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Mainz Biomed N.V. Ordinary Shares - MYNZ STOCK NEWS

Welcome to our dedicated page for Mainz Biomed N.V. Ordinary Shares news (Ticker: MYNZ), a resource for investors and traders seeking the latest updates and insights on Mainz Biomed N.V. Ordinary Shares stock.

Mainz Biomed N.V. (symbol: MYNZ) is a pioneering company in the field of molecular genetic diagnostics, dedicated to providing patient-friendly testing solutions for life-threatening conditions. With a mission to improve early detection rates and thereby save lives through science, Mainz Biomed develops market-ready products that are both accurate and easy to use.

One of their key innovations is ColoAlert®, a non-invasive, at-home screening test for colorectal cancer (CRC). Utilizing real-time Polymerase Chain Reaction (PCR) to detect molecular-genetic biomarkers in stool samples, ColoAlert® offers high sensitivity and specificity. This test is available in select European countries and is poised for FDA approval in the United States through the ongoing 'ReconAAsense' clinical trial.

Mainz Biomed aims to expand its market reach by fostering partnerships with laboratories and healthcare providers. The company is also committed to advancing the early detection of other cancers, including pancreatic cancer, through products like PancAlert, which is currently in early stages of development.

Recently, Mainz Biomed showcased ColoAlert® at the UDH Congress, emphasizing its role in enhancing comprehensive health strategies. The company reported a 69% year-over-year revenue increase for ColoAlert® and maintained a stable financial condition with a $7.1 million cash balance at year-end.

In collaboration with healthcare professionals, Mainz Biomed continues to contribute to scientific research and knowledge exchange. This commitment was highlighted by their latest clinical studies, ColoFuture and eAArly DETECT, which demonstrated extraordinary statistical significance in CRC and advanced adenoma detection.

For more details, visit Mainz Biomed's official website at www.mainzbiomed.com.

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Mainz Biomed NV (NASDAQ:MYNZ) has announced key activities for May 2023, including the commencement of voluntary quarterly financial reporting, starting with Q1 results due on May 16, 2023. CEO Guido Baechler will present at the Equity Forum Spring Conference in Frankfurt on May 17, where he will discuss the company’s progress in expanding sales in Europe and advancing regulatory approvals in the U.S. The company is focused on its flagship product, ColoAlert®, a non-invasive colorectal cancer screening test, and is conducting pivotal studies to establish its efficacy and market potential. Results from the eAArly Detect study are anticipated in mid-2023, with further enrollment in U.S. studies expected in the second half of the year. The U.S. market for colorectal cancer screening presents a significant opportunity, with over $4 billion in potential revenue.

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Mainz Biomed (NASDAQ:MYNZ) has partnered with Instituto de Microecologia in Madrid to market its at-home colorectal cancer detection test, ColoAlert, to physicians and patients in Spain and Portugal. This collaboration enhances Mainz Biomed's testing network in Europe, where colorectal cancer (CRC) is a leading cause of morbidity and mortality. With over 10,500 new CRC cases reported in Portugal in 2020 and significant early-stage survival rates exceeding 90%, accessibility to reliable screening is crucial. The ColoAlert test offers high sensitivity in detecting tumors via stool DNA analysis, surpassing traditional methods. Mainz Biomed aims to increase consumer access to affordable screening to improve early detection and prevention. The potential market for CRC screening in the US is estimated at over $4 billion, highlighting a significant commercial opportunity.

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On April 10, 2023, Mainz Biomed (NASDAQ:MYNZ) reported a significant 130% increase in revenue from its ColoAlert product year-over-year, reaching $519,728. The company ended 2022 with a strong cash balance of $17.1 million, supporting its growth strategies. Key developments included expanding its commercial activities in Germany and Italy, acquiring exclusive rights to novel mRNA biomarkers, and progressing clinical studies aimed at enhancing colorectal cancer detection. Mainz Biomed raised $25.8 million through a follow-on share offering and appointed industry veterans to its leadership team, indicating a robust commitment to product development. Despite a growing revenue stream, the company faced substantial operating losses, amounting to $26.4 million in net losses for the fiscal year.

