Tristel plc announced that the U SA Food and Drug Administration ("FDA") has completed its review of the Company's De Novo request for classification (Class II) of Tristel ULT as a high level disinfectant, and has granted its approval for immediate sale. Tristel DUO, the Company's intermediate level disinfectant approved by the USA Environmental Protection Agency for use on the ultrasound console and the non-invasive parts of the endocavity probe, is now registered in all states of the USA. The Company estimates that over 215 million ultrasound scans are carried out in the United States annually.

Approximately 20% of these scans require high level disinfection and the remainder require low or intermediate level disinfection. With the FDA approval, Tristel has two products approved in the USA that can meet the disinfection needs for all ultrasound scans. This is a unique competitive position.

The United States nationwide launch of Tristel ULT will commence in October this year, following Tristel DUO's market introduction late last year. The Company has already established a manufacturing base with Parker Laboratories Inc., New Jersey, and will utilise Parker's national distribution network for the ultrasound market.