TSO3 to resubmit for U.S. clearance

TSO3 (TSX:TOS) has received instructions from U.S. regulatory authorities to resubmit a 510k for its Sterizone 125L + Sterilizer with “additional data” and to “better establish the link between the sterilizer and a variety of accessory products used in the sterilizer,” which are also subject to 510k clearance and have been previously submitted.

“TSO3 is eager to quickly provide additional data on the Sterizone 125L+ Sterilizer and to link the various accessory products together to support our superior claims”, CEO Ric Rumble said in a statement.

He estimated that it would take about four weeks to complete the collection of data and modify the submission document.

“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”, he added.