TSO3 Inc. has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a universal design of its STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Sterilizer was originally cleared for commercialization in the U.S. in December 2014. The new clearance enables the company to streamline assembly and shipping around a single sterilizer platform that meets global regulations for electromechanical design.
In December 2015, TSO3 announced that it had completed studies in order to support expanded use of the STERIZONE® VP4 Sterilizer in the U.S. and had filed for such claims with the U.S. FDA. FDA clearance of the additional claims would represent an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for multi-channel endoscopic devices such as colonoscopes. The expanded claims sought in the U.S. represent similar claims for the STERIZONE® VP4 Sterilizer available in Canada and Europe.
In November of 2015, TSO3 signed Getinge Infection Control AB, a global leader in infection control solutions, as the exclusive distributor for the STERIZONE® VP4 Sterilizer. Getinge has submitted purchase orders for the full amount of its minimum purchase commitment for 2016, with the first shipments rolled out in January. The company believes it is in a position to assemble and deliver in excess of 100 sterilizers in 2016.
