Tristel PLC FDA De Novo approval (5723B)
June 05 2023 - 2:00AM
UK Regulatory
TIDMTSTL
RNS Number : 5723B
Tristel PLC
05 June 2023
TRISTEL plc
("Tristel" or the "Company")
FDA De Novo approval
Tristel ULT approved by the FDA as a high level disinfectant for
use on endocavity ultrasound probes and skin surface
transducers
Tristel expects to gain significant market share in the world's
largest ultrasound market
Tristel plc (AIM: TSTL), the manufacturer of infection
prevention products utilising proprietary chlorine dioxide
technology, announces that the USA Food and Drug Administration
("FDA") has completed its review of the Company's De Novo request
for classification (Class II) of Tristel ULT as a high level
disinfectant, and has granted its approval for immediate sale.
Tristel DUO, the Company's intermediate level disinfectant
approved by the USA Environmental Protection Agency for use on the
ultrasound console and the non-invasive parts of the endocavity
probe, is now registered in all states of the USA.
The Company estimates that over 215 million ultrasound scans are
carried out in the United States annually. Approximately 20% of
these scans require high level disinfection and the remainder
require low or intermediate level disinfection. With the FDA
approval, Tristel has two products approved in the USA that can
meet the disinfection needs for all ultrasound scans. This is a
unique competitive position.
The United States nationwide launch of Tristel ULT will commence
in October this year, following Tristel DUO's market introduction
late last year. The Company has already established a manufacturing
base with Parker Laboratories Inc., New Jersey, and will utilise
Parker's national distribution network for the ultrasound market.
Parker is the largest supplier of ultrasound transmission gels in
the USA. As both a gel and an appropriate disinfectant must be used
in every ultrasound scan procedure, the combination of Tristel and
Parker products promises a powerful combination.
Whilst Tristel is a new market entrant in the USA, the Company
is very familiar with the competitive landscape which is almost
identical in the other 40 plus countries in which Tristel operates.
Approximately half of Tristel's global revenue is generated from
the ultrasound market.
Further details of the Company's North American commercial
strategy will be outlined to equity analysts and investors through
a series of presentations over the next few weeks. Further details
will be announced in due course.
Paul Swinney, Chief Executive of Tristel, said: "This FDA
approval enables our full-blown entry into the United States
ultrasound market and is a significant inflection point for the
Company. We will now be present in the single largest ultrasound
market in the world. This milestone achievement will allow us to
significantly increase our global revenue along with our profit
potential as we put Tristel's and Parker's resources behind Tristel
ULT and DUO in the USA."
The information communicated in this announcement is inside
information for the purposes of Article 7 of Regulation
596/2014.
Tristel plc www.tristel.com
Paul Swinney, Chief Executive Tel: 01638 721 500
Liz Dixon, Chief Financial Officer
finnCap
Geoff Nash/Charles Beeson, Corporate Tel: 020 7220 0500
Finance
Alice Lane, Corporate Broking
Walbrook PR Ltd Tel: 020 7933 8780 or tristel@walbrookpr.com
Paul McManus / Lianne Applegarth Mob: 07980 541 893 / 07584 391 303
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 or visit 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.
END
MSCUSSVROKUNRAR
(END) Dow Jones Newswires
June 05, 2023 02:00 ET (06:00 GMT)
Tristel (LSE:TSTL)
Historical Stock Chart
From Sep 2024 to Oct 2024
Tristel (LSE:TSTL)
Historical Stock Chart
From Oct 2023 to Oct 2024