Nevada
(State or other jurisdiction of incorporation)
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2-93277-D
(Commission File Number)
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87-0412648
(I.R.S. Employer Identification No.)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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99.1
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MEDIZONE INTERNATIONAL, INC.
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By: /s/ Philip A. Theodore
Executive Vice President |
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Transparency – we seek to be open regarding our activities, efforts and results, while ensuring that we are compliant with financial-regulatory disclosure requirements;
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Note: our approach to shareholder communications is to ensure full compliance with regulatory guidelines, thereby using public announcements, our website and other “public” means of communication. As a result, we refrain from individual shareholder interactions/communications to ensure open, compliant communications to shareholders and other interested parties. Those inquiries that can be addressed will typically be handled by Investor Relations (John Pentony: j.pentony@medizoneint.com);
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Integrity – we agree to treat our colleagues, customers, shareholders, stakeholders and others in an honest, fair manner, recognizing that we are seeking to provide a solution to improved health to millions worldwide, while delivering highly attractive investment returns to our shareholders and meaningful career opportunities to our team;
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Quality & Customer Focus – we seek to provide the highest quality product/service at a fair price, along with the necessary support to ensure that our customers and those that benefit from our technology are fully satisfied and achieve the results we communicate;
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Competitiveness – we seek to be successful in our development and commercial activities, providing improved solutions based upon science, technology, manufacturing, distribution and other business activities; in summary, we seek to be the “best competitor” in the eyes of our customers and those that benefit from AsepticSure® and any future products/services we might offer; we seek to be classified as a “best investment” in the view of our shareholders and others in the investment community;
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Note: We recently began a series of commercial roll-out interactions with potential customers, recognizing that the first step in AsepticSure® utilization begins with real-world trial, use, validation and adoption. Our goal is to establish real-world use and evaluation of AsepticSure® within a variety of customer areas that will lead to formal adoption of our technology and product.
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Innovation – we recognize that the pace of science and technology is such that we have to continuously adapt to changing needs related to infection control and decontamination. While we can’t predict future needs, we seek to ensure that the products/services that we provide continue to meet the various market needs and regulatory expectations.
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Achieve the necessary regulatory approvals that enable the commercialization of AsepticSure® for broad use in disinfection within a broad scope of markets (e.g., healthcare; pharmaceutical/laboratory industry; military; sports industry; etc.) throughout the world;
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Note: On January 18, we had a successful meeting with the FDA and have agreed upon the path and additional activities necessary to pursue approval of AsepticSure® as a Class II Medical Device. We are pleased that the FDA has accepted our already completed Environmental Safety studies, eliminating any additional studies in that area. We have completed our proposed protocols for the Materials Compatibility studies and Efficacy studies, which are currently under review. Once we have agreed upon protocols, the respective activities will commence, which we anticipate completing before the end of Third Quarter, followed by our submission to the FDA. We are confident in our ability to successfully demonstrate the necessary results in support of our goal of submitting our test results to the FDA and achieving approval. Regarding the timeframe for approval, we can only estimate that timeline, which we expect will be less than six months following submission.
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Establish a commercial operation that utilizes internal and external expertise to achieve strong commercial penetration and adoption of AsepticSure® within our targeted markets, globally, supporting continued growth and expansion of our business;
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Note: Recently, we’ve commenced commercial presentations and discussions with various potential AsepticSure® customers within the U.S. Historically, the Company has conducted multiple validation demonstrations of AsepticSure®, but we’ve yet to achieve a real-world trial and validation use of our technology.
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Build a capital structure that enables the Company to successfully pursue the necessary regulatory approvals and commercial operations in support of achieving a profitable, revenue generating business providing highly attractive shareholder value while delivering improved disinfection control to industry markets worldwide;
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Note: We have been challenged with a cash balance that is insufficient to appropriately support the business building activities and operations that are necessary to achieve adoption and use of AsepticSure® in the various targeted industry markets and geographic regions. This has been a major challenge to the Company since at least early 2017.
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Improve health and lives worldwide through the adoption and use of AsepticSure®.
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Note: this ultimate goal is only achievable if we’re able to successfully proceed with our FDA activities and a solid commercialization of AsepticSure®.
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