Trinity Biotech Achieves Breakthrough Clinical Trial Results for Redesigned CGM Sensor
Trinity Biotech (Nasdaq: TRIB) has announced breakthrough clinical trial results for its next-generation continuous glucose monitoring technology, CGM+. The trial demonstrated that their redesigned needle-free glucose sensor can deliver accurate readings over a 15-day wear period without requiring finger-stick calibration.
The company's innovative CGM+ platform features a modular design that reduces disposable components and integrates multiple health metrics including heart activity, body temperature, and physical activity data. This approach aims to significantly lower costs compared to existing market solutions, addressing accessibility barriers in the projected $28 billion CGM market by 2030.
Trinity Biotech (Nasdaq: TRIB) ha annunciato risultati rivoluzionari di uno studio clinico per la sua tecnologia di monitoraggio continuo della glicemia di nuova generazione, CGM+. Lo studio ha dimostrato che il loro sensore della glicemia riprogettato, senza aghi, 猫 in grado di fornire letture accurate durante un periodo di utilizzo di 15 giorni senza richiedere la calibrazione con la puntura del dito.
La piattaforma innovativa CGM+ dell'azienda presenta un design modulare che riduce i componenti monouso e integra molteplici parametri di salute, tra cui attivit脿 cardiaca, temperatura corporea e dati sull'attivit脿 fisica. Questo approccio punta a ridurre notevolmente i costi rispetto alle soluzioni attuali sul mercato, affrontando le barriere di accesso nel mercato CGM stimato a 28 miliardi di dollari entro il 2030.
Trinity Biotech (Nasdaq: TRIB) ha anunciado resultados innovadores en un ensayo cl铆nico de su tecnolog铆a de monitorizaci贸n continua de glucosa de nueva generaci贸n, CGM+. El ensayo demostr贸 que su sensor de glucosa redise帽ado, sin aguja, puede ofrecer lecturas precisas durante un periodo de uso de 15 d铆as sin necesidad de calibraci贸n con pinchazos en el dedo.
La innovadora plataforma CGM+ de la compa帽铆a presenta un dise帽o modular que reduce los componentes desechables e integra m煤ltiples m茅tricas de salud, incluyendo actividad card铆aca, temperatura corporal y datos de actividad f铆sica. Este enfoque pretende reducir significativamente los costes respecto a las soluciones actuales del mercado, abordando las barreras de accesibilidad en el mercado de CGM proyectado en 28.000 millones de d贸lares para 2030.
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須岇偓鞚� 順侅嫚鞝侅澑 CGM+ 頂岆灚韽检潃 鞚柬殞鞖� 攵�頀堨潉 欷勳澊電� 氇搱順� 靹り硠毳� 韸轨鞙茧 頃橂┌ 鞁灔 頇滊彊, 觳挫槰, 鞁犾泊 頇滊彊 雿办澊韯� 霌� 鞐煬 瓯搓皶 歆�響滊ゼ 韱淀暕頃╇媹雼�. 鞚措煬頃� 鞝戧芳鞚� 旮办〈 鞁滌灔 靻旊（靺橃棎 牍勴暣 牍勳毄鞚� 韥矊 雮稊電� 瓴冹潉 氇╉憸搿� 頃橃棳, 2030雲勱箤歆� 280鞏� 雼煬 攴滊搿� 鞓堨儊霅橂姅 CGM 鞁滌灔鞐愳劀鞚� 鞝戧芳靹� 鞛ル步鞚� 頃挫唽頃橂牑 頃╇媹雼�.
Trinity Biotech (Nasdaq: TRIB) a annonc茅 des r茅sultats r茅volutionnaires d'un essai clinique pour sa technologie de surveillance continue de la glyc茅mie de nouvelle g茅n茅ration, CGM+. L'essai a d茅montr茅 que leur capteur de glyc茅mie repens茅, sans aiguille, peut fournir des mesures pr茅cises sur une p茅riode de port de 15 jours sans n茅cessiter de calibration par piq没re au doigt.
La plateforme innovante CGM+ de la soci茅t茅 pr茅sente une conception modulaire qui r茅duit les composants jetables et int猫gre plusieurs indicateurs de sant茅, notamment l'activit茅 cardiaque, la temp茅rature corporelle et les donn茅es d'activit茅 physique. Cette approche vise 脿 r茅duire significativement les co没ts par rapport aux solutions existantes sur le march茅, en s'attaquant aux barri猫res d'acc猫s sur le march茅 des CGM estim茅 脿 28 milliards de dollars d'ici 2030.
Trinity Biotech (Nasdaq: TRIB) hat bahnbrechende Ergebnisse aus einer klinischen Studie f眉r seine n盲chste Generation der kontinuierlichen Glukose眉berwachungstechnologie, CGM+, bekanntgegeben. Die Studie zeigte, dass ihr neu gestalteter nadelfreier Glukosesensor 眉ber einen 15-t盲gigen Tragezeitraum genaue Messwerte liefern kann, ohne dass eine Fingerstich-Kalibrierung erforderlich ist.
Die innovative CGM+-Plattform des Unternehmens verf眉gt 眉ber ein modulares Design, das Einwegkomponenten reduziert und mehrere Gesundheitsmetriken integriert, darunter Herzaktivit盲t, K枚rpertemperatur und Daten zur k枚rperlichen Aktivit盲t. Dieser Ansatz zielt darauf ab, die Kosten im Vergleich zu bestehenden Marktl枚sungen deutlich zu senken und damit die Zugangsbarrieren im auf 28 Milliarden Dollar gesch盲tzten CGM-Markt bis 2030 anzugehen.
