This morning, Quebec City based TSO3 (TSX: TOS) updated the markets on the status of their FDA 510(k) filing for their low temperature hospital sterilizer, Sterizone VP4.
In a press release, the company stated that it has submitted revised labeling to FDA for both the sterilizer and accessory devices. In August of this year, the company began hinting that it was progressing with labeling discussions with FDA. Since then analysts and investors have been speculating that FDA clearance is imminent. One of the most vocal, and long-standing, advocates of TSO3, Canaccord’s Sara Elford, in a recent update to investors, predicted FDA clearance for the Sterizone VP4 before the end of 2014.
In today’s press release, Ric Rumble, TSO3’s CEO is quoted as saying, “We have tangible evidence that progress is being made towards final clearance of the new system and the company will update accordingly as new developments occur.” So clearly Mr. Rumble also feels that a FDA decision is looming. If the Sterizone VP4 were to be cleared by FDA, it would mark the end of 4 year regulatory journey, that has taken far longer then management or investors could have predicted.
TSO3 does not currently have a distribution partner for the Sterizone VP4, although it does have a Letter of Intent with Swedish infection control firm Getinge AB. It would therefore seem logical that an announcement on a new distribution agreement, either with Getinge or another sterilization company, would likely be on the heels of FDA 510(k) clearance.
At press time, shares of TSO3 were up 13.5% to $1.26.