Mainz Biomed Establishes Physician-Led Laboratory Expanding Service Offering for Privately Insured Patients in Germany

Mainz Biomed N.V. 

(NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, announces the opening of the ‘European Oncology Lab’ (EOL). The physician-led facility represents an expansion of the Company’s collaboration with Laboratory Dr. Buhlmann with a shared location in Saarland, Germany.

Via the EOL, medical professionals or patients can now order ColoAlert® directly with Mainz Biomed as a laboratory medical service, meeting a crucial requirement to invoice private health insurance companies. This advancement makes it more convenient for approximately 8.7 million individuals, or 10.5% of Germany’s population are covered by private health insurance (PHI) as estimated by the Association of Substitute Health Insurance Funds in 2022.

Darin Leigh, Chief Commercial Officer of Mainz Biomed, commented: “This expansion marks a significant milestone in our mission to make early CRC detection more accessible for patients in Germany. The ability to invoice ColoAlert as a laboratory medical service opens a new revenue growth opportunity in addition to our established commercial sales channels. Given that March is Colorectal Cancer Awareness Month, we are very excited about this new opportunity to create visibility around the importance of earlier CRC detection.

In addition to this new offering, Mainz Biomed has a unique business model of partnering with third-party laboratories and experienced distribution partners as opposed to the traditional methodology of operating a single facility for test processing. Additionally, the Company sells the CRC screening solution via its own online shop and provides CRC screening services to corporations with established corporate health programs (“betriebliches Gesundheitsmanagement”).

ColoAlert® offers a non-invasive, highly sensitive, and specific screening for colorectal cancer, utilizing advanced PCR technology to detect molecular-genetic biomarkers (DNA) in stool samples. This innovative approach provides a significant advantage over traditional fecal occult blood tests (FIT), enabling earlier and more accurate detection of CRC.

Physicians and privately insured patients interested in ColoAlert® are encouraged to contact Mainz Biomed or visit www.coloalert.de for more information on how to access the test.

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 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.   

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.