| Over a month ago | ||||
Mainz Biomed announced… Mainz Biomed announced the appointment of Darin Leigh as chief commercial officer. Darin comes to the role with over 25 years of product lifecycle management and global commercial operations experience across Europe, the United States and Asia. More recently, as chief commercial officer at emergency medical services company CDR Health, Darin was part of the commercial team that delivered millions of dollars in new contracts as CDR scaled testing, vaccination and monoclonal antibody treatment services in response to the Covid-19 pandemic for the state of Florida. | ||||
Mainz Biomed announced… Mainz Biomed announced that it has received supportive feedback from the FDA on the company's pre-submission package profiling the potential pivotal clinical trial design for ColoAlert, its detection test for colorectal cancer, or CRC. As Mainz prepares to launch ColoAlert's pivotal clinical trial, the company also announced the formal commencement of its reimbursement process for ColoAlert by scheduling an initial meeting with The Centers for Medicare and Medicaid Services, or CMS, in April. The CMS is a federal agency in the U.S. Department of Health and Human Services, or HHS, that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children's Health Insurance Program and health insurance portability standards. | ||||
Mainz Biomed announced… Mainz Biomed announced partnerships with Sentinel Diagnostics and Alcedis GmbH to support ColoFuture, its clinical study evaluating the potential to integrate a portfolio of novel mRNA biomarkers into ColoAlert, the company's highly efficacious, and easy-to-use detection test for colorectal cancer, or CRC. Under the terms of the partnership, Mainz will have access to the SENTiFIT 270 Analyzer, Sentinel's automated Fecal Immunochemical Test, or FIT, processing system for the ColoFuture study. An essential component of ColoAlert is the utilization of a FIT which provides a complete review of blood in the stool, a condition often associated with cancerous polyps and colorectal carcinoma. It is the combination of ColoAlert and FIT results that provide the diagnostic outcome. This partnership enables Mainz to transition from deploying a manual FIT processing methodology to an automated system for potential future use in the EU commercial setting and in the company's forthcoming U.S. clinical trial. In addition to the Sentinel appointment, Mainz is pleased to partner with Alcedis, a full-service contract research organization providing clinical trial management for biotechnology and medical device companies across the globe. Under the terms of the engagement, Alcedis will provide Mainz with the full range of services and responsibilities associated with executing ColoFuture, including patient recruitment, overseeing study protocol compliance, and the documentation and reporting of patient results. | ||||
| Over a quarter ago | ||||
Mainz Biomed announced… Mainz Biomed announced that its pre-submission filed with the FDA for ColoAlert has been accepted for review. By accepting the pre-submission for review, the FDA will provide feedback to the company on its proposed pivotal U.S. clinical trial design for ColoAlert, its detection test for colorectal cancer. The FDA feedback is expected in calendar Q2, and will offer Mainz the opportunity to gain preliminary insight and guidance on the potential technical parameters and endpoints of the study, which is on track to commence in 2023. | ||||
Mainz Biomed announced a… Mainz Biomed announced a partnership with Labor MVZ Dr. Stein + Kollegen, or Laboratory Monchengladbach. Laboratory Monchengladbach, one of the largest diagnostics laboratories in the North Rhine-Westphalia region of Germany, will commercialize ColoAlert, Mainz Biomed's detection test for colorectal cancer, ot CRC. With a team of over 500 employees that includes biologists, chemists, doctors and other specialists, Laboratory Monchengladbach services over 2500 physicians, processing over 5M samples in total annually and screening approximately 1000 patients per week specifically for CRC. Under the terms of the partnership, Mainz Biomed will co-brand ColoAlert with Laboratory Monchengladbach, and sell its polymerase chain reaction, or PCR, assay kits for advanced colorectal cancer detection, on an on-demand basis for use by Labor Monchengladbach's network of physicians and their patients. In order to optimize awareness and adoption, Mainz Biomed and Labor Monchengladbach will also collaborate to deliver a comprehensive marketing and education campaign to include direct-to-consumer advertising, cross channel promotion to physician networks, webinars and sales representative training. | ||||
Mainz Biomed announced it… Mainz Biomed announced it has commenced ColoFuture, an international clinical study to evaluate the potential to integrate a portfolio of novel mRNA biomarkers into ColoAlert, the company's highly efficacious, and easy-to-use detection test for colorectal cancer which is being commercialized across Europe. The ColoFuture study will evaluate the effectiveness of these biomarkers to enhance ColoAlert's technical profile to extend its capability to include the identification of advanced adenomas, a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert's rates of diagnostic sensitivity and specificity. | |
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The deal priced below… The deal priced below last closing price of $20.25. Boustead is acting as sole book running manager for the offering. | |
Boustead Securities is… Boustead Securities is acting as sole book-running manager for the offering. | |
Mainz Biomed announced it… Mainz Biomed announced it has formally contracted with DCN Dx, an international developer of point-of-care diagnostics, and provider of product development services. Emily Friedland, VP of clinical research at DCN Dx will spearhead the preparation and initiation of Mainz's European centric clinical study to evaluate the potential to integrate a portfolio of recently acquired novel mRNA biomarkers into ColoAlert, the company's detection test for colorectal cancer. This suite of biomarkers which were in-licensed from Socpra Sciences Sante Et Humaines S.E.C. in early January, have demonstrated the ability to detect pre-cancerous lesions including advanced adenomas, a type of pre-cancerous polyp often attributed to colorectal cancer. The study is on track to commence in the first half of 2022. Under the terms of the engagement, DCN Dx will be responsible for the selection of additional clinical research organizations and assist Mainz's management with the development of robust study protocols and associated clinical processes. |
