[6-K] Trinity Biotech plc Current Report (Foreign Issuer)

Rhea-AI Filing Summary

Trinity Biotech plc notified investors via Form 6-K that it issued a press release announcing the launch of an FDA-cleared Preeclampsia Testing Service. The company filed that press release as Exhibit 99.1 to the Form 6-K and stated the report is being incorporated by reference into its Form S-8 registration statements. The filing is signed by Chief Executive Officer John Gillard. The Form contains no financial results, pricing, partner or rollout details, and provides no operational or revenue metrics for the new service.

Positive

• Announcement of an FDA-cleared Preeclampsia Testing Service
• Press release formally filed as Exhibit 99.1 to the Form 6-K

Negative

• None.

Insights

Financial Analyst

TL;DR: FDA-cleared service launch is a potentially material commercial milestone; the filing gives no financial detail to quantify near-term impact.

The announcement of an FDA-cleared Preeclampsia Testing Service is a discrete regulatory and commercial milestone that can enable U.S. market offering. However, the Form 6-K itself provides no revenue, pricing, expected adoption, or cost information, limiting immediate ability to assess earnings or cashflow impact. Incorporation of the press release as Exhibit 99.1 ensures the disclosure is official, but investors should seek subsequent filings or company releases for commercialization metrics needed to model financial effects.

Industry Specialist (Diagnostics)

TL;DR: Regulatory clearance plus a formal launch signals readiness to commercialize a diagnostic service, but operational details are missing from the filing.

The filing confirms an FDA-cleared testing service for preeclampsia and a formal launch communication, which are important for market access and payer engagement. The disclosure lacks specifics on laboratory partners, testing throughput, reimbursement strategy, or deployment timeline, so the filing confirms the milestone but does not describe how the service will be commercialized or scaled. This is notable for clinical adoption assessment but not sufficient to estimate market penetration or revenue conversion.

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 August 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 August 7, 2025, the Company issued a press release announcing its Launch of FDA-cleared Preeclampsia Testing Service. A copy of the press release is filed herewith as Exhibit 99.1.

EXHIBIT INDEX

Exhibit		Description
99.1		Trinity Biotech Announces Launch of FDA-cleared Preeclampsia Testing Service.

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:  August 7, 2025

FAQ

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

The company announced the launch of an FDA-cleared Preeclampsia Testing Service and filed the related press release as Exhibit 99.1 to the Form 6-K.

How was the announcement disclosed by Trinity Biotech (TRIB)?

The announcement was disclosed via a Form 6-K, with the press release attached as Exhibit 99.1 and incorporated by reference into the company's Form S-8 registration statements.

Does the Form 6-K include financial or commercial details for the new test?

No. The filing does not include financial results, pricing, partner agreements, or a commercial rollout timeline for the testing service.

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

John Gillard, Chief Executive Officer, signed the report on behalf of the registrant.

Is the press release available as part of the filing record?

Yes. The press release announcing the launch is filed as Exhibit 99.1 to the Form 6-K.