East Anglia-based infection prevention products manufacturer Tristel has launched a wholly-owned subsidiary in the United States, as part of its drive to enter the lucrative North American market.
Tristel, which is based at Snailwell, near Newmarket, has also just delivered a submission for regulatory clearance by the US Environmental Protection Agency (EPA) for its Duo chlorine dioxide disinfection foam.
Approval is expected during the second half of the company’s new financial year, which began on July 1, although it will then need to secure state-by-state approval before it can begin selling Duo around the US.
EPA clearance will enable Duo to claim intermediate disinfection of all non-porous surfaces. This includes medical instruments which represents Tristel’s core activity worldwide and accounts for around 80% of the company’s revenues.
In all other markets worldwide Duo is classified as a high-level disinfectant, and Tristel is continuing to work on submissions to the US Food and Drug Administration (FDA) to permit Duo to claim high-level disinfection of medical instruments in the US too. These submissions are expected to be made during the first half of its 2018-19 financial year.
Tristel said: “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, which has established its US subsidiary in the state of Delaware, is also developing four more submissions to be made to the EPA during the coming 12 months for other products, also chlorine dioxide based.
Paul Swinney, chief executive at Tristel, 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.”
He added: “Duo has patent protection in both the United States 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.”
In a separate announcement today, Tristel revealed that it has invested 750,000 US dollars (about £580,000) to take a 3.27% equity stake in Mobile ODT, an Israeli company which is combining smartphone technology with hand-held medical devices to provide diagnostics at the point of care.
Francisco Soler, chairman of Tristel, and Paul Barnes, a non-executive director, are also making personal investments and Tristel will have a seat on the Mobile ODT board.
In February, Tristel reported that revenues for the six months to December 31, 2016, were 22% higher compared with the same period a year earlier, at £9.75m against £8.01m.
This included a 45% increase in overseas sales, to £4.2m from £2.9m, representing 43% of total revenue against 36% during the previous year’s first half.
Earnings before interest, tax and depreciation grew by 21%, to £2.3m from £1.9m, with pre-tax profits 15% higher, at £1.7m against £1.48m.
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