Mainz Biomed Announces Submission for FDA Breakthrough Device Designation
for its Next Generation CRC Screening Test

Issuer: Mainz BioMed N.V. / Key word(s): Regulatory Admission
Mainz Biomed Announces Submission for FDA Breakthrough Device Designation
for its Next Generation CRC Screening Test

09.07.2024 / 09:01 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Mainz Biomed Announces Submission for FDA Breakthrough Device Designation
for its Next Generation CRC Screening Test

On the basis of its positive clinical studies Mainz Biomed has now defined
the final configuration including its novel mRNA biomarkers of the Next
Generation Test to be used in pivotal registration study ReconAAsense

A recent clinical analysis of this new configuration demonstrates
sensitivity for colorectal cancer of 97% and 88% for advanced adenomas, with
specificity of 93%

BERKELEY, US - MAINZ, Germany - July 9, 2024 - Mainz Biomed N.V. (NASDAQ:
MYNZ), a molecular genetics diagnostic company specializing in the early
detection of cancer, announced that it has submitted its application to the
U.S. Food and Drug Administration (FDA) requesting Breakthrough Device
Designation for its non-invasive Next Generation colorectal cancer (CRC)
product including the Company's novel portfolio of mRNA biomarkers. Subject
to the FDA's review, a Breakthrough Device Designation could significantly
accelerate approval.

The regulatory submission follows consistently excellent read-outs of its
clinical studies ColoFuture and eAArly Detect, as well as data from a pooled
study including both the European and the US arm that were presented at ASCO
2024. On the basis of these studies Mainz Biomed has now defined the final
configuration of its Next Generation Test integrating the Fecal
Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by
an advanced AI and machine learning algorithm that the Company plans to use
in its Next Generation product, and the FDA premarket approval study.

The configuration of the Next Generation Test was tested in a clinical
setting. The analysis involved 295 clinical subjects from 21 specialized
gastroenterology centers across the United States and highlighted the
remarkable efficacy of Mainz Biomed's multimodal screening test. This
combination enables precise differentiation among colorectal cancer (CRC),
advanced adenomas (AA), non-advanced adenomas, and samples with no
pathological findings.

Key Findings

  * Sensitivity for Colorectal Cancer: 97% (95% confidence interval:
    83.3-99.9)

  * Sensitivity for Advanced Precancerous Lesions: 88% (95% confidence
    interval: 77.2-94.5)

* Specificity: 93% (95% confidence interval: 88.4-98.3)

Guido Baechler, Chief Executive Officer at Mainz Biomed, commented, "On the
back of our extremely positive clinical results in all our recent studies,
finalizing the test which will be used in the pivotal ReconAAsense study and
approval process has been an elementary milestone for our Company. Our Next
Generation Test has shown a significant improvement in sensitivity for
advanced adenomas and high-grade dysplasias, combined with high sensitivity
and specificity for CRC. Moreover, we believe that our unique decentralized
model of working with third party laboratory partners provides better access
to underserved communities and our simple collection process will increase
the adherence to testing. These benefits support our mission to transform
colorectal cancer screening practices and reduce global cancer mortality
rates."

The FDA's Breakthrough Devices Designation is a program for certain medical
devices and device-led combination products that provide for more effective
treatment or diagnosis of life-threatening or irreversibly debilitating
diseases or conditions. It is intended to allow patients and health care
providers timely access to medical devices by speeding up development,
assessment, and review for premarket approval, 510(k) clearance, and De Novo
marketing authorizations. Breakthrough Devices must meet the FDA's rigorous
standards for device safety and effectiveness in order to be authorized for
marketing.

Please visit Mainz Biomed's official website for investors at
mainzbiomed.com/investors/ or subscribe to our news alert to keep up to date
on our pivotal FDA PMA clinical trial ReconAAsense and further corporate
news.

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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 planning to run 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

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

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 9, 2024. 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.


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   Language:       English
   Company:        Mainz BioMed N.V.
                   Robert-Koch-Strasse 50
                   55129 Mainz
                   Germany
   Internet:       mainzbiomed.com
   EQS News ID:    1940797

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