Trinity Biotech plc TRIB has completed its first pre-pivotal clinical trial in Europe for its next-generation continuous glucose monitor (CGM). This trial assessed the effectiveness of significant technology enhancements since acquiring the CGM from Waveform Technologies in January 2024. The results confirm the progress in improving performance, usability and cost-efficiency, positioning Trinity Biotech for further advancements.
CGMs are wearable devices that track real-time glucose levels using biosensors under the skin. The trial results showed that the refined sensor achieved a mean absolute relative difference (MARD) that significantly improved upon the performance of the previous Waveform device.
Likely Trend of TRIB Stock Following the News
Following the news, shares of TRIB rose 13.3% to $1.36 at yesterday’s closing.
Shares of Trinity Biotech have plunged 36.6% year to date against the industry’s 11.7% growth. The S&P 500 has risen 20.8% in the same time frame.
Trinity Biotech's recent announcement of positive pre-pivotal clinical trial results for its next-generation CGM signals a strong development milestone. This progress in the wearable biosensor space is expected to generate positive investor sentiment, showcasing the company's potential to expand its market presence in diabetes management.
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Impact of TRIB’s Positive Pre-Pivotal Clinical Trial for Next-Gen CGM
Trinity Biotech developed a research and development plan to enhance the performance and usability of its CE-marked, 15-day wear CGM device. Key design modifications, including a reduction in biosensor wire length and enhanced in-body performance, were validated in the study.
With the CGM market projected to exceed $20 billion by 2029, driven by the rising prevalence of diabetes and demand for reliable, user-friendly glucose monitoring solutions, Trinity Biotech is well-positioned to capture significant market share. Its next-generation CGM technology is expected to provide an affordable, factory-calibrated solution designed for ease of use and sustainability.
The trial’s positive outcome paves the way for further optimizations and a pivotal trial in 2025, bringing the company closer to delivering an affordable, sustainable solution for diabetes management. TRIB will conduct another pre-pivotal clinical trial with the next phase of refinements based on data from the recently completed trial prior to starting the pivotal trial.
Market Prospects Favoring TRIB
Per a report in Precedence Research, the global digital diabetes management market size is estimated to be worth $31.9 billion in 2024. It is anticipated to reach $171.6 billion by 2034 at a CAGR of 18.3%.
The robust growth is likely to be driven by the major industry leaders operating in digital diabetes management, focusing on providing innovative products and introducing advanced technologies in this market.
Recent Development at Trinity Biotech
Last month, Trinity Biotech signed a non-binding Letter of Intent with Bayer to launch its CGM device in China and India. As part of this effort, Trinity Biotech is conducting an in-country study in India to gather feedback from diabetes patients and healthcare professionals. This study will help refine the CGM design for its upcoming launch in India.
Favorable Earnings Surprise Trend for TRIB
Trinity Biotech has an estimated long-term growth rate of 20%. TRIB’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 15.38%.
Zacks Rank & Other Key Picks
Currently, Trinity Biotech sports a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks in the broader medical space are Rockwell Medical RMTI, Tenet HealthCare (THC) and Aveanna Healthcare AVAH. While Rockwell Medical carries a Zacks Rank #1, Tenet HealthCare and Aveanna Healthcare carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Rockwell Medical earnings surpassed estimates in each of the trailing four quarters, with the average being 87.9%.
RMTI’s shares have gained 93.1% compared with the industry's 11.7% growth year to date.
Tenet HealthCare has an estimated long-term growth rate of 18.3%. THC's earnings surpassed estimates in each of the trailing four quarters, with the average being 58.5%.
Tenet HealthCare has gained 102.2% compared with the industry's 42.6% growth year to date.
Aveanna Healthcare's earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 47.5%.
AVAH's shares have gained 57.5% year to date compared with the industry’s 16.9% growth.
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