The UK-based company has incorporated a wholly-owned subsidiary in Delaware, USA, and made an EPA submission for its Duo chlorine dioxide disinfection foam
Tristel is seeking EPA approval to market specific products in the US
Manufacturer of infection prevention products, Tristel, has established its presence in the US by incorporating a wholly-owned subsidiary in the State of Delaware. This initiative is part of the company’s stated intention to enter the North American infection prevention market.
On 30 June, Tristel made a submission for regulatory clearance by the US Environmental Protection Agency (EPA) of its Duo chlorine dioxide disinfection foam.
The company expects to receive approval in the second half of its financial year commencing 1 July, 2017. Following EPA federal approval, the company will then need to secure state-by-state approval before it can commence selling Duo.
The EPA clearance will enable Duo to claim intermediate disinfection of all non-porous surfaces, including those of medical instruments. 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 Food and Drug Administration (FDA) for 510(K) clearance in respect of Duo. The 510(K) approval will permit Duo to claim high-level disinfection of medical instruments. Tristel expects to complete and make these submissions during the first half of its financial year commencing 1 July, 2018.
In all other markets worldwide, Duo is classified as a high-level disinfectant. It is important to note that there is no difference in formulation or performance of the Duo product submitted to the EPA and the Duo product that will be submitted to the FDA in due course.
The company continues to develop a further four additional submissions to be made to the EPA during the coming 12 months for other products selected from its global portfolio. These products are also chlorine dioxide based.
Paul Swinney, CEO, said: “We are very pleased with the progress that our team has made in reaching our first major milestone to enter the North American infection prevention market – a submission to the EPA for approval of our Duo chlorine dioxide foam. Attaining this milestone keeps us on track to achieve our objective of generating revenues in the North American market during the 2018-19 financial year.
“Duo has patent protection in both the US and Canada.
“We are now formulating our manufacturing and distribution strategy for North America and will provide further detail at the time of our preliminary results announcement in October.”