Leading the Way in Evidence-Based Cancer Screening Innovations

 Mainz Biomed Presents ColoAlert® at UDH Congress 2024: Leading the Way in Evidence-Based Cancer Screening Innovations

BERKELEY, US – MAINZ, Germany – March 12^th 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, is proud to announce its upcoming participation at the 39th UDH Congress 2024, taking place on March 16th & 17th 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), is the gut and its significance in the manifestation of diseases.

Mainz Biomed’s showcase at the UDH Congress underscores the Company’s dedication to bridging the latest in scientific research with the wide spectrum of healthcare practices. Mainz Biomed’s engagement reflects a deep respect for the diverse methodologies within the healthcare community, emphasizing the commitment to contributing evidence-based, innovative solutions like ColoAlert®.

ColoAlert®, Mainz Biomed’s flagship product, is a testament to the Company’s mission, providing a highly accurate, easy-to-use, at-home colorectal cancer (CRC) screening kit. Its advanced tumor DNA analysis technology significantly improves early detection rates, a crucial factor in effective CRC management. By presenting ColoAlert® at the UDH Congress, Mainz Biomed highlights the role of cutting-edge molecular diagnostics in enhancing comprehensive health strategies, demonstrating the synergy between technological innovation and patient-centric care.

This initiative is part of Mainz Biomed’s broader strategy to foster collaboration and knowledge exchange across the health sector. The Company aims to elevate the standard of care and advocate for the health and well-being of individuals through science-backed solutions.

For more details on Mainz Biomed’s participation in the UDH Congress and to learn about the Company’s innovative diagnostic solutions, please visit Mainz Biomed’s official website at mainzbiomed.com.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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About ColoAlert®
ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country. 

About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US. 

About Mainz Biomed N.V.  
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com.  

For media inquiries 

In Europe:

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

In the U.S.:

Blueprint Life Science Group
Hershel Berry
+1 415 505 3749
hberry@bplifescience.com  

For investor inquiries, please contact info@mainzbiomed.com
 

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.