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 [...]

TSO3 new sterilizer system gets European okay

TSO3’s (TSX:TOS) new sterilization system was cleared for sale in Europe after meeting the European Union’s new medical device directive for Class IIb medical devices, allowing TSO3 to label its product with the CE mark. “We are pleased that a review of our quality system, electromechanical design and microbiological data, has been independently validated as [...]

TSO3 in $16 million bought deal

TSO3 (TSX:TOS) has agreed to sell 10 million new shares at a price of $1.60 each in a bought deal to a syndicate of underwriters led by Canaccord Adams. The stock closed at $1.80 yesterday. Gross proceeds of $16 million will be used by TSO3 for new product initiatives, working capital and general corporate purposes. [...]

TSO3 gets boost from FDA decision

The FDA has advised U.S. health care administrators to discontinue use of Steris Corp.’s (NYSE:STE) peracetic acid-based endoscope reprocessing device System 1 within 18 months. In a research report, Versant Partners says the FDA decision is positive for TSO3 (TSX:TOS) because a competitor will exit the market by mid-2011.  Analyst Doug Loe writes that TSO3’s [...]

3M to distribute TSO3 sterilizer

TSO3 (TSX:TOS) has signed an agreement with 3M to be the exclusive distributor of its Sterizone 125L sterilization system. The accord “pairs innovation in technology with innovation in marketing, sales and service on a global scale,” TSO3 CEO Ric Rumble said in a statement.  “It supports 3M’s existing Infection Prevention business strategy, while significantly enhancing [...]

Versant starts TSO3 at “buy”

Versant Partners initiated coverage of TSO3 (TSX:TOS) with a “buy” and 12-month price target of $2.50 after the maker of ozone-based sterilizers for healthcare markets won FDA approval last week to expand the intended claims of its Sterizone 125L sterilizer.  The stock closed at $1.61 on Friday. Analyst Doug Loe writes that TSO3 is in [...]