- Elimination of finger-stick calibration requirement over 15-day wear period
- Innovative modular design reduces disposable components and lowers costs
- Integration of multiple health metrics (glucose, cardiovascular, temperature, activity) in one device
- Successfully addressed major technical hurdle, aligning with market leaders' standards
- Targeting large market opportunity projected to reach $28B by 2030
- Product still in development phase, not yet commercialized
- Faces competition from established market leaders
- Regulatory approval still pending
Insights
Trinity Biotech's breakthrough CGM sensor eliminates finger-stick calibration, potentially disrupting market with lower-cost, integrated monitoring platform.
Trinity Biotech has achieved a critical technical milestone in the development of their next-generation CGM+ platform. Their clinical trial results demonstrate that their redesigned glucose sensor can operate for a full 15 days without requiring finger-stick calibration鈥攎eeting the standard set by market leaders but with a differentiated architecture.
The elimination of finger-stick calibration represents a significant user experience improvement, removing a pain point that has historically limited CGM adoption. More importantly, Trinity's approach incorporates a modular design that reduces disposable components, which directly addresses the cost barrier that has restricted CGM access.
What makes this development particularly noteworthy is the multi-parameter monitoring capability. Unlike conventional CGMs that track glucose alone, Trinity's platform integrates cardiovascular metrics, temperature, and activity monitoring in a single device. This multi-modal approach aligns with the industry's shift toward comprehensive health monitoring rather than isolated biomarker tracking.
From a technical perspective, this achievement de-risks their commercialization pathway by solving what the company described as their "most uncertain technical hurdle." The innovation appears to be in three key areas: physical sensor design modifications, enhanced signal processing algorithms, and proprietary operational improvements. Together, these enable reliable glucose readings without the calibration requirement that has complicated user experience with older-generation devices.
With the global CGM market projected to grow from
Clinical data confirms elimination of requirement for finger-stick calibration, de-risking pathway to commercialization for the company鈥檚 next-generation CGM+ biosensor platform
DUBLIN, Aug. 12, 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 compelling positive clinical trial results demonstrating a major technical breakthrough and de-risking the commercial pathway for its next-generation continuous glucose monitoring (CGM) technology, called CGM+. For the first time, trial data confirms that Trinity Biotech鈥檚 redesigned proprietary needle-free glucose sensor delivers accurate glucose readings across a full 15-day wear period without the need for finger-stick calibration, while also facilitating an innovative CGM design that reduces disposable components, significantly lowering the cost of care compared to current leading market products. As the high cost of existing CGM devices continues to hinder widespread adoption, Trinity Biotech鈥檚 innovative approach is designed to enhance accessibility and increase utilization of CGM technology.
鈥淭his milestone represents the most significant technical achievement since we began redevelopment of our acquired CGM technology,鈥� said John Gillard, CEO of Trinity Biotech. 鈥淭he elimination of the requirement for finger-stick calibration was achieved through a combination of sensor design modifications, refined signal processing, and proprietary enhancements to sensor operation. With this, we鈥檝e successfully addressed the most uncertain technical hurdle and brought our glucose sensor in line with the standards of market leaders 鈥� but critically with a highly differentiated product architecture that promises to be more affordable, reusable, and sustainable while also supporting the single device integration of heart activity, body temperature and physical activity data.鈥�
New Trial Data Confirms:
- No finger-stick calibration required over a 15-day sensor wear period.
- Enhanced user convenience, comfort, and reliability through proprietary glucose sensor improvements.
- Successful technical de-risking which increases confidence in next-gen product performance and regulatory pathway.
The clinical validation of the calibration-free sensor marks a critical step toward commercialization of Trinity Biotech鈥檚 next-generation CGM+ platform. The glucose sensor tested in this trial is integral to the Company鈥檚 modular CGM+ device, which is in the later stages of development, with a focus on scalability, cost-efficiency, and environmental impact 鈥� key factors that support broader market access and long-term adoption.
The global CGM market is projected to grow from approximately
Trinity Biotech鈥檚 CGM+ wearable biosensor designed to seamlessly integrate glucose, cardiovascular, temperature, and activity monitoring in one sleek modular device.
Forward-Looking Statements
This release includes statements that constitute 鈥渇orward-looking statements鈥� within the meaning of the Private Securities Litigation Reform Act of 1995 (the 鈥淩eform Act鈥�), including but not limited to statements related to Trinity Biotech鈥檚 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 鈥渕ay,鈥� 鈥渂elieves,鈥� 鈥減rojects,鈥� 鈥渆xpects,鈥� 鈥渁nticipates,鈥� 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鈥檚 distributors, losses or system failures with respect to Trinity Biotech鈥檚 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鈥檚 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鈥檚 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 鈥淩isk Factors鈥� in Trinity Biotech鈥檚 annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech鈥檚 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: .
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| Contact: | Trinity Biotech plc | RedChip Companies Inc. |
| 听 | Gary Keating, Ph.D (353)-1-2769800 | Dave Gentry, CEO (1)-407-644-4256 (1)-800-RED-CHIP (733-2447) [email protected]听 |
| 听 | 听 | 听 |
A photo accompanying this announcement is available at
FAQ
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