Tristel submits additional details for FDA disinfectant clearance
By Josh White
Date: Thursday 10 Apr 2025
(Sharecast News) - Tristel announced on Thursday that it has submitted the additional information requested by the US Food and Drug Administration for its Tristel OPH disinfectant, moving the product closer to potential FDA clearance, which it now expects by the end of June.
The AIM-traded firm described Tristel OPH as a high-level disinfectant foam designed for use on ophthalmic medical devices, including reusable tonometers, pachymeters, and lenses that contact the cornea.
It said the FDA filing referenced Tristel ULT, a similar disinfectant cleared by the agency in June 2023 for use on ultrasound probes, as the predicate device under the 510(k) process.
The company said it believed FDA approval for Tristel OPH could significantly change ophthalmic disinfection practices in North America.
It said many semi-critical ophthalmic devices in the US were currently disinfected with lower-level solutions such as alcohol wipes or soaked in sodium hypochlorite or hydrogen peroxide, which are less effective and time-consuming.
Tristel said its product offered a more efficient alternative that could address long-standing operational inefficiencies in the sector.
Tristel added that around 16 million ultrasound procedures are performed annually in North America, underlining the potential market for high-level disinfection products in clinical settings.
"We are extremely pleased to have submitted the additional information to the FDA for Tristel OPH," said chief executive officer Matt Sassone.
"The ophthalmic opportunity within the US remains strong and we continue to make good progress on establishing our commercial route to market.
"With the timing of submission, a month ahead of the ultimate deadline, we have given ourselves the best opportunity to have the FDA decision in time for the Association for Professionals in Infection Control and Epidemiology conference in Phoenix, Arizona mid-June, the largest annual event in the USA for reaching critical Infection Preventionist community and decision makers."
At 1205 BST, shares in Tristel were up 4.96% at 307p.
Reporting by Josh White for Sharecast.com.
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