Medizone to launch further AscepticSure testing in pursuit of FDA de novo pathway

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Medizone AsepticSure

Medizone International (OTC:MZEI) said yesterday that following meetings with the FDA, it has decided to pursue de novo clearance with the agency for its AscepticSure disinfection system, and such pursuit will require further data collection on the device.

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 said it is aware of additional testing it will need to conduct and the data that will be needed to support its de novo application.

Medizone said it is hoping to submit an application for de novo clearance by the end of the third quarter.

“Our discussions with the FDA regarding the regulatory pathway for approval of AsepticSure were positive, productive, detailed and specific.  During the discussions, the FDA stated its position that there is no predicate device that is substantially equivalent to AsepticSure because of its unique method of action.  As a result, we will apply for de novo classification of the system.  Furthermore, we now have a clear understanding of the additional testing that we will need to conduct and the additional data that we will need to submit to support our de novo application. We anticipate being able to perform the additional testing and to provide the additional data within a few months, which would permit us to submit an application for de novo classification by the end of the third quarter.  If our application for De Novo classification is granted, we believe we will enjoy a significant competitive advantage over other disinfection technologies,” prez & chief medical office Dr. Michael Shannon said in a press release.

Last October, Medizone said it won CE Mark approval in the European Union for its AsepticSure disinfection system.

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