Strategic Offshore Manufacturing Move Expected to Drive Gross Margin Expansion, EBITDA Accretion and Cashflow GenerationDUBLIN, Nov. 18, 2025 (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 received World Health Organization (WHO) approval for the offshored and outsourced upstream manufacturing activities of its market leading Uni-Gold™ HIV ra ...

Core Insights - Trinity Biotech plc has announced a strategic collaboration with a leading bioinformatics company to enhance the analysis of clinical trial data for its EpiCapture test, a PCR-based epigenetic liquid biopsy for monitoring prostate cancer progression [1][3] - The EpiCapture test offers a non-invasive method to detect DNA methylation patterns associated with high-grade prostate cancer, aiming to improve patient care by reducing unnecessary invasive procedures [2][5] - Prostate cancer represents a significant clinical and economic burden, with approximately 1 in 8 men diagnosed in the U.S. and annual costs for diagnosis and treatment exceeding $10 billion [4] Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [9] - The company develops and markets diagnostic systems for point-of-care and clinical laboratory segments, recently entering the wearable biosensor market through the acquisition of Waveform Technologies Inc. [9] - Trinity Biotech's products are utilized to detect infectious diseases and quantify various chemistry parameters in blood samples, with a distribution network spanning over 75 countries [9] Clinical Development - The collaboration aims to support the late-stage development of the EpiCapture test, preparing it for regulatory approval and commercialization [3][7] - A study published in The Journal of Clinical Oncology – Precision Oncology indicated that EpiCapture accurately predicted all high-grade cancers when used with the PSA test, highlighting its potential to enhance clinical decision-making [6]

Core Viewpoint - Trinity Biotech plc is welcoming a proposal from its largest investor, Perceptive Advisors, to convert a portion of its outstanding debt into equity, which is seen as a strategic initiative to strengthen the company's balance sheet and enhance financial flexibility [1][2]. 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, with recent expansion into the wearable biosensor industry through the acquisition of Waveform Technologies Inc. [5]. - Products include diagnostics for infectious diseases and quantification of Haemoglobin A1c and other chemistry parameters in various blood samples [5]. Investor Relations - Perceptive Advisors, a leading life sciences investment firm with approximately $8 billion in assets, has been a supportive partner during Trinity Biotech's transformation [2][7]. - The proposed equitization program aims to align the interests of all stakeholders, including shareholders, and is expected to facilitate discussions that are mutually beneficial [3][2].

Company Overview - Trinity Biotech plc is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [5][6] - The company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments [5][6] Recent Developments - The company announced the appointment of Paul Tivnan as a Non-Executive Director on its Board of Directors [1] - Mr. Tivnan has over 25 years of senior leadership experience in finance, capital markets, and corporate governance across various sectors, including infrastructure and cleantech [2][3] - His previous roles include CFO of Deriva Energy LLC and CFO of Brookfield Renewable Ireland, where he led a successful IPO [2][3] Strategic Goals - The appointment of Mr. Tivnan is aimed at strengthening corporate governance and bringing diverse perspectives to the Board as the company pursues growth opportunities in diagnostics and wearable health technologies [3] - Trinity Biotech is focused on executing its transformation strategy and developing a range of biosensor devices, starting with a continuous glucose monitoring product [6]

Core Insights - Trinity Biotech has received regulatory approval to initiate offshore and outsourced manufacturing of its TrinScreen™ HIV rapid test, marking a significant step in its transformation strategy [1][2][3] - The transition to an outsourced production model is expected to drive gross margin expansion, free up working capital, and reduce fixed costs, thereby supporting the company's broader profitability and growth objectives [1][4] 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 [5]

Company Overview - Trinity Biotech plc (TRIB) is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [2] Key Developments - Trinity Biotech announced positive clinical trial results for its next-generation continuous glucose monitoring (CGM) technology, CGM+, confirming accurate glucose readings over a 15-day wear period without finger-stick calibration [1][8] - The redesigned proprietary needle-free glucose sensor reduces disposable components, significantly lowering the cost of care compared to current leading market products [1][8] - The CGM+ platform is designed to enhance accessibility and increase utilization of CGM technology, addressing the high cost of existing devices that hinders widespread adoption [3] Technical Achievements - The elimination of finger-stick calibration is considered the most significant technical achievement for TRIB, aligning its glucose sensor with market leaders while offering a differentiated product that is more affordable, reusable, and sustainable [4] Market Potential - The global CGM market is projected to grow from $13 billion in 2025 to $28 billion by 2030, driven by rising diabetes prevalence and demand for real-time health data, which is expected to provide a significant boost to Trinity Biotech's business [5] Product Development - Trinity Biotech unveiled its new flagship product, CGM+, which is positioned for the $260 billion AI wearables market and combines multi-sensor data with real-time analytics to meet the demands of AI-powered healthcare [6] Competitive Landscape - Medtronic plc (MDT) and Abbott Laboratories (ABT) are notable peers in the diabetes management space, with both companies making advancements in CGM technology and reporting robust growth in their respective diabetes care segments [7][9] - DexCom, Inc. (DXCM) also reported strong revenue growth and received FDA clearance for its Dexcom G7 15 Day CGM System, showcasing extensive clinical evidence for its usage in various diabetes conditions [10]

