In my view, this might be the most important shareholder update I have had the privilege to write. As a result of the recently reported 6-month follow up at Belleville General Hospital, the two most frequently asked questions - questions that have repeatedly been asked by medical professionals and hospital administrators - have now been answered. How often do we need to clean a room with AsepticSure® and how do we justify the cost?
This past summer Belleville General Hospital suffered a MRSA outbreak that had infected 7 patients on a 14-bed ward. According to the hospital’s Chief of Staff, “On average we have had one or two new MRSA cases per month on the ward.”
AsepticSure was brought in and the outbreak was immediately quashed. A 6-month review - following a single AsepticSure cleaning last summer - revealed there had not been a single new case of MRSA on the ward since the disinfection!
These results have demonstrated two very important things. First, the answer to the often-asked question of'cleaning frequency.' In our laboratories we have repeatedly demonstrated that if bactericidal kill is intentionally limited to 99.9% (3 log), then in a few hours the remaining 0.1% of bacteria begins growing back and in just five days it can be measured at full strength. This fact is a reason why hospitals continue to struggle with reinfection issues. Until AsepticSure there simply was not a way to obtain 100% bactericidal kill in a hospital room using currently accepted cleaning protocols. This is a core reason why hospitals have continued to endure the endless cycles of never-ending new infections. The source of infection had never been fully eliminated. The 6-month Belleville results have demonstrated that AsepticSure has the potential to break the reinfection cycle! Belleville demonstrated that in a real world hospital environment you can break the bacterial regrowth cycle, just as has been demonstrated in our laboratories, by obtaining a 100% kill with AsepticSure. When all of the bacteria are killed, the bacterial regrowth cycle is halted.
We now believe an AsepticSure disinfected room will remain safe until a new bacteria is introduced into the room from another source. Following AsepticSure disinfection there simply is no bacteria left in the room that can regenerate and infect again! Thus the answer to the cleaning frequency question is becoming clear. While additional cleanings would always be encouraged to provide a positive preventative measure, simply cleaning rooms known to house an infected patient following their discharge or movement from the room can make a world of difference! In the example at Belleville General, a single cleaning made 6-months of MRSA free difference!
As for the How do I justify the cost of the system question, again using the Belleville General Hospital example, the financial savings by avoiding six or more infections over 6-months (based on the previously reported new infection averages by the hospital’s Chief of Staff of one to two new infections per month) equates to a savings that would more than pay for the system. The United States Center for Disease Control (CDC) places the cost of treating each new hospital acquired infection at $25,000. Using the CDC figure, AsepticSure would have justified the cost of acquisition and it was only used one time in the 7 rooms!
The business case has been made! The cost / benefit analysis clearly works. AsepticSure is proving it can greatly reduce infection rates while retaining significant financial resources through obvious cost avoidance.
Based on a few key telephone calls placed to my office by hospital administrators in the United States inquiring about early adoption following the January 23rd press release, the medical community appears to be arriving at the same conclusion.
US Market Entry
Now that our health care and bioterrorism countermeasures patents have both been Granted by the United States Patent and Trademark Office and we have been given FDA clearance as a Class 1 medical device, we are close to entry into the US market. Only EPA approval remains. While no one dare predict the timing of a government agency action, it would appear our EPA application is once again moving forward in a positive direction, as reported by our regulatory team.
As with many new inventive technologies that break barriers that once looked impenetrable, this journey has taken a bit longer than we anticipated. However, the potential rewards now look to be greater than we had ever before envisioned.