Tristel teams up with Parker Labs ahead of US approval for 'Duo'

The AIM-traded firm said the collaboration with Parker prepared it for its entry into the United States infection prevention marketplace, in advance of the grant of approval by the United States Environmental Protection Agency for Duo, which was expected during the second half of the current financial year.

It said the initiative was part of its stated intention to enter the North American infection prevention market, unveiled in the company's preliminary results announcement in October 2015.

In pursuit of the plan, on 30 June last year Tristel made a submission for regulatory clearance by the EPA of its Duo chlorine dioxide disinfection foam.

Following EPA federal approval, the company would need to secure state-by-state approval before sales of Duo could commence

The EPA clearance would enable Duo to claim intermediate disinfection of all non-porous surfaces, including those of medical instruments such as ultrasound probes.

Such applications form Tristel's core activity globally, accounting for around 80% of its revenues.

In addition, the board said it was continuing to develop two submissions to be made to the FDA for 510(K) clearance in respect of Duo.

The 510(K) approval would permit Duo to claim high-level disinfection of medical instruments.

“We are very pleased to conclude this collaboration with Parker, whose president and main shareholder we first met some 15 years ago,” said Tristel CEO Paul Swinney.

“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.”