Trinity Biotech Plc - TRIB STOCK NEWS

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.

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) has amended agreements with Perceptive Advisors, securing additional liquidity of approximately $5.5 million through cash and payment-in-kind interest. The company also extended a $5 million deferred payment for the Waveform Technologies biosensor assets to November 2025.

As part of the agreement, Trinity granted Perceptive 1.5 million additional ADS warrants and repriced existing warrants to $0.80 per ADS. The company recently received WHO approval for transferring late-stage manufacturing of TrinScreen HIV and Uni-Gold HIV to a lower-cost offshore manufacturer, advancing its Comprehensive Transformation Plan focused on achieving long-term profitability through operational efficiency.

Trinity Biotech (TRIB) has received early approval from the World Health Organization (WHO) to transfer the manufacturing of TrinScreen HIV and Uni-Gold HIV tests to a lower-cost offshore facility. This approval is a key milestone in the company's Comprehensive Transformation Plan, enabling the later-stage manufacturing processes of both rapid HIV tests at an outsourced provider. The company plans to begin manufacturing at the new location in Q1 2025, a move expected to improve margins and enhance shareholder value.

Trinity Biotech (TRIB) reported Q3 2024 total revenue of $15.2 million, up 3% year-over-year, driven by strong Point-of-Care product revenue growth of 60% Y/Y to $4.3 million. The company's operating loss improved by 51% to $2.2 million from $4.5 million in Q3 2023. TrinScreen HIV sales reached $2.4 million in Q3. The company reiterates guidance to achieve approximately $20 million of annualized run-rate EBITDASO on revenues of $75 million by Q2 2025. Trinity completed two strategic acquisitions in lab-based diagnostics and continues progress on its CGM development. Cash balance decreased to $2.8 million at quarter-end.

Trinity Biotech (Nasdaq: TRIB), a commercial stage biotechnology company specializing in diabetes management solutions and human diagnostics, will announce its Q3 2024 financial results on Friday, November 15, 2024. The company will host a conference call at 10:00 AM ET. Trinity Biotech focuses on developing diagnostic systems and has recently entered the wearable biosensor industry through the acquisition of Waveform Technologies Inc.'s biosensor assets. The company sells directly in the US, Germany, France, and the UK, while maintaining distribution partnerships across 75 countries worldwide.

Trinity Biotech (Nasdaq: TRIB) has successfully regained compliance with Nasdaq's minimum market value of publicly held shares (MVPHS) requirement. The company received confirmation from Nasdaq on November 6, 2024, following a previous deficiency notice received on November 21, 2023, when its MVPHS fell below the required $15 million threshold. After presenting its compliance plan to the Nasdaq Hearings Panel on July 16, 2024, Trinity was granted an extension until October 31, 2024. The company has now met the requirement, ensuring continued listing on the Nasdaq Global Select Market.

Trinity Biotech (TRIB) has announced a strategic investment in Novus Diagnostics, acquiring a 12.5% equity stake valued at $2.5 million through the issuance of 1.4 million ADS. The investment aims to accelerate the development of Novus' rapid sepsis testing platform, which promises 15-minute bloodstream infection test results. Current sepsis testing methods take days, while this point-of-care solution could transform diagnosis and treatment of a condition that affects 1.7 million people and causes 350,000 deaths annually in the U.S. The investment values Novus at $20 million post-investment.

Trinity Biotech (TRIB) has acquired EpiCapture , marking its entry into oncology diagnostics. The acquisition, valued at approximately $3 million plus $0.5 million in milestone-based payments, was paid through 1.7 million ADS issuance. EpiCapture develops a non-invasive urine-based test for monitoring aggressive prostate cancer progression, potentially reducing the need for invasive biopsies. The test, when combined with PSA testing, has shown promising results in clinical studies. Trinity Biotech plans to leverage its manufacturing expertise and certified laboratory to commercialize the test in the US and explore additional markets.