A U.S. regulator has instructed Quebec-based TSO3 Inc. (TSX:TOS) to resubmit additional data and documentation for its Sterizone 125L sterilizer.
The Canadian medical equipment maker says it's confident it will obtain U.S. approval for the device but unsure of how long it will take.
Based in Quebec City, TSO3 specializes in medical instrument sterilization technology for hospitals.
"We estimate the time to complete the collection of data and modify the submission document will be approximately four weeks, which is about the same amount of time that it takes companies to respond to questions from the Agency during the review process, said Ric Rumble, TSO3's president and chief executive.
"We remain absolutely confident in our ability to gain U.S. regulatory clearance for this product, however, as it has always been the case, we are unable to accurately predict the timing of such clearance."
TSO3 shares closed Monday at $1.48, down two cents, at the Toronto Stock Exchange.