TSO3 Prepares for European Product Launch

Company Pursues Prion Inactivation Claims and Expands Portfolio with Double-Door Option for Revolutionary STERIZONE® VP4 Sterilizer

 

QUÉBEC CITY, July 18, 2016  - TSO3 Inc. (TOS.TO) (« TSO3 » or the « Company »), an innovator in sterilization technology for medical devices in healthcare settings, today announced a series of initiatives in support of a planned European launch of the Company's STERIZONE® VP4 Sterilizer this year.

 

The Company has initiated studies in France in support of obtaining Prion inactivation claims for that market. In addition, the Company has completed development of a double door, or "pass-through", option for the STERIZONE® VP4 Sterilizer which is highly desirable in many European markets.

Prions are implicated in diseases such as transmissible spongiform encephalopathies which cause BSE, frequently referred to as "mad cow disease". TSO3 is conducting tests using the "standard protocol for prions" (PSP), a protocol established by the French regulatory agency ANSM, Agence nationale de sécurité du médicament et des produits de santé (formerly referred to Afssaps). Initial studies conducted in France indicate that the STERIZONE® VP4 Sterilizer is effective under in vitro conditions. The study now extends to include additional in vitro and in vivo testing.

 

In addition to pursuing this European claim expansion, TSO3 has completed development of a double door or "pass-through" option for its STERIZONE® VP4 Sterilizer. With development complete, TSO3 plans to complete documentation to secure the European CE mark, which would clear this option for sale in Europe – the largest anticipated market for the device. The Company expects to begin shipments to Getinge Infection Control, the Company's exclusive global distribution partner, so that installations could occur in end-customer facilities in the first quarter of 2017. While the double door option is less popular in the U.S., the Company plans to pursue clearance to sell the device in the U.S. in the ordinary course.

 

"Prion inactivation claims are required in the French market when medical devices are used in selected "high risk" surgeries such as neurological and ophthalmic procedures," said TSO3 President and CEO, R.M. (Ric) Rumble. "Likewise, pass-through systems are highly desirable in certain sterilization department designs where a wall separates dirty from clean and clean from sterile inventory. Assuring that our product line meets these requirements enables the Company, through our global distribution partner Getinge, to launch in Europe effectively and efficiently."

 

About the STERIZONE® VP4 Sterilizer

 

The STERIZONE® VP4 Sterilizer is a low-temperature sterilization system that utilizes the dual-sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilization of heat and moisture sensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, creating a cost-effective, error-free sterilization process. The device's unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This capability removes the guesswork and potential for human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines. 

 

The STERIZONE® VP4 Sterilizer is the only FDA cleared low temperature sterilizer that can process a mixed load consisting of general instruments, single channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 lb It is also the only terminal sterilization method cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes and gastroscopes - an industry first for any medical device sterilization process. The ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity). Other H2O2 sterilizers are limited to load weights of up to only 25 lb and require dedicated fixed cycles for different types of instruments (reducing overall throughput).