Industry Leading Clinical Data Position the Company for FDA Premarket Approval Study
BERKELEY, US – MAINZ, Germany – July 3, 2024 — Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments of the first six months ending June 30, 2024, and provided a corporate update. The Company expects to release its half year financial results in September 2024.
Key Highlights During First Half 2024
- Mainz Biomed presented industry leading results of its pooled study at ASCO 2024; which confirmed the previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia; the results from the pooled study represents the third consecutive confirmation of the consistently good performance of Mainz Biomed’s mRNA biomarkers to detect CRC and precancerous lesions
- Mainz Biomed was awarded a Poster of Distinction at Digestive Disease Week presenting data from its eAArly DETECT study, positioning the Company for its planned FDA trial; the poster presented industry leading results: 97% sensitivity for colorectal cancer, 82% for advanced precancerous lesions; the study demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected
- The Company participated in the 39th UDH Congress 2024, in Fellbach, Germany. One of the main focus topics for this year’s event, organized by the German Complementary Medicine Association (Union Deutscher Heilpraktiker, Landesverband Baden-Württemberg), was the gut and its significance in the manifestation of diseases
- Mainz Biomed participated and exhibited at the esteemed Gynecology Congress (‘Gynäkologie und Geburtshilfe aktuell’) in Stuttgart, Germany. This engagement signifies the Company’s commitment to advancing colorectal cancer screening through their innovative diagnostic solution ColoAlert® and highlights the pivotal role of gynecologists in the early detection of this prevalent disease
- The Company continues to make strong progress in the development of strategic partners to assist in the Mainz Biomed’s efforts to achieve pre-market approval from the FDA and in its go-to-market strategy in the U.S.
- Mainz Biomed partnered with Trusted Health Advisors to support its U.S. go-to-market strategy for the next generation early colorectal cancer diagnostic test; Jay Wohlgemuth, former Chief Medical & Scientific Officer of Quest Diagnostics and Dr. Ray Tabibiazar, a seasoned industry executive, are leading the collaboration
- The Company formed a strategic partnership with TomaLab, a premier biotechnology laboratory based in Milan, to launch the Company’s flagship product, ColoAlert® in Italy. The partnership signifies a major step forward in enhancing colorectal cancer screening and diagnostics within the Italian healthcare system as it enables the implementation of ColoAlert® into Italy’s robust healthcare framework, providing patients with access to a cutting-edge diagnostic solution that combines convenience with clinical excellence
“I’m extremely pleased with the progress achieved during the first half of 2024 as we execute our ambitious corporate growth strategy driven by our incredible clinical results in three studies published so far this year,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed “We head into the second half of 2024 with a great deal of momentum as we plan for the beginning of enrollment planning for the ReconAAsense U.S. FDA pivotal CRC study.”
