Mainz Biomed Announces Live Launch of ColoAlert® with Bioclinica in Romania

Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces the live launch of Mainz Biomed’s flagship product, ColoAlert® — a highly effective and user-friendly at-home detection test for colorectal cancer (CRC) - with strategic partner Bioclinica, a national leader in the Romanian healthcare sector. This partnership signifies a pivotal step towards enhancing healthcare outcomes in the country through advanced diagnostics.

CRC incidence rates in Romania are among the highest in Europe. With no national screening program in place, population data from Romania underscores the urgency to have diagnostic tests publicly available in the country to enhance CRC screening practices. With 1.6 million individuals aged 40 to 49 years, 6.1 million aged 50 to 74 years, and 1.5 million aged over 75 years, the potential market for ColoAlert® is substantial, reaching 9.2 million tests per year.

The collaboration with Bioclinica adds significant value to Mainz Biomed's mission. Leveraging the renowned expertise and extensive network of Bioclinica, ColoAlert® will immediately become available to a large portion of the Romanian population. Bioclinica, a trusted supplier of healthcare products with over 25 years of experience in medical diagnostics, operates 15 associated laboratories and 146 collection points across Romania. Mainz Biomed and Bioclinica will collaborate on co-marketing activities to ensure the successful commercial launch of ColoAlert® across the country.

"We are delighted to see ColoAlert® now made available to Romanian’s through our key partnership with Bioclinica," commented Darin Leigh, Chief Commercial Officer of Mainz Biomed. "Our collaboration demonstrates a shared commitment to introducing state-of-the-art diagnostic solutions that can have a transformative impact on public health. Early detection is paramount in combating diseases like colorectal cancer, and our collaboration with Bioclinica exemplifies our mission to ensure more people globally have access to diagnostic tests that can give them a life-changing headstart on this disease."

Colorectal cancer remains a significant public health concern globally, with Europeans disproportionately affected. While Europeans make up only one tenth of the world population, about 25% of all annual cancer cases occur in Europe. As the second most lethal cancer on the continent, CRC demands innovative solutions that can transform its diagnosis and treatment landscape. Mainz Biomed's ColoAlert® addresses this challenge head-on by providing an efficient and user-friendly screening test that empowers individuals to take proactive measures against CRC.

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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.   

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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.