Trinity Biotech expands rollout of FDA-cleared HbA1c column system

Trinity Biotech plc submitted a Form 6-K to provide investors with a press release about its diabetes testing technology.

Rhea-AI Filing Summary

Trinity Biotech plc submitted a Form 6-K to provide investors with a press release about its diabetes testing technology. The company announced that it is expanding the global rollout of its high-capacity column system that is used with its FDA-cleared HbA1c testing solution, which helps measure long-term blood sugar control. This expansion follows the company securing the necessary regulatory clearances to offer the system in additional markets. The full details of the announcement are contained in an attached press release, filed as Exhibit 99.1.

FAQ

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What did Trinity Biotech (TRIB) report in this Form 6-K?

Trinity Biotech reported that it issued a press release announcing the expansion of the global rollout of its high-capacity column system for its FDA-cleared HbA1c testing solution, following regulatory clearances.

What product is Trinity Biotech (TRIB) expanding globally?

The company is expanding the global rollout of a high-capacity column system that is part of its FDA-cleared HbA1c testing solution.

What regulatory status does Trinity Biotech’s HbA1c solution have?

The HbA1c testing solution associated with the high-capacity column system is described as FDA-cleared, and the company states it has secured additional regulatory clearances supporting the expanded rollout.

How is the press release made available in the Trinity Biotech (TRIB) filing?

The press release is included as Exhibit 99.1 to the Form 6-K under the title “Trinity Biotech Expands Global Rollout of High-Capacity Column System for FDA-Cleared HbA1c Testing Solution After Securing Regulatory Clearances.”

Does this Trinity Biotech (TRIB) Form 6-K tie into other SEC registration statements?

Yes. The Form 6-K states that it is incorporated by reference into Trinity Biotech’s Registration Statements on Form S-8 with File Nos. 333-182279, 333-195232 and 333-253070.

Who signed this Trinity Biotech (TRIB) Form 6-K?

The Form 6-K was signed on behalf of Trinity Biotech plc by John Gillard, the company’s Chief Executive Officer, dated December 15, 2025.

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Accepted by SEC EDGAR 12/18/2025 - 01:34 PM EST Learn about SEC filing dates

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 December 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 December 15, 2025, the Company issued a press release announcing it Expands Global Rollout of High-Capacity Column System for FDA-Cleared HbA1c Testing Solution After Securing Regulatory Clearances. A copy of the press release is filed herewith as Exhibit 99.1.

EXHIBIT INDEX

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

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/ John Gillard
		John Gillard
		Chief Executive Officer

Date:  December 15, 2025