Picture of Tristel logo

TSTL Tristel News Story

0.000.00%
gb flag iconLast trade - 00:00
IndustrialsAdventurousSmall CapHigh Flyer

REG - Tristel PLC - De Novo FDA submission for Tristel Duo ULT

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220630:nRSd6799Qa&default-theme=true

RNS Number : 6799Q  Tristel PLC  30 June 2022

Tristel plc

("Tristel" or the "Company")

 

De Novo FDA submission for Tristel Duo ULT

 

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products,
reports that it has submitted its De Novo request for approval to the FDA, the
United States regulatory body responsible for medical device disinfectants.
Tristel Duo ULT is used for the disinfection of ultrasound probes.

 

Tristel Duo ULT is a high-level disinfectant foam that can be used on
ultrasound probes used for intra-cavitary and skin surface diagnostic
procedures. Ultrasound probe disinfection is one of Tristel's most important
areas of focus within the hospital infection prevention market and accounts
for approximately 40% of the Company's global revenue which analysts forecast
at £28 million for the current financial year.

 

To the Company's knowledge, Tristel Duo ULT is the first disinfectant to make
a De Novo request to the FDA, reflecting the novelty of the product. Duo ULT
is widely used throughout Europe, the Middle East, Asia, and Australasia and
during the Company's current financial year the product will have been used in
over 8 million disinfection procedures of ultrasound probes worldwide.

 

The FDA's De Novo review and approval process stipulates a 150-day decision
timeframe. Additional data requests are commonplace, and the FDA website
states that the average duration for review and approval is approximately 11
months.

 

The Company is also proceeding with the state registration of another version
of Duo which has been approved by the United States EPA for the disinfection
of general medical surfaces. The Company has received 24 state approvals and
anticipates that all others will have been received by the end of 2022.

 

The Company will manufacture and distribute both Duo products via its
commercial partnership with Parker Laboratories, New Jersey ("Parker"). Parker
is a leading manufacturer in the USA market for the conductive gels and
sheaths that are used in all ultrasound procedures, and Parker has a
nationwide distribution network.

 

Paul Swinney, Chief Executive of Tristel plc, comments: "After five years of
testing and data generation we are very pleased to have finally submitted our
De Novo request for approval to the FDA. We have made an investment of £2.8
million in the project which has all been expensed.

 

"The United States is the largest ultrasound market in the world and our
competitors will be the same as those we compete with in all our other markets
worldwide. To our knowledge no new high-level disinfectant has been approved
by the FDA and introduced into the United States since 2011, other than
variants of previously approved products. Duo ULT is recognised as a leading
high-level disinfectant throughout the rest of the world, and our entry into
the United States market will be a significant inflection point for the
Company."

 

Tristel holds a shareholder open day at its Newmarket headquarters on 18 July
and will release a trading update on the day.

 

 

The information contained within this announcement is deemed to constitute
inside information as stipulated under the Market Abuse Regulations (EU No.
596/2014) which is part of UK law by virtue of the European Union
(Withdrawal) Act 2018. Upon the publication of this announcement, this inside
information is now considered to be in the public domain.

 

 

 

 

For further information please contact:

 

 Tristel plc                            Tel: 01638 721 500
 Paul Swinney, Chief Executive Officer
 Liz Dixon, Chief Financial Officer

 Walbrook PR Ltd                        Tel: 020 7933 8780 or tristel@walbrookpr.com
 Paul McManus                           Mob: 07980 541 893
 Lianne Applegarth                      Mob: 07584 391 303

 finnCap                                Tel: 020 7220 0500
 Geoff Nash/ Charles Beeson (Corporate Finance)
 Alice Lane (ECM)

 

 

 

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  MSCFLFLVRSIAFIF

Recent news on Tristel

See all news