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REG - Tristel PLC - UK and EU regulatory approval update

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RNS Number : 3374E  Tristel PLC  26 February 2024

TRISTEL plc

("Tristel", the "Company", or the "Group")

 

UK and EU regulatory approval update for surface disinfection system

 

Sustainable alternative to commonly used pre-wetted plastic wipes to become
available in Europe

 

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products
utilising proprietary chlorine dioxide technology, announces that all reviews
under the Medical Devices Regulation 2002 ("UK MDR") and the European Union
Medical Device Regulation 2017/745 ("EU MDR") for approval of the Company's
TANK ClO₂ Sporicidal Disinfectant system have been successfully concluded
and a positive recommendation for UKCA and MDR certification has been made.

 

The TANK system and accompanying capsules are the newest additions to the
Cache range, which provides sporicidal surface disinfection in a format which
is a sustainable alternative to commonly used pre-wetted plastic wipes.

 

Following MDR approvals Tristel will be able to accelerate sales activity for
this product throughout Europe and across geographies that recognise the high
standard of safety and quality demonstrated by products conforming to the new
EU MDR. The Directors believe that approval, will give Tristel the opportunity
to deliver significant growth in sales of the Cache product range going
forward, targeting a largely untapped sporicidal surface disinfection market.
The Company expects to officially launch these latest products in Europe
before the current financial year end on 30 June 2024.

 

For the year ended 30 June 2023 revenues from the Cache range totalled £3.3m,
representing 9.2% of total annual turnover.

 

About TANK ClO₂ Sporicidal Disinfectant and the Cache range
(https://thecachecollection.com (https://thecachecollection.com) )

TANK ClO₂ Sporicidal Disinfectant is a storage and distribution system
powered by ClO₂ sporicidal disinfectant capsules. One TANK ClO₂ Sporicidal
Disinfectant capsule makes 10 litres of sporicidal solution, which is the same
as 2,000 sporicidal wipes wetted with 5ml of liquid. Rather than relying on
convenience products that do harm once they are disposed of, TANK uses plastic
thoughtfully. The core components are reusable, and all the plastic items
within the system are recyclable. Users can apply TANK ClO₂ Sporicidal
Disinfectant working solution with a Doser, Foamer or Sprayer, and reduce
plastic waste by pairing TANK working solution with any dry wipe.

 

 

The TANK ClO₂ Sporicidal Disinfectant system

 

 

The broader Cache product range for sporicidal surface disinfection

 

For further information on the TANK ClO₂ Sporicidal Disinfectant system
please view the product brochure here:

https://thecachecollection.com/wp-content/uploads/2021/09/Mkt-Bro-1508-6-TANK-ClO2-Sporicidal-Brochure-EN.pdf
(https://thecachecollection.com/wp-content/uploads/2021/09/Mkt-Bro-1508-6-TANK-ClO2-Sporicidal-Brochure-EN.pdf)

 

Paul Swinney, CEO of Tristel, commented: "Whilst our Cache product range is
intended for environmental surfaces, many of the surfaces in a hospital
setting are considered medical devices and so it is key for any disinfection
products to comply with the new EU Medical Device Regulation. It is a very
significant achievement to have concluded all reviews successfully and we
expect to receive our recommendation for certification from our Notified Body
very shortly. Conformity with MDR will allow us to apply CE marking to these
new products and gives us the opportunity to deliver significant growth in
sales of the Cache product range going forward."

 

For further information please contact:

 

 Tristel plc                                      Tel: 01638 721 500
 Paul Swinney, Chief Executive Officer            www.investors.tristel.com (http://www.investors.tristel.com/)
 Liz Dixon, Chief Financial Officer

 Walbrook PR Ltd                                  Tel: 020 7933 8780 or tristel@walbrookpr.com
 Paul McManus                                     Mob: 07980 541 893
 Charlotte Edgar                                  Mob: 07884 664 686

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

 

About Tristel plc

Tristel plc is a global infection prevention company focussed on the
manufacture and supply of products using its unique proprietary chlorine
dioxide (ClO(2)) chemistry. The Company is a market leader in manual
decontamination of medical devices, supplying hospitals under the Tristel
(https://tristel.com/) brand, and under the Cache
(https://thecachecollection.com/) brand provides products for sporicidal
surface disinfection, in a format which is a sustainable alternative to
commonly used pre-wetted plastic wipes.

 

Tristel's head office and manufacturing facility is located in Snailwell, near
Cambridge, and operates globally employing approximately 250 people across 14
subsidiaries selling into 40 countries.

 

The Company has been listed on the London Stock Exchange's AIM market since
2005 (AIM: TSTL).

 

For more information about Tristel's product range please visit:
https://tristel.com (https://tristel.com)

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