TS03’s low-temperature 125 litre STERIZONE® sterilizer is designed for terminal sterilization of heat and moisture sensitive medical devices.
Shares of Quebec City based TSO3 (TSX:TOS), surged yesterday after their earnings call left investors optimistic that an arduous 4-year wait for FDA clearance for the company’s ozone-based sterilizer might finally be near. The stock had been steadily moving upwards after a press release a few weeks ago announcing that FDA had asked the company for some additional information on their clearance submission. However, in yesterday’s earnings release the company’s CEO Ric Rumble stated, “Together with the agency, we are working on how best to document the sterilizer performance for U.S. customers,” which would seem to imply that FDA clearance is imminent.
TSO3 is developing its Sterizone VP4 sterilizer for the low temperature hospital sterilizer market. The product has already been cleared for sale in Europe and Canada. U.S. clearance has proven evasive for the company. But it seems, based on the company’s comments, that the most recent filing, known as a 510(k), could receive a thumbs up from FDA shortly. The Sterizone VP4, once commercially available, has the potential to become the gold-standard low temperature sterilizer in the U.S. Compared to its competition, the Sterizone VP4 demonstrates superiority on cycle time and maximum load weight.
On the call, Rumble stated that the company was pursuing a label with FDA for their sterilizer that would be “substantially enhanced over what anyone else can do in the industry.” Clearly the delays with FDA haven’t diminished the company’s confidence that once cleared, the Sterizone VP4 could potentially dominate the low temperature sterilizer market.
There was also substantial interest on the call around potential channel partnerships TS03 will require in order to effectively commercialize the Sterizone VP4. TS03 was once partnered with 3M for their new sterilizer, but that relationships ended in 2012. They have subsequently signed a Letter of Intent with Swedish infection control firm Getinge AB. However Mr. Rumble implied on the call that there were a number of companies that have come to the bargaining table in anticipation of FDA clearance for the Sterizone VP4.