Tristel PLC Health Canada regulatory approval submission
04 Septembre 2023 - 8:00AM
RNS Non-Regulatory
TIDMTSTL
Tristel PLC
04 September 2023
TRISTEL plc
("Tristel" or the "Company")
Health Canada regulatory approval submission for Tristel ULT
Accelerated timetable to allow earlier commercial launch in
Canada in H2 FY 2024
Tristel plc (AIM: TSTL), the manufacturer of infection
prevention products, announces that it has submitted its
application to Health Canada to approve Tristel ULT as a Class II
Medical Device for endocavity ultrasound probes and skin surface
transducers.
Tristel ULT is a hand-applied high-level disinfectant foam for
medical devices and was approved by the United States Food and Drug
Administration (FDA) in June this year ( RNS 5723B ) for use on
endocavity ultrasound probes and skin surface transducers.
Tristel OPH, a high-level disinfectant for ophthalmic
instruments, has already been approved by Health Canada as a Class
II Medical Device in June 2021 ( RNS 9130C ).
Having submitted the application earlier in the current
financial year than expected, the Company now expects a decision on
its Tristel ULT application early next year compared to original
guidance of H1 FY 2025 (i.e the 6 month period ending 31 December
2024). If the application succeeds this will allow commercial
launch during H2 FY 2024 instead of during H2 FY 2025.
Tristel ULT will be manufactured by Tristel's North American
business partner, Parker Laboratories Inc., New Jersey, and will be
distributed to Canadian ultrasound users through Parker's
distributor network.
Paul Swinney, Chief Executive Officer of Tristel, said: "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 H1 FY 2025. 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.
"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 1
October 2023.
"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 16 October 2023."
For further information please contact:
Tristel plc Tel: 01638 721 500
Paul Swinney, Chief Executive
Officer
Liz Dixon, Chief Financial
Officer
Walbrook PR Ltd Tel: 020 7933 8780 or tristel@walbrookpr.com
Paul McManus Mob: 07980 541 893
Lianne Applegarth Mob: 07584 391 303
finnCap Tel: 020 7220 0500
Geoff Nash/ Charlie Beeson (Corporate
Finance)
Sunila de Silva (ECM)
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END
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