Mainz Biomed Announces Distribution Partnership with Praxisdienst for ColoAlert®

Mainz Biomed N.V. 

(NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, is pleased to announce a distribution partnership with Praxisdienst, Germany’s largest online retailer for medical products. This collaboration, which commenced in February 2024, marks an important step in Mainz Biomed’s mission to enhance healthcare delivery across Germany, focusing on the accessibility of their flagship product, ColoAlert®.

ColoAlert® represents a breakthrough in the early detection of colorectal cancer, offering a convenient, non-invasive at-home stool test that goes beyond traditional screening methods. Unlike standard tests that only detect the presence of blood in the stool, ColoAlert® utilizes advanced technology to identify tumor DNA, providing a more comprehensive screening option. This innovative approach ensures higher detection rates, especially in cases where tumors do not bleed, thereby facilitating the early diagnosis of colorectal cancer. Early detection is crucial, as it significantly enhances the treatability of this condition, potentially saving lives.

Praxisdienst has consistently demonstrated its capacity for innovation and leadership in the medical products market. Praxisdienst’s achievements, including the "Deutscher Gesundheits-Award 2022" in the "Medical Technology - Online Shops" category and its recognition as a Top Innovator in 2023, highlight its dedication to excellence and innovation.

This partnership will harness Praxisdienst's extensive distribution network alongside Mainz Biomed's leading-edge diagnostic technologies, ensuring broader access to their sophisticated medical solutions for healthcare professionals and patients throughout Germany.

Darin Leigh, CCO of Mainz Biomed, expressed enthusiasm about the partnership: "We are delighted to partner with Praxisdienst to distribute ColoAlert®, our innovative at-home screening test for colorectal cancer. This collaboration is not only in line with our strategic objectives but also underscores our commitment to providing superior diagnostic solutions to the healthcare sector. We are confident that this partnership will have a profound impact on healthcare standards and patient care in Germany by making early detection of colorectal cancer more accessible."

For more information about Mainz Biomed and our innovative products, please visit Mainz Biomed's website. To learn more about Praxisdienst and its extensive range of medical products, visit Praxisdienst's website.

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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 CancerColorectal 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.

About PraxisdienstPraxisdienst stands as Europe's leading online retailer for medical products, catering to healthcare professionals across the continent. Led by CEO Michael Heine and renowned for its innovative approach and commitment to quality, Praxisdienst provides a comprehensive array of medical supplies and equipment through a user-friendly online shopping experience.

For media inquiries

In Europe:MC Services AGAnne Hennecke/Caroline Bergmann+49 211 529252 [e-mail]

In the U.S.:Blueprint Life Science GroupHershel Berry+1 415 505 [e-mail]

For investor inquiries, please contact [e-mail]

Forward-Looking StatementsCertain 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.