REG - Tristel PLC - Additional info. submitted to FDA for Tristel OPH

TristelAnnouncement

10/04/2025 07:00

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RNS Number : 4027E  Tristel PLC  10 April 2025

TRISTEL plc

("Tristel" or the "Company")

 

Additional information submitted to the FDA for Tristel OPH

 

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products,
confirms it has submitted the additional information requested by the U.S.
Food and Drug Administration (FDA) for Tristel OPH, a high-level disinfectant
foam for use on ophthalmic medical devices, including re-usable tonometers,
pachymeters and lenses that make contact with the cornea. The Company now
expects a decision from the FDA by the end of June 2025.

 

As announced in September 2024
(https://www.londonstockexchange.com/news-article/TSTL/fda-510-k-submission-for-tristel-oph/16661280)
, the 510(k) filing for Tristel OPH will use Tristel ULT as its predicate
device. Tristel ULT, a high-level disinfectant labelled for use on endocavity
ultrasound probes and skin surface transducers, was cleared for sale in the US
by the FDA in June 2023, following the Company's De Novo submission.

 

With c.16 million ultrasound procedures taking place every year in North
America, the Board continues to believe that FDA clearance has the potential
to transform ophthalmic disinfection practice in the region. Tristel OPH
addresses operational inefficiencies arising from complex and time-consuming
decontamination practice. In addition, very few semi-critical ophthalmic
devices are subject to effective high-level disinfection in the US. Low-level
disinfectant options such as alcohol wipes are used as an alternative, or
devices may be soaked in sodium hypochlorite (Milton) or hydrogen peroxide in
open trays with long contacts times.

 

Matt Sassone, Chief Executive Officer of Tristel, commented: "We are extremely
pleased to have submitted the additional information to the FDA for Tristel
OPH. 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 APIC (Association for Professionals in Infection Control and Epidemiology)
conference in Phoenix, AZ mid-June, the largest annual event in the USA for
reaching critical Infection Preventionist community and decision makers."

 

For further information please contact:

 

 Tristel plc                                                                  Via Walbrook PR
 Matt Sassone, Chief Executive Officer                                        www.investors.tristel.com (http://www.investors.tristel.com/)
 Liz Dixon, Chief Financial Officer

 Walbrook PR Ltd                                                              Tel: 020 7933 8780 or tristel@walbrookpr.com
 Paul McManus / Lianne Applegarth / Alice Woodings    Mob: 07980 541 893/ 07584 391 303/ 07407 804 654

 Cavendish Capital Markets Ltd                                                Tel: 020 7220 0500
 Geoff Nash / Camilla Hume / Trisyia Jamaludin (Corporate Finance)
 Sunila de Silva (ECM) / Louise Talbot (Sales)

 

About Tristel plc

Tristel plc is a global infection prevention company focussed on the
manufacture and supply of products using its unique proprietary chlorine
dioxide (ClO(2)) chemistry. The Company is a market leader in manual
decontamination of medical devices, supplying hospitals under the Tristel
(https://tristel.com/) brand, and under the Cache
(https://thecachecollection.com/) brand provides products for sporicidal
surface disinfection, a more sustainable alternative to commonly used
pre-wetted plastic wipes.

 

Tristel's head office and manufacturing facility is located in Snailwell, near
Cambridge, and operates globally employing approximately 270 people across 16
subsidiaries selling into 40+ countries. The Company targets annual revenue
growth of between 10% and 15% and an EBITDA margin of at least 25% and the
business is profitable, with no debt and has a progressive dividend policy.

 

The Company has been listed on the London Stock Exchange's AIM market since
2005 (AIM: TSTL).

 

For more information about Tristel's product range please visit:
https://tristel.com (https://tristel.com)

 

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