Québec City, December 17, 2014 – TSO3 Inc. (TSX: TOS) (“TSO3” or the “Corporation”) an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company has received US regulatory clearance, 510(k), for its STERIZONE® VP4 low temperature Sterilizer and its accessories. The clearance allows the Company to sell the product in the world’s largest sterilization market.
“We are exceptionally pleased to inform our shareholders, employees and suppliers as well as end-users of low temperature sterilization methods that the Company has been granted regulatory clearance for its next generation sterilizer in the US market. This is a transformational day for the Company”, stated Mr. R.M (Ric) Rumble, TSO3’s President and CEO.
”As a Company, our mission statement is to Create the Improved Standard in Healthcare Sterile Reprocessing™. This regulatory clearance represents a meaningful milestone in achieving this objective. The Company received a 510(k) with a newly assigned Product Code, which highlights the uniqueness of our technology and establishes a new benchmark in the field of low temperature sterilization”, added Mr. Rumble.
“Throughout the lengthy clearance process, we pursued a regulatory strategy aimed at supporting our substantial claims advantage over existing low temperature solutions. As a direct result of this strategy, TSO3 is now in a position to market a cleared product in the all-important US market, with claims that match and/or exceed those of every competitive product”, Mr. Rumble explained.
With the clearance now in hand, the Company will focus its energy on a ramp-up of operations and initiate targeted commercial activities in the US. As commercial discussions with potential partners are still underway, TSO3 expects to manage the initial product launch directly as a way to maximize shareholder value while it finalizes its strategic review.
Founded in 1998, TSO3’s activities encompass research, development, commercialization and licensing of sterilization processes for heat-sensitive medical devices, related equipment, accessories and consumable supplies. TSO3 designs products for sterile processing areas in the hospital environment and offers an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals.
For more information about TSO3, visit the Company’s Web site at www.tso3.com.
The statements in this release and oral statements made by representatives of TSO3 relating to matters that are not historical facts (including, without limitation, those regarding the timing or outcome of any financing undertaken by TSO3) are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, general business and economic conditions, the condition of the financial markets, the ability of TSO3 to obtain financing on favourable terms and other risks and uncertainties.
The TSX has neither approved nor disapproved the information contained herein and accepts no responsibility for it.
-30-Back to Posts