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Mainz Biomed NV (NASDAQ:MYNZ) announced that three German companies have adopted its ColoAlert® colorectal cancer screening test in their health programs. This initiative aims to increase accessibility to screening, given that Germany sees nearly 73,000 new CRC cases each year. CEO Guido Baechler emphasized the importance of early detection for better treatment options and outcomes. The ColoAlert® test promises high sensitivity and specificity, making it a superior option compared to traditional tests. The company is also pursuing FDA approval for the test, while tackling a significant market opportunity in the U.S., estimated over $4 billion.

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Mainz Biomed (NASDAQ:MYNZ) announced successful results from a feasibility study evaluating its novel gene expression biomarkers for colorectal cancer (CRC) detection. The study showed that the company's proprietary nucleic acid extraction and PCR processes effectively obtained DNA and mRNA from patient samples stored for over 15 years. Two mRNA biomarkers demonstrated significant efficacy in detecting disease signals in advanced adenoma and CRC specimens. The ongoing eAArly DETECT clinical trial is set to report its findings in mid-2023, which may influence the inclusion of these biomarkers in the ReconAAsense pivotal trial aimed at FDA approval.

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Mainz Biomed NV (NASDAQ:MYNZ) announced that CFO Bill Caragol will present at the Sidoti March Virtual Investor Conference on March 22, 2023, at 12:15 ET. The event will also include one-on-one investor meetings on March 22-23, 2023. Registration for the presentation is free and available at Sidoti's website. Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with its flagship product, ColoAlert, designed for at-home colorectal cancer screening. The company is currently seeking FDA approval for ColoAlert, which is already available in select EU markets.

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FAQ

What is the current stock price of Mainz Biomed N.V. Ordinary Shares (MYNZ)?

The current stock price of Mainz Biomed N.V. Ordinary Shares (MYNZ) is $4.96 as of December 23, 2024.

What is the market cap of Mainz Biomed N.V. Ordinary Shares (MYNZ)?

The market cap of Mainz Biomed N.V. Ordinary Shares (MYNZ) is approximately 12.0M.

What does Mainz Biomed specialize in?

Mainz Biomed specializes in developing molecular genetic diagnostic solutions for early detection of life-threatening conditions, such as colorectal and pancreatic cancers.

What is ColoAlert®?

ColoAlert® is Mainz Biomed's flagship product, a non-invasive, at-home test for colorectal cancer that uses PCR technology to detect molecular-genetic biomarkers in stool samples.

Where is ColoAlert® available?

ColoAlert® is currently available in select European countries and is undergoing FDA approval for the U.S. market.

What recent achievements has Mainz Biomed made?

Mainz Biomed recently presented significant clinical study results at the UDH Congress and reported a 69% year-over-year revenue increase for ColoAlert®.

What is the ReconAAsense trial?

The ReconAAsense trial is Mainz Biomed's FDA-registration study designed to evaluate ColoAlert® for U.S. regulatory approval.

What other products does Mainz Biomed have in development?

Apart from ColoAlert®, Mainz Biomed is developing PancAlert, an early-stage screening test for pancreatic cancer.

How does ColoAlert® differ from other CRC screening tests?

ColoAlert® offers higher accuracy and earlier detection rates compared to traditional fecal occult blood tests (FOBT), thanks to its advanced PCR-based technology.

What is Mainz Biomed’s mission?

Mainz Biomed's mission is to save lives through science by providing accurate, easy-to-use diagnostic solutions for early detection of deadly conditions.

How does Mainz Biomed contribute to the healthcare sector?

Mainz Biomed contributes through scientific research, innovative diagnostic solutions, and partnerships with healthcare professionals to improve early detection and patient care.

Where can I find more information about Mainz Biomed’s investor relations?

For more information on investor relations, visit Mainz Biomed’s official website at www.mainzbiomed.com/investors/.

Mainz Biomed N.V. Ordinary Shares

Nasdaq:MYNZ

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12.02M
3.26M
5.8%
0.25%
5.57%
Diagnostics & Research
Healthcare
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