Welcome to our dedicated page for Mainz Biomed NV news (Ticker: MYNZ), a resource for investors and traders seeking the latest updates and insights on Mainz Biomed NV 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.
Mainz Biomed (NASDAQ:MYNZ) is marking Colorectal Cancer Awareness Month with a focus on transforming screening into prevention. The company highlights that colorectal cancer (CRC) remains the second leading cause of cancer deaths globally, causing over 930,000 deaths annually, with 150,000 diagnoses in the U.S. and 22,836 deaths in Germany.
The company's research has yielded promising results through their ColoFuture and eAArly DETECT studies, achieving 82% sensitivity in advanced adenoma detection with 97% specificity using mRNA biomarkers, FIT test, and AI algorithms. Their flagship product, ColoAlert®, is expanding through laboratory partnerships, including a recent collaboration in Switzerland.
To increase accessibility, Mainz Biomed has implemented at-home testing solutions through European Oncology Lab's web platform. The company emphasizes that while CRC is highly preventable, low screening participation continues to make it a leading cause of cancer deaths, driving their mission to enhance early detection and prevention strategies.
Mainz Biomed (NASDAQ:MYNZ) has announced a strategic partnership with labor team w ag to launch ColoAlert®, a DNA-based colorectal cancer (CRC) screening test, in Switzerland. This marks Mainz Biomed's first entry into the Swiss market, where thousands of new CRC cases are diagnosed annually.
The partnership combines Mainz Biomed's DNA-based diagnostic expertise with labor team w's established laboratory services network. The ColoAlert® test will be available through labor team w's healthcare provider network starting in spring 2025, offering Swiss patients access to advanced CRC screening technology.
This collaboration aims to increase CRC screening participation rates and improve early detection capabilities in Switzerland. The partnership represents an expansion of Mainz Biomed's European market presence with its flagship product ColoAlert®, which is the first DNA-based CRC screening test in Europe.
Mainz Biomed (NASDAQ:MYNZ) and GANZIMMUN Diagnostics have launched an enhanced version of the ColoAlert colorectal cancer screening test across Germany, timing the release with March's Colorectal Cancer Awareness Month. The improved test, first introduced in mid-2024, features a proprietary DNA stabilizing buffer that ensures accurate results regardless of sample volume variations.
The launch coincides with Germany's updated national screening guidelines, which now provide equal access to colorectal cancer screening for both men and women starting at age 50, eliminating previous gender-based differences. This change follows research by the Institute for Quality and Efficiency in Health Care (IQWiG) that found no significant gender-based variations in recommended screening methods.
According to Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed, this development advances their mission of improving colorectal cancer prevention and detection. The collaborative effort between Mainz Biomed and GANZIMMUN demonstrates their commitment to enhancing cancer diagnostics through innovative solutions.
Mainz Biomed (NASDAQ:MYNZ) has successfully regained full compliance with Nasdaq Capital Market listing requirements. The company received formal notice from Nasdaq on January 23, 2025, confirming its compliance with the minimum stockholders' equity requirement under Listing Rule 5550(b)(1). This follows their previous confirmation of compliance with the minimum bid price requirement under Rule 5550(a)(2). As a result, MYNZ will maintain its listing and continue trading on the Nasdaq Capital Market.
Mainz Biomed (NASDAQ:MYNZ) has launched eAArly DETECT 2, a U.S. feasibility study to evaluate its next-generation colorectal cancer (CRC) test. The study will assess the performance of the company's proprietary mRNA biomarkers, AI-developed algorithm, and FIT test across approximately 2,000 average-risk patients.
The study aims to validate previous promising results and is expected to complete enrollment in the second half of 2025, with topline results targeted for Q4 2025. Following this study, Mainz Biomed plans to finalize protocols for ReconAAsense, their U.S. pivotal study scheduled for 2026.
The next-generation test incorporates five novel gene expression biomarkers acquired from Sherbrooke University in 2022, designed to detect both advanced adenomas (precancerous polyps) and early-stage CRC with high accuracy.
Mainz Biomed (NASDAQ:MYNZ) has partnered with Quest Diagnostics to advance its colorectal cancer screening test. Quest will provide laboratory services for Mainz's ReconAAsense FDA study, which will involve approximately 15,000 subjects across 150 US sites. The agreement includes an option for Quest to obtain semi-exclusive rights for testing services pending FDA approval.
The company's ColoAlert test, utilizing PCR technology to analyze stool samples for cancer DNA, has demonstrated promising sensitivity in detecting colorectal cancer and advanced adenomas. This development targets a significant market opportunity, as about one-third of US residents aged 50-75 have never undergone colorectal cancer screening, representing a potential $4.0B+ market in the US.
Mainz Biomed (NASDAQ:MYNZ) has completed its previously announced follow-on offering, raising $8.0 million in gross proceeds. The offering consisted of 1,367,521 units priced at $5.85 per unit. Each unit includes one ordinary share (or prefunded warrant), one Class A warrant, and one Class B warrant to purchase ordinary shares.
The Class A warrants are exercisable at $5.85 per share with a five-year expiration, while Class B warrants, also exercisable at $5.85, will expire either 30 days after the eAArly Detect 2 study results or one year from issuance. Maxim Group served as the sole placement agent for this at-the-market offering under Nasdaq rules.
Mainz Biomed (NASDAQ:MYNZ) has announced the pricing of a follow-on offering expected to raise $8.0 million in gross proceeds. The offering consists of 1,367,521 units, each priced at $5.85 and including one ordinary share (or prefunded warrant), one Series A warrant, and one Series B warrant.
The Series A warrants will be exercisable at $5.85 per share with a five-year expiration, while Series B warrants, also exercisable at $5.85, will expire either 30 days after the eAArly Detect 2 study results or one year from issuance. Maxim Group is serving as the sole placement agent, with the offering expected to close around December 16, 2024.
Mainz Biomed (NASDAQ:MYNZ) announced a 1-for-40 reverse stock split effective December 3, 2024. The split will reduce outstanding shares from approximately 80.1 million to 2.0 million. This action aims to increase market price per share to comply with Nasdaq's continued listing requirements. The company received notice of non-compliance with Nasdaq's minimum bid price requirement of $1.00 and the $2,500,000 minimum stockholders' equity requirement. Following a staff determination letter, Mainz Biomed plans to request a hearing to stay any suspension or delisting action.
Mainz Biomed (NASDAQ:MYNZ) has announced a collaborative agreement with Thermo Fisher Scientific to jointly develop and potentially commercialize Mainz's Next Generation colorectal cancer screening product. The collaboration will utilize Thermo Fisher's technologies, instrumentation, and information translation systems to develop proprietary mRNA-based screening tests.
The partnership aims to enhance Mainz Biomed's non-invasive test that targets both early detection of colorectal cancer and precancerous lesions, particularly advanced adenomas. The development will take place at Mainz Biomed's laboratories in Mainz, Germany, focusing on creating a home collection colorectal screening tool with enhanced adenoma detection capabilities.
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