Core Insights - Trinity Biotech has received regulatory approval from the New York State Department of Health for the PreClara™ Ratio (sFlt-1/PlGF) biomarker test, which is set to launch in Q3 2025, aimed at assessing preeclampsia risk in pregnant women [1][2] Company Developments - The approval is a significant milestone in Trinity Biotech's maternal health strategy, enhancing its position in the U.S. diagnostics market [2] - The PreClara™ test provides clinicians with actionable insights for managing patients with hypertensive disorders of pregnancy, potentially impacting around 500,000 women annually in the U.S. [2][4] - The test is expected to lead to neonatal cost savings exceeding $10 million per 1,000 patients by reducing preterm deliveries and NICU admissions [2] Industry Context - Preeclampsia affects approximately 5-8% of pregnancies and is a leading cause of maternal and neonatal complications, contributing to about 11% of maternal deaths and 15% of premature births in the U.S. [4] - The NYSDOH approval also sets the stage for the future introduction of PrePsia™, a proprietary technology for early pregnancy risk assessment related to preeclampsia [3]

Core Insights - Trinity Biotech has achieved a significant technical breakthrough with its next-generation continuous glucose monitoring (CGM) technology, CGM+, eliminating the need for finger-stick calibration and enhancing the commercial pathway for its biosensor platform [1][2][3] Company Developments - The redesigned needle-free glucose sensor provides accurate readings over a 15-day wear period without finger-stick calibration, reducing disposable components and lowering care costs compared to existing market products [1][3][6] - The successful technical de-risking of the glucose sensor increases confidence in the product's performance and regulatory pathway, aligning it with market leaders while offering a differentiated product architecture [2][6] Market Potential - The global CGM market is projected to grow from approximately $13 billion in 2025 to about $28 billion by 2030, driven by rising diabetes prevalence and demand for real-time health data [4] - Trinity Biotech's innovative CGM+ platform aims to expand access to glucose monitoring technology for millions who are currently priced out of existing systems, emphasizing affordability, reusability, and sustainability [4][6] Product Features - The CGM+ wearable biosensor is designed to integrate glucose monitoring with cardiovascular, temperature, and activity data in a single modular device, enhancing user convenience and reliability [7][6]

Core Insights - Trinity Biotech has launched the FDA-cleared PreClara Ratio (sFlt-1/PlGF) biomarker test aimed at improving management of hypertensive disorders in pregnancy, with plans for rollout in Q3 2025 [1][2] - The test is expected to provide significant clinical and economic benefits, potentially saving over $10 million per 1,000 patients by reducing preterm deliveries and neonatal intensive care admissions [3] Company Developments - The launch of the sFlt-1/PlGF test is part of a strategic collaboration with Thermo Fisher Scientific, enhancing Trinity Biotech's capabilities in maternal health diagnostics [2] - CEO John Gillard emphasized that this launch marks a strategic milestone in the company's maternal health strategy and reflects its commitment to addressing urgent healthcare needs [3] Industry Context - Hypertensive disorders of pregnancy affect approximately 500,000 women annually in the U.S., making it a leading cause of maternal and neonatal complications [2] - Preeclampsia affects 5-8% of pregnancies and is responsible for about 11% of maternal deaths and 15% of premature births in the U.S., with cases nearly doubling since 2007 [5]

Core Insights - Trinity Biotech plc has launched CGM+, a next-generation wearable biosensor platform aimed at the $260 billion AI wearables market, currently in the later stages of development [1][10][12] Product Features - CGM+ integrates a minimally invasive electrochemical glucose sensor with continuous monitoring of heart activity, body temperature, and physical activity, all within a single modular device [2][9] - The device is designed for real-time AI analysis, providing insights into metabolic factors such as sleep, stress, and physical activity [2][10] - The proprietary needle-free glucose sensor technology reduces disposable components and waste, lowering the cost of care compared to existing market products [3][4] Market Positioning - CGM+ is positioned at the intersection of high-growth sectors, targeting both clinical and consumer health markets [12][13] - The product aims to bridge the gap between medical-grade monitoring and consumer wellness insights, establishing Trinity Biotech as a leader in intelligent wearables [2][7] Strategic Outlook - The company anticipates a commercial launch of CGM+ in mid-2026, with multiple revenue streams expected from device sales, AI analytics subscriptions, and partnerships with healthcare providers and insurers [13][14] - CGM+ is seen as a foundational platform for AI-native health applications, supporting both clinical workflows and consumer health optimization [11][10] Industry Growth Projections - The global continuous glucose monitoring market is projected to grow from $13.28 billion in 2025 to $28.72 billion by 2030, with a CAGR of 16.68% [16] - The AI in healthcare market is forecasted to reach approximately $200 billion by 2030, growing at a CAGR of 37.6% [16] - The wearable AI market is expected to surpass $260 billion by 2032, with a CAGR of 27.0% [16]