Trinity Biotech Reports Landmark First-Day Accuracy Gains in CGM Pre-Pivotal Trial

Rhea-AI Summary

Trinity Biotech (TRIB) announced significant improvements in its next-generation continuous glucose monitoring (CGM) system from its latest pre-pivotal trial. The trial, involving 30 diabetic participants over a 15-day period, demonstrated a 35% improvement in Mean Absolute Relative Difference (MARD) and over 50% improvement in Mean Absolute Difference (MAD) during the critical first-day performance compared to the previous Waveform product.

Key achievements include superior signal quality, enhanced post-insertion reliability, and a 25-30% overall improvement in MARD over earlier Waveform CGM sensors. The company's redesigned ergonomic modular CGM system focuses on affordability and sustainability with reusable and rechargeable components.

Trinity Biotech plans regulatory submissions in Europe in 2025 and FDA filing in 2026. Additional pre-pivotal clinical trials on device enhancements are scheduled to begin in Q1 2025. The global CGM market is projected to exceed $20 billion by 2029.

Positive

• 35% improvement in first-day MARD accuracy
• 50% improvement in first-day MAD accuracy
• 25-30% overall improvement in MARD compared to previous sensors
• Low-glucose precision now aligned with industry benchmarks
• Reusable and rechargeable components design to reduce user costs

Negative

• Regulatory approvals still pending (Europe 2025, US 2026)
• Additional pre-pivotal trials needed before commercialization

Insights

Medical Device Analyst

The latest pre-pivotal trial results from Trinity Biotech represent a significant technological breakthrough in the CGM space, particularly addressing the critical "first-day problem" that has long plagued the industry. The 35% improvement in MARD and 50% improvement in MAD during the first 24 hours of wear are remarkable achievements that could potentially disrupt the current CGM market dynamics.

The technical improvements are particularly noteworthy in three key areas: First, the enhanced first-day accuracy directly addresses a major user pain point and safety concern, potentially reducing the risk of incorrect dosing decisions during the important initial wear period. Second, the alignment with industry benchmarks for low-glucose precision is important for hypoglycemia management, a critical safety feature for Type 1 diabetics. Third, the modular, reusable design could significantly reduce the total cost of ownership, potentially expanding market access.

From a market perspective, Trinity's timing is strategic. With the CGM market projected to reach $20 billion by 2029, there's significant opportunity for new entrants with differentiated technology. The focus on affordability and sustainability through reusable components could capture market share in both established markets and underserved populations, particularly in price-sensitive regions.

However, the regulatory timeline (EU submission in 2025, FDA in 2026) suggests revenue impact won't materialize until late 2026 or 2027. The planned additional pre-pivotal trials in Q1 2025 indicate potential further improvements but also suggest the final product specifications aren't yet locked. This methodical approach, while prudent, gives competitors time to advance their own technologies.

Market Research Analyst

Trinity Biotech's strategic positioning in the CGM market demonstrates sophisticated market understanding. The focus on both technical excellence and accessibility addresses a critical market gap - while current CGM leaders have achieved remarkable accuracy, their solutions remain prohibitively expensive for many potential users.

The reusable, modular design represents a paradigm shift in the CGM business model. Current market leaders operate on a razor-and-blades model with disposable sensors, whereas Trinity's approach could significantly reduce recurring costs. This could be particularly disruptive in markets where insurance coverage for CGM devices is

The market opportunity extends beyond traditional diabetes management. The emphasis on sustainability and affordability, combined with strong accuracy metrics, positions Trinity to potentially capture share in the growing wellness and preventive health segments. The $20 billion market projection by 2029 likely understates the total addressable market when considering these expanded use cases.

However, market penetration will face significant challenges. Established players have strong relationships with healthcare providers, insurance companies and extensive support infrastructure. Trinity will need to demonstrate not just technical superiority but also build trust and support systems to facilitate adoption. The regulatory timeline suggests a methodical approach to market entry, which could help build credibility but may also allow competitors to strengthen their market positions.

Trinity Biotech’s patented technology represents a paradigm shift in the global CGM market, projected to exceed $20 billion by 2029

DUBLIN, Feb. 06, 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 new findings from its latest pre-pivotal trial, highlighting significant improvements in first-day performance for its next-generation continuous glucose monitoring (CGM) system.

The latest analysis confirms that first-day accuracy - a critical performance metric for CGM users - shows an approximately 35% improvement in Mean Absolute Relative Difference (MARD) and a more than 50% improvement in Mean Absolute Difference (MAD) with Trinity Biotech’s redesigned CGM sensor compared to the previously marketed Waveform product. The first 24 hours of CGM wear have been a persistent weak spot across the industry, with sensor accuracy often fluctuating due to the body’s natural response to insertion. These advancements promise to address a key pain point for users, as inconsistent glucose readings on the first day of wear have historically led to user frustration and safety concerns.

Builds On Other Breakthrough Results from Latest Pre-Pivotal Trial

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. As previously reported, the trial evaluated modifications made by Trinity’s R&D team to technology acquired from Waveform Technologies, Inc. that enhance sensor design and performance, which in addition the significant first-day performance improvement, also yielded the following 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.

Revolutionizing CGM Accessibility and Performance
Trinity Biotech’s redesigned ergonomic modular CGM system is designed with affordability, accuracy, and sustainability in mind. The device’s reusable and rechargeable components are designed to reduce costs for users while minimizing environmental impact. The Trinity CGM represents a paradigm shift in the market, and promises to make continuous glucose monitoring more accessible to millions of individuals who have previously been unable to afford it.

Next Steps: Advancing Toward Commercialization
These latest findings reinforce Trinity’s confidence in delivering a high-performance, calibration-free CGM system that meets the FDA’s iCGM standards. The Company remains on track for regulatory submissions in Europe in 2025, followed by a U.S. FDA filing in 2026, with commercialization efforts targeting both diabetes patients and broader health-conscious consumers. Building on the success of its latest trial, Trinity now plans to begin further pre-pivotal clinical trials in Q1 2025 on additional device enhancements.

To stay updated on Trinity Biotech’s CGM developments, visit 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, 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’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 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
				(1)-646-751-4363
				investorrelations@trinitybiotech.com

FAQ

What accuracy improvements did TRIB's new CGM system show in the pre-pivotal trial?

Trinity Biotech's CGM system showed a 35% improvement in Mean Absolute Relative Difference (MARD) and over 50% improvement in Mean Absolute Difference (MAD) during first-day performance compared to the previous Waveform product.

When will TRIB submit its CGM system for regulatory approval?

Trinity Biotech plans to submit for European regulatory approval in 2025, followed by FDA filing in 2026.

How many participants were involved in TRIB's latest CGM pre-pivotal trial?

The pre-pivotal trial involved 30 diabetic participants, primarily with Type 1 diabetes, who wore multiple sensors over a 15-day period.

What are the key features of TRIB's new CGM system design?

The system features a redesigned ergonomic modular design with reusable and rechargeable components, focused on affordability and sustainability while minimizing environmental impact.

What is the projected size of the global CGM market that TRIB is targeting?

The global CGM market is projected to exceed $20 billion by 2029.