Trinity Biotech to Begin European Pre-Pivotal Trial to Optimize its CGM Sensor
Trinity Biotech (Nasdaq: TRIB) has received regulatory approval to begin its European pre-pivotal trial for its next-generation continuous glucose monitoring (CGM) system. The trial aims to optimize device performance ahead of a pivotal trial scheduled for 2025. The pre-pivotal trial, set to start imminently and expected to conclude by the end of July, will evaluate the analytical performance of the CGM technology enhancements made by Trinity Biotech following its acquisition earlier this year. The collected data will be used to refine the device further. John Gillard, President and CEO, emphasized the importance of the CGM solution and AI-driven analytics as long-term growth drivers for the company.
- Regulatory approval received for European pre-pivotal trial.
- Pre-pivotal trial aims to optimize next-gen CGM technology.
- Trial to be completed by end of July.
- Plans for a pivotal trial in 2025.
- Focus on AI-driven health and wellness analytics as growth drivers.
- Potential delays and risks associated with clinical trials.
- Upcoming pivotal trial in 2025 could face regulatory hurdles.
- Uncertainty about the market launch timeline.
Insights
The commencement of a pre-pivotal trial for Trinity Biotech's Continuous Glucose Monitoring (CGM) system is a significant development. CGM devices are critical for diabetes management as they provide real-time glucose readings, enabling better blood sugar control. The European regulatory approval indicates confidence in the device's safety and potential efficacy, setting a solid foundation for the pivotal trial planned in 2025.
From a clinical standpoint, the pre-pivotal trial will scrutinize the analytical performance of the CGM enhancements. This means evaluating the precision and accuracy of glucose measurements, which are vital for patient trust and compliance. If the trial demonstrates superior performance compared to existing CGMs, it could position Trinity Biotech as a formidable player in the diabetes care market.
However, it is essential to note that the technology must still pass the more extensive pivotal trial before market launch. Investors should be mindful of the inherent risks and uncertainties at this stage.
From a financial perspective, Trinity Biotech's initiation of the European pre-pivotal trial is a forward-looking move. Successful trials can lead to new revenue streams, particularly in the lucrative diabetes management market. Europe represents a significant market and regulatory approval for trials there is a positive indicator for potential expansion.
Investors should watch for the completion of this trial by the end of July, as positive results could serve as a robust catalyst for share price appreciation. However, it's important to consider the overall landscape. The pivotal trial in 2025 will be the ultimate determinant of market entry, which includes navigating regulatory landscapes and achieving strong clinical endpoints.
Additionally, while the short-term outlook is promising, investors should ponder the long-term potential. If the CGM technology is successfully optimized and commercialized, it could significantly bolster Trinity Biotech’s revenue growth and profitability. A close eye should be kept on R&D expenses and funding sources to ensure financial health is maintained during this development phase.
The diabetes management market is highly competitive, with established players like Dexcom and Abbott dominating the CGM sector. Trinity Biotech’s move to begin a pre-pivotal trial in Europe signals their ambition to carve out a niche in this space. Market differentiation will be crucial; thus, focusing on the enhancements and AI-driven health analytics could offer a unique selling proposition.
Investors should consider the broader market trends. There is a growing demand for advanced, user-friendly and accurate CGM devices due to rising diabetes prevalence. If Trinity Biotech can demonstrate that their next-generation CGM device meets these needs effectively, it could capture substantial market share.
However, market entry comes with challenges, including potential delays in regulatory approvals and the need for a strong marketing strategy to compete with well-entrenched competitors. Continuous monitoring of competitive actions and technological advancements in the market is advised.
DUBLIN, June 24, 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 announced steps to advance its next generation continuous glucose monitoring (“CGM”) solution towards market launch. Since acquiring the CGM technology earlier in the year, Trinity Biotech has been working on further innovations and improvements to the original device. The Company has now received regulatory approval to conduct its initial European pre-pivotal trial that will inform the larger pivotal trial that will be required for product registration and launch.
This pre-pivotal trial will begin imminently and is expected to be completed by the end of July. The study will assess the analytical performance of CGM technology enhancements implemented by Trinity Biotech. The data from this analytical performance assessment will be utilised to advance the technical optimization of the next generation CGM device ahead of the pivotal trial that is planned in 2025.
Trinity Biotech President and Chief Executive Officer, Mr John Gillard stated “We believe our CGM solution and AI-driven health and wellness analytics technology are key long-term growth drivers for Trinity Biotech. As such, we are pleased to have received regulatory approval to conduct our initial European pre-pivotal trial which is the next step in advancing the technical optimisation of our continuous glucose monitoring technology.”
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, Germany, France and the U.K. 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.
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.
| Contact: | Trinity Biotech plc | LifeSci Partners, LLC |
| Gary Keating, Ph.D. | Eric Ribner | |
| (353)-1-2769800 | (1)-646-751-4363 | |
| E-mail: investorrelations@trinitybiotech.com |
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