Mainz Biomed Publishes CEO Statement; CEO Guido Baechler Eyes Major Growth and U.S. FDA Trials in 2025

Core Insights - Mainz Biomed is focused on maximizing shareholder value through strategic plans, clinical developments, and an upcoming FDA trial anticipated for 2025, which is expected to facilitate entry into the U.S. market [1][2] - The company believes that 2025 will be a transformative year, positioning it for substantial growth in global markets, particularly through innovative diagnostic solutions [2] Corporate Flagship Product - Mainz Biomed's mRNA-based next-generation colorectal cancer (CRC) screening test has shown significant clinical success, with sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas [3] - The test targets early detection of colorectal cancer and precancerous lesions, which is crucial for timely intervention and cancer prevention [3] Clinical Development and FDA Trials - The company plans to submit a comprehensive dataset for FDA approval in 2025, following a strategic decision to withdraw its Breakthrough Device Designation application to focus on expanding its clinical research program [5][6] - Positive data from clinical feasibility studies presented at major conferences provide a strong foundation for the upcoming FDA trials, which represent a key milestone for U.S. market penetration [6] Innovative Diagnostic Pipeline - Mainz Biomed is advancing a robust pipeline of diagnostic technologies, including PancAlert, aimed at early detection of multiple cancers, which will diversify revenue streams and strengthen its leadership in cancer diagnostics [7] - The company has redeveloped its first-generation ColoAlert screening test, simplifying workflow and reducing retest rates, with positive feedback from lab communities [8] Market Position and Valuation - Management believes that the current stock price does not reflect the company's true value, emphasizing a commitment to delivering key milestones and executing its strategy to unlock shareholder value [9] - The company is scaling operations across Europe and other international markets while preparing for significant growth opportunities in the U.S. healthcare market [11][12]