Tristel Regulatory News (TSTL)

Tristel plc

("Tristel" or "the Company")

Commercial collaboration with Parker Laboratories Inc., USA

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products, announces that it has entered into a manufacturing and marketing agreement with Parker Laboratories Inc., USA ('Parker') whereby Parker will manufacture Tristel's Duo chlorine dioxide foam disinfectant for the North, Central and South American market and will market the product in the ultrasound marketplace throughout the region. This collaboration with Parker prepares Tristel for its entry into the United States infection prevention marketplace in advance of the grant of approval by the United States Environmental Protection Agency ('EPA') for Duo which is expected during the second half of the current financial year.

Parker (www.parkerlabs.com) was founded in 1958 and is family-owned and managed. The company pioneered the development of conductive gels for use in ultrasound. It manufactures its products in a 95,000 sq ft facility in Fairfield, New Jersey and is registered with the United States Food and Drug Administration ('FDA') as a manufacturer of medical devices. All Parker products are manufactured under Good Manufacturing Practice ('GMP') directives. Parker's products are available to ultrasound practitioners in every country throughout the world. Its Aquasonic 100 gel is the market leader in the United States where the company has nationwide distribution through a network of approximately 500 distributors. Parker is also a market leader in the ultrasound market in Canada and throughout Central and South America.

This initiative is part of Tristel's stated intention to enter the North American infection prevention market. This plan was unveiled in the Company's preliminary results announcement in October 2015. In pursuit of this plan, on 30 June 2017 Tristel made a submission for regulatory clearance by the EPA of its Duo chlorine dioxide disinfection foam. Following EPA federal approval, the Company will need to secure state-by-state approval before sales of Duo can commence

The EPA clearance will enable Duo to claim intermediate disinfection of all non-porous surfaces, including those of medical instruments such as ultrasound probes. This is Tristel's core activity worldwide and accounts for approximately 80% of the Company's revenues. In addition, the Company continues to develop two submissions to be made to the FDA for 510(K) clearance in respect of Duo. The 510(K) approval will permit Duo to claim high-level disinfection of medical instruments. It is important to note that in all other markets worldwide, Duo is classified as a high-level disinfectant.

Paul Swinney, CEO of Tristel plc, comments: "We are very pleased to conclude this collaboration with Parker, whose President and main shareholder we first met some fifteen years ago. The company is extremely well-known in ultrasound having been around for so many years under the long-term ownership and management of the Buchalter family. Our collaboration will give us the platform to access the ultrasound marketplace throughout the United States and the Americas, first with our EPA approved Duo product and in due course with our FDA approved Duo."

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The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2014.