8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 25, 2017

Medizone International, Inc.

(Exact name of registrant as specified in its charter)

Nevada	2-93277-D	87-0412648
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)
350 East Michigan Avenue, Suite 500 Kalamazoo, MI		49007
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (269) 202-5020

Not applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On August 25, 2017, Medizone International, Inc. (“Company”) issued a press release announcing the Company’s intention to submit a marketing application to the U.S. Food and Drug Administration (“FDA”) for the use of AsepticSure® as a medical device. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d)  Exhibits

Exhibit Number	Description
99.1	Press Release dated August 25, 2017.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	MEDIZONE INTERNATIONAL, INC.
Date: August 28, 2017	/s/ David A. Esposito
	David A. Esposito
	Chief Executive Officer

EX-99.1

Exhibit 99.1

Medizone International Announces Next Steps with FDA on AsepticSure^®

Medizone International prepares plans to submit a marketing application to FDA for use of AsepticSure as a medical device

Kalamazoo, Michigan, Friday, August 25, 2017 — 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.