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(Alliance News) - Tristel PLC on Tuesday said its Tristel ULT device has been approved by Health Canada as a high-level disinfectant for use on endocavity ultrasound probes and skin surface transducers.
The Cambridgeshire, England-based infection prevention product manufacturer said the timing of this regulatory approval comes "well ahead" of its original aim for gaining approval before the end of the first half of financial 2025.
This means Tristel could be launching the device commercially this year.
Due to approval in Canada, as well as the US Food & Drug Administration authorisation it received in June, the firm said Tristel ULT can now be manufactured and sold throughout the whole of North America by commercial partner Parker Laboratories Inc.
Parker completed its first production run of Tristel ULT in October and is actively introducing the product to its US distribution network, Tristel said.
The first hospital users in the US are trialling and purchasing the product.
Chief Executive Officer Paul Swinney said: "Our North American business strategy focuses on entering each of the key market segments that we dominate in other countries. Ultrasound is our largest segment globally in terms of disinfection procedure events, followed by ENT, cardiology and airway management. Ophthalmology is a very significant global opportunity in terms of disinfection events, but in all countries very few procedures that should be performed with a high-level disinfectant in fact are."
Shares in Tristel rose 2.3% to 440.00 pence each in London on Tuesday afternoon.
By Sabrina Penty, Alliance News reporter
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