Company Offers Single-Cycle Solution that can Replace Steam and Legacy Low-Temperature Sterilization Practices
Québec City, Québec – July 25, 2016 – TSO3 Inc. (TSX: TOS) (“TSO3” or the “Company”), an innovator in sterilization technology for medical devices in healthcare settings, has completed sterile efficacy validation for multiple, heavy-duty battery-powered orthopedic instrument sets in a single sterilization cycle of the Company’s STERIZONE® VP4 Sterilizer.
These large and heavy instrument sets consist of batteries, attachments, handpieces and inserts. The instrument sets are often “split up” and sterilized in multiple steam cycles or a combination of the traditional steam and legacy low-temperature sterilization (LTS) systems. The STERIZONE® VP4 Sterilizer has been validated to process complete instrument sets in a single cycle — allowing the instruments to travel together within a hospital and arrive sterile at the operating room together. This means faster turn-around times, simpler instrument management and cost-effective reprocessing when compared to traditional steam and LTS systems.
“This sterile efficacy validation demonstrates our STERIZONE® VP4 Sterilizer’s ability to streamline medical device reprocessing for orthopedic instrument sets,” said TSO3 President and CEO R.M. (Ric) Rumble. “Our technology replaces the need for steam sterilization of these sets and allows customers to keep their instrument sets together during reprocessing, which allows for efficient, flexible, safe and cost-effective healthcare sterile reprocessing to improve patient care.”
TSO3 recently announced that it had received U.S. clearance for extended claims relating to the terminal sterilization of multi-channel flexible endoscopes. The FDA clearance of additional claims represents an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust systems like high-level disinfection, particularly for video colonoscopes and gastroscopes.
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 sterilization process with error free cycle selection. 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).
More information about the STERIZONE® VP4 Sterilizer is available through TSO3’s website, under the Products section: https://www.tso3.com/en/products/sterizone-vp4/
Founded in 1998, TSO3’s activities encompass the sale, production, maintenance, research, development and licensing of sterilization processes, related consumable supplies and accessories for heat-sensitive medical devices. The Company designs products for sterile processing areas in the hospital environment that offer an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals. It also offers services related to the maintenance of sterilization equipment and compatibility testing of medical devices with such processes.
For more information about TSO3, visit the Company’s web site at www.tso3.com
The statements in this release and oral statements made by representatives of TSO3 relating to matters that are not historical facts (including, without limitation, those regarding the timing or outcome of TSO3’s sales, business or operations) are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, the ability of the Company to obtain the required regulatory clearance to market its products on a worldwide basis;general business and economic conditions, the condition of the financial markets, the ability of TSO3 to obtain financing on favourable terms and other risks and uncertainties.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any jurisdiction in which such offer, solicitation or sale would be unlawful.Back to Posts