Tristel creates fresh launchpad to US growth

Tristel plc, the Cambs company that makes infection prevention products, has establish a significant foothold in the United States ultrasound market with products utilising its proprietary chlorine dioxide technology.

It has now launched Tristel DUO into the North American market in conjunction with the company’s manufacturing and distribution partner, Parker Laboratories in New Jersey.

Parker is a leading manufacturer in the US market for the conductive gels and sheaths used in all ultrasound procedures and has a nationwide distribution network.

Tristel DUO is a disinfecting foam approved by the USA Environmental Protection Agency for the cleaning and disinfection of general medical surfaces – including skin surface ultrasound transducers. 

DUO is widely used throughout Europe, the Middle East, Asia and Australasia and during the company's current financial year the product will be used in over 11 million ultrasound probe disinfection procedures worldwide.

The US launch is coordinated across three conferences and trade shows taking place simultaneously this week: the American Society of Diagnostic Medical Sonography in Atlanta (29 Sept – 1 Oct); the American Association of Vascular Access in Minneapolis (30 Sept – 3 Oct), and the American Emergency Nurses Association in Denver (30 Sept – 3 Oct).

Neal Buchalter, President of Parker Laboratories, said: “Tristel’s products are used in 35 countries and for millions of disinfection procedures every year. 

“We’re proud of this new partnership with Tristel, as it reflects our continued commitment to improving the safety of any procedure involving ultrasound equipment.”

In June Tristel achieved a major milestone by making its De Novo submission to the USA Food and Drug Administration for its DUO ULT product which is used as a high-level disinfectant for ultrasound intra-cavity probes. 

Following the FDA’s complete review of the submission, it has provided the Company with an Additional Information request – commonplace within the De Novo submission process. 

The company and its advisers are confident that the 180-day timeline set by the FDA to return the information will be met. 

Tristel CEO Paul Swinney said: “We are delighted to have products entering the North American hospital market in partnership with Parker Laboratories who are specialists in the ultrasound arena.

“In all the countries in which we operate, hospital ultrasound is one of our most important segments. We have high hopes for our EPA approved product.

“Our opportunities will expand enormously with an accompanying FDA approval and it is good the review of our submission is progressing. Additional Information requests are expected in this process and we are confident that we will be in a position to return the requested information on time. 

“Nothing has changed in terms of our overall view on the timescale for the completion of this process and the likelihood of success. We remain excited about the opportunity America holds in terms of potential revenue and profit contributions.

“Our global outlook remains positive. We have a highly focused business, we now have products available in the largest single healthcare market in the world, an exciting pipeline of new product innovations, and a strong balance sheet to support our growth.”