Core Insights - Trinity Biotech has announced the successful results of a clinical study for an enhanced version of its EpiCapture™ prostate cancer test, which utilizes machine learning for improved risk prediction of aggressive prostate cancer [1][6]. Group 1: Product Development and Clinical Validation - The next-generation EpiCapture™ test incorporates machine learning tools that consider additional patient features, including ethnicity, alongside DNA biomarkers, leading to more accurate risk prediction scores [2]. - The upgraded test was evaluated in a clinical study involving approximately 750 patient samples, providing a more ethnically diverse cohort than previous studies [5]. - The new version of the EpiCapture™ test achieved a clinical accuracy (Area Under the Curve, AUC) of 85%, indicating strong performance in oncology diagnostics [6]. Group 2: Market Context and Need - 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 national expenditures for prostate cancer care exceeding $20 billion annually [4]. - The EpiCapture test offers a less invasive and more accessible alternative to traditional diagnostic methods, addressing barriers to early detection such as the high costs and risks associated with MRI scans and needle biopsies [3]. Group 3: Commercialization Strategy - Trinity Biotech plans to commercialize the EpiCapture test as a proprietary Laboratory Developed Test (LDT) through its New York State Department of Health certified diagnostics reference laboratory, facilitating rapid rollout across the U.S. [8]. - This marks Trinity Biotech's first entry into the precision oncology diagnostics market, reflecting the company's strategic evolution towards precision medicine applications [9]. Group 4: Expert Commentary - John Gillard, CEO of Trinity Biotech, emphasized that the enhanced EpiCapture test represents significant progress in prostate cancer risk prediction and the company's innovation agenda [10]. - Dr. Antoinette Perry from University College Dublin highlighted the study's strong performance and the test's unique incorporation of ethnicity as a variable in its predictive algorithm, addressing the variations in prostate cancer incidence and outcomes across different populations [10].

DUBLIN and NEW YORK, March 18, 2026 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced it has entered into a collaboration agreement with the University at Buffalo, New York (“UB”). The partnership focuses on advancing and commercializing a suite of proprietary biomarkers for the earlier and more accurate detection of Sjögren’s Syndrome, one of the most ...

Core Insights - Trinity Biotech has initiated the commercial rollout of its updated laboratory blood glucose monitoring solution in Brazil, specifically the next-generation HbA1c column system for its Premier Hb9210™ platform, following local regulatory approval [1][2] Company Developments - The upgraded boronate affinity column system has been introduced in Brazil, a significant market for diabetes management, which has one of the largest diabetes populations globally, estimated at approximately 16 to 18 million adults [2][4] - The Premier Hb9210™ platform has achieved the prestigious International Federation of Clinical Chemistry (IFCC) "Gold" classification for 2026, marking it as the only HbA1c system worldwide to receive this recognition, which highlights its clinical accuracy and precision [2][3] - Bruna Gigliotti has been appointed to lead the local Brazilian commercial organization, enhancing the company's market execution in anticipation of increased adoption of the Premier Hb9210™ platform [6] Market Context - Brazil's diabetes prevalence is on the rise, necessitating reliable and high-specificity HbA1c testing technologies to support effective diabetes management [4] - The boronate affinity technology used in the Premier Hb9210™ offers advantages in Brazil's diverse population, as it is less affected by haemoglobin variants, thereby improving patient outcomes and clinician confidence [5]

DUBLIN and WILSONVILLE, Ore., March 11, 2026 (GLOBE NEWSWIRE) -- 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‑generati ...

