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Release issued 14th April 2005
The Health Protection Agency (HPA) has recently been awarded a grant of £327k (approximately $710k CAN) by the UK Department of Health (DH) to study the effectiveness of the TSO3 Ozone Sterilizer for deactivation of prions. Prions are infectious proteins which are responsible for Transmissible Spongiform Encephalopathy (TSE) agents such as Bovine Spongiform Encephalopathy (BSE) or Creutzfeldt-Jakob Disease (CJD).
"The potential transmission of CJD from patient to patient via contaminated surgical instruments has been a concern worldwide for a number of years", said Dr. Neil Raven, Research Manager of the HPA. "The data from the preliminary tests conducted by TSO3 lead us to believe that the Ozone Sterilizer could be a significant part of the solution to the problem of variant CJD (vCJD), the human form of mad cow disease. That is why we have been working for nearly a year and a half on developing a protocol with TSO3 and obtaining the funding from the DH".
"We are one of the rare foreign companies to benefit from a grant of this size. The interest Britain is showing to our technology both confirms the need for a sterilization method that will deactivate prions and ozone's potential for being one of the solutions," said Simon Robitaille, Vice President, Operations, and Director of Research at TSO3.
Prions are particularly tough molecules that are not deactivated by conventional washing and sterilization procedures used within hospitals. Preliminary tests conducted by TSO3 have demonstrated the potential of the Ozone Sterilizer to deactivate prion proteins. In a series of subsequent tests, conducted by the National Research Council of Canada in Winnipeg during 2004, TSO3 was able to develop protocols that are adapted to the practices within hospitals. TSO3 is also working with international regulatory agencies to ensure protocols will be recognized.
More details on the programme of work
The testing of the machine will be performed at the HPA's research centre at Porton Down near Salisbury in England, where there are specialist microbiological containment facilities that enable scientists to safely work with TSE agents. The work will involve conducting a series of experiments to determine how effective the machine is at deactivating prions by using internationally recognised laboratory tests currently recognised as good models for the human disease. This protocol is necessary for TSO3 to claim that its Ozone Sterilizer effectively eliminates prions that are a threat to humans. Work is planned to begin later this year and is expected to take about 24 months.
Testing to be conducted in England is essentially to optimize use of the device against prions, and is part of a broader programme from TSO3 studying all the parameters essential for sterilization, notably the prior cleaning and preparation of instruments, as well as the safety margins.
The time required for all the work necessary for the commercialization of a sterilizer that can deactivate prions, including the development of a prion indicator, is estimated at about three years from the start of the new series of tests.
Current phase of commercialization independent from prion research program
TSO3 points out that the business plan for the 125L Ozone Sterilizer is based only on the current features of the technology - effective, fast and economical. However, in terms of R&D, prions remain a priority for the Company. "If we can show that our technology deactivates prions, our ozone sterilizer could become a universal sterilization technology," added Jocelyn Vézina, the Chief Executive Officer at TSO3.
About the Health Protection Agency
The Health Protection Agency is an independent body that protects the health and well-being of everyone in England and Wales. The Agency plays a critical role in protecting people from infectious diseases and in preventing harm when hazards involving chemicals, poisons or radiation occur. HPA also prepares for new and emerging threats, such as a bio- terrorist attack or virulent new strains of disease.
The Agency's Centre for Emergency Preparedness and Response at Porton Down in Wiltshire is internationally recognised as a centre of excellence for work with infectious disease and the manufacture of licensed pharmaceuticals.
Information about the HPA can be found at www.hpa.org.uk/business
Media Contact: Dr. Phil Luton Tel +44 (0) 1980 612725, Fax +44 (0) 1980 612241, Email phil.luton@hpa.org.uk
About TSO3
TSO3 Inc. is located in Québec City, Québec, Canada, and was founded in 1998. TSO3 currently has 48 employees, 19 of whom work exclusively in the Research and Development department. The Company's mission is to develop and market innovative and comprehensive sterilization solutions.
TSO3 has perfected an innovative sterilization process using ozone as the sterilizing agent. The first product based on this technological platform is the 125L Ozone Sterilizer, which is intended for hospital sterilization units. The 125L - named after its 125-litre/4.3-cubic-foot capacity - was designed to sterilize heat and moisture-sensitive surgical and diagnostic devices which are expensive and in high demand from the surgical suite. The ozone sterilization process is a safe, efficacious, fast and cost-effective response to evolving sterilization needs.
The 125L Ozone Sterilizer by TSO3 was cleared for commercialization by Health Canada and more recently by the U.S. Food and Drug Administration (FDA). TSO3 expects the first sales in 2005.
For more information about TSO3, visit the Company's Web site at www.tso3.com
If you want to find out more about the company visit Health Protection Agency profile.
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