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. ![]() 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. “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 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. Presents an opportunity to achieve gold-standard status for at home CRC screening. Ramped-up preparations for pivotal FDA PMA clinical trial (ReconAAsense) which remains on track to commence patient enrollment in mid-2024.Launched corporate health program with Germany serving as initial market via integration into Country’s BGM system (“betriebliches Gesundheitsmanagement”).Established commercial operations in major markets including Spain, Poland, Romania, Portugal, Israel, and the UK.Expanded international commercialization of ColoAlert®, a highly efficacious and easy-to-use DNA-based detection test for CRC being sold via Company’s unique business model of marketing products via partnerships with third-party laboratories versus the traditional methodology of operating a single facility.eAArly DETECT reported sensitivity for CRC of 97% with a specificity of 97% and a sensitivity for AA of 82%.ColoFuture reported sensitivity for colorectal cancer (CRC) of 94% with specificity of 97% and advanced adenoma (AA) sensitivity of 80%.Announced groundbreaking results from ColoFuture (Europe) and eAArly DETECT (U.S.) clinical studies evaluating the potential to integrate portfolio of novel gene expression (mRNA) biomarkers into a next generation version of ColoAlert ®.Key Commercial, Product Development and Operational Highlights Included: (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today a year end summary of its corporate and product development progress. ![]() ![]()
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |