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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 (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.
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.
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.
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.
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.
Mainz Biomed (NASDAQ: MYNZ) has partnered with Labor Staber to market its flagship product, ColoAlert, an at-home colorectal cancer screening test. Labor Staber, with over 35 years of experience, operates across Germany, enhancing consumer access to reliable screening tests. CEO Guido Baechler emphasized their mission to save lives through early detection of colorectal cancer, the third most common cancer globally, with over 1.9 million new cases reported in 2020. ColoAlert's advanced technology allows for higher sensitivity in detecting tumors and is currently awaiting FDA approval for U.S. markets, presenting a significant market opportunity.
Mainz Biomed NV (NASDAQ:MYNZ), a molecular genetics diagnostic company, is launching several initiatives to raise awareness of colorectal cancer (CRC) detection in Germany. With around 73,000 new cases annually, CRC is a leading cause of cancer-related mortality, yet boasts a 90% survival rate when diagnosed early. The company is sponsoring the Gastro Update 2023 in Mainz and Berlin, and hosting a Patient Education Day in Mainz on March 11, 2023. Its flagship product, ColoAlert, offers non-invasive at-home CRC screening, aiming for better detection rates compared to traditional tests. Mainz Biomed is poised to expand further into the US market following FDA approval.
Mainz Biomed (NASDAQ:MYNZ) is organizing events in Germany for Colorectal Cancer Awareness Month this March. The aim is to raise awareness about the importance of early detection of colorectal cancer, which recorded over 1.9 million new cases globally in 2020. Hosting training sessions for healthcare professionals and an educational event for patients, Mainz Biomed emphasizes the efficacy of their at-home CRC detection kit, ColoAlert. CEO Guido Baechler stated the initiative targets reducing colorectal cancer statistics and improving early diagnosis.
Mainz Biomed N.V. announced that its CFO, Bill Caragol, will participate in a Virtual Fireside Chat with ClearThink IR on March 1, 2023, at 12 noon ET, via the Paltalk platform. The chat aims to inform potential investors about the company’s products and strategic growth initiatives. Mainz Biomed specializes in molecular genetic diagnostics for early cancer detection, primarily through its ColoAlert test for colorectal cancer (CRC), which is already CE-IVDR marked and available in several countries. The U.S. market opportunity for CRC screening is estimated at approximately $3.7 billion annually.
On February 21, 2023, Mainz Biomed (NASDAQ:MYNZ) announced it has executed option agreements to acquire the intellectual property portfolio for its ColoAlert product and novel mRNA biomarkers. This acquisition, done in collaboration with Uni Targeting Research AS and SOCPRA Sciences, aims to enhance the early detection capabilities of colorectal cancer (CRC). The full ownership of the IP is expected to streamline operations and lower costs for the company. Mainz is actively evaluating the mRNA biomarkers in two significant clinical studies, ColoFuture and eAArly DETECT, aiming for FDA approval to expand CRC screening options, potentially impacting their market share in a $3.7 billion opportunity.
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