Mainz Biomed to Exhibit ColoAlert at MEDICA 2021, the World’s Largest Medical Trade Fair

Rhea-AI Summary

Mainz Biomed (NASDAQ:MYNZ) announced its participation in MEDICA 2021, the largest medical trade fair, showcasing its ColoAlert diagnostic test for colorectal cancer from November 15-18 in Düsseldorf, Germany. After a successful IPO, the company aims to ramp up commercial activities for ColoAlert, which detects CRC with high sensitivity and specificity. The test is currently available in select EU countries, with plans for U.S. approval underway. The potential U.S. market for ColoAlert is estimated at $3.7 billion annually, considering the growing population of Americans aged 50 and above.

Positive

• Participation in MEDICA 2021 enhances visibility for ColoAlert.
• ColoAlert shows nearly as high sensitivity and specificity as colonoscopy, indicating strong diagnostic potential.
• The U.S. market opportunity for ColoAlert is approximately $3.7 billion per year, suggesting significant revenue potential.

Negative

• None.

BERKELEY, Calif. and MAINZ, Germany, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to announce that Company representatives will be attending MEDICA 2021 to showcase ColoAlert, its highly efficacious and easy-to-use diagnostic test for colorectal cancer. MEDICA, the world’s largest medical trade fair, takes place in Düsseldorf, Germany from November 15-18th, 2021. Throughout the conference, Mainz will be hosting meetings in Hall 3, Stand J27.

"On the heels of our successful IPO on Nasdaq this past November, we are thrilled to participate in this important industry forum as we begin ramping-up commercial activities for ColoAlert, our flagship product," commented Guido Baechler, Chief Executive Officer of Mainz Biomed.

MEDICA 2021 is expected to attract almost 3000 exhibitors and visitors from over 50 countries working across all sectors of the healthcare industry. The 40 year old event brings together leading figures within healthcare, research, and politics to demonstrate and discuss the latest innovations in outpatient and clinical care and themes including laboratory technology and diagnostics, sports medicine & physiotherapy, big data, interventional imaging and surgery and telemedicine.

About ColoAlert

ColoAlert 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 Cancer

Colorectal 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. In the USA, Mainz Biomed will begin the clinical study and regulatory process in the first half of 2022 for U.S. FDA 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 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 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.

FAQ

What is the significance of Mainz Biomed attending MEDICA 2021?

Mainz Biomed's attendance at MEDICA 2021 emphasizes its commitment to increasing visibility and commercial activities for its ColoAlert colorectal cancer diagnostic test.

What is ColoAlert and how does it work?

ColoAlert is a non-invasive diagnostic test for colorectal cancer that detects tumor DNA and CRC cases at early stages using proprietary methods and fecal immunochemistry.

What is the potential U.S. market size for ColoAlert?

The potential U.S. market opportunity for ColoAlert is estimated to be approximately $3.7 billion annually, targeting the growing population of Americans aged 50 and above.

When is Mainz Biomed expecting U.S. FDA approval for ColoAlert?

Mainz Biomed plans to begin the clinical study and regulatory process for U.S. FDA approval of ColoAlert in the first half of 2022.

What are the key features of ColoAlert?

ColoAlert is CE-IVD marked, non-invasive, easy to administer, and has high sensitivity and specificity for colorectal cancer detection.