Tristel PLC on Monday said it submitted its application to Health Canada to approve Tristel ULT as a class 2 medical device for endocavity ultrasound probes and skin surface transducers.
The Cambridgeshire-based maker of infection prevention products said Tristel ULT is a hand-applied disinfectant foam for medical devices and was approved by the US Food & Drug Administration in June for use on endocavity ultrasound probes and skin surface transducers.
Tristel noted that disinfectant for ophthalmic instruments Tristel OPH has already been approved by Health Canada as a class 2 medical device in June 2021.
Having submitted the application earlier in the current financial year than expected, Tristel said it now expects a decision on its Tristel ULT application early next year compared to original guidance of the first half of the financial year ending December 31, 2024.
If the application succeeds, Tristel said this will allow commercial launch during the second half of its financial year ending December 31 this year, instead of during the second half of its financial year ending December 31, 2024.
Trsitel said Tristel ULT will be manufactured by its business partner Parker Laboratories Inc in New Jersey and will be distributed to Canadian ultrasound users through Parker’s distributor network.
‘When we received our FDA approval for Tristel ULT in June we set out for our shareholders our commercial strategy for North America. This included the submission to the Canadian regulatory authority of Tristel ULT during the current financial year and its approval before the end of [its first half of the financial year ending December 31, 2024]. I am pleased to report that we have accelerated our plans and can look forward to a commercial launch into the Canadian ultrasound market during our second half,’ said Chief Executive Officer Paul Swinney.
‘Tristel OPH, which is labelled for use on ophthalmic devices, has been successfully launched and is being sold to Canadian hospitals by our distribution partner Innova Medical. Parker Laboratories is well advanced in preparing to manufacture the Tristel foam disinfectants and we are on target to launch into the United States ultrasound market on or before October 1.
‘We will provide a detailed update on our North America business plan and the progress we are making worldwide in our year-end results presentation scheduled for October 16.’
Shares in Tristel were up 3.0% to 342.44 pence each in London on Monday afternoon.
Copyright 2023 Alliance News Ltd. All Rights Reserved.
