Trinity Biotech Provides an Update on the Continued Development of Its Continuous Glucose Monitor Technology
Trinity Biotech plc (Nasdaq: TRIB) has provided an update on its continuous glucose monitor (CGM) technology development. The company was granted a European patent (EP3703565) for a novel method enhancing indwelling sensor performance, particularly for glucose biosensors. Recent testing confirmed the effectiveness of this patented process in improving their glucose biosensor performance.
The innovative 'conditioning' process, housed within Trinity Biotech's reusable transmitter unit, significantly reduces the CGM's initial 'run-in' time, enabling quicker reliable measurements. It also improves the device's accuracy relative to laboratory reference methods and enhances the Mean Absolute Relative Difference (MARD). This advancement aims to create a more user-friendly, fully self-calibrating device, addressing the current need for periodic re-calibration using separate finger-stick blood glucose monitors.
Trinity Biotech plc (Nasdaq: TRIB) ha fornito un aggiornamento sullo sviluppo della sua tecnologia di monitoraggio della glicemia continuo (CGM). L'azienda ha ricevuto un brevetto europeo (EP3703565) per un metodo innovativo che migliora le prestazioni del sensore indossabile, in particolare per i biosensori della glicemia. I recenti test hanno confermato l'efficacia di questo processo brevettato nel migliorare le prestazioni del loro biosensore per la glicemia.
Il processo innovativo di 'condizionamento', racchiuso all'interno dell'unità di trasmettitore riutilizzabile di Trinity Biotech, riduce significativamente il 'tempo iniziale' di funzionamento del CGM, consentendo misurazioni affidabili più rapide. Inoltre, migliora l'accuratezza del dispositivo rispetto ai metodi di riferimento di laboratorio e aumenta la Differenza Media Assoluta Relativa (MARD). Questo progresso mira a creare un dispositivo più user-friendly e completamente auto-calibrato, rispondendo all'attuale necessità di ri-calibrazione periodica usando monitor della glicemia con pungidito separati.
Trinity Biotech plc (Nasdaq: TRIB) ha proporcionado una actualización sobre el desarrollo de su tecnología de monitorización continua de glucosa (CGM). La empresa ha obtenido una patente europea (EP3703565) para un método novedoso que mejora el rendimiento de los sensores de permanencia, en particular para los biosensores de glucosa. Las pruebas recientes han confirmado la efectividad de este proceso patentado en la mejora del rendimiento de sus biosensores de glucosa.
El innovador proceso de 'acondicionamiento', alojado en la unidad de transmisor reutilizable de Trinity Biotech, reduce significativamente el tiempo de 'arranque' inicial del CGM, permitiendo mediciones fiables más rápidas. También mejora la precisión del dispositivo en relación con los métodos de referencia de laboratorio y aumenta la Diferencia Media Absoluta Relativa (MARD). Este avance tiene como objetivo crear un dispositivo más fácil de usar, completamente autocalibrado, respondiendo a la necesidad actual de recalibraciones periódicas utilizando monitores de glucosa en sangre por punción.
Trinity Biotech plc (Nasdaq: TRIB)는 연속 혈당 모니터(CGM) 기술 개발에 대한 업데이트를 제공했습니다. 이 회사는 포도당 바이오센서를 포함한 체내 센서 성능을 향상시키는 새로운 방법에 대해 유럽 특허(EP3703565)를 받았습니다. 최근 테스트 결과, 이 특허받은 과정이 포도당 바이오센서의 성능을 개선하는 데 효과적이라는 것이 확인되었습니다.
Trinity Biotech의 재사용 가능한 송신기 유닛에 포함된 혁신적인 '조정' 프로세스는 CGM의 초기 '증착' 시간을 크게 줄여 보다 빠르고 신뢰할 수 있는 측정을 가능하게 합니다. 또한, 실험실 기준 방법에 비해 장치의 정확성을 향상시키고 평균 절대 상대 오차(MARD)를 개선합니다. 이 발전은 사용자가 보다 쉽게 사용할 수 있는 완전 자동 보정 장치를 개발하는 것을 목표로 하며, 별도의 손가락 혈당 모니터를 사용하여 주기적으로 재조정해야 하는 현재의 요구에 대응합니다.
Trinity Biotech plc (Nasdaq: TRIB) a fourni une mise à jour sur le développement de sa technologie de surveillance continue de la glycémie (CGM). La société a obtenu un brevet européen (EP3703565) pour une méthode novatrice améliorant les performances des capteurs implantés, en particulier pour les biosenseurs de glucose. Des tests récents ont confirmé l'efficacité de ce procédé breveté pour améliorer la performance de leurs biosenseurs de glucose.
Le processus innovant de 'conditionnement', intégré dans l'unité de transmetteur réutilisable de Trinity Biotech, réduit considérablement le temps de 'rodage' initial du CGM, permettant des mesures fiables plus rapides. Il améliore également la précision de l'appareil par rapport aux méthodes de référence de laboratoire et augmente la Différence Absolue Relative Moyenne (MARD). Cette avancée vise à créer un appareil plus convivial, entièrement autonoté, répondant au besoin actuel de recalibrations périodiques utilisant des moniteurs de glucose par piqûre.
