Medizone today announced that it will meet with representatives of the FDA on January 18, 2018 to discuss the planned submission of a marketing application for AsepticSure.
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| [28-November-2017] |
| KALAMAZOO, Mich., Nov. 28, 2017 /PRNewswire/ -- Medizone, manufacturer of the AsepticSure® Disinfection System, today announced that it will meet with representatives of the U.S. Food and Drug Administration (“FDA”) on January 18, 2018 to discuss the planned submission of a marketing application for AsepticSure®. The FDA has confirmed that Medizone’s pre-submission filing contains all necessary information to permit the FDA to proceed with further review of the submission. Medizone’s CEO, David A. Dodd commented, “Our discussions with the FDA regarding AsepticSure® have been detailed and productive. We are looking forward to reaching an understanding with the FDA regarding the appropriate regulatory pathway and supporting data for the device in the near future and to making any necessary regulatory filings promptly after reaching agreement. If the FDA concludes that our pathway to regulatory approval requires that we pursue De Novo reclassification, we believe that we will be able to demonstrate that the application for the AsepticSure® reclassification can be granted and that the FDA pathway will provide us with a significant competitive advantage over other disinfection systems.” 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 and Section 21E of the Securities Exchange Act. 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: Medizone International, Inc. For more information, visit:
View original content:http://www.prnewswire.com/news-releases/medizone-to-meet-with-us-food-and-drug-administration-regarding-the-asepticsure-disinfection-system-a-revolutionary-disinfection-technology-300562509.html SOURCE Medizone International, Inc. | ||
Company Codes: OTC-BB:MZEI, OTC-QB:MZEI |
