Regulatory approvals in China and South Korea

Tristel plc

("Tristel" or the "Company")

Tristel's Duo for Ultrasound approved in China and Sporicidal Wipe approved in South Korea

Tristel plc (AIM: TSTL), the manufacturer of infection prevention and contamination control products, announces that its Duo High-Level disinfectant has been approved in China by the Shanghai Centre for Disease Control and Prevention and its Sporicidal Wipe has been approved in South Korea by the Korean Ministry of Food and Drug Safety. Both the Duo and Sporicidal Wipe are high-level disinfectants used on invasive ultrasound probes and endoscopic instruments.

Duo is a hand-held dispenser which applies the Company's powerful chlorine dioxide chemistry as a foam to the surface of medical devices. The Sporicidal Wipe performs the same function but incorporates the chlorine dioxide into a wipe.  Both Tristel products are widely used throughout Europe, the Middle East and the Asia-Pacific region. Sales of chlorine dioxide foam and wipe products for medical device disinfection were £8.6 m in the six-month period ending 31 December 2018, an increase of 23% on the corresponding period in the previous year.

Tristel has a well-established presence in both China and South Korea, selling other products from its medical device disinfectants portfolio. In China, Tristel will sell Duo through its own sales force. In South Korea, Tristel will sell the Sporicidal Wipe through its distributor, HP&C Ltd. This company has been Tristel's distributor since 2013 and is the Company's second largest distributor worldwide in terms of sales.

Paul Swinney, CEO of Tristel commented: "Every regulatory approval we achieve represents an important milestone in our progress, but these two approvals have special significance.  Duo ULT provides Chinese public hospitals with an affordable and easy-to-use method for the high-level disinfection of intra-vaginal ultrasound probes.  Infection prevention experts within the country acknowledge the need for a disinfection technology that will enable hospitals to raise their standards to those commonplace elsewhere.  However, reimbursement levels for an ultrasound procedure in the public hospital sector preclude the use of the few internationally recognised alternatives to Duo.  These are typically more expensive and more complicated to deploy. 

In South Korea our chlorine dioxide technology has had to achieve approval as a new drug and the process has taken over four years.  Our distributor is optimistic for the future long-term prospects of our technology in the South Korean hospital market."            

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