Mainz Biomed CEO issues statement on upcoming milestones

Mainz Biomed released a statement to shareholders highlighting its strategic plans for maximizing shareholder value, clinical developments, and its upcoming FDA trial anticipated for 2025, which aims to pave the way for entry into the U.S. market. Highlights of the statement by CEO Guido Baechler include: “Our groundbreaking clinical results with our mRNA-based next-generation CRC screening test and our strategic pathway to FDA trials, which we plan to start in 2025, demonstrate our commitment to expanding into the world’s largest healthcare market. These efforts, combined with our growing international footprint, underscore why we believe Mainz Biomed is currently undervalued relative to its potential…Like all our shareholders, management and the Board of Directors are concerned and disappointed with the performance of our stock price. We commit to our shareholders that we will continue to strive to deliver what we have promised under difficult market conditions. We are strongly convinced that 2025 will be a transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through our innovative diagnostic solutions.” mRNA-based next-generation CRC screening tests are redefining standards in early cancer detection. Mainz Biomed’s flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, demonstrating clinical success in both U.S. and European trials. Presentations this year have highlighted sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas. In early July the company submitted for FDA Breakthrough Device Designation for its next generation CRC screening test. Following feedback from the FDA, the company has decided to withdraw its BDD application to focus on extending its clinical research program. Mainz Biomed will expand its dataset to include a larger average-risk patient population with its pivotal ReconAAsense trial. The company plans to submit this comprehensive data in 2025 to FDA. Successful completion of the FDA trial will allow Mainz Biomed’s next generation CRC screening test to be marketed to Americans at risk of colorectal cancer. Mainz Biomed is advancing a pipeline of diagnostic technologies aimed at detecting multiple cancers. Mainz has redeveloped and relaunched an expanded version of its first-generation CRC screening test currently commercialized in Germany and selected other countries in Europe.