Infection prevention company Tristel plc (AIM: TSTL) announced on Monday that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Tristel OPH product, enabling immediate sales in the United States.

Tristel OPH is a high-level disinfectant foam designed for use on ophthalmic medical devices that contact the cornea, such as tonometers and pachymeters, as well as various imaging and biometry probes.

With around 16 million ophthalmic procedures conducted annually in North America, the company sees strong potential for Tristel OPH to improve disinfection practices across the region. The product addresses key drawbacks of traditional methods - such as lengthy contact times, occupational health risks, and device degradation from chemical soaks - by offering a fast, two-minute contact time and point-of-care convenience.

Tristel has partnered with Parker Laboratories for local US manufacturing and is already engaging with leading US eye institutes eager to adopt the solution.

This milestone adds to Tristel's global leadership in chlorine dioxide-based disinfection solutions for medical devices and surfaces. The company remains focused on sustainable growth, targeting 10-15% annual revenue increases and a 25%+ EBITDA margin.