RCS - Tristel PLC - Health Canada regulatory approval submission

TristelAnnouncement

04/09/2023 07:00

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RNS Number : 1658L  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
(https://tristelgroup.com/wp-content/uploads/2023/06/TSTL-Tristel-ULT-FDA-classification-05.06.23.pdf)
) 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
(https://tristelgroup.com/wp-content/uploads/2021/06/TSTL-Regulatory-Approvals-24.06.21-Reach-.pdf)
).

 

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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