Trinity Biotech (Nasdaq: TRIB) details major progress on CGM+ glucose platform

Rhea-AI Filing Summary

Trinity Biotech plc reports major technical progress on its next-generation, calibration‑free CGM+ continuous glucose monitoring platform, supported by more than 650 days of clinical testing data. The updated sensor and electronics architecture materially improved glucose measurement accuracy across multi‑day wear, indicating the system can meet modern CGM accuracy standards.

The company also developed a needle‑free insertion process and a modular device design aimed at lowering costs and improving sustainability versus current market‑leading CGMs. CGM+ uses multimodal sensing and AI‑native analytics to generate personalized metabolic health insights, and Trinity Biotech anticipates initiating a pivotal clinical trial in 2026, targeting regulatory submissions in key global markets afterward.

Insights

Medical devices & diagnostics analyst

Trinity Biotech advances CGM+ toward pivotal trials with improved accuracy and usability.

Trinity Biotech highlights more than 650 days of clinical data on its CGM+ platform, showing a material reduction in Mean Absolute Relative Difference (MARD) versus prior studies. Meeting industry accuracy standards is essential for competitive positioning in continuous glucose monitoring and for progressing toward regulatory review.

The company also emphasizes a needle‑free insertion process and a modular device architecture designed to reduce cost and improve sustainability compared with current market‑leading CGMs. These features address known barriers to broader CGM adoption, such as comfort and affordability, within a fast‑growing $15bn CGM market and related sectors.

Management plans to move CGM+ through final design and anticipates initiating a pivotal clinical trial in 2026, followed by regulatory submissions in key global markets. Actual commercial impact will depend on future trial outcomes, regulatory feedback, and how clinicians and users respond to the AI‑native multimodal sensing and metabolic insight features.

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 March 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 and 333-253070).

 EXPLANATORY NOTE

On March 10, 2026, the Company issued a press release announcing further major technical breakthroughs in advancing its Next Generation CGM+ Platform. A copy of the press release is filed herewith as Exhibit 99.1.

EXHIBIT INDEX

Exhibit		Description
99.1		Trinity Biotech Announces Further Major Technical Breakthroughs in Advancing Next Generation CGM+ Platform

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:  March 10, 2026

Exhibit 99.1

CONFIDENTIAL UNTIL RELEASED

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

Trinity Biotech Announces Further Major Technical

Breakthroughs in Advancing Next Generation CGM+ Platform

- Clinical trial results support progression of CGM+ toward regulatory submissions and scaled commercialization

- Anticipating initiation of pivotal clinical trial in 2026

- Updated electronics architecture delivers significant improvement in glucose measurement accuracy, with a material

reduction in MARD across multi-day wear

- Multimodal sensing platform powered by advanced AI-native analytics to deliver personalized metabolic health insights

- CGM+ next-generation modular device architecture designed to reduce cost and improve sustainability versus

current market-leading CGMs

- Company is positioning device to participate in fast-growing $15bn CGM market and adjacent sectors

DUBLIN, Ireland and OREGON, United States of America (XXXX, 2026) - Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced a number of significant technical advancements in the development of its next-generation, finger-stick calibration-free Continuous Glucose Monitoring (CGM) system, CGM+, marking a major step toward bringing the technology to global markets.

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

“These are some of the most important technical advancements to date in our CGM+ development program. The glucose measurement accuracy gains achieved by the incorporation of key components of our enhanced electronics architecture gives us strong conviction to accelerate into pivotal trials this year. The fact that these enhanced electronic components also underpin our innovative multi-modal sensing architecture gives us a valuable foundation from which we intend to deliver a truly differentiated device, CGM+, to key markets globally.

Metabolic health problems sit at the center of the world’s disease burden, with rising incidence of obesity, diabetes, hypertension, and related cardiometabolic disorders. In everyday life, metabolic health shapes how we perform, recover, and age. Key metabolic health factors include glucose levels, activity, sleep, and stress - metrics that are measurable and personalized. Using AI-native health monitoring, CGM+ is being designed to translate these metrics into powerful insights to support better metabolic health.

Our innovation agenda is central to our growth ambitions at Trinity Biotech, and our latest results highlight our commitment to deliver industry-leading innovation, precision, and quality. We are excited with what we have achieved, and we are increasingly confident that CGM+ provides Trinity Biotech with the platform to deliver a significant step-change in the growth and scale of the company. We look forward to initiating a pivotal clinical trial and bringing this important solution to market.”

The Company has collected more than 650 days of clinical testing data across a number of trials on an updated glucose sensor architecture which has now been integrated with key next-generation electronic components. The updated system delivered a substantial improvement in glucose measurement accuracy across multi-day wear, achieving a material reduction in Mean Absolute Relative Difference (MARD) compared to prior clinical studies of the upgraded glucose sensor.  These results now provide strong evidence that the upgraded system can meet the industry standards for glucose measurement accuracy of modern CGMs.

The new electronics also underpin CGM+’s unique multimodal data-capture capabilities, which are designed to support advanced, AI-driven analytical models. Utilizing this multimodal approach, the Company aims to position CGM+ not only as a glucose sensor, but as an important enabling platform for broader AI-enhanced digital health, with a particular focus on personalized metabolic health insights.

