Mainz Biomed provides year-end corporate review 2023

Mainz Biomed N.V announced a year end summary of its corporate and product development progress. Key Commercial, Product Development and Operational Highlights Included: Announced groundbreaking results from ColoFuture and eAArly DETECTclinical studies evaluating the potential to integrate portfolio of novel gene expression biomarkers into a next-generation version of ColoAlert; ColoFuture reported sensitivity for colorectal cancer of 94% with specificity of 97% and advanced adenoma sensitivity of 80%; eAArly DETECT reported sensitivity for CRC of 97% with a specificity of 97% and a sensitivity for AA of 82%; Expanded international commercialization of ColoAlert; Established commercial operations in major markets including Spain, Poland, Romania, Portugal, Israel, and the UK; Launched corporate health program with Germany serving as initial market via integration into Country’s BGM system; Ramped-up preparations for pivotal FDA PMA clinical trial which remains on track to commence patient enrollment in mid-2024. Presents an opportunity to achieve gold-standard status for at-home CRC screening. “This past year was an exceptional period for the Company as we executed our international commercial strategy for flagship product ColoAlert while advancing product development programs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The latter half of 2023 was especially exciting given the groundbreaking results from the ColoFuture and eAArly DETECT studies which reported extraordinary statistical significance for CRC lesion detection and advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease. This outstanding outcome enables optimal trial design for the ReconAAsense pivotal FDA PMA study that if successful, will now represent disruptive innovation in self-administered CRC screening, providing the opportunity to bring to market the most advanced diagnostic tool on the market. As such, we head into 2024 with a great deal of momentum as we make final preparations for ReconAAsense, with patient enrollment targeted to commence mid-year. On the commercial front, we’ll continue to expand our international footprint while strengthening our presence in established markets.”