AsepticSure Generation III
As a clarification, all AsepticSure systems ever built have demonstrated the same level of efficacy: Greater than 6-log, greater than 99.9999% kill of all bacterial and viral pathogens throughout the entire space disinfected. This level of efficacy has stopped new cases of HAI in their tracks, as demonstrated in a number of Canadian hospitals through the collection of accumulated data. 11 months without a single new MRSA infection at Belleville General and 5 months as of June 2015, for C-difficile at Trenton Memorial as examples. In each situation, a single AsepticSure cleaning broke the reinfection cycle in these previously contaminated hospital rooms.
Ever since confirming at our Innovation Park, Queens University Laboratories that MRSA plated onto a standard FDA petri dish with a partial kill of 3 log performed (99.9% bacterial kill), the petri dish then simply set aside and observed, and in 5 hours the remaining 0.1% of bacteria began to regenerate, complete elimination of the infective pathogen was proven as essential! In 5 days the bacteria had then grown to an infective level of 5-log. It was clear that the unprecedented level of AsepticSure disinfection achieved is truly required to render the treated space a 100% safe, infection free zone. Once a room is disinfected with AsepticSure, no infections can be generated from that space until a new infective pathogen is introduced! The infective reservoir has been eliminated by AsepticSure! This explains one of the root causes of hospital-acquired infections, using conventional cleaning practices alone does not work. Only AsepticSure totally eliminates the infective source – every time!
If all AsepticSure systems achieve the same level of efficacy, what are the differences between Generations I, II and III?
EFFICIENCY and INFORMATION!
Generation I and II AsepticSure systems were essentially the same with the exception of the Internet based communication system introduced with Generation II. This allowed the systems performance to be monitored and recorded from any place on the planet. As a recent example, we have monitored Al-Hidaya’s use of AsepticSure in Saudi Arabia with the same clarity of ozone-charge times, hydrogen peroxide ramp rates, treatment hold times and ozone destruct as if we were there. It is an amazing communications technology and a great product support tool. Globally, all AsepticSure Generation I systems have now been converted to Generation II.
One operating limitation for AsepticSure has always centered around the cubic size of the area to be treated and the capacity of the equipment to treat that area. The basic operational parameters involve sealing the room, charging the space to 80 PPM O3 with vaporized 1.4% hydrogen peroxide misted in with the ozone, (creating Trioxidane), and targeting 80% relative humidity. Following the disinfection cycle hold time, the room is cleared of any residual O3 and H2O2. The results of ozone destruct and air quality restoration has been independently certified as meeting all International Safety Standards for immediate re-occupancy.
Moving to Generation III:
In early November of last year, our engineering team began development on a new ozone generator, utilizing a revolutionary UV bulb that was proving to generate ozone more efficiently. Following experimental proof of concept work using different generator sizes and designs, we arrived at what proved to be our next generation ozone generator. The new design produces twice the ozone output per generator, while requiring less electrical power! The new generator was also designed as a ‘plug and play’ replacement for our current generators, allowing current systems to be upgraded.
By January of 2015, we were testing a fully functioning prototype system of AsepticSure using this new technology. We have been testing this new system all year and it has proven absolutely reliable. It consistently outputs more than twice as much ozone as the previous system, which equates to being able to treat twice the space with a single system, where two systems might have been required before. Or in the same size space, room turn time is significantly decreased. For the balance of 2015, we worked with this new system both in-laboratory and in-hospital, recently in the Province of Alberta. Like our previous systems, this new system is modular in design and up to 4 systems may be operated at one time. We consider the efficiency demonstrated a game changer. Moving forward, only Generation III systems will be produced by Medizone.
Following this successful test period, the company placed an initial order for 24 new generators of this design. We now have them inventoried. The first customer for the conversion to Generation III is our Canadian distributor, Contamination Control Company (C3) http://www.contaminationcontrolcorp.com. Two of their Generation II systems will be converted the first of the new year. In-house, we will be converting all Medizone systems in our inventory to Generation III during Q1, 2016.
While the new generators are the most significant upgrade to Generation III, many other improvements and refinements are included. There is a new touch screen for the control panel and updated software operating system; the remote, wireless computer control system has been replaced with a modern tablet, which allows more flexibility in operation; a hard wire port has been added for those rare circumstances when you might prefer to not operate through wireless communication for fear of possibly upsetting critical wireless devices operating in the same area, such as on a critical coronary care unit; there are now dual humidity sensors that cross check each other, adding to reliability.
Fresh engineering drawings are being completed and QPS testing to Global standards will be underway in January. QPS testing, similar to UL certification, will certify the system as safe electronically and approved for sale in the global market. Initial production runs should be underway by March.
Looking forward to the New Year, we are optimistic regarding developments in numerous markets. No absolute predictions just yet, but internally we are seeing reasons to be optimistic for both the Canadian and US markets as we enter 2016.
I also believe the South American market is in good hands with GYD S.A. Their regional roll out will initially take more time as the regulatory process needs to be addressed on a country-by-country basis. Our South American distributor, GYD S.A. has begun the process in Chile, Columbia and Brazil.
Saudi Arabia remains somewhat of a mystery. With the new King came a new Minister of Health and many other personnel changes within their regulatory agencies. Al-Hidaya continues to work with the individuals involved with a goal of obtaining full regulatory approvals. Given that AsepticSure has recently been ruled not to be a medical device by the Saudi FDA, perhaps they are getting closer. The Al-Hidaya commitment has been demonstrated through the hiring and training of additional technicians to operate the systems, the expanded training was assisted by Medizone personnel in October. Medizone has also provided additional support to Al-Hidaya for the Saudi FDA and Minister of Health.
Regarding future production: Assuming we see product demand increasing as we move through the new year, we should be positioned to move production delivery numbers from 5 – 10 systems per month initially, to 10 – 20 and upwards to 50 or more if required in two month incremental increases. New production is not expected to be initiated prior to March with QPS in place.
Revolutionary science takes awhile for people to wrap their head around. Certainly this has been the case for Medizone with AsepticSure. It truly is an educational process for the science and medical community. You must eliminate all infective pathogens to be successful in disease reduction, that is number one. Frankly, very few doctors are currently aware of that fact. However, given the growing accumulation of successful data from in-hospital work that clearly shows the elimination of new cases of infection from AsepticSure treated rooms, they will come to appreciate it. Once the CFO’s of the medical system sit down and begin to analyze the cost data, comparing the acquisition and use costs associated with AsepticSure compared to the savings from disease reduction based on the US CDC estimates of $26,000 to treat each new HAI, the conversation should clearly shift in our favor. The journey has been long for all of us. It has taken untold hours of dedicated work to get where we are today, on the threshold of medical and commercial success with a technology the world never imagined possible, until now, Generation III of AsepticSure.
Edwin G. Marshall
Chairman of the Board
Chief Executive Officer