The next-generation components are also critical to enabling the CGM+ device’s user-friendly modular design which drives significant cost and sustainability benefits compared to current market leading CGMs. The cost of current CGM solutions remains one of the main barriers to broader adoption of this important technology.

In addition, Trinity Biotech has conducted successful trials on an updated needle-free glucose sensor insertion process. This new insertion process is fundamental to the next‑generation, user-friendly modular design and is yet another important milestone in confirming the technical viability of the updated device design.

The Company believes that these breakthrough results significantly strengthen the device’s technical readiness, reduce system level risk, and support the progression of CGM+ toward regulatory submissions and scaled commercialization. CGM+ has the potential to make high quality metabolic intelligence more affordable, more intuitive, and more widely available than ever before.

Anticipating Initiation of Pivotal Clinical Trial In 2026

Since the unveiling of CGM+ in July 2025, Trinity Biotech has continued to innovate and refine this next-generation biosensor platform. Prior breakthrough results released in August 2025 on its redesigned proprietary needle-free glucose sensor, confirmed the elimination of the requirement for finger-stick calibration and de-risked the commercialization pathway for CGM+.

The Company is collaborating with clinicians, scientists, user groups, and digital health leaders to further optimize its innovative multi-sensor CGM+ architecture which is being designed to collect multiple selected physiological metrics alongside glucose in a single modular device.

Advanced AI‑native analytics will transform this complex, multifactorial data into personalized and actionable insights, giving CGM+ users a seamless connected experience and clinicians a powerful treatment tool.

Based upon enthusiastic feedback from key stakeholders and given the strength of these recent clinical trial results, Trinity Biotech is now advancing the CGM+ program through the final design phase and anticipates initiating a pivotal clinical trial in 2026, targeting regulatory submissions in key global markets immediately thereafter.

CGM+ is uniquely positioned at the confluence of advanced glucose monitoring technology, AI-native healthcare analytics, and increasing demand for AI wearables. Market dynamics indicate strong growth in these already sizeable markets and recent forecasts predict strong growth in the coming years:

• Global CGM Market: Projected to grow from $15.3B in 2026 to $31.4B by 2031 (CAGR: 15.4%)¹

• AI in Healthcare: Forecast to reach approximately $250B by 2031, growing at a 35.7% CAGR²

• Wearable AI: Expected to reach $360B by 2034, growing at a 24.7% CAGR³

For more information on CGM+ please visit our dedicated website https://cgm.trinitybiotech.com/

¹ https://www.mordorintelligence.com/industry-reports/continuous-glucose-monitoring-market

² https://www.mordorintelligence.com/industry-reports/artificial-intelligence-in-healthcare-market

³ https://www.fortunebusinessinsights.com/wearable-ai-market-109561

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 technical breakthroughs did Trinity Biotech (TRIB) announce for its CGM+ platform?

Trinity Biotech reported significant technical advancements for CGM+, including an updated glucose sensor and electronics architecture that delivered a material reduction in MARD across multi‑day wear. The results indicate the upgraded system can meet industry standards for glucose measurement accuracy of modern continuous glucose monitors.

When does Trinity Biotech (TRIB) anticipate starting the pivotal clinical trial for CGM+?

Trinity Biotech anticipates initiating a pivotal clinical trial for its CGM+ continuous glucose monitoring system in 2026. The company states that, following this pivotal study, it is targeting regulatory submissions in key global markets, moving the platform closer to potential scaled commercialization if results remain supportive.

How is Trinity Biotech’s CGM+ designed to improve user experience and sustainability?

CGM+ features a next‑generation modular device architecture designed to reduce cost and improve sustainability versus current market‑leading CGMs. Trinity Biotech also reports successful trials of a needle‑free glucose sensor insertion process, which is fundamental to the user‑friendly modular design and supports the device’s updated configuration.

What role do AI and multimodal sensing play in Trinity Biotech’s CGM+ system?

CGM+ incorporates multimodal sensing and advanced AI‑native analytics to capture multiple physiological metrics, including glucose, in a single device. Trinity Biotech plans to use these data to generate personalized metabolic health insights, aiming to support better metabolic health for users and provide clinicians with a powerful treatment tool.

How much clinical testing data has Trinity Biotech collected for CGM+ so far?

Trinity Biotech reports collecting more than 650 days of clinical testing data across several trials on its updated glucose sensor architecture, now integrated with next‑generation electronics. This dataset supported the observed improvement in glucose measurement accuracy and the material reduction in MARD versus earlier clinical studies of the upgraded sensor.

What market opportunity is Trinity Biotech targeting with the CGM+ platform?

The company is positioning CGM+ to participate in a fast‑growing $15bn continuous glucose monitoring market and adjacent sectors. It also highlights that CGM+ sits at the intersection of advanced glucose monitoring, AI‑native healthcare analytics, and rising demand for AI wearables, supported by external market forecasts referenced in the release.

How does CGM+ fit within Trinity Biotech’s broader business focus?

Trinity Biotech describes itself as a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. CGM+ is its next‑generation continuous glucose monitoring product and a central part of its strategy to drive growth and scale alongside existing diagnostic systems and global distribution channels.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EXHIBIT 99.1 27.8 KB