Tristel PLC Commercial collaboration with Parker Laboratories (8400I)
March 26 2018 - 1:00AM
UK Regulatory
TIDMTSTL
RNS Number : 8400I
Tristel PLC
26 March 2018
Tristel plc
("Tristel" or "the Company")
Commercial collaboration with Parker Laboratories Inc., USA
Tristel plc (AIM: TSTL), the manufacturer of infection
prevention products, announces that it has entered into a
manufacturing and marketing agreement with Parker Laboratories
Inc., USA ('Parker') whereby Parker will manufacture Tristel's Duo
chlorine dioxide foam disinfectant for the North, Central and South
American market and will market the product in the ultrasound
marketplace throughout the region. This collaboration with Parker
prepares Tristel for its entry into the United States infection
prevention marketplace in advance of the grant of approval by the
United States Environmental Protection Agency ('EPA') for Duo which
is expected during the second half of the current financial
year.
Parker (www.parkerlabs.com) was founded in 1958 and is
family-owned and managed. The company pioneered the development of
conductive gels for use in ultrasound. It manufactures its products
in a 95,000 sq ft facility in Fairfield, New Jersey and is
registered with the United States Food and Drug Administration
('FDA') as a manufacturer of medical devices. All Parker products
are manufactured under Good Manufacturing Practice ('GMP')
directives. Parker's products are available to ultrasound
practitioners in every country throughout the world. Its Aquasonic
100 gel is the market leader in the United States where the company
has nationwide distribution through a network of approximately 500
distributors. Parker is also a market leader in the ultrasound
market in Canada and throughout Central and South America.
This initiative is part of Tristel's stated intention to enter
the North American infection prevention market. This plan was
unveiled in the Company's preliminary results announcement in
October 2015. In pursuit of this plan, on 30 June 2017 Tristel made
a submission for regulatory clearance by the EPA of its Duo
chlorine dioxide disinfection foam. Following EPA federal approval,
the Company will need to secure state-by-state approval before
sales of Duo can commence
The EPA clearance will enable Duo to claim intermediate
disinfection of all non-porous surfaces, including those of medical
instruments such as ultrasound probes. This is Tristel's core
activity worldwide and accounts for approximately 80% of the
Company's revenues. In addition, the Company continues to develop
two submissions to be made to the FDA for 510(K) clearance in
respect of Duo. The 510(K) approval will permit Duo to claim
high-level disinfection of medical instruments. It is important to
note that in all other markets worldwide, Duo is classified as a
high-level disinfectant.
Paul Swinney, CEO of Tristel plc, comments: "We are very pleased
to conclude this collaboration with Parker, whose President and
main shareholder we first met some fifteen years ago. The company
is extremely well-known in ultrasound having been around for so
many years under the long-term ownership and management of the
Buchalter family. Our collaboration will give us the platform to
access the ultrasound marketplace throughout the United States and
the Americas, first with our EPA approved Duo product and in due
course with our FDA approved Duo."
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 (Corporate Broking)
The information communicated in this announcement is inside
information for the purposes of Article 7 of Regulation
596/2014.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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