Medizone Intl. (fka MZEIQ)

[Tane61]

FDA: Mean direct de novo review time 295 days

http://www.meddeviceonline.com/doc/the-de-novo-classification-process-a-work-in-progress-0001

The mean de novo review time for direct de novo submissions only, all of which have been filed post-FDASIA, is 295 days (median 274 days). However, over the entire history of the de novo process since 1997, the current review times remain much higher than in the 1997-2004 period.

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Liquidity and Capital Resources

As of June 30, 2017, our working capital deficiency was $4,341,831, compared to a working capital deficiency of $4,126,861 as of December 31, 2016. As of June 30, 2017, we had $59,223 of available cash. During the six months ended June 30, 2017, we issued 5,000,000 common shares at $0.06 per share for proceeds of $300,000.

We have incurred significant losses from inception through June 30, 2017, which have resulted in an accumulated deficit of $39,324,055. The stockholders’ deficit as of June 30, 2017 was $4,282,149, compared to $4,046,145 as of December 31, 2016. This change is due to proceeds from the sale of restricted shares of common stock being less than the net loss for the six months ended June 30, 2017. We will continue to require additional financing to fund operations and to continue to test and market our disinfection system. We believe we will require funding of approximately $1,500,000 over the next 12 months, based on current operations, for: (1) continued production manufacturing and related activities; (2) research, development, and marketing activities; and (3) limited general corporate purposes.

We anticipate that we will be able to raise additional funds, as needed, from certain of the accredited investors who have purchased shares during previous years, although we have no agreements at this time with any of these investors to purchase our securities, and there can be no assurance that these investors will purchase additional shares.

Going Concern

Our unaudited condensed interim consolidated financial statements included in this report on Form 10-Q have been prepared with the assumption that we will continue as a going concern. There is substantial doubt that we will be able to continue as a going concern. Through the date of this report on Form 10-Q, we have relied almost exclusively upon financing from the sale of our equity securities to sustain operations. Additional financing will be required if we are to continue as a going concern. If we do not obtain additional financing in the near term, we will be required to curtail or discontinue operations, or seek protection under U.S. bankruptcy laws. Even if additional financing becomes available, there can be no assurance that it will be on terms favorable to us. In any event, this additional financing will likely result in immediate and possibly substantial dilution to existing stockholders.

Forward-Looking Statements and Risks

The statements contained in this report on Form 10-Q that are not historical are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements discuss our expectations, hopes, beliefs, anticipations, commitments, intentions and strategies regarding the future. They may be identified by the use of the words or phrases that include “believes,” “expects,” “anticipates,” “should,” “plans,” “estimates,” and “potential,” among others. Forward-looking statements include, but are not limited to, statements contained in Management’s Discussion and Analysis of Financial Condition and Results of Operations regarding our financial performance, revenue and expense levels in the future and the sufficiency of existing liquidity to fund future operations and capital spending needs. Actual results could differ materially from the anticipated results or other expectations expressed in such forward-looking statements for the reasons detailed in our Annual Report on Form 10-K for the year ended December 31, 2016.

We believe that many of the risks discussed in our previously issued SEC filings are part of doing business in the industry in which we operate and will likely be present in all periods reported. The fact that certain risks are endemic to the industry does not lessen their significance. The forward-looking statements contained in this report are made as of the date of this report and we assume no obligation to update them or to update the reasons why actual results could differ from those projected in such forward-looking statements.

Among others, risks and uncertainties that may affect our business, financial condition, performance, development, and results of operations include:

·Rigorous government scrutiny and regulation of our products and planned products;
·Potential effects of adverse publicity regarding ozone and related technologies or industries;
·Failure to sustain or manage growth including the failure to continue to develop new products; and
·The potential inability to obtain needed financing or to obtain funding on terms favorable to us.

https://www.sec.gov/Archives/edgar/data/753772/000118518517001679/medizoneintl10q063017.htm

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MZEI UNABLE TO MAKE ANY HOSPITAL SALES IN FIRST 5 YEARS

TO DATE, NOT ONE (1) SALE TO A HOSPITAL NOR ONE (1) HOSPITAL SERVICE CONTRACT HAS BEEN REPORTED, WORLDWIDE (The manufacture of the first production machine was announced back in April 2012)