REG - Tristel PLC - FDA clearance for Tristel OPH

TristelAnnouncement

12/05/2025 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250512:nRSL2330Ia&default-theme=true

RNS Number : 2330I  Tristel PLC  12 May 2025

TRISTEL plc

("Tristel" or the "Company")

 

FDA clearance for Tristel OPH

 

Ophthalmic high-level disinfectant now approved for immediate sale in the US

 

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products,
announces that the US Food and Drug Administration ("FDA") has completed its
review of the Company's 510(k) filing for Tristel OPH, and has granted its
clearance for immediate sale. Tristel OPH is a high-level disinfectant ("HLD")
foam for use on ophthalmic medical devices, including re-usable tonometers,
pachymeters, lenses, retinal imaging probes, A-scan and B-scan biometry probes
that make contact with the cornea.

 

With c.16 million ophthalmic procedures taking place every year in North
America, the Board believes that FDA clearance has the potential to transform
ophthalmic disinfection practice in the region.

 

Until now, the only FDA-cleared HLD method available for ophthalmic devices
involves soaking in an open tray. This method is slow, given the long contact
times required to be effective, and has as a result proven to be impractical
to implement at point of care. In addition, the use of chemicals, such as
sodium hypochlorite or hydrogen peroxide in an open tray, leads to
occupational health concerns and may require costly implementation of
ventilation. Prolonged exposure in a chemical soak can also lead to device
damage.

 

To address the problems, some clinics have turned to costly single-use
devices, for which there is not always an option, while others have
compromised by using low-level disinfectants options, such as alcohol wipes.

 

In comparison, Tristel OPH has a short contact time of two minutes, is
compatible with all widely used ophthalmic medical devices, is easily used at
the point of care and is instantly deployable.

 

The Company has already established local US manufacturing with its partner
Parker Laboratories, and numerous leading eye institutes in the US have
already approached Tristel to become early adopters in anticipation of FDA
clearance for Tristel OPH.

 

Matt Sassone, Chief Executive Officer of Tristel, commented: "We are delighted
to receive FDA clearance for our second high level disinfectant product in the
US. 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.

 

"Our commercial strategy builds 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, AZ mid-June, the
largest annual event in the US for reaching critical Infection Preventionist
community and decision makers."

 

The information communicated in this announcement is inside information for
the purposes of Article 7 of Regulation 596/2014.

 

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)

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  REAABMLTMTABBBA