“We look forward to an ongoing productive dialogue with FDA to demonstrate the potential of AsepticSure to make a positive impact in the US healthcare sector,” commented David A. Esposito, Chairman and Interim CEO of Medizone International. “As we address these next steps with FDA, we continue to support expanding our sales and marketing efforts in other segments in the US and markets across the world.”
In November 2016, Medizone received clearance from the U.S. Environmental Protection Agency (“EPA”) (Reg. No. 90607-3) to market AsepticSure ozone disinfectant formula for use for disinfection of non-porous surfaces in hospitals, clinics, hotels, sporting venues and in the food industry, long-term care facilities, and other critical infrastructures.
The Company will continue to market AsepticSure in the US under the previously announced EPA clearance in non-medical uses as it works through the FDA regulatory process.
Medizone will continue to support commercial operations in markets outside the United States, which are not affected by this decision. In addition to the EPA clearance, the AsepticSure technology has received market approval from regulators for use and distribution in Canada, New Zealand, and Chile, and is currently seeking approvals in other countries in South America, Europe and Asia.
This Press Release may contain certain forward looking statements that could involve substantial risks and uncertainties, including, but not limited to, the results of ongoing clinical studies, economic conditions, product and technology development, production efficiencies, product demand, competitive products, competitive environment, successful testing and government regulatory issues. Additional risks are identified in the company’s filings made with the Securities and Exchange Commission.
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SOURCE Medizone International, Inc.