KALAMAZOO, Mich., Aug. 25, 2017 /PRNewswire/ -- Medizone
International, Inc. (OTCQB: MZEI) announced that it has received a written response from the U.S. Food and Drug Administration
("FDA") on the Company's 513(g) submission for disinfection of exposed surfaces and equipment within medical facilities with
AsepticSure®. The FDA recommended that the Company proceed to market through the de novo classification pathway given its
novel technology compared to other FDA-regulated disinfection systems. Regulation through the de novo pathway requires that
the medical device be low- to moderate- risk. The company intends to support its application with data demonstrating
AsepticSure's safety and efficacy profile and low risk nature. FDA invited Company representatives to schedule follow up
meetings to discuss the best approach for introduction of the AsepticSure technology into the U.S. market. Successfully
completing this regulatory pathway would further support the significant competitive advantage of AsepticSure in the
marketplace.
"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.
For press information on Medizone International, please contact:
John Pentony, Investor and Media Relations
T: 01 269-202-5020
E: j.pentony@medizoneint.com
For more information, visit:
http://www.medizoneint.com
Email: operations@medizoneint.com
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SOURCE Medizone International, Inc.