REG - Tristel PLC - Successful submission of additional data to US FDA

TristelAnnouncement

27/03/2023 07:00

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RNS Number : 2245U  Tristel PLC  27 March 2023

TRISTEL plc

("Tristel" or the "Company")

 

Successful submission of additional data to the US FDA

 

Additional Information Request completed on-time for De Novo submission

FDA decision expected before 30 June 2023

 

Tristel plc (AIM: TSTL), the manufacturer of infection prevention products
utilising proprietary chlorine dioxide technology, announces that it has
successfully submitted the additional data requested by the US Food and Drug
Administration (FDA) to enable the FDA's decision to grant market clearance
for its Duo ULT high-level disinfectant. A decision is expected before 30 June
2023.

 

In September last year, the Company received the FDA's detailed response to
its De Novo submission made in June 2022. The agency grants the applicant a
180-day period in which to generate and submit the additional data requested.
Tristel has successfully accomplished this within the agreed timescale.

 

The FDA will now commence its final review of the De Novo submission and the
agency's internal rules require it to make its decision by the Company's
financial year-end.

 

The FDA approval will enable Duo's use for high-level disinfection of
intra-cavity ultrasound probes. Duo is already approved by the US
Environmental Protection Agency for use on skin-surface ultrasound
transducers.

 

Disinfection of ultrasound probes and transducers accounts for approximately
40% of Tristel's global revenue. The United States is the largest single
ultrasound market in the world and access