Mainz Biomed Announces Partnership with the Instituto de Microecologia to Expand ColoAlert® Commercialization in Spain and Portugal

 Mainz Biomed Announces Partnership with the Instituto de Microecologia to Expand ColoAlert^® Commercialization in Spain and Portugal 

The Instituto de Microecologia to market at-home detection test for colorectal cancer to physicians and their patients. 

BERKELEY, US – MAINZ, Germany – April 26, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced that it has added the Instituto de Microecologia in Madrid to its growing network of lab partners across Europe and in select international markets. ColoAlert^®, Mainz Biomed’s flagship product, is a highly efficacious and easy-to-use, at-home detection test for colorectal cancer (CRC). For more than 60 years, the Instituto de Microecologia has been a pioneer in microbiota studies and food sensitivity, focused on disseminating the importance of intestinal health through microbiological analysis and diagnosis of microbiota profiles and specific health parameters. Entering the market and beginning commercialization in Spain and Portugal signify the continued expansion of Mainz Biomed’s impact in Europe.

“As we continue to form partnerships with third-party diagnostic labs such as the Instituto de Microecologia for test kit processing, our aim is to increase consumer access to affordable and reliable CRC screening tests like ColoAlert^®,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “Early screening has the potential to dramatically impact the treatment and prevention of this deadly disease, as well as save lives.”

According to the World Cancer Research Fund International, CRC is the third most common cancer worldwide and Portugal ranks seventh in total global CRC rates with 10,501 cases reported in 2020. On its website, the Institute lists CRC as the second leading cause of death from cancer in Spain and the most frequent malignant tumor, with 41,441 new cases each year affecting 1 in 20 men and 1 in 30 women before the age of 74. The probability of survival exceeds 90% when detected at an early stage.

The Instituto de Microecologia is widely known across Spain for its pioneering work in intestinal health. It offers a wide range of diagnostic and analytical services and is continuously advancing its scientific and technical capabilities through ongoing internal research alongside external collaborations. The Institute deploys the most innovative diagnostic techniques by continuously auditing procedures to ensure delivery of the highest standard of quality and reliability of diagnostic results.

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 (Gies 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 NV
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 or follow us on LinkedIn, Twitter and Facebook.

For media inquiries, please contact press@mainzbiomed.com

In Europe:

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

In the US:

Spectrum Science
Melissa Laverty/Valerie Enes
+1 540 272 6465
mainz@spectrumscience.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 May 5, 2022. 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.