OxyFile #598
MEDIZONE SHAREHOLDER LETTER January 23, 1998 Dear Shareholder, Since taking the reins of Medizone International approximately six months ago, I can finally report that the business and regulatory errors of the past appear to be behind us. We can now begin to execute our research and development plans with a clear and concise understanding of where we are and how to reach our goal of obtaining regulatory approval for the patented Medizone ozone technology for treating lipid enveloped viruses of the blood. Today I can report that we will soon be current with our SEC filings. The 1996 audit and the 10K report have been completed and should be filed by the time you receive this letter. Within a few weeks we will also be in full compliance with our 1997 SEC filings. The audits for 1997 are on schedule to be completed on time. This is a major accomplishment as the filings had been badly neglected. Bringing these important documents current required new management to investigate all past Company claims and ensure that the record was set straight. This we have done. As required by the SEC, our 1997 filing of the 10K report will be completed and filed on or before March 31, 1998. Hopefully you all received our October 29, 1997 letter to shareholders where I discussed our plans to visit Italy. The reasons for this trip were two-fold. First, we needed to reaffirm our commitment to commencing Human Clinical Trials in Europe. The objective is to receive European Union (EU) regulatory approval first and later return to the United States to seek United States Food and Drug Administration (FDA) approval. Another objective of the trip was to ascertain the status of the MEDIZONE ozone-generator being built for us in Italy by Multiossigen. This trip was successful. After meeting with Multiossigen, we determined our long-term objectives would be better served if we redesigned the instrument. A prototype of the generator should be ready for our review this quarter. In order to conduct human clinical trials, we must have a certified instrument to use in conducting the studies. This certification is expected by mid-summer. Once the studies begin, they will be conducted under strict European Standards. As I write this letter, I do not yet know if we will begin a Phase I or a Phase II study. We are hoping to begin a Phase II study treating adults with HIV. Although we no longer have an open Investigational New Drug Application (IND) with the Food and Drug Administration (FDA), we were told that data gathered from the European studies would be acceptable to use as part of an FDA filing. Undoubtedly the FDA will require additional data, but it was reassuring to learn that they will accept the data generated from the clinical trials in Europe. You have been extremely patient and loyal shareholders. You have demonstrated your commitment and belief in this innovative technology and the possibilities it offers humankind. Research and development stage companies work for years to obtain the regulatory approvals necessary to bring a new drug or medical instrument to the marketplace. Although we have been at this for a long time and expect to be awhile longer, I believe the climate for the acceptance of ozone as a viable human medical treatment is better than ever. With the additional funding we hope to receive in the not too distant future, we should be able to forge ahead and reach our goal within the next several years. Thanks to your support, it is once again an exciting and energizing time for Medizone. For a complete update on the Company, I suggest you call our Investor Relations firm, CTC, at (937) 434-2700 and request a copy of the 1996 10K report. Best wishes for a Happy New Year. Milton G. Adair President/CEO This letter contains certain forward-looking statements about the Company's goals and anticipated future performance. The industry in which the Company proposed to operate is dynamic and intensely competitive and there are many factors that could cause the forward-looking statements contained herein not to occur or the timing of the occurrence to be delayed. With the exception of historical information, the matters discussed in this letter are forward-looking statements that 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 and competitive environment, availability of raw materials and critical manufacturing equipment and facilities and other risks identified in filings made with the Securities and Exchange Commission. Source: http://www.medizoneint.com