Core Insights - Trinity Biotech has made significant advancements in its next-generation Continuous Glucose Monitoring (CGM) system, CGM+, which is moving towards regulatory submissions and commercialization [1][9] - The company anticipates initiating a pivotal clinical trial in 2026, following positive results from previous trials [1][12] Technical Advancements - The updated electronics architecture has led to a substantial improvement in glucose measurement accuracy, achieving a material reduction in Mean Absolute Relative Difference (MARD) during multi-day wear [4][7] - The incorporation of advanced electronic components supports a unique multimodal data-capture capability, enabling AI-driven analytics for personalized metabolic health insights [5][11] Market Positioning - CGM+ is positioned to participate in the rapidly growing $15 billion CGM market, with projections indicating growth from $15.3 billion in 2026 to $31.4 billion by 2031, reflecting a CAGR of 15.4% [7][15] - The device's modular design aims to reduce costs and improve sustainability compared to current market-leading CGMs, addressing one of the main barriers to broader adoption [6][9] Innovation and Collaboration - The company is collaborating with clinicians, scientists, and digital health leaders to optimize the CGM+ architecture, which is designed to collect multiple physiological metrics alongside glucose [11] - Feedback from stakeholders has been enthusiastic, prompting the company to advance the CGM+ program through its final design phase [12]

Core Viewpoint - Trinity Biotech plc has provided an update on its trading activities for Q4 2025, highlighting both challenges and strategic advancements in its business operations, particularly in the areas of HIV testing and diabetes management solutions [1]. Trading Update - The company expects Q4 2025 revenue to be between approximately $11.5 million and $12.5 million, a decrease from $15.9 million in Q4 2024, primarily due to disruptions in the global health market for HIV testing and adjustments in manufacturing processes [8]. Business Update - The company is focused on profitable growth and advancing its innovation agenda, including the flagship development of CGM+ [3]. - Key regulatory approvals have been secured, including the outsourcing of production for the Uni-Gold™ HIV rapid test, which is a priority in the Comprehensive Transformation Plan [4]. - The company is experiencing strong demand for its Uni-Gold™ HIV test and expects this segment to contribute significantly to revenue in 2026 [5]. - The transition to outsourced manufacturing aims to reduce fixed costs and mitigate revenue variability, although it may introduce temporary fluctuations in quarterly revenue [6]. - The company is enhancing its diabetes care solutions, having received a Gold Classification from the IFCC for its Premier Hb9210 HbA1c monitoring solution and is expanding its commercial efforts in the US and Brazil [7][10]. Pipeline Developments - The company continues to advance key strategic growth projects, including the development of CGM+, EpiCapture for prostate cancer monitoring, and PrePsia for early pregnancy screening [13].

Registration No. 333- As filed with the Securities and Exchange Commission on February 25, 2026 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRINITY BIOTECH PLC (Exact name of registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) Ireland 2835 Not Applicable IDA Business Par ...

- Agreement provides additional funding tool of up to $25 million over a period of up to 36 months - Underpins the Company’s ambitions to expand its commercialisation activities and advance its innovation agenda DUBLIN, Feb. 25, 2026 (GLOBE NEWSWIRE) -- 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 entered into a $25 million Standby Equity Purchase Agreeme ...

DUBLIN, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, received notice on February 19, 2026 from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company no longer meets the requirement in Nasdaq Listing Rule 5450(b) that listed securities maintain a minimum market value of publicly held shares (“MVPHS”) of $15,000,000, based on Nasdaq’s review of the ...

Core Viewpoint - Trinity Biotech plc has received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement for its American Depositary Shares (ADSs), which must be at least $1.00 per share for 30 consecutive business days [1][2]. Company Compliance Status - The notice does not immediately affect the trading status of the Company's ADSs, which will continue to be listed on the Nasdaq Global Select Market under the symbol "TRIB" [2]. - The Company has a 180-calendar day period, until August 10, 2026, to regain compliance with the minimum bid price requirement [2]. - To regain compliance, the closing bid price of the Company's ADSs must meet or exceed $1.00 for at least ten consecutive business days during this grace period [2]. Management's Response - The Company's management is actively monitoring the bid price of its ADSs and intends to cure the deficiency within the grace period [3]. - Various options are being evaluated by management to regain compliance and maintain the continued listing of the ADSs [3]. Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [5]. - The Company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, and has recently entered the wearable biosensor industry through the acquisition of Waveform Technologies Inc. [5]. - Products include systems to detect infectious diseases and quantify Haemoglobin A1c levels, with sales occurring directly in the U.S. and through international distributors in over 75 countries [6].