Tristel PLC (AIM:TSTL) shares gained just over 13% in Monday’s early deals as the USA Food and Drug Administration (FDA) approved Tristel ULT, its ‘high level’ disinfectant product intended for medical equipment such as ultrasound probes, for immediate sale.
It allows the company’s intended October launch of ULT to proceed.
Tristel DUO can already be used in the United States, as an intermediate-level disinfectant on the ultrasound console and the non-invasive parts of the endocavity probe, the company said. Duo was launched in the US in late 2022.
Some 215 million ultrasound scans are carried out in the United States annually, it highlighted, adding that 20% of these scans require high-level disinfection whilst the remainder require low or intermediate-level disinfection.
Tristel said the new FDA approval means it has products in the US market that can meet the disinfection needs for all ultrasound scans, which it described as “a unique competitive position”.
"This FDA approval enables our full-blown entry into the United States ultrasound market and is a significant inflection point for the company,” said chief executive Paul Swinney.
“We will now be present in the single largest ultrasound market in the world.
“This milestone achievement will allow us to significantly increase our global revenue along with our profit potential as we put Tristel's and Parker's resources behind Tristel ULT and DUO in the USA."
Tristel shares were up nearly 50p or 13.7% changing hands at 412.24p each.