A Mid-Summer Review of Medizone Activities
August 10, 2015
We have observed that our AsepticSureâ project for hospital room disinfection has moved into a new phase of acceptance among a growing group of medical professionals. This signals both a critical and monumental shift, tilting us increasingly towards commercial success and global recognition for achieving a standard of disinfection that prior to AsepticSure was simply impossible.
In general, I believe shareholders accepted the reality of AsepticSure’s ability to achieve greater than 6-log kill of infective pathogens in a health care setting – and the positive implications for health care – far sooner than the medical professionals. Why? The world of science and medicine is generally pretty conservative. Before AsepticSure, achieving even a 3-log kill of infective pathogens (99.9%) throughout an entire health care room was simply not possible. Most health care professionals already thought they were doing all they could – and all that was necessary. I cannot tell you how many times we have heard, “We are following FDA protocols and using all of the latest cleaning solutions. That is the best we can do.”
The resistance to adopting AsepticSure came for two primary reasons. First, the healthcare professionals believed they were doing all they could and second, they probably did not believe AsepticSure truly could achieve a 6-log kill throughout the entire room. After all, no one had ever come remotely close to that. Keep in mind the difference between a 3-log kill and a 6-log kill is a thousand-fold increase! That is a scientific revolution, and revolutionary science takes awhile to be understood, then intellectually accepted, and finally adopted as the new standard.
A big wake up call occurred when our Dr. Michael Shannon discovered in-laboratory that a 5-log control of MRSA plated onto a standard FDA petri dish and then “killed” to 3-log would regenerate to a full 5-log strength again in five days. This explained why hospitals continue to have such significant infection problems despite their best cleaning efforts. They never completely eliminated the reservoir of bacteria in the problem rooms!
It took many steps to arrive at the point where the medical community really began to acknowledge the efficacy of AsepticSure. It began with the peer-reviewed article published in the American Journal of Infection Control, followed in July of 2011 by an Award for Innovation at the World Health Organization’s First International Conference on Prevention and Infection Control in Geneva. Then came a major turning point, the actual demonstration of the elimination of new MRSA infections for eleven months from a hospital ward that had previously averaged one to two new MRSA infections a month.
Supporting work continued. In August of 2014, the National Research Council of Canada confirmed that AsepticSure achieved the same level of a greater than 6-log kill against both Adenovirus and Coronavirus as it achieves with bacterial pathogens. In September of 2014, an Environmental Safety Report on AsepticSure was completed by the highly respected private firm, Walsh & Associates, working with the Analytical Services Unit of Queen’s University. The bottom line of the report was simple. Following the AsepticSure disinfection process, the moment the door to the treated room is opened, the room meets all international safety standards and is available for immediate occupancy.
Then, in May of 2015, Dr. Shannon reported he had completed 25 test runs using the same FDA recommended test strips used for confirmation of sterilization of medical instruments in autoclave runs. These internationally recognized bio-markers were confirming our other findings that whole room disinfection was being obtained with AsepticSure. AsepticSure eliminates all infective pathogens throughout the entire room 100% of the time!
Spore forming bacteria are at the top of the pathogenic resistance list. They are the most elusive of bacteria, easily spread within a facility and difficult to kill. On June 15th at IPAC-2015, it was reported that in November of 2014, there were four C.difficile infected patients on a 25-bed ward with one mortality at Trenton Memorial Hospital in Ontario. AsepticSure came to the rescue and no additional infections have been reported after seven months and counting. AsepticSure efficacy is no longer simply laboratory research or hypothetical in nature. Its effectiveness is being confirmed in-hospital with each use and is building a track record of no new cases of hospital acquired infections (HAI) in rooms that have been disinfected with AsepticSure. Using the $26,000 CDC figure as estimated cost for treating each new HAI, the favorable cost/benefit factor adds up in a hurry!
In a shareholder update posted on June 11th, we reported that the Alberta Ministry of Health had contacted us and requested we demonstrate AsepticSure at two hospitals in Edmonton and Calgary. We look forward to those demonstrations. The originally proposed dates had been pushed back by the Ministry due to vacation conflicts. The Ministry is now in the process of confirming new dates.
As the Ministry had stated to us, “only AsepticSure is being considered as the disinfection system of choice for the Province.” Importantly, the Ministry of Health recognizes the efficacy of AsepticSure. The demonstrations are intended to familiarize staff and demonstrate how easily AsepticSure is integrated into their cleaning practices. Based on the positive responses we have received from administrators, nursing and cleaning staff at Belleville General Hospital, Trenton Memorial Hospital and most recently, Cambridge Hospital, which is North of Toronto, we should be well received.
Should, as anticipated, the Alberta Ministry of Health then support the funding of AsepticSure for hospitals within their Province that request our system, that would signal an important turning point, demonstrating the adoption of AsepticSure at a high government level.
It should be noted that the dinner sponsored by Medizone at the IPAC-2015 conference was attended by 22 professionals from across Canada, all holding high level positions within the healthcare system. Both Dr. Michael Shannon and Dr. Dick Zoutman made presentations at the dinner. They were very well received. Assuming our anticipated success in Alberta, the Canadian market should begin to open up.
In the June 1st AsepticSure Progress Update, I briefly touched on the US market and proposed trials to lead our entry into that market. Since that time, we have been contacted by a second, smaller hospital group that is privately owned. Both of these health care systems are interested in AsepticSure trials, with the intention of becoming early adopters in the US market, following a similar demonstration of efficacy and success to what is being demonstrated in Canada.
It has been determined that prior to formal EPA approval of AsepticSure an Experimental Use Permit from EPA would be required to undertake a US trial. As reported in our recent SEC filing on Form 10Q, in a letter dated June 29th, received on July 18th, the Agency confirmed that their “preliminary analysis of the material as submitted was found to be in full compliance with the standards for submission of data contained in PR Notice 11-03.” The agency has assigned PRIA category A540 to AsepticSure as an Oxidative Catalyst. While we cannot predict the actions of the agency, we have every reason to believe that our submission will be viewed favorably. The data submitted was very complete and to our best knowledge should have answered all of the agency’s questions. Dates for moving forward in the US are now being reviewed based on EPA requirements.
Chairman of the Board
Chief Executive Officer