Tristel OPH gets US FDA clearance
By Josh White
Date: Monday 12 May 2025
(Sharecast News) - Tristel announced on Monday that it has received FDA clearance to begin immediate sales of its ophthalmic disinfectant foam, Tristel OPH, in the United States.
The AIM-traded firm said the high-level disinfectant was approved for use on a range of reusable ophthalmic instruments, including tonometers, retinal imaging probes, and biometry devices that come into contact with the cornea.
It said the clearance was a significant opportunity in a market with around 16 million ophthalmic procedures annually across North America.
Tristel said its Tristel OPH product offered a faster and more practical alternative to the only previously FDA-cleared method, which involves chemical soaking in open trays with long contact times and occupational health concerns.
The new product, which has a two-minute contact time and was suitable for point-of-care use, was expected to replace both inefficient soak systems and low-level alternatives such as alcohol wipes.
Tristel said it had established US manufacturing through partner Parker Laboratories, adding that several leading eye institutes were preparing to adopt the product.
"We are delighted to receive FDA clearance for our second high level disinfectant product in the US," said chief executive officer Matt Sassone.
"Tristel OPH directly addresses a long-standing unmet need in ophthalmic device reprocessing-offering a fast, safe and practical alternative to the outdated and often hazardous methods still in use.
"Tristel OPH is the first FDA-cleared HLD specifically validated for use on ophthalmic devices meeting user requirements for efficacy, device compatibility and in-use safety."
Sassone said the company's commercial strategy built on the valuable learnings from launching Tristel ULT in the US.
"With an experienced local team and endorsement from ophthalmic device manufacturers we are well prepared to support early adopters and drive sustained growth in this important market.
"We are very excited to bring this new product to market in the US and perfectly timed to be showcased at the APIC - Association for Professionals in Infection Control and Epidemiology - conference in Phoenix, Arizona mid-June, the largest annual event in the US for reaching critical infection preventionist community and decision makers."
At 1122 BST, shares in Tristel were up 1.52% at 401p.
Reporting by Josh White for Sharecast.com.
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