evaluates more than 200 HbA1c analytical systems from approximately 60 manufacturers, including the largest global diagnostic companies. Systems are ranked based on analytic precision and bias, with Gold representing the pinnacle of performance.

The global market for laboratory HbA1c testing is currently valued at over $2 billion per year and is projected to surpass $3.5 billion by 2030¹. This anticipated growth is largely due to the rising incidence of diabetes. Senior commercial executives of Trinity Biotech are attending the World Health Expo from February 10-12, 2026 to discuss these and other advancements that strengthen Trinity Biotech’s position in the expanding $2 billion HbA1c testing market.

¹ https://www.maximizemarketresearch.com/market-report/global-hba1c-laboratory-tests-market/81466/

Management Commentary

John Gillard, Trinity Biotech CEO, commented:

“Achieving IFCC Gold Classification is a testament to our core focus on industry-leading innovation, precision, and quality at Trinity Biotech. It further enhances our standing in the broader glucose monitoring market and diabetes care where we already support millions of patients around the world annually with our HbA1c testing technology.

We are deeply committed to diabetes care and broader metabolic health management, with Trinity Biotech’s cumulative investment in our diabetes care technologies already approaching approximately $100 million to date. Central to this commitment is the pioneering development of our continuous glucose monitoring innovation, CGM+ that is being designed to augment glucose monitoring with other metabolic health metrics in a single AI-powered device.

With several exciting R&D milestones anticipated over the course of this year, we are advancing strongly in our mission to help everyone measure and manage metabolic health for healthier, longer lives.”

For more information about Trinity Biotech and the Premier Hb9210™ system, please contact info@trinitybiotech.com

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, our ability to reduce our debt and improve our capitalization, 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.

Exhibit 99.2

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

Trinity Biotech Secures Regulatory Approval for Commencement

of Upstream Manufacturing Activities of Uni-Gold™ HIV Rapid

Test Under Its Offshored and Outsourced Model, Supporting

Financial Performance Transformation

 - Approval Marks Final Regulatory Milestone Required to Enable Launch of Upstream Manufacturing

Activities Under New Offshored & Outsourced Production Model

- Expected to Drive Gross Margin Expansion, Improve Working Capital Efficiency, and Enhance Long‑Term Scalability

- Represents a Key Final Component of the Company’s Comprehensive Transformation Plan

DUBLIN, Ireland (February 10, 2026) - Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced it has now received full  regulatory approval for the commencement of upstream manufacturing activities for its flagship World Health Organization (WHO) prequalified Uni-Gold™ HIV rapid test under the Company’s offshored and outsourced production model.

This latest approval from the in‑country healthcare product regulatory authority marks the final major regulatory milestone required to fully implement Trinity Biotech’s new offshore & outsourced manufacturing model for Uni-Gold™ HIV, enabling the Company to transition some upstream processes to a more cost‑efficient and highly scalable offshore manufacturing platform.

The strategic transition is expected to:

• Expand gross margins;

• Improve working capital;

• Enhance scalability to support future Uni-Gold™ HIV demand growth;

• Strengthen the Company’s long‑term financial profile as part of its Comprehensive Transformation Plan.

This local regulatory approval builds on Trinity Biotech’s WHO approval for Uni-Gold™ HIV in November 2025, which authorised the Company’s upstream manufacturing approach and served as the technical foundation for this final in‑country manufacturing clearance.

John Gillard, Trinity Biotech President & Chief Executive Officer, commented:

“This approval is a critical final milestone in the execution of our Comprehensive Transformation Plan. Combined with our prior WHO authorisation, Trinity now has the regulatory approvals to fully realise the potential of this outsourced and offshored manufacturing model for Uni-Gold™ HIV. This model will expand our margin profile, enhance our working capital efficiency, and provide the scalability required to serve the global HIV rapid testing market for years to come.”

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.

FAQ

What did Trinity Biotech (TRIB) disclose in its latest Form 6-K?

Trinity Biotech reported two milestones: IFCC Gold Classification for its Premier Hb9210™ HbA1c analyser and full regulatory approval to start upstream manufacturing of its Uni‑Gold™ HIV rapid test under an offshored, outsourced model, supporting its broader transformation strategy.

What is significant about Trinity Biotech’s Premier Hb9210 HbA1c analyser achievement?

The Premier Hb9210™ HbA1c analyser earned IFCC Gold Classification for 2026, and is described as the only HbA1c system worldwide to receive this highest certification level. This recognition underscores its analytic precision in a laboratory HbA1c testing market valued at over $2 billion annually.

How large is the HbA1c laboratory testing market mentioned by Trinity Biotech (TRIB)?

Trinity Biotech cites the global laboratory HbA1c testing market as currently valued at over $2 billion per year, with projections to surpass $3.5 billion by 2030. The company positions its Premier Hb9210™ platform within this expanding diabetes care segment.

What regulatory approval did Trinity Biotech receive for the Uni-Gold HIV rapid test?

Trinity Biotech obtained full in‑country regulatory approval to commence upstream manufacturing of its Uni‑Gold™ HIV rapid test under an offshored and outsourced production model. The company describes this as the final major regulatory milestone needed to fully implement the new manufacturing approach.

How does Trinity Biotech expect the new Uni-Gold HIV manufacturing model to affect its business?

Management states that the offshored and outsourced manufacturing model for Uni‑Gold™ HIV is expected to drive gross margin expansion, improve working capital efficiency, and enhance long‑term scalability, positioning the company to better serve the global HIV rapid testing market.

How much has Trinity Biotech invested in its diabetes care technologies?

Trinity Biotech’s CEO notes that cumulative investment in the company’s diabetes care technologies is already approaching approximately $100 million. This spending supports its HbA1c testing platform and development of continuous glucose monitoring and broader metabolic health solutions.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 15.6 KB
• EX-99.2 EXHIBIT 99.2 16.2 KB