Chairman's Message - May 5, 2015
Biological Indicators Now Confirming 100% Disinfection with AsepticSure!
The ability of AsepticSure to disinfect critical health care settings to greater than 6-log (>99.9999% kill) throughout the entire room is now being confirmed using the same biological indicators used with autoclaves to assure medical instruments are sterile.
Biological indicators are recognized by most medical authorities throughout the world as being the closest to the ideal quality assurance monitors for the autoclave sterilization process employed in most hospitals. Indicators are now commercially available to directly measure the effectiveness of disinfection by using the most resistant microorganisms (such as Bacillus spores) and are now used routinely to ensure that surgical instruments are absolutely free of pathogens prior to their use. Since the Bacillus spores used in biological indicators are more resistant and present in greater numbers than are the common microbial contaminants found on patient-care equipment, the successful demonstration that the spores on a biological indicator have been completely inactivated confirms that all other pathogens potentially found in a hospital have been killed to a level of 6-logs or greater. Biological indicators are considered the only process indicators that can directly monitor the lethality of a given cleaning process and are recommended by the FDA for all autoclave usage. Spore test strips have now become the reference standard for routine quality assurance of hospital instrument sterilization and according to the FDA, they should be utilized with each autoclave load.
What does this have to do with AsepticSure? Several weeks ago our lab at Queen's University began testing such strips commonly used in North America in their search for a reliable means of confirming that rooms decontaminated with AsepticSure were properly cleaned. We discovered that spore test strips are completely inactivated (killed) when placed in a room during an AsepticSure run. Over twenty-five runs have now been completed using two different commonly used types of spore test strips and in each case the results have been the same.
Our research team has placed spore strips under beds, on the floor, on walls and behind objects. The spore strips have proven that all potential pathogens are killed 100% of the time. The implications of this finding are profound in that our AsepticSure system can now demonstrate, via independent, internationally recognized testing processes, a level of decontamination previously not considered achievable outside of an autoclave. Is it possible to disinfect a hospital room to the same level as surgical equipment such as forceps and scalpels being used in an operating room? Up until now the world would have said "impossible", but not any more.
Breaking into the Hospital Market
Challenging! Yes, it has been a real challenge introducing new disinfection technology to the hospital market. In hindsight, I suspect that many in health care, and possibly even the regulatory community, simply did not believe the results we were publishing. This is a skeptical audience at best. Who could blame them? Companies with other technologies such as UV were making very attractive claims they could not back up. Those claims have now been debunked by peer-reviewed literature. At long last, the situation seems to be changing in our favor. As the honeymoon with UV is dying off, the word of AsepticSure’s now demonstrated ability to break the re-infection cycle in-hospital is spreading. On a neonatal care unit, well babies were no longer at risk, following the elimination of Psdudomonas aeruginosa in the room. Rooms once infected with MRSA and C.difficile at two different Canadian hospitals became disease free. Indeed, the entire ward became disease free following the decontamination of previously infected rooms.
And now, independent verification of complete disinfection in any hospital room is possible using internationally recognized, commonly used, biological indicators.
In Canada the level of interest being shown is heating up. Demonstrations have been conducted and numerous others scheduled at a number of hospitals in different provinces. An inquiry has even been received from a Provincial Ministry of Health regarding AsepticSure with a distinct possibility of a province adopting it in the future. A comment from the Ministry's representative, “it is the only technology we are considering,” is very encouraging.
Meanwhile, the company is preparing to shift much of its focus onto the US market in the not-too-distant future. AsepticSure’s time is coming!
The Kingdom of Saudi Arabia (KSA)
On December 17th of last year we posted that “we anticipate our team traveling to the KSA early in 2015, demonstrating the system and supporting the distributor in establishing a commercial sales, training and product support program for the region.”
The situation then shortly began to significantly shift, beginning with the sudden death of King Abdullah bin Abdulaziz in January. In February, his successor, King Salman bin Abdulaziz Al Saud replaced Abdel Bin Mohamed Faqih as Minister of Health. Within six weeks of his tenure, the newly appointed Minister of Health was then also replaced.
Now, as of April 29th, Khaled Bin Abdulaziz Al-Faleh has been appointed as Minister of Health for Saudi Arabia. This is the third person appointed Minister of Health since February of this year. The Crown Prince (1st in line to the Crown) has also been replaced. These successive events have caused decisions to be delayed regarding health care as these reorganizations take place, creating uncertainty as to new timelines or final outcomes.
Environmental Protection Agency
Medizone has completed all required efficacy testing in accordance with the latest protocol approved by the EPA in late December 2014. At present, we are dealing with various complex, but solvable regulatory requirements, such as the need for a US sourced EPA registered peroxide. This is more technical than simply adopting any suitable peroxide product, as the EPA approved use labeling for the product must correspond to our EPA approved use labeling for AsepticSure. We expect this issue to be resolved to the satisfaction of the agency in the very near future, whereupon we can proceed with what is believed to be a final and complete formal submission. The EPA efficacy protocol was understandably very demanding and we take great pride in the fact that our AsepticSure system performed flawlessly and reinforced our conviction that our novel process can effectively decontaminate even the most difficult of hospital settings. That being said, this is a sensitive regulatory process in which the Agency cannot be compromised or pressured for a decision. We are pleased to report that the Agency has become more helpful in working with our regulatory team.
AsepticSure Patent Update
Medizone International has thus far achieved five granted patents including three in the United States, one in Canada and one in Singapore. Importantly, as reported by our patent attorneys, a number of additional International applications are also progressing nicely and appear headed toward approval. The importance of demonstrated and continuing success with our AsepticSure intellectual property program to the company’s future valuation cannot be overstated. Combined with the now proven efficacy of AsepticSure, we believe the long-term value of our company should grow dramatically once we demonstrate demand in both the Canadian and US market coupled with increased production and product delivery.
Medizone International, Inc. (MZEI.OB)
4000 Bridgeway, Suite 401
Telephone: (415) 331-0202
Telephone: (510) 686-1238