The company company says it now hopes to get EPA approval for its foam-based chlorine dioxide product around May next year
Tristel, the manufacturer of infection prevention, contamination control and hygiene products, has been informed by the Environmental Protection Agency ( EPA) in the US that additional information is required to support its submission of Duo, developed for the potential disinfection of endocavity ultrasound probes.
A meeting with the EPA in October 2016 and subsequent communications with the agency guided the scope and content of the Company’s Duo submission which was made on 30 June 2017. The EPA has now informed the Company that it has changed its approach and additional information has been requested.
This additional data has largely been compiled and submitted. As a result, the EPA approval is now expected in May 2018, rather than late 2017 as originally anticipated. Approval will be followed by the state by state registration process and the Company’s revenue expectations are not affected by this slight delay.
The EPA has jurisdiction over low and intermediate disinfectants for surfaces and non-critical devices such as Duo's disinfection of ultrasound consoles. The FDA has jurisdiction of high level disinfections of semi-critical devices (e.g. ultrasound probes, opthalmic and ENT devices, submissions for which are still not expected until the second half of 2018.
Paul Swinney, CEO, said: “Whilst we are disappointed that the EPA’s change of approach will require us to restart the submission timetable and incur a five-month delay to the timetable that we originally anticipated, our expectation for first revenues from North America in financial year 2018-19 remains unchanged.”