Tristel makes FDA submission for high-level disinfectant foam

Infection prevention products manufacturer Tristel announced the submission of a premarket notification 510(k) to the US Food and Drug Administration (FDA) on Thursday, for its high-level disinfectant (HLD) foam, Tristel OPH.

The AIM-traded firm said the product was designed specifically for ophthalmic medical devices, such as reusable tonometers, pachymeters, and lenses that come into contact with the cornea.

It said the FDA filing was based on Tristel ULT, a disinfectant cleared by the FDA in June last year for use on ultrasound probes and skin surface transducers.

Tristel said it believed that FDA clearance for Tristel OPH could “transform” disinfection practices for ophthalmic devices in North America.

Under the Spaulding classification, devices that come into contact with mucous membranes, such as ophthalmic instruments, are classified as semi-critical and require high-level disinfection.

However, many such devices in the US are currently disinfected using less effective methods, like alcohol wipes, or require time-consuming processes such as soaking in sodium hypochlorite or hydrogen peroxide.

Tristel said its OPH product was the only high-level disinfectant specifically developed for ophthalmic devices.

If the 510(k) submission succeeds, it would become the only FDA-cleared HLD for ophthalmic devices, offering a quicker, more efficient alternative with no need for chemical soaking.

That, the board said, could be a game changer for the approximate 16 million ophthalmic procedures annually in the US that require high-level disinfection, including those for glaucoma diagnosis and cataract surgeries.

The disinfectant was already approved by Health Canada as a class two medical device in 2021, setting a precedent for its safety and effectiveness.

“We are delighted to have completed our FDA 510(k) filing for Tristel OPH in line with the original US product development plan set out by the company in June last year,” said chief executive officer Matt Sassone.

“We believe that our unique product designed specifically for high level disinfection of ophthalmic devices has the potential to transform infection prevention practices in the US.

“We continue to target FDA clearance by the end of 2024 and look forward to updating shareholders as we put in place a distribution agreement for the US later this year.”

At 1125 BST, shares in Tristel were down 0.35% at 431p.

Reporting by Josh White for Sharecast.com.