REG - Tristel PLC - Canadian regulatory approval for Tristel ULT

TristelAnnouncement

23/01/2024 07:00

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RNS Number : 5203A  Tristel PLC  23 January 2024

TRISTEL plc

("Tristel" or the "Company")

 

Canadian regulatory approval for Tristel ULT

US FDA submission on schedule for Tristel OPH

 

Tristel ULT approved by Health Canada as a high-level disinfectant

for use on endocavity ultrasound probes and skin surface transducers

 

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products
utilising its proprietary chlorine dioxide technology, announces that Health
Canada has approved Tristel ULT as a Class II Medical Device for endocavity
ultrasound probes and skin surface transducers. The timing of this regulatory
approval comes well ahead of the Company's original aim for gaining approval
before the end of H1 FY 2025 and allows commercial launch during FY 2024.

 

Health Canada approval, alongside approval from the US Food and Drug
Administration ("FDA") received in June 2023, means that Tristel ULT can now
be manufactured and sold throughout the whole of North America by Tristel's
commercial partner Parker Laboratories Inc. ("Parker") as a high-level
disinfectant for ultrasound instruments.

 

Parker completed its first production run of Tristel ULT in October 2023 and
is actively introducing the product to its United States distribution network.
This activity will now be extended to the Canadian market. The first hospital
users in the United States are trialling and purchasing the product. Tristel
will provide a more detailed update in its interim results on 26 February
2024.

 

North American ophthalmic market

Tristel is preparing its dossier for Tristel OPH, a high-level disinfectant
for use on ophthalmic instruments, for submission to the FDA and has requested
a pre-submission meeting with the agency. The review meeting date is scheduled
for early March 2024. The Company anticipates completing its submission
seeking 510(k) approval in the summer and receiving FDA approval by the end of
the year.

 

Tristel OPH was approved by Health Canada in June 2021. Tristel OPH was
launched into the Canadian ophthalmic market as a high-level disinfectant for
ophthalmic instruments including re-usable tonometers and lenses that contact
the cornea during the Company's last financial year. The product is being
distributed throughout the country by Innova Medical Ophthalmics Inc.,
Toronto, a subsidiary of Advancing Eyecare, Jacksonville, Florida. Tristel OPH
is being used by public health authorities in all the major Canadian
provinces.

 

Paul Swinney, CEO of Tristel, commented: "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.

 

"Tristel OPH is the world's only high-level disinfectant specifically designed
and labelled for use on ophthalmic instruments and is currently being used for
two million disinfection events across all our markets. However, we estimate
that globally the number of tonometer uses for glaucoma assessment total
several hundred million annually.

 

"We are making good progress building out the North American business strategy
that we have communicated to our shareholders. This latest approval of Tristel
ULT in Canada and our anticipated entry into the United States ophthalmic
market later this year, leveraging our growing penetration of the Canadian
market, establishes the foundation for the substantial business we intend to
build across the continent."

 

 

 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 (mailto:tristel@walbrookpr.com)
 Paul McManus                                   Mob: 07980 541 893

 Charlotte Edgar                                Mob: 07884 664 686

 Cavendish Capital Markets Limited              Tel: 020 7220 0500
 Geoff Nash/Charlie Beeson (Corporate Finance)
 Sunila de Silva (ECM)

 

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulation
("MAR") EU no.596/2014. Upon the publication of this announcement via
Regulatory Information Service ("RIS"), this inside information is now
considered to be in the public domain.

 

 

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