TSO3 Obtains FDA Authorization to Commercialize its Ozone Sterilizer and Chemical Indicator

QUEBEC CITY -- TSO3 Inc. announced today it has obtained the authorization of the U.S. Food and Drug Administration (FDA) for the commercialization of its 125L Ozone Sterilizer as well as the chemical indicator that accompanies it.

"After several years of research and testing, we are very pleased to now be at the commercialization stage, for which we have been actively preparing in recent months," stated Jocelyn Vezina, CEO of TSO3 Inc. "We are on the verge of inaugurating a new era in sterilization by offering the market -- for the first time in 50 years -- an alternative that is fast, safe and cost-effective."

The sterilization process developed by TSO3 uses ozone as the sterilizing agent. The first product based on this technological platform is the 125L Ozone Sterilizer, intended for hospital sterilization units. The 125L Ozone Sterilizer (with a 125-litre / 4.3-cubic-foot capacity) was designed to allow the sterilization of the new generation of surgical and diagnostic instruments made of materials -- especially polymers -- that are not heat resistant. The ozone sterilization process is a safe, effective, fast and cost-effective response to new sterilization needs.

The chemical indicator looks like a small sticker and has a chromaphore which changes colour when the required sterilization parameters have been met. This sticker, about 13 cm2 (2 square inches), is essential to the commercialization of the 125L Ozone Sterilizer from TSO3, as a method of validation is required by the authorities for any sterilization process.

"The FDA approval for us validates a technology that we already though had great potential and hearing that news, we are even more exited about participating in the referral site program," said Helen Vandoremalen, BScN, director of the central sterilization unit at Sunnybrook and Women's College Health Sciences Centre in Toronto, one of the six hospitals in Canada in the referral site program for the 125L Ozone Sterilizer.

With the licensing by Health Canada of the initial product, the 125L Ozone Sterilizer, since May 3, 2002, and now with the authorization from the American Food and Drug Administration, TSO3 intends to attack the North American hospital sterilization unit market, which represents a replacement market of about $880 million.

In this regard, TSO3 recently announced the signing of a distribution agreement with U.S. company Skytron, a medical equipment distributor that has a huge distribution network, including 120 sales representatives, 100 service representatives and support facilities, and serves operating theatres and decontamination/sterilization units throughout North America.

Ozone possesses strong oxidative properties that make it a very efficient sterilizing agent. It is also an inexpensive sterilizing agent, requiring only medical grade oxygen and water that are readily available in hospitals. The 125L Ozone Sterilizer developed by TSO3 produces its own sterilizing agent, releasing only oxygen and water vapor into the atmosphere.

Since the time of Louis Pasteur, sterilization by autoclave (steam under pressure) has been shown to be the best sterilization process for medical and surgical instruments. However, steam -- which requires temperatures over 121 degrees C -- negatively impacts the heat-sensitive materials used in the manufacture of the new generation of instruments. One of the major features of sterilization with ozone is that it operates at low temperature.

Another significant advantage of this new technology is its safety for the operator, patients and the environment. According to several environmental groups, the most commonly used method of cold sterilization -- ethylene oxide -- carries risks related to the nature of the gas. Ethylene oxide is recognized as carcinogenic and neuro-toxic. It is also explosive and handling it is dangerous. The Occupational Safety and Health Administration (OSHA) has indicated a desire to see this gas banned. In some American states, the use of this gas incurs a "pollute and pay" tax.

According to the standards and regulations of the Canadian Standards Association, instruments sterilized with ethylene oxide must be ventilated for periods varying from 12 to 24 hours. However, the residual ethylene oxide released into the environment apparently continues to pose environmental problems.

In addition to being an advantageous alternative in terms of health and the environment, sterilization with ozone could produce significant savings for operating facilities. The process itself is very inexpensive. For similar installation costs, the cost of the sterilizing agent for one cycle is US $0.06 (about CAN $0.10), while sterilization with ethylene oxide costs US $7.35 (about CAN $11). Another process, combining hydrogen peroxide and plasma, costs US $8 (about CAN $12) to sterilize a smaller quantity of instruments, due to the reduced load capacity of the sterilization chamber.

Sterilization with ozone offers a further important economical advantage in respect to ethylene oxide: it allows for a smaller instrument inventory as the instruments are ready to use upon complete sterilization. As the other method requires an aeration period of between 12 to 24 hours, a costly larger inventory must be maintained to ensure the constant availability of instruments.

It has been proven that Creutzfeldt-Jakob disease (CJD), the human form of Mad Cow disease, can be transmitted from one patient to another through contaminated surgical instruments, even after the instruments have been sterilized with current methods.

For nearly three years, TSO3 has been running an R&D program to test the potential of sterilization with ozone for deactivating prions, the infectious protein that causes this disease. Results of recent testing carried out in collaboration with the National Research Council of Canada demonstrated the great potential of ozone sterilization to overcome this problem.

However, further testing is necessary, as well as the implementation of a protocol reached by consensus among the members of the international scientific community. Nevertheless, this is a new and exiting opportunity to tremendously accelerate the sales of ozone sterilizers. To this end, TSO3 is currently developing a prion indicator, a small device that would test whether prions were destroyed during the sterilization cycle. Potential sales for this product alone are in the order of US$100 million per year.

TSO3 Inc., founded in Quebec in 1998, employs 38 people, 16 of whom work exclusively on research and development. The company's mission is to develop and commercialize global, innovative sterilization solutions.

Source: TSO3 INC.