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You are here: BioMedTech Bug-busting Tristel courts US FDA

Bug-busting Tristel courts US FDA

Paul Swinney, CEO at Tristel

Bug-busting specialist Tristel, which operates from the Cambridge UK technology cluster, is engaging with the FDA in a bid to have its infection control products adopted in the lucrative US market.

CEO Paul Swinney tells Business Weekly that Tristel is receiving emails almost daily from hospitals in North America keen to trial the products.

“It may take time to win FDA approval but the US is right at the top of our wish list as we explore new territories. Our FD Liz Dixon and I have travelled extensively to identify new territories for our technology and the US is prime for what we can offer.”

Dixon added: “We can demonstrate a strong track record to the FDA having gone through a stringent regulatory process in other countries – notably China – but also Australasia and in Germany. We have never been better placed to exploit the potential North America represents for our products.”

In a transformational last 12 months, Tristel has increased sales by 156 per cent in Germany, 118 per cent in Australasia and 77 per cent in Asia. Sales have also held steady in other markets, such as Russia, through distributors.

Tristel has a suite of related products that help hospitals kill potentially lethal superbugs. That doesn’t just involve keeping wards clean but ensuring that instrumentation remains bug free – and that is another growing area of business for Tristel, which has doubled its space and capacity at its headquarters in Newmarket, just along the road from Europe’s innovation capital.

Swinney said: “We are working on next generation products, related to the existing ones, and as well as pushing into more export markets we are looking at new applications for the technology.

“There would appear to be major opportunities in skin, in pre-hospital, military medicine and humanitarian aid arenas – and in areas of instrument hygiene that haven’t been adequately addressed by hospitals to date, such as ophthalmology.

“Lenses and prisms come into contact with the cornea and if not properly cleaned with an infection control product can lead to conjunctivitis and other infections. In the past there has been a tendency in some hospitals to just tuck the instruments away and ignore the problem but – thankfully for patients’ welfare – we are now receiving a widespread welcome for our technology.

“It has taken time to get hospital administrators to realise the benefits when set against the cost. Ours are new products so represent a new cost for hospitals who often struggle with budgetary constraints.”

Growth in export markets is only part of the expansion strategy. Swinney insists there is still “plenty of gas in the UK market with the NHS.”

Tristel is springing off the most solid of platforms, as today’s preliminary results for the year to December 31 demonstrate. Revenue was up 46 per cent to £6.4 million and Tristel turned a pre-tax loss in 2012 to a £0.7m pre-tax profit in 2013. International sales were 45 per cent ahead to £2m.

Swinney said: “It’s been quite a transformation from the previous year and the upward momentum has continued into the first half. There is lots of potential for significant growth for many years to come.

“We have a compelling case to put to customers. Our products are fast-acting in killing infection and safe for the user. We have also been investing in fresh innovations in different areas of instrumentation hygiene.”

Tristel experienced explosive headcount growth a couple of years ago as it expanded in Newmarket and opened up operations around the world but has scaled back to more manageable proportions.

Swinney said: “The challenge is always to replicate the quality and ethos of our head office into our overseas operations and distributor networks and there is always a danger in trying to go too fast. We are managing our global growth in incremental stages.

“Newmarket has proved a great place for our headquarters: We have doubled our leased space here, extended our facilities and have been able to recruit from a strong and skilled local workforce. Having the R & D and manufacturing at one base also makes us a much more cohesive business.”

The share price was up five per cent to 43p on early trading following the results announcement.

• PHOTOGRAPH SHOWS: Paul Swinney, CEO at Tristel

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