Mainz Biomed NV Stock Price, News & Analysis

Mainz Biomed (NASDAQ:MYNZ) has secured a Technology Rights Agreement with TTS, gaining access to a portfolio of mRNA biomarkers aimed at enhancing its ColoAlert colorectal cancer screening test. This agreement positions ColoAlert to possibly become the leading at-home screening solution, with previous studies indicating high sensitivity (75% for advanced adenomas and 95% for colorectal cancer). The company plans to initiate a clinical study in Europe to assess these biomarkers, targeting a launch in the first half of 2022. ColoAlert is already CE-IVD marked and aims for U.S. regulatory approval soon.

Mainz Biomed (NASDAQ:MYNZ) announced the appointment of Karen Richards as Vice President of Regulatory Affairs. This strategic hire is expected to aid in navigating U.S. regulatory processes for their colorectal cancer detection product, ColoAlert. With over 30 years in the in vitro diagnostics sector, Richards' extensive experience includes spearheading regulatory approvals globally. ColoAlert, already marketed in Europe, detects early-stage colorectal cancer and has a significant market potential in the U.S., estimated at $3.7 billion annually, given the rising population of those eligible for testing.

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.