In September 2024, Mainz Biomed (MYNZ) announced feedback received from the FDA for the breakthrough device designation with the request to expand the current clinical data set with additional average risk population. In October 2024, the Company made the strategic decision to focus its efforts on three key initiatives for the remainder of 2024 and into 2025 in order to maximize shareholder value. Those initiatives are: The continued growth of its ColoAlert business in Europe; Development of its next generation colorectal cancer screening product; and Running a 2,000 patient study, with average risk patients in the U.S., to read out in the second half of 2025. With eAArly DETECT 2, the Company addresses the recent FDA feedback and prepares for a new submission for breakthrough device designation with an expanded data set, including a larger average-risk patient population. In line with these strategic initiatives, the Company restructured its operations and implemented cost reductions which included decreasing its operating costs, primarily driven by the reduction of personnel and external consulting costs.
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Read More on MYNZ:
- Mainz Biomed reports 1H EPS (48c) vs. ($1.00) last year
- Mainz Biomed Sees Revenue Growth Amid Cost Reductions
- Mainz Biomed Secures Additional $1.5M Funding
- Mainz Biomed reports increased demand for enhanced ColoAlert product
- Mainz Biomed Executes Convertible Note Agreement
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