The following letter was received from Dennis G. Maki, MD, Ovid O. Meyer Professor of Medicine, Section of Infectious Diseases, Department of Medicine.

Carl Ricciardi
ALTAPURE, LLC
P.O. Box 166
Tomahawk, WI 54487

RE: ALTAPURE Peracetic acid-Hydrogen Peroxide Aerosol Technology

Dear Mr. Ricciardi,

This letter formally states my continuing interest in undertaking prospective clinical evaluations of ALTAPURE's novel antiseptic aerosol technology for preventing surface contamination by microorganisms that pose a threat to human health, particularly in the healthcare setting or food industry.

I was very impressed by the results of our initial challenge experiments in a test chamber last summer undertaken to evaluate the ALTAPURE technology in a simulated healthcare setting. The results confirmed that a brief exposure to the dilute peracetic acid-hydrogen peroxide aerosol totally sterilized a wide variety of solid surfaces as well as fabrics heavily monocontaminated by clinical isolates of methicillin-resistant Staph aureus (MRSA), vancomycin-resistant Enterococcus (VRE), Pseudomonas aeruginosa, Acinetobacter baumannii and, especially, the spores of Clostridium difficile.

The next logical step was trials in patient-care hospital rooms to assess the capacity of the peracetic acid-hydrogen peroxide aerosol to sterilize a wide variety of contaminated surfaces as well as patient care items and apparatus used repeatedly on multiple patients and vulnerable to surface contamination by MRSA, VRE, A. baumannii and C-Diff. In these experiments, baseline levels of contamination with a large inoculum of each of the test organisms would be measured and after an 8-15 minute exposure to the aerosol, residual contamination would be assessed to determine if the technology could provide rapid, complete and safe decontamination of every exposed surface in a patient care room, as well as multi-use patient care items. If it could, the technology would have much promise in clinical patient care, allowing simpler and far more reliable – vis-à-vis, total - - decontamination of every surface in patient care areas, especially hospital and clinic rooms, as well as the innumerable multi-use patient-care items that are currently decontaminated in a desultory manner, if they are even periodically decontaminated at all.

As you know, we have just completed these studies in two unoccupied hospital rooms in my university hospital, inoculating in duplicate on contiguous ~ 10 cm2 areas more than a dozen surfaces - - mattresses, bedside tables, bedrails, curtains, doorknobs, cabinet handles, faucet handles and sinks, toilet seats, shower curtains, walls and doors – with approximately 10,000 colony-forming-units of each the above hospital pathogens, letting the inocula dry overnight then culturing the first inoculum at each site to measure the baseline level of contamination, after which the room was exposed for ~8 minutes to the dilute peracetic acid-hydrogen peroxide aerosol. After scavenging the aerosol and the surface had dried (<1 hour), we sampled each exposed duplicate inoculated site and again found total sterilization, most impressively, even with 10,000 spores of C-Diff.

MRSA, VRE, P. aeruginosa, A. baumannii and, especially, C-Diff comprise a huge and growing reservoir of emerging antibiotic-resistant human pathogens that are now being spread widely throughout the environments of modern-day hospitals and clinics, and are implicated in more than a million healthcare-associated infections each year in North America alone. I am specifically speaking to environmental items that are touched and handled by hundreds of healthcare workers on an ongoing basis, such as the keyboards and the mouses of computer workstations on clinical units, the controls of EKG monitors, manometric blood pressure cuffs and, especially, bedside table, doorknobs and bedrails in patient care rooms. Contamination of these surfaces is extremely common, and growing studies indicate that such contamination is an important source of multi-resistant nosocomial pathogens that are transmitted directly to patients (or onto the hands of healthcare workers, then, secondarily to vulnerable patients), resulting in devastating infections.

We now have the data to justify proceeding to the last phase, a large comparative clinical trial of this technology, comparing the outcomes of patients in units where patient-care rooms are regularly decontaminated with the peracetic acid-hydrogen peroxide aerosol as contrasted with units where surfaces and items are decontaminated conventionally, with liquid disinfectants manually applied (controls). We would follow thousands of patients during hospitalization in each group, with new episodes of hospital-acquired colonization and infection by multi-resistant hospital organisms - - particularly MRSA, VRE, multi-resistant gram-negative bacilli and C-Diff - - as the outcome variables. If such a trial showed that environmental disinfection with the novel peracetic acid-hydrogen peroxide aerosol brought substantially reduced colonization and infection by multi-resistant hospital organisms in patients, it would have a huge impact and prompt hospitals and clinics around the world to want to adopt this technology.

I have been doing research on prevention of hospital infections for nearly 40 years and have had a research lab to support such studies since joining the faculty of the University of Wisconsin in 1974. Copies of my MiniBio and Curriculum Vitae are appended. My laboratory technicians and research nurses are highly experienced and well qualified to provide the microbiologic and clinical-epidemiologic support for studies of the type summarized above. I look forward to pursuing a clinical trial of this technology at University of Wisconsin Hospitals in Madison. I am appreciative of the materials you have provided regarding your ALTRAPURE technology's initial in vitro evaluations, safety and certification by the EPA.

Thank you.

Yours very truly,

Dennis G. Maki, MD
Ovid O. Meyer Professor of Medicine
Section of Infectious Diseases, Department of Medicine