Mainz Biomed N.V. Ordinary Shares - MYNZ STOCK NEWS

Mainz Biomed (NASDAQ: MYNZ) has announced a new corporate health program in Germany for its colorectal cancer screening test, ColoAlert. This initiative aims to tap into the €1 billion annual market by integrating ColoAlert into BGM, a health network servicing 48 of Germany's largest companies. The program provides employees with easy access to colorectal cancer testing, addressing a critical health need as CRC is a leading cause of cancer-related deaths in Europe. The company's strategy includes launching an online portal for test registration and results communication, enhancing early detection and employee well-being.

Mainz Biomed N.V. (NASDAQ:MYNZ) released a corporate summary for the fiscal year 2022, highlighting significant advancements in cancer diagnostics. Key achievements include the initiation of pivotal studies such as the eAArly DETECT and ReconAAsense, aimed at enhancing colorectal cancer detection. The company expanded international partnerships, improved its leadership team, and secured a USD 25.8 million public offering. A focus on the development of ColoAlert and PancAlert reflects its commitment to advancing early detection methods, with results expected in 2023 for ongoing studies.

BERKELEY, Calif. and MAINZ, Germany, Dec. 20, 2022 - Mainz Biomed (NASDAQ:MYNZ) announced the enrollment of its first patient in the eAArly DETECT study, part of the ColoFuture initiative. This study evaluates novel mRNA biomarkers to enhance the ColoAlert test for colorectal cancer (CRC), targeting advanced adenomas. Enrollment is expected to conclude in Q1 2023, with results anticipated in 1H 2023. The study aims to improve diagnostic sensitivity and specificity, vital in CRC prevention. The company is also preparing for its U.S. pivotal study, ReconAAsense, set to begin in 2023.

Mainz Biomed has received approval for its pivotal study, ReconAAsense, aimed at evaluating the clinical performance of its colorectal cancer detection test. The study will enroll approximately 15,000 subjects across 150 sites in the U.S., with results expected in 2025. This study is crucial for obtaining FDA marketing authorization and enhancing the technical profile of Mainz Biomed's tests for detecting advanced adenomas, which can lead to colorectal cancer. The eAArly DETECT study aims to integrate novel biomarker technology to improve diagnostic sensitivity.

Mainz Biomed (NASDAQ:MYNZ) has appointed Amy Levin as Vice President of Regulatory Affairs, effective immediately. Levin brings over 20 years of regulatory experience from Roche, where she significantly contributed to international regulatory strategies. Her role will focus on guiding the FDA submission process for ColoAlert, a DNA-based test for colorectal cancer. CEO Guido Baechler praised her strategic thinking and experience, which are crucial as the company aims for operational excellence and regulatory compliance in clinical trials.

Mainz Biomed NV (NASDAQ:MYNZ) has announced that its executive team will participate in two significant conferences: the Deutsches Eigenkapitalforum 2022 in Frankfurt from November 28-30 and Cantor Fitzgerald’s Medical & Aesthetic Dermatology Conference in Miami on December 8, 2022. At the Eigenkapitalforum, a presentation is scheduled for November 29 at 9:30 a.m. CET. The Cantor Fitzgerald event will feature one-on-one meetings with industry leaders. Mainz Biomed is known for its early cancer detection solutions, notably ColoAlert, aimed at colorectal cancer screening.

Mainz Biomed NV (NASDAQ:MYNZ) has initiated the eAArly DETECT study, expanding its ColoFuture project into the U.S. The study focuses on integrating novel mRNA biomarkers into its ColoAlert test for colorectal cancer (CRC). Enrollment is expected to finish by Q1 2023, with results anticipated in the first half of 2023. These biomarkers aim to enhance detection of advanced adenomas, a pre-cancerous condition linked to CRC. The study could expedite the U.S. pivotal study, which is set to begin later this year, potentially transforming self-administered CRC screening.

Mainz Biomed (NASDAQ:MYNZ) provided a Q3 2022 update highlighting key developments. The company launched its ColoAlert test in Italy and the UAE, targeting colorectal cancer detection. The ongoing ColoFuture study aims to enhance ColoAlert's capabilities and is on track for results in H1 2023. Mainz Biomed is also preparing for a pivotal U.S. clinical trial expected to start in Q4 2022, with results anticipated in 2025. A new Medical Advisory Board was formed to support product development. These initiatives signify Mainz Biomed's commitment to advancing cancer diagnostics.

Mainz Biomed NV (NASDAQ:MYNZ) has nominated Dr. Heiner Dreismann as Chairman of the Board and Gregory Tibbitts to its Board of Directors. The extraordinary general meeting is set for the week of December 12, 2022, to vote on their appointments. Dr. Dreismann brings over 35 years of diagnostics experience, having previously served as Roche Molecular Diagnostics CEO. Mr. Tibbitts, a CPA with 30 years in financial strategy, has extensive experience in the life sciences sector. Their appointments aim to strengthen Mainz Biomed's strategic and financial governance, particularly as it prepares for a pivotal U.S. clinical trial for its ColoAlert product.