REG - Tristel PLC - North America update

TristelAnnouncement

29/09/2022 13:00

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RNS Number : 2011B  Tristel PLC  29 September 2022

Tristel plc

("Tristel", the "Company" or the "Group")

 

North America update

 

US Launch of EPA registered Tristel DUO

FDA De Novo Submission update

 

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products,
provides an update on progress in addressing the commercial opportunity in the
United States ultrasound market with products utilising its proprietary
chlorine dioxide technology.

 

Launch of Tristel DUO into the North American Market

Tristel announces that it has now launched Tristel DUO into the North American
market in conjunction with the Company's manufacturing and distribution
partner, Parker Laboratories ("Parker"). Parker is a leading manufacturer in
the USA market for the conductive gels and sheaths that are used in all
ultrasound procedures, and has a nationwide distribution network.

 

Tristel DUO is a disinfecting foam approved by the USA Environmental
Protection Agency (EPA) for the cleaning and disinfection of general medical
surfaces - including skin surface ultrasound transducers. DUO is widely used
throughout Europe, the Middle East, Asia, and Australasia and during the
Company's current financial year the product will be used in over 11 million
ultrasound probe disinfection procedures worldwide.

 

The launch is coordinated across three conferences and trade shows taking
place simultaneously this week: the American Society of Diagnostic Medical
Sonography in Atlanta (29 Sept - 1 Oct); the American Association of Vascular
Access in Minneapolis (30 Sept - 3 Oct), and the American Emergency Nurses
Association in Denver (30 Sept - 3 Oct).

 

Neal Buchalter, President of Parker Laboratories, commented: "Tristel's
products are used in 35 countries and for millions of disinfection procedures
every year. We're proud of this new partnership with Tristel, as it reflects
our continued commitment to improving the safety of any procedure involving
ultrasound equipment."

 

https://www.parkerlabs.com/wp-content/uploads/2022/09/Parker-Tristel-Duo-Strategic-release_-FINAL-2.pdf
(https://www.parkerlabs.com/wp-content/uploads/2022/09/Parker-Tristel-Duo-Strategic-release_-FINAL-2.pdf)

 

FDA De Novo Submission - additional information request

In June Tristel achieved a major milestone event by making its De Novo
submission to the USA Food and Drug Administration (FDA) for its Tristel DUO
ULT product which is used as a high-level disinfectant for ultrasound
intra-cavity probes. Following the FDA's complete review of the submission, it
has provided the Company with an Additional Information request.

 

As previously outlined to shareholders, Additional Information requests are
commonplace within the De Novo submission process, and therefore the previous
guidance on the average duration for review and approval of approximately 11
months remains accurate for this submission. The Company and its advisors are
confident that the 180-day timeline set by the FDA to return the information
will be met. The overall expected timescale for the process is unchanged.

 

Paul Swinney, CEO of Tristel plc, comments: "We are delighted to have products
entering the North American hospital market in partnership with Parker
Laboratories who are specialists in the ultrasound arena.  In all the
countries in which we operate, hospital ultrasound is one of our most
important segments. We have high hopes for our EPA approved product.

 

"Our opportunities will expand enormously with an accompanying FDA approval
and it is good the review of our submission is progressing. Additional
Information requests are expected in this process and we are confident that we
will be in a position to return the requested information on time. Nothing has
changed in terms of our overall view on the timescale for the completion of
this process and the likelihood of success. We remain excited about the
opportunity America holds in terms of potential revenue and profit
contributions.

 

"Our global outlook remains positive. We have a highly focussed business, we
now have products available in the largest single healthcare market in the
world, an exciting pipeline of new product innovations, and a strong balance
sheet to support our growth."

 

The information communicated in this announcement contains inside information
for the purposes of Article 7 of the Market Abuse Regulation (EU) No.
596/2014.

 

 

 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)

 

About Parker Laboratories (www.parkerlabs.com (http://www.parkerlabs.com) ).

Parker Laboratories is a leading global medical product company that develops,
manufactures, and sells ultrasound and electromedical contact media and
accessories, as well as leading lines of instrument cleaners and
disinfectants. A worldwide leader in ultrasound medical products for over 60
years, Parker has consistently been at the forefront of technological advances
in the industry. Its flagship product, Aquasonic(®)100 ultrasound
transmission gel, is the world standard for medical ultrasound.

 

 

 

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