[6-K] TRINITY BIOTECH PLC Current Report (Foreign Issuer)
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
Trinity Biotech plc filed a Form 6-K highlighting two growth initiatives in diabetes care. Senior executives are attending the ATTD 2026 conference in Barcelona to advance collaborations and commercialization plans for the next‑generation CGM+ continuous glucose monitoring platform, which is being prepared for a pivotal clinical trial in 2026.
The company has also begun commercial rollout in Brazil of its upgraded Premier Hb9210 HbA1c column system after local regulatory approval. The Premier Hb9210 platform is described as the only HbA1c system worldwide with IFCC “Gold” classification for 2026, and Trinity Biotech has strengthened its Brazilian commercial leadership with the appointment of Bruna Gigliotti.
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Insights
Trinity Biotech advances CGM program and expands HbA1c footprint in Brazil.
Trinity Biotech is emphasizing two strategic pillars: a next‑generation CGM+ wearable platform and its Premier Hb9210 HbA1c lab system. Executives are using the ATTD 2026 diabetes conference to pursue collaborations and commercialization pathways ahead of a pivotal CGM clinical trial planned for
Conference engagement suggests reliance on partners for clinical research, technology integration and distribution. Actual adoption will depend on trial outcomes, partner quality and competitive dynamics in continuous glucose monitoring and HbA1c testing, which are not quantified here.
In Brazil, the company is rolling out its updated Premier Hb9210 HbA1c column system after local regulatory approval, highlighting IFCC “Gold” classification for
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 11, 2026, the Company issued a press release announcing the senior executives were attending the ATTD 2026 (Advanced Technologies & Treatments for Diabetes) conference in Barcelona this week to progress
strategic collaborations and commercialization plans for the Company’s next‑generation Continuous Glucose Monitoring (“CGM”) platform. On March 12, 2006, the Company issued a press release announcing it had begun rollout of its Premier Hb9210 HbA1c
Column System in Brazil following regulatory approval. Copies of the press releases are filed herewith as Exhibit 99.1 and Exhibit 99.2.
EXHIBIT INDEX
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Exhibit
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Description
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99.1
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Trinity Biotech Senior Executives to Attend ATTD 2026 to Advance Collaborations
Following Strong Progress in CGM Program
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99.2
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Trinity Biotech Begins Rollout of Innovative Glucose Monitoring System In Key Market
Following Regulatory Approval of Next-Generation Premier Hb9210 HbA1c Column System
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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.
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TRINITY BIOTECH PLC
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Trinity Biotech plc
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(Registrant)
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By:
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/s/ Paul Murphy
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Paul Murphy
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Interim Chief Financial Officer
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Date: March 16, 2026
Exhibit 99.1
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Contact:
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Trinity Biotech plc
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RedChip Companies Inc.
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Gary Keating, PhD
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Dave Gentry, CEO
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(353)-1-2769800
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(1)-407-644-4256
(1)-800-RED-CHIP (733-2447)
TRIB@redchip.com
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Trinity Biotech Senior Executives to Attend ATTD 2026 to
Advance Collaborations Following Strong Progress in CGM Program
- Company accelerating partner engagement ahead of pivotal clinical trial to be initiated in 2026
DUBLIN, Ireland and OREGON, United States of America (March 11, 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 senior members of its executive leadership team will attend the ATTD 2026 (Advanced Technologies & Treatments for Diabetes) conference in
Barcelona this week to progress strategic collaborations and commercialization plans for the Company’s next‑generation Continuous Glucose Monitoring (“CGM”) platform, CGM+.
The Company’s presence at ATTD follows compelling clinical performance data from its latest CGM technology developments (March 10, 2026 release link here), which formed the basis for Trinity
Biotech’s decision to advance the program into a pivotal clinical trial in 2026. These results now provide strong evidence that the upgraded system can meet the industry standards for glucose measurement accuracy of modern CGMs. Ahead of this major
development milestone, ATTD 2026 provides an important platform for the Company to accelerate partner engagement and prepare for the next phase of development and commercial readiness.
“Our CGM program has reached a meaningful inflection point, and ATTD is an ideal forum to deepen the partnerships necessary to bring this important innovation to
market,” said John Gillard, Trinity Biotech President & Chief Executive Officer. “With pivotal clinical trial preparations underway, our team will be engaging
with prospective collaborators across clinical research, technology integration, and commercial distribution as we build momentum with this exciting platform.”
Trinity Biotech’s CGM+ platform is being developed as part of the Company’s broader strategy to create integrated, AI-native healthcare analytics that support data-driven health solutions to enhance
the management of diabetes and metabolic health worldwide.
For more information on CGM+ please visit our dedicated website https://cgm.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, 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
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Contact:
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Trinity Biotech plc
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RedChip Companies Inc.
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Gary Keating, PhD
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Dave Gentry, CEO
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(353)-1-2769800
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(1)-407-644-4256
(1)-800-RED-CHIP (733-2447)
TRIB@redchip.com
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Trinity Biotech Begins Rollout of Innovative Glucose Monitoring
System In Key Market Following Regulatory Approval of Next-Generation
Premier Hb9210 HbA1c Column System
- Company begins roll out of innovative diabetes care HbA1c column system in Brazil
- Commercial leadership strengthened with key appointment
DUBLIN, Ireland (March 12, 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 it has commenced the commercial rollout in Brazil of its updated laboratory blood glucose monitoring solution, the next‑generation
HbA1c column system for its Premier Hb9210TM platform, following receipt of local regulatory approval.
This approval enables the introduction of the Company’s upgraded boronate affinity column system into one of the world’s largest diabetes markets. The enhanced Premier Hb9210 TM platform
recently became the only HbA1c system worldwide to receive the prestigious International Federation of Clinical Chemistry (IFCC) “Gold” classification for 2026, a designation recognising the highest levels of clinical accuracy, precision and
traceability.
“Brazil is one of the world’s most important diabetes markets, and regulatory approval of our upgraded Premier Hb9210 HbA1c system marks a significant step forward
for our haemoglobin business and positions it well for long-term profitable growth,” said John Gillard, President & CEO of Trinity Biotech. “With the Premier Hb9210 achieving IFCC Gold status for 2026 —
the only system globally to do so — we are delivering world‑leading accuracy to a market that needs it most.”
Brazil: An Important Diabetes Market
Brazil represents a major strategic market for Trinity Biotech. The country has one of the largest diabetes populations globally, with approximately 16 to 18 million adults living with diabetes and
its prevalence continuing to rise in both urban and rural areas. This growing clinical burden underscores the urgent need for reliable, high‑specificity HbA1c testing technologies capable of supporting diabetes management.
The Premier Hb9210’s boronate affinity technology provides a meaningful advantage in the Brazilian clinical environment. Unlike many other HbA1c analysis technologies, boronate affinity methods are
insensitive to haemoglobin variants, which occur at elevated rates within Brazil’s genetically diverse population. This reduces the risk of inaccurate results, false classifications, and unnecessary treatment adjustments — directly improving patient
outcomes and clinician confidence.
Strengthened Commercial Leadership in Brazil
Trinity Biotech also announced that Bruna Gigliotti has recently joined the Company to lead its local Brazilian commercial organisation. Her appointment strengthens the Company’s local market
execution in anticipation of accelerated adoption of its Premier Hb9210TM platform.
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.
Filing Exhibits & Attachments
2 documentsPress Releases
Trinity Biotech Plc