UK and EU regulatory approval update

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)

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:

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."