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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.
Mainz Biomed N.V. (NASDAQ:MYNZ) has partnered with GANZIMMUN Diagnostics to co-brand its colorectal cancer detection test, ColoAlert, in Germany. GD is one of Europe's leading labs, processing around 5,500 orders daily with an expert team of over 370 professionals. GD will purchase customized PCR assay kits from Mainz to enhance colorectal cancer prevention efforts in major cities like Mainz, Wiesbaden, and Frankfurt. This collaboration aims to establish efficient commercial partnerships to improve test accessibility and reliability, positioning ColoAlert as a critical diagnostic tool in early cancer detection.
Mainz Biomed has launched ColoAlert.de, an e-commerce platform allowing German residents to access its colorectal cancer screening test directly. The test offers highly accurate results within nine working days, catering to those facing challenges in obtaining in-person screenings due to the COVID-19 pandemic. The company aims to enhance early detection of colorectal cancer, which affects 370,000 diagnosed patients annually in the EU, reducing mortality rates and healthcare costs in the process.
Mainz Biomed (NASDAQ:MYNZ) announced on Nov 30, 2021, its collaboration with Precision for Medicine to support U.S. regulatory and reimbursement strategies for ColoAlert, a colorectal cancer diagnostic test. This partnership aims to enhance the test's market access and FDA approval process, crucial for its commercial success.
ColoAlert, which boasts high sensitivity and specificity, is already available in Europe. It offers significant potential in the U.S. market, with an estimated opportunity of $3.7 billion annually as the population over 50 increases.
Mainz Biomed has appointed Dr. Soren Thestrup-Nielsen M.D. to its Strategic Advisory Board, enhancing its expertise in cancer diagnostics. With over 25 years in the medical device industry, Dr. Thestrup-Nielsen will focus on product strategy and market development for the company's flagship product, ColoAlert, which is geared for colorectal cancer detection. The company plans to begin clinical studies for U.S. FDA approval in early 2022. This strategic addition aims to bolster Mainz Biomed’s commercial efforts in Europe and the U.S.
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.
Mainz Biomed N.V. (NASDAQ:MYNZ) announced the appointment of Dr. Heiner Dreismann to its Strategy Advisory Board. Dr. Dreismann, former President and CEO of Roche Molecular Systems, brings over 35 years of experience in life sciences. His expertise is expected to enhance Mainz Biomed's initiatives, particularly in the commercial rollout of ColoAlert in Europe and the upcoming U.S. regulatory strategy. The company is focused on developing early detection technologies for cancer, with plans for FDA clinical studies beginning in 2022.
Mainz Biomed N.V. (NASDAQ:MYNZ) announced the issuance of an additional 300,000 shares after underwriters exercised their over-allotment option, bringing total gross proceeds from its public offering to $11.5 million. The initial offering of 2,000,000 shares priced at $5.00 per share on November 4, 2021, was part of a $10 million effort. The company, focused on molecular genetic diagnostics for early cancer detection, has begun trading on the Nasdaq Capital Market as of November 5, 2021.
Mainz Biomed N.V. (NASDAQ:MYNZ) announces its flagship product, ColoAlert, an early detection test for colorectal cancer, has completed European registration and is rolling out commercially. The company is set to launch a clinical study for FDA approval in the U.S. CEO Guido Baechler remarked on the significance of the Nasdaq listing as a growth platform. ColoAlert boasts high sensitivity and specificity, offering a cost-effective testing solution. With an estimated U.S. market opportunity of $3.7 billion, the product aims to enhance early detection rates significantly.
Mainz Biomed N.V. (NASDAQ:MYNZ) announced the commencement of its stock trading on the Nasdaq Capital Market on Nov. 5, 2021, closing at $9.99 per share, above its public offering price of $5.00. The company successfully completed a public offering of 2,000,000 shares, resulting in gross proceeds of $10 million. Mainz Biomed specializes in molecular genetic diagnostics for early cancer detection, notably the ColoAlert test for colorectal cancer, with plans for FDA approval in 2022. The offering was underwritten by Boustead Securities, LLC.
Mainz Biomed N.V. (Nasdaq:MYNZ) announced the commencement of trading of its shares on the Nasdaq Capital Market as of November 5, 2021, following a public offering. The company priced 2,000,000 common shares at $5.00 each, aiming to raise gross proceeds of $10,000,000. This offering is set to close around November 9, 2021, pending customary conditions. Mainz Biomed specializes in molecular genetic diagnostics, with products like ColoAlert for colorectal cancer detection and PancAlert, a pancreatic cancer screening test.
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