Mainz Biomed Appoints Michele Pedrocchi, Former Head of Roche Diagnostics Business Development, to Strategic Advisory Board
January 12 2022 - 3:01AM
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”),
a molecular genetics diagnostic company specializing in the early
detection of cancer, announced today the appointment of Dr. Michele
Pedrocchi to its Strategic Advisory Board.
“Having Michele join our Strategic Advisory Board is a fantastic
addition given his prolific background in the in vitro diagnostics
space,” commented Guido Baechler, Chief Executive Officer of Mainz
Biomed. “Michele’s vast experience launching IVD products in
multiple international markets is especially timely for our
flagship product, ColoAlert which is in the early stage of its
commercial lifecycle, and I’m looking forward to his counsel and
direction as we expand ColoAlert’s commercial imprint across Europe
and other international territories.”
Dr. Pedrocchi is a seasoned healthcare executive with over 25
years of international experience at Roche spanning in vitro
diagnostics, digital health, and personalized medicine. During his
tenure at Roche, Dr. Pedrocchi held senior leadership positions
across corporate strategy, commercial and business development,
including serving as Global Head of Strategy and Business
Development for Diagnostics. Under his leadership, the division
pioneered the entry into digital health and executed more than 20
acquisitions and 500 licensing deals. Prior leadership positions
held at Roche included multiple international roles where Dr.
Pedrocchi served as in-country and regional general manager and
consistently built a track record of profitably growing businesses
in emerging and mature markets. Moreover, he had an instrumental
role in introducing patient selection through Companion Diagnostics
(CDx) and establishing polymerase chain reaction (PCR) as a routine
diagnostics methodology. Dr. Pedrocchi is currently an Independent
Strategic Advisor and Non-Executive Director to private and public
healthcare companies.
“I am thrilled to join the Strategic Advisory Board of Mainz
Biomed,” said Dr. Pedrocchi. “The Company is addressing a real
issue in early cancer detection with a forward-looking approach: by
extracting clinically relevant information from the combination of
multiple markers and by making this accessible to a broader
population via standardized laboratory kits, the company is going
to have a major impact on patients around the world. I am truly
looking forward to working with Guido and the team in making this
happen.”
In his advisory role with Mainz Biomed, Dr. Pedrocchi will play
an active role in supporting the Company’s business model of
partnering with third-party laboratories, exploring distribution
relationships and other types of commercial partnerships. In
addition, Dr. Pedrocchi will support the management team as it
evaluates strategic partnerships for Mainz’s pipeline of product
candidates inclusive of licensing and M&A opportunities.
About ColoAlertColoAlert detects colorectal
cancer (CRC) via a simple-to-administer test with a sensitivity and
specificity nearly as high as the invasive colonoscopy*. The test
utilizes proprietary methods to analyze cell DNA for specific tumor
markers combined with the fecal immunochemistry test (FIT) and is
designed to detect tumor DNA and CRC cases in their earliest
stages. The product is CE-IVD marked (complying with EU safety,
health and environmental requirements) and is transitioning to
compliance with IVDR. The product is commercially available in a
selection of countries in the European Union. Mainz Biomed
currently distributes ColoAlert through a number of clinical
affiliates. Once approved in the U.S., 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.*Dollinger MM et al.
(2018)
About Colorectal CancerColorectal cancer (CRC)
is the second most lethal cancer in the U.S. and Europe, but also
the most preventable with early detection providing survival rates
above 90%. Annual testing costs per patient are minimal, especially
when compared to late-stage treatments of CRC which cost patients
an average of $38,469 per year. The American Cancer Society
estimates that in 2021 there will be approximately 149,500 new
cases of colon and rectal cancer in the U.S. with 52,980 resulting
in death. Recent FDA decisions suggest that screening with stool
DNA tests such as ColoAlert in the US should be conducted once
every three years starting at age 45. Currently, there are 112
million Americans aged 50+, a total that is expected to increase to
157 million within 10 years. Appropriately testing these US-based
50+ populations every three years as prescribed equates to a US
market opportunity of approximately $3.7 Billion per year.
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. ColoAlert is
currently marketed across Europe with an FDA clinical study and
submission process intended to be launched in the first half of
2022 for U.S. regulatory approval. Mainz Biomed’s product candidate
portfolio includes PancAlert, an early-stage pancreatic cancer
screening test based on Real-Time Polymerase Chain Reaction-based
(PCR) multiplex detection of molecular-genetic biomarkers in stool
samples, and the GenoStick technology, a platform being developed
to detect pathogens on a molecular genetic basis.
For more information, please visit
www.mainzbiomed.com
For media enquiries, please contact
press@mainzbiomed.com
For investor enquiries, please contact
ir@mainzbiomed.com
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 Prospectus filed on October 12, 2021
and amended on October 25, 2021 and November 1, 2021. 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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