The company has reached decisions regarding the regulatory pathway for approval of the system and the additional information that must be generated to support a marketing application.
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| [18-January-2018] |
| KALAMAZOO, Mich., Jan. 18, 2018 /PRNewswire/ -- Medizone, manufacturer of the AsepticSure® system, today announced that as a result of its meeting with representatives of the U.S. Food and Drug Administration (FDA) on January 18, 2018, it has reached decisions regarding the regulatory pathway for approval of the system and the additional information that must be generated to support a marketing application. Medizone’s President and Chief Medical Officer, Dr. Michael Shannon commented, “Our discussions with the FDA regarding the regulatory pathway for approval of AsepticSure® were positive, productive, detailed and specific. During the discussions, the FDA stated its position that there is no predicate device that is substantially equivalent to AsepticSure® because of its unique method of action. As a result, we will apply for De Novo classification of the system. Furthermore, we now have a clear understanding of the additional testing that we will need to conduct and the additional data that we will need to submit to support our De Novo application. We anticipate being able to perform the additional testing and to provide the additional data within a few months, which would permit us to submit an application for De Novo classification by the end of the third quarter. If our application for De Novo classification is granted, we believe we will enjoy a significant competitive advantage over other disinfection technologies.” About Medizone International, Inc. Medizone International, Inc. is focused on commercializing the AsepticSure® System, a superior disinfectant technology compared to conventional systems or practices. The company developed the AsepticSure® System to combine oxidative compounds (O3 and H202) to produce a unique mixture of free radicals (H2O3 known as trioxidane) with much higher oxidative potential than ozone or hydrogen peroxide alone. After securing broad IP protection for the use of trioxidane for both healthcare and non-healthcare facility disinfecting systems and bioterrorism applications, Medizone released its AsepticSure® System for use in Canada, and several other global markets. Safe Harbor Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Our actual results could differ materially from those projected in these forward-looking statements, which involve a number of risks and uncertainties, including the risk that government and international agencies and organizations may not adopt our system, global economic conditions generally, government regulation, manufacturing and marketing risks, adverse publicity risks, risks associated with our entry into the U.S. and other markets, expansion and operations. The contents of this release should be considered in conjunction with the risk factors, warnings, and cautionary statements that are contained in our most recent filings with the Securities and Exchange Commission. For press information on Medizone International, please contact: For more information, visit:
View original content:http://www.prnewswire.com/news-releases/medizone-determines-regulatory-pathway-for-the-asepticsure-system-a-revolutionary-disinfection-technology-following-meeting-with-us-fda-300584958.html SOURCE Medizone International, Inc. | ||
Company Codes: OTC-BB:MZEI.OB, OTC-PINK:MZEI, OTC-QB:MZEI |