Trinity Biotech plc (Nasdaq: TRIB) hat ein Update zur Entwicklung seiner kontinuierlichen Glukoseüberwachungstechnologie (CGM) bereitgestellt. Das Unternehmen erhielt ein europäisches Patent (EP3703565) für ein neuartiges Verfahren zur Verbesserung der Leistung von Implantatsensoren, insbesondere für Glukose-Biosensoren. Jüngste Tests bestätigten die Wirksamkeit dieses patentierten Verfahrens zur Verbesserung der Leistung ihrer Glukose-Biosensoren.
Der innovative 'Bedingungsprozess', der in der wiederverwendbaren Sendereinheit von Trinity Biotech untergebracht ist, reduziert die anfängliche 'Einfahrzeit' des CGM erheblich, was schnellere und zuverlässige Messungen ermöglicht. Außerdem verbessert er die Genauigkeit des Geräts im Vergleich zu Laborreferenzmethoden und erhöht die mittlere absolute relative Abweichung (MARD). Dieser Fortschritt zielt darauf ab, ein benutzerfreundlicheres, vollständig selbstkalibrierendes Gerät zu schaffen, das dem aktuellen Bedarf an periodischer Neukalibrierung mit separaten Fingerstech-Blutglukosemonitoren gerecht wird.
- Granted European patent (EP3703565) for novel method enhancing indwelling sensor performance
- Patented process confirmed effective in improving glucose biosensor performance
- Conditioning process significantly reduces CGM 'run-in' time, enabling quicker reliable measurements
- Improved accuracy relative to laboratory reference methods for blood glucose testing
- Enhanced Mean Absolute Relative Difference (MARD), the standard measure of CGM accuracy
- Current CGM technology requires periodic re-calibration using separate finger-stick blood glucose monitors
Trinity Biotech's patent for enhancing CGM performance marks a significant advancement in diabetes management technology. The patented process addresses two critical issues in CGM devices: the run-in period and accuracy. By reducing the settling time and improving the Mean Absolute Relative Difference (MARD), this technology could potentially increase user adoption and improve patient outcomes.
The move towards a self-calibrating device aligns with market trends, potentially positioning Trinity Biotech more competitively. However, it's important to note that pre-pivotal trials are still pending and success in these trials will be pivotal for market entry. The company's focus on affordability and sustainability through a self-inserted biosensor wire could be a unique selling point in the growing CGM market, but execution and regulatory approval will be key factors to watch.
The CGM market is experiencing rapid growth, with a projected CAGR of
However, Trinity Biotech faces stiff competition from established players like Dexcom and Abbott. The success of their technology will depend on how it performs in clinical trials and its ability to obtain regulatory approvals. The elimination of finger-stick calibration could be a game-changer, but the company needs to demonstrate consistent accuracy and reliability to gain market share. Investors should monitor the progress of pre-pivotal trials and subsequent regulatory submissions as key milestones for assessing the company's market potential.
DUBLIN, Ireland, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today provided an update on the continued development of its glucose biosensor technology. Earlier this year Trinity Biotech was granted a European patent (EP3703565) for a novel method that enhances the performance of an indwelling sensor, such as a glucose biosensor. Recent testing of this patented process has confirmed its effectiveness in improving the performance of Trinity Biotech’s glucose biosensor. Trinity Biotech intends to use this breakthrough process to stabilise and improve the functionality of the glucose biosensor in its next generation continuous glucose monitor (CGM) technology.
CGMs are small patch-like wearable medical devices that use biosensor wires under the skin to measure glucose in real-time. These devices are increasingly popular in diabetes management and health monitoring.
Patent EP3703565 describes an innovative process, within Trinity Biotech’s reusable transmitter unit, that “conditions” the CGM biosensor wire. Typically, CGM devices experience a “run-in” or “settling” period immediately following insertion during which glucose readings are unreliable. The conditioning process significantly reduces this run-in time, enabling reliable measurements more quickly. In addition, this conditioning process has demonstrated notable improvements in the accuracy of the device relative to laboratory reference methods for blood glucose testing and improve the biosensor’s Mean Absolute Relative Difference (MARD), the standard measure of accuracy used to compare CGM devices.
Trinity Biotech’s Chief Technology Officer, Dr Gary Keating, said: “The technology covered by this patent represents a major advancement for our CGM platform. The CGM technology we acquired in January already offers strong advantages in terms of affordability and sustainability, thanks to its unique self-inserted biosensor wire. However, in advance of the acquisition, we recognised that the requirement for users to periodically re-calibrate the device using a separate finger-stick blood glucose monitor was not in line with the market leading solutions and was a barrier to broader adoption. We believed that this patented conditioning process would likely play an important role in further enhancing the technology towards a more user-friendly, fully self-calibrating, device. Our post-acquisition testing of this conditioning process has confirmed its effectiveness and – together with other refinements to the biosensor wire design – will be further evaluated in upcoming pre-pivotal trials to create an optimized CGM that can be rapidly introduced into global markets.”
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 characterised 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 our purchase of the assets of Waveform, 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, 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 human diagnostics and diabetes management solutions, 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 | LifeSci Partners, LLC |
| Gary Keating, Ph.D. | Eric Ribner |
| (353)-1-2769800 | (1)-646-751-4363 |
| investorrelations@trinitybiotech.com | |
| RedChip Companies Inc. | |
| Dave Gentry, CEO | |
| (1)-407-644-4256 | |
| TRIB@redchip.com |
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