Trinity Biotech PLC 6-K, filed Nov 18, 2025
Trinity Biotech PLC (TRIB)
6-K
2025-11-18
For: 2025-11-18
View Original
Added on
April 12, 2026
About this 6-K
Trinity Biotech PLC filed this 6-K on November 18, 2025.
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 November 2025
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 November 14, 2025, the Company issued a press release announcing its Collaboration to Advance Epigenetic Analysis for EpiCapture Prostate Cancer Test. A copy of the press release is filed herewith as Exhibit 99.1.
EXHIBIT INDEX
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Exhibit
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Description
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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/ John Gillard
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John Gillard
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Chief Executive Officer
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Date: November 14, 2025
Exhibit 99.1
| Contact: | Trinity Biotech plc | RedChip Companies Inc. |
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Gary Keating, Ph.D.
(353)-1-2769800
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Dave Gentry, CEO
(1)-407-644-4256
(1)-800-RED-CHIP (733-2447)
TRIB@redchip.com
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Trinity Biotech Announces Collaboration to Advance
Epigenetic Analysis for EpiCapture Prostate Cancer Test
DUBLIN, Ireland (November 14, 2025) - Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management
solutions, including wearable biosensors, today announced a strategic collaboration with a leading bioinformatics company to conduct advanced analysis on clinical trial data for EpiCapture, the company’s PCR-based epigenetic liquid biopsy test
for monitoring the risk of prostate cancer progressing to more aggressive forms of the disease.
Offering a non-invasive method to monitor disease progression, the EpiCapture test detects DNA methylation patterns associated with high-grade prostate cancer. This collaboration will apply sophisticated
bioinformatics tools to enhance the depth of analysis and support the continued development of the test.
This collaboration supports the advancement of the EpiCapture test, which is currently in late-stage development, to regulatory approval and commercialization. This initiative is part of Trinity Biotech’s broader
strategy to expand the company’s portfolio of innovative, clinically impactful technologies.
Addressing a Significant Clinical and Economic Burden
Prostate cancer is the most common non-skin cancer among men in the U.S., with about 1 in 8 men diagnosed during their lifetime and the cost for diagnosis and treatment estimated at over
approximately $10 billion annually.
Because prostate cancer can often progress slowly, accurate monitoring is essential. Many patients undergo repeated invasive procedures, such as prostate biopsies, which carry risks including
infection, bleeding, and urinary complications. Approval and adoption of a reliable, non-invasive test like EpiCapture could help reduce unnecessary interventions and improve patient care.
Clinical Promise
A study published in The Journal of Clinical Oncology – Precision Oncology demonstrated that EpiCapture
correctly predicted all high-grade cancers when used alongside the widely adopted PSA test. These findings support the test’s potential to improve clinical decision-making and patient outcomes.
Trinity Biotech will continue to leverage its diagnostic expertise and New York State certified reference laboratory to support EpiCapture’s development and prepare for regulatory submission and
commercialization.
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.