REG - Tristel PLC - FDA 510(k) submission for Tristel OPH

TristelAnnouncement

12/09/2024 07:00

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RNS Number : 8393D  Tristel PLC  12 September 2024

Tristel plc

("Tristel" or the "Company")

 

FDA 510(k) submission for Tristel OPH

 

Premarket Notification 510(k) medical device filing for high-level
disinfection of ophthalmic devices

 

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products,
announces that it has filed a Premarket Notification 510(k) with the US Food
and Drug Administration ("FDA") for Tristel OPH, a high-level disinfectant
("HLD") foam for use on ophthalmic medical devices, including re-usable
tonometers, pachymeters and lenses that make contact with the cornea.

 

The 510(k) filing for Tristel OPH will use Tristel ULT as its predicate
device. Tristel ULT, a HLD 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.

 

The Board believes that FDA clearance has the potential to transform
ophthalmic disinfection practice in North America. According to the Spaulding
classification(1), semi-critical devices require reprocessing with a HLD
because they touch mucous membranes or non-intact skin, which is the case for
nearly all ophthalmic devices. Very few semi-critical ophthalmic devices are
subjected to an effective HLD in the US. Low-level disinfectant options such
as alcohol wipes are used as an alternative, or devices may be soaked in
sodium hypochlorite (bleach) or hydrogen peroxide in open trays with long
contacts times.

 

Tristel OPH is the only HLD in the world designed specifically for ophthalmic
devices and if 510(k) filing is successful it would become the only FDA
cleared HLD, effective with short contact times and no requirement to soak
devices in chemicals in an open tray, available for use in the c. 16m
ophthalmic procedures that require HLD annually in the US, such as glaucoma
diagnosis and cataract surgeries.

 

Tristel OPH was approved by Health Canada as a Class II Medical Device in June
2021.

 

Matt Sassone, Chief Executive Officer of Tristel, commented: "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.
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."

 

Notes

(1)The Spaulding Classification (1968) developed by Dr. Earle H. Spaulding,
defines how an item for patient care (e.g. medical device) should be
disinfected based on its intended use.

 

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 / Charlotte Edgar         Mob: 07980 541 893 / Mob: 07884 664 686

 Cavendish Capital Markets Limited      Tel: 020 7220 0500
 Geoff Nash / Camilla Hume / Trisyia Jamaludin (Corporate Finance)
 Sunila de Silva (Corporate Broking)
 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, in a format which is a 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 250 people across 14
subsidiaries selling into 60 countries.

 

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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