Executive Summary

"Healthcare-Associated Infections kill nearly 100,000 people and add an extra $30B in costs every year."*

In spite of years of research into ways of reducing cross-infections, this critical problem has persisted in health care facilities, primarily due to the time and labor costs associated with using liquid disinfectants to treat contaminants that are disseminated through both direct contact and aerosolized transmission. Many patients, physicians, nurses, hospital administrators and insurance companies have experienced the high risks of Hospital-Associated Infections (HAIs) caused by exposure to unsterile Operating Rooms (ORs), Intensive Care Units (ICUs), Emergency Rooms (ERs), post-operative settings and even waiting rooms. In addition to the patients’ and staff’s suffering, this situation causes insurance companies to experience substantial annual losses and rising premium rates as contingent liabilities continue to increase.

In August 2008, the FreshStart by Prompt Care® process received US patent 7,407,624 B2, for effectively decontaminating enclosed spaces. The process provides a highly effective low cost means to significantly reduce HAIs and patient deaths, while also reducing the health care facility’s contingent liability exposure.

Current Situation

Healthcare facilities rely primarily on liquid chlorine or other derivative liquid cleaning and sanitizing chemicals, subsequently leaving many of the surfaces that are difficult to reach within the facility recurrently untreated. Conversely, the FreshStart process employs gaseous-state hydroxyl radicals (OH-) to eliminate the effects of the remaining untreated infectious pathogens, virus (@10ppm w/dwell times < 10 sec.) and most bacteria (@10ppm w/dwell times < 15 min.). In addition to being a more powerful sterilizing agent**, since the OH- is applied in a gaseous state it provides superior reach into areas such as HVAC air ducts, the crevices of acoustical ceiling tiles, the tops of doors/door jams and the many other difficult-to-reach surfaces of stationary equipment and fixtures wherein virus and bacteria such as MRSA are often detected. Finally, it should also be noted that the patented process embodies the full range of EPA and OSHA indoor-air-quality (IAQ) requirements by ensuring zero treatment exposure to the public, patients and/or facility staff, while also providing the building’s owners a significant advantage in obtaining US EPA LEED Certification for their facility.

Oxidizing Agent – Redox Potential (Volt)**

Agent	Redox Potential (Volt)
Hydroxyl Radicals	+2.80
Ozone Gas	+2.07
Hydrogen Peroxide	+1.77
Permanganate	+1.67
Chlorine Dioxide	+1.57
Chlorine Gas	+1.36
Oxygen (baseline)	0

Hospital Applications

The National Nosocomial Infections Surveillance (NNIS) System of the Centers for Disease Control and Prevention (CDC) performed a survey from October 1986 to April 1998. They ranked hospital wards according to their association with central-line bloodstream infections. The highest rates of infection occurred in the burn ICU, the neonatal ICU, and the pediatric ICU. These infections are estimated to occur in 5% of all acute-care hospitalizations; the incidence rate is 5 infections per 1,000 patient-days. Based on the 35 million patients admitted to 7,000 acute-care institutions in the United States, the incidence of Hospital Acquired Infections is more than 2 million cases per year. HAIs result in an additional 26,250 deaths (range 17,500–70,000) and added expenditures in excess of $4.5 billion, providing a substantial opportunity for health care cost reduction through the increased sterilization of these facilities.

Medical Facility Efficacy Study — Proposal

Prompt Care is proposing a cooperative study of the efficacy of the FreshStart process in sterilizing pre-selected medical facility rooms. These rooms could be patient rooms, operating rooms or other post-op rooms where sterilization is critical to the health of the hospital’s patients and staff. It is proposed that the study encompass from three (3) to ten (10) rooms including their HVAC systems. The proposed initial study parameters are as follows: 1. Medical Facility and PCI jointly agree on rooms to be tested, 2. Facility cleans and sanitizes the rooms according to their standard procedures, with cleaning staff unaware of any special testing to be performed, 3. Facility performs Indoor-Air Quality (IAQ) tests in the room, testing for viruses and bacteria using standard protocols, 4. Immediately following the initial IAQ test PCI will treat the room with the FreshStart process, and 5. Immediately following the PCI treatment, the facility will again test the room for viruses and bacteria and the results of the two IAQ tests will be compared to determine the process’s baseline of process efficacy for that facility.

Additional Applications

The U.S. EPA estimates that 50% of the homes in the United States have at least one occupant whose health is negatively impacted by indoor air pollution, including mold and other allergens. At $495 per service (test marketing done at $495 for 1,500 ft.² w/10 ft. ceiling height) there is a potential recurring market of $20B. The American Academy of Allergy, Asthma and Immunology estimates that there are 17 million Americans with asthma. These sufferers are clustered two per household, indicating a potential of over eight million homes. Serving these homes establishes another recurring market potential of greater than $4B. The U.S. Census Bureau estimates that there are over five million businesses with employees in the U.S. Serving these businesses once per year at $1,000 per service yields an incremental market of $5B.

Company’s Results to Date

• Received patent for multiple processes and embodiments with supporting follow-on patents currently pending for equipment and specific application methodologies.
• Received Federal Registration for trade mark FreshStart by Prompt Care®.
• Provided service to more than fifteen hundred (1,500) homes, offices, warehouses, school buildings, vehicles and boats, with more than $600,000 in revenue generated during initial field testing.
• Received customer surveys indicating that greater than 96% of customers have or would recommend the service.
• Received anecdotal evidence that in buildings where one or more of the occupants used antihistamines to mask their symptoms of indoor allergies, many of those individuals substantially reduced or suspended their use of antihistamines for periods ranging from three (3) months to thirty six (36) months following the treatment.
• Established that a mobile service model, using the company’s patent pending equipment (pictured above), is capable of generating recurring revenues of greater than $1,200 per day, per service vehicle, at margins greater than 50%.
• Developed company owned and/or franchisee owned mobile service business models with a Technician training syllabus in place that is capable of being replicated for expansion into multiple regions of the country.
• Formed alliances with nationally recognized medical professionals, decontamination specialists, research institutions and industry trade organizations.

Distribution Channel Opportunities

1. Specific use Sales and/or Licensing for Medical facilities (i.e. health care facilities and/or governments).
2. Company owned mobile service business – (fewest market entry barriers).
3. Franchised operations – local, regional and/or national – (additional paths for expanding market entry).
4. Licensed mobile service process and/or equipment through existing regional/national service organizations.
5. Equipment sales and/or leasing – mobile and/or stationary – (current discussions on 4 & 5 are under NDA).

Business Model Strategies – Available Options

• Project Teaming/SBIR/STTR – Develop research programs with select teaming partners for developing grant opportunities with the Department of Health and Human Services, the Department of Homeland Security and appropriate local, state and federal agencies. Projects will be focused on determining the efficacy of the processes as well as demonstrating the significant health and cost benefits available for abating the effects of virus, bacteria, allergens, surface mold, and most VOCs (whether intentionally or unintentionally introduced).
• Mobile Service – Launch home/office mobile service business with positive cash flow within 11 months of funding.
• National Roll-out – Implement a national plan based on the modular business model and existing training syllabus.

*HHS Secretary Kathleen Sebelius and Congressman Dave Obey (D-WI), the Chairman of the House Appropriations Committee, November 10, 2009 announcement of the release of Recovery Act funding to improve care in the nation's ambulatory surgical centers.
**The hydroxyl radical has a very short in vivo half-life of approx. 10^-9 s and a high reactivity; Sies, Helmut (March 1993) "Strategies of antioxidant defense," European Journal of Biochemistry.

This page was converted from the original Executive Summary (November 17, 2009) PDF document.