Trinity Biotech Announces Breakthrough Results From Pre-Pivotal Trial of Disruptive Continuous Glucose Monitoring (CGM) Technology
Trinity Biotech (TRIB) has announced significant results from its pre-pivotal trial for its next-generation continuous glucose monitoring (CGM) system. The trial, involving 30 diabetic participants over a 15-day period, demonstrated notable improvements including a 25-30% enhancement in accuracy metrics (MARD) compared to previous Waveform CGM sensors.
The company's innovative CGM features a reusable applicator and rechargeable transmitter, designed to reduce costs significantly compared to current market leaders. The system showed superior signal quality, enhanced post-insertion reliability, and industry-standard low-glucose precision.
Trinity aims to target the global CGM market, projected to exceed $20 billion by 2029. The company plans to file for EU regulatory approval in 2025 and FDA approval in 2026. Currently, the two largest CGM manufacturers serve only 10 million users out of 800 million people living with diabetes worldwide, primarily due to cost barriers.
Trinity Biotech (TRIB) ha annunciato risultati significativi dal suo trial pre-pivotal per il suo sistema di monitoraggio continuo della glicemia (CGM) di nuova generazione. Il trial, che ha coinvolto 30 partecipanti diabetici per un periodo di 15 giorni, ha dimostrato notevoli miglioramenti, inclusi un aumento del 25-30% nei parametri di accuratezza (MARD) rispetto ai precedenti sensori CGM Waveform.
Il CGM innovativo dell'azienda presenta un applicatore riutilizzabile e un trasmettitore ricaricabile, progettati per ridurre significativamente i costi rispetto agli attuali leader di mercato. Il sistema ha mostrato una qualità del segnale superiore, una maggiore affidabilità post-inserzione e una precisione nei livelli di glucosio bassa conforme agli standard di settore.
Trinity punta a rivolgersi al mercato globale del CGM, previsto per superare $20 miliardi entro il 2029. L'azienda prevede di presentare domanda per l'approvazione normativa nell'UE nel 2025 e per l'approvazione della FDA nel 2026. Attualmente, i due maggiori produttori di CGM servono solo 10 milioni di utenti su 800 milioni di persone che vivono con il diabete in tutto il mondo, principalmente a causa di barriere di costo.
Trinity Biotech (TRIB) ha anunciado resultados significativos de su ensayo pre-pivotal para su sistema de monitoreo continuo de glucosa (CGM) de próxima generación. El ensayo, que involucró a 30 participantes diabéticos durante un período de 15 días, demostró mejoras notables, incluido un aumento del 25-30% en las métricas de precisión (MARD) en comparación con los sensores CGM Waveform anteriores.
El innovador CGM de la empresa cuenta con un aplicador reutilizable y un transmisor recargable, diseñado para reducir significativamente los costos en comparación con los actuales líderes del mercado. El sistema mostró una calidad de señal superior, una mejor confiabilidad posterior a la inserción y una precisión baja de glucosa conforme a los estándares de la industria.
Trinity tiene como objetivo dirigirse al mercado global de CGM, que se proyecta que superará $20 mil millones para 2029. La empresa planea presentar una solicitud para la aprobación regulatoria de la UE en 2025 y para la aprobación de la FDA en 2026. Actualmente, los dos principales fabricantes de CGM sirven solo a 10 millones de usuarios de un total de 800 millones de personas que viven con diabetes en todo el mundo, principalmente debido a barreras de costos.
트리니티 바이오텍 (TRIB)이 차세대 연속 혈당 모니터링(CGM) 시스템에 대한 주요한 결과를 사전 시험에서 발표했습니다. 이 시험은 15일 동안 30명의 당뇨병 환자를 대상으로 하였으며, 기존의 웨이브폼 CGM 센서에 비해 정확도 지표(MARD)가 25-30% 향상되는 등의 주목할 만한 개선을 보여주었습니다.
회사의 혁신적인 CGM은 재사용 가능한 어플리케이터와 충전형 송신기를 갖추고 있어 현재 시장의 선두 제품들보다 비용을 크게 줄이는 데 도움이 됩니다. 이 시스템은 우수한 신호 품질, 삽입 후 신뢰성 향상 및 산업 표준에 맞는 저혈당 정밀성을 보여주었습니다.
트리니티는 2029년까지 200억 달러 이상에 이를 것으로 예상되는 글로벌 CGM 시장을 목표로 하고 있습니다. 회사는 2025년 EU 규제 승인을, 2026년에는 FDA 승인을 신청할 계획입니다. 현재 두 개의 주요 CGM 제조업체가 전 세계 8억 당뇨병 환자 중 단 1천만 명의 사용자만을 지원하고 있으며, 이는 주로 비용 장벽 때문입니다.
Trinity Biotech (TRIB) a annoncé des résultats significatifs de son essai pré-pivot pour son système de surveillance continue de la glycémie (CGM) de nouvelle génération. L'essai, qui a impliqué 30 participants diabétiques sur une période de 15 jours, a démontré des améliorations notables, y compris une augmentation de 25 à 30 % des métriques de précision (MARD) par rapport aux capteurs CGM Waveform précédents.
Le CGM innovant de l'entreprise présente un applicateur réutilisable et un émetteur rechargeable, conçu pour réduire considérablement les coûts par rapport aux leaders actuels du marché. Le système a montré une qualité de signal supérieure, une fiabilité améliorée après insertion et une précision des faibles niveaux de glucose conforme aux normes de l'industrie.
Trinity vise à cibler le marché mondial du CGM, qui devrait dépasser 20 milliards de dollars d'ici 2029. L'entreprise prévoit de demander l'approbation réglementaire de l'UE en 2025 et l'approbation de la FDA en 2026. Actuellement, les deux plus grands fabricants de CGM ne servent que 10 millions d'utilisateurs sur 800 millions de personnes vivant avec le diabète dans le monde, principalement en raison des barrières de coût.
Trinity Biotech (TRIB) hat bedeutende Ergebnisse aus seiner prä-pivotalen Studie für sein neues kontinuierliches Glukoseüberwachungssystem (CGM) bekannt gegeben. Die Studie, an der 30 diabetische Teilnehmer über einen Zeitraum von 15 Tagen beteiligt waren, zeigte bemerkenswerte Verbesserungen, darunter eine 25-30%ige Steigerung der Genauigkeitsmetriken (MARD) im Vergleich zu früheren Waveform-CGM-Sensoren.
Das innovative CGM des Unternehmens verfügt über einen wiederverwendbaren Applikator und einen wiederaufladbaren Sender, der darauf ausgelegt ist, die Kosten im Vergleich zu den derzeitigen Marktführern erheblich zu senken. Das System zeigte eine überlegene Signalqualität, verbesserte Zuverlässigkeit nach dem Einsetzen und eine branchenübliche Präzision bei niedrigen Glukosespiegeln.
Trinity zielt darauf ab, den globalen CGM-Markt zu bedienen, dessen Gesamtvolumen bis 2029 voraussichtlich 20 Milliarden Dollar übersteigen wird. Das Unternehmen plant, 2025 einen Antrag auf Genehmigung in der EU und 2026 bei der FDA einzureichen. Derzeit bedienen die beiden größten CGM-Hersteller nur 10 Millionen Nutzer von 800 Millionen Diabetikern weltweit, hauptsächlich aufgrund von Kostenbarrieren.
- 25-30% improvement in accuracy metrics (MARD) over previous sensors
- Cost-reducing design with reusable components
- Achieved industry-standard precision for low blood sugar readings
- Clear regulatory timeline: EU approval filing in 2025, FDA in 2026
- Targeting underserved market of 800 million diabetics worldwide
- Commercial launch still years away (2025-2026)
- Will face competition from established market leaders with $11B annual sales
- Requires regulatory approvals in both EU and US markets
Insights
The pre-pivotal trial results from Trinity Biotech's CGM system represent a potential disruption in the $20 billion CGM market. The 25-30% improvement in Mean Absolute Relative Difference (MARD) is particularly noteworthy, as MARD is the gold standard for CGM accuracy. The alignment with industry benchmarks for low glucose precision (MAD) addresses a critical safety concern for Type 1 diabetes patients.
The innovative modular design with reusable components targets a significant market inefficiency. Current CGM leaders Dexcom and Abbott serve only 10 million users out of 800 million people with diabetes globally, primarily due to cost barriers. Trinity's approach could substantially reduce both unit costs and environmental impact through its reusable applicator and transmitter design.
Key market implications include:
- Potential for significant market expansion in price-sensitive regions, particularly emerging markets
- Reduced environmental impact through reusable components could appeal to environmentally conscious consumers and healthcare systems
- Meeting iCGM standards would enable integration with insulin pumps, opening additional revenue streams
The regulatory timeline appears achievable given the strong pre-pivotal data. However, success will depend on maintaining these performance metrics in larger pivotal trials and navigating the complex regulatory landscape for integrated diabetes management systems.
Trinity Biotech's market positioning represents a calculated disruption of the duopolistic CGM market. Current market leaders have built their business models on high-margin disposable components, creating a significant barrier to adoption. Trinity's reusable design could fundamentally alter market dynamics.
Market opportunity analysis:
- Current CGM penetration is just 1.25% of the global diabetes population
- The CGM market's projected growth to $20 billion by 2029 could be conservative if cost barriers are removed
- Emerging markets represent a vast untapped opportunity, particularly in regions with rising diabetes prevalence
The company's focus on affordability while maintaining performance standards could trigger a market-wide shift toward more cost-effective solutions. This could pressure incumbent manufacturers to adapt their pricing strategies or risk losing market share in price-sensitive segments.
Trinity Biotech’s patented technology represents a paradigm shift in the global CGM market, projected to exceed
DUBLIN, Ireland, Jan. 28, 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 results from its latest pre-pivotal clinical trial for its next-generation continuous glucose monitoring (CGM) system. The pre-pivotal clinical trial, which included 30 diabetic participants—primarily individuals with Type 1 diabetes—represents a significant milestone in Trinity's mission to deliver affordable, high-performance CGM technology.
Trinity Biotech’s redesigned ergonomic modular device features a reusable applicator and a rechargeable wearable transmitter that eliminates costly disposable components while delivering a seamless user experience. By using more durable, reusable components, enabled by Trinity’s proprietary self-inserting sensor technology, the Trinity CGM is designed to deliver care at a significantly lower cost than today’s two largest manufacturers. By addressing affordability—a key barrier to adoption of this life changing technology —Trinity’s innovative approach has the potential to bring CGM technology to millions of individuals who have been priced out of the market. This disruptive design not only expands access but also redefines sustainability in the CGM space, further differentiating Trinity’s solution from current market leaders.
“We believe that our patented technology—featuring a modular, eco-friendly design and cutting-edge sensor performance—represents a paradigm shift in the CGM market, which is projected to exceed
Study Results Underscore Breakthrough Performance
Trinity Biotech’s latest pre-pivotal trial involved 30 diabetic participants, primarily individuals with Type 1 diabetes, each of whom wore multiple sensors over a 15-day period. The trial evaluated modifications made by Trinity’s R&D team to technology acquired from Waveform Technologies, Inc. that enhance sensor design and performance, yielding exceptional results:
- Superior Signal Quality: Significant improvements in signal clarity compared to previously released Waveform CGM sensors.
- Enhanced Reliability Post-Insertion: Sensor performance immediately after placement demonstrated markedly improved consistency, reducing variability for users.
- Breakthrough Accuracy: A 25
-30% improvement in the key accuracy metric—mean absolute relative difference (MARD)—over earlier Waveform CGM sensors. - Industry-Standard Low-Glucose Precision: Accuracy for low blood sugar readings (measured by mean absolute difference, or MAD) is now aligned with industry benchmarks, a critical achievement for hypoglycemia management.
Next Steps: Advancing Toward Commercialization
These results significantly bolster confidence in Trinity’s ability to deliver a calibration-free CGM system that meets FDA’s iCGM standard, enabling seamless integration with insulin pumps. Building on this success, Trinity expects to complete further clinical trials on additional device enhancements and remains on track to file for regulatory approval in the European Union in 2025, followed by filing for U.S. FDA approval in 2026, setting the stage for commercial rollouts targeting both diabetes patients and the broader market of individuals seeking real-time glucose insights.
To keep up to date with Trinity Biotech’s CGM developments please visit our dedicated CGM microsite - https://cgm.trinitybiotech.com
Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s 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 “may,” “believes,” “projects,” “expects,” “anticipates,” 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, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s 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’s products and services, the continuing development of its products, required government approvals, continuing international government financial support for healthcare programs, 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’s 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 “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2023 and Trinity Biotech’s 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: www.trinitybiotech.com.
| Contact: | Trinity Biotech plc | RedChip Companies Inc. | ||
| Gary Keating, Ph.D | Dave Gentry, CEO | |||
| (353)-1-2769800 | (1)-407-644-4256 | |||
| (1)-800-RED-CHIP (733-2447) | ||||
| TRIB@redchip.com | ||||
| LifeSci Partners, LLC | ||||
| Eric Ribner | ||||
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| investorrelations@trinitybiotech.com |
FAQ
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