Tristel PLC Regulatory approval for EPA, Canada & South Korea
24 Junio 2021 - 1:00AM
RNS Non-Regulatory
TIDMTSTL
Tristel PLC
24 June 2021
Tristel plc
("Tristel" or the "Company")
Regulatory approval for EPA, Canada and South Korea
Tristel plc (AIM: TSTL), the manufacturer of infection
prevention products, announces that it has received three
significant regulatory approvals.
United States Environmental Protection Agency (EPA)
Tristel received its first approval from the EPA for its
foam-based disinfectant for surfaces in April 2018. We successfully
enhanced the performance claims of the product with a second
approval in January 2019 and then registered the product in three
States before curtailing the nationwide registration programme
until a third submission could be made to bolster further the
competitive positioning of the product. This submission was made in
October 2020 and we have now received the third approval for Jet.
This expands the product's efficacy claims to include mycobacteria,
and all efficacy claims are within a contact time of two minutes.
We expect to complete State-by-State registration by the end of
June 2022, including California where our existing registration
will require amendment, which can be a lengthy process.
We have appointed Parker Laboratories, New Jersey, as our United
States manufacturing partner for Jet and will sell the product
through Parker's nationwide network of distributors on a
non-exclusive basis, commencing in FY23. Other distribution
channels will be put in place ahead of the US launch.
Health Canada
Tristel Duo OPH has been approved by Health Canada as a class 2
medical device and is included in Health Canada's Medical Device
License Listing. Duo OPH is a high-level disinfectant intended for
use on ophthalmic instruments including ultrasound devices and
re-usable tonometers and lenses that contact the cornea.
We sell Duo OPH in over 15 countries and worldwide sales in FY21
will be approximately GBP650,000. Duo OPH is the only specialist
high-level disinfection product for ophthalmic devices in the
world. Awareness of the need for high-level disinfection in
diagnostic eye care is growing, although COVID-19 caused
ophthalmologists and optometrists in all countries to curtail their
activities in 2020.
Parker Laboratories will manufacture the product and we are in
discussions with potential distribution partners in Canada.
An explanation of the infection risks in ophthalmology can be
found Click here
South Korea Ministry of Food and Drug Safety
We obtained approval for the Tristel Sporicidal Wipe from the
Korean Ministry of Food and Drug Safety in March 2019. The
application had taken four years as our chlorine dioxide chemistry
had to achieve approval as a new drug. The Sporicidal Wipe is the
key component in our Trio Wipes System, which is widely used for
small endoscopic devices used in ear, nose and throat clinics.
Tristel Duo ULT has now been approved as a high-level
disinfectant for ultrasound devices, and with Trio will be sold
throughout South Korea by HP&C Ltd., Tristel's distributor
since 2013.
Duo is a hand-held dispenser which applies the Company's
powerful chlorine dioxide chemistry as a foam to the surface of
medical devices. Tristel Duo is widely used throughout Europe, the
Middle East and the Asia-Pacific region and the Company is seeking
approval for Duo ULT from the United States Food and Drug
Administration (FDA). Worldwide sales of all Duo branded products
for medical device disinfection, including Duo ULT and Duo OPH,
will exceed GBP4.3m in FY21.
Paul Swinney, CEO of Tristel commented: "Every regulatory
approval we achieve represents an important milestone in our
progress, and these three approvals are very significant.
"The enhanced claim set that we have achieved for Jet now
justifies taking the product through state-wide registration in the
USA and gearing up our manufacturing and distribution partnership
with Parker Laboratories.
"The approval of Duo OPH by Health Canada represents our first
successful registration of a medical device high-level disinfectant
in North America. We are actively pursuing a submission to the USA
FDA for Duo ULT and we are buoyed by this successful application in
Canada.
"The approval in South Korea increases the visibility of our
chlorine dioxide technology in the country and extends our
distributor's involvement into more clinical areas within a
hospital."
For further information please contact:
Tristel plc Tel: 01638 721 500
Paul Swinney, Chief Executive
Officer
Liz Dixon, Finance Director
Walbrook PR Ltd Tel: 020 7933 8780 or tristel@walbrookpr.com
Paul McManus Mob: 07980 541 893
Lianne Cawthorne Mob: 07854 391 303
finnCap Tel: 020 7220 0500
Geoff Nash / Giles Rolls, Corporate
Finance
Alice Lane, ECM
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