REG - Tristel PLC - FDA De Novo approval

TristelAnnouncement

05/06/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230605:nRSE5723Ba&default-theme=true

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 (http://www.tristel.com)
 Paul Swinney, Chief Executive                 Tel: 01638 721 500
 Liz Dixon, Chief Financial Officer

 finnCap
 Geoff Nash/Charles Beeson, Corporate Finance  Tel: 020 7220 0500
 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 (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  MSCUSSVROKUNRAR