Medizone International (OTC:MZEI) said today that it won CE Mark approval in the European Union for its AsepticSure disinfection system.
The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the atmosphere in the room and restores it to within EPA standards.
The Kalamazoo, Mich.-based company is pursuing a de novo clearance from the FDA in the U.S. for AsepticSure.
“The receipt of CE Mark approval is a significant and important step in the commercial development of AsepticSure in key European markets, which is an integral element in our international growth strategy for this game-changing product and technology. The CE Mark validates product adherence to the European Commission’s quality assurance and safety requirements, while providing an unprecedented solution to ensuring disinfection of all pathogens,” CEO David Dodd said in prepared remarks.
“Using conventional double cleaning practices or disinfection technology, it is simply not possible to achieve even a 3-log (99.9%) bactericidal and virucidal kill throughout an entire targeted room. AsepticSure routinely achieves a minimum kill at least a thousand times greater than conventional cleaning methods across all pathogens on all surfaces within a contaminated space. We are delighted to see our advanced technology now available to the European market and look forward to the acceptance and adoption of AsepticSure within both healthcare and non-healthcare environments throughout Europe,” added president & medical affairs director Dr. Michael Shannon.