Could begin selling the device in Canada by June
Medizone International’s manufacturing partner SMTC Corporation has completed the first production unit of the US firm’s AsepticSure disinfection technology for hospital use.
Following performance confirmation testing of the initial unit, four additional units will immediately be manufactured for independent validation testing and subsequently placed into commercial service.
The first five production units are expected to be delivered to Medizone by the end of April.
Michael Shannon, president and director of medical affairs at the San Francisco-based firm said: “A combination of scientific, developmental and technological advancements made by the company over the past 12 months has seen us arrive at the brink of an exciting new era in Medizone's history.
“I have no doubt whatsoever that AsepticSure is poised to become the gold standard for hospital disinfection.”
Medizone International's chairman and ceo Edwin Marshall added that Health Canada will not regulate AsepticSure as either a medical device or disinfectant, nor will it require a new DIN (drug identification number) for the AsepticSure catalyst.
“The company views this ruling by Health Canada in the most favourable light. It means that following standard validation testing of the initial production units over the coming four weeks, the company may then begin commercial sales of AsepticSure in Canada.”
Medizone has also submitted a Request for Designation in the US to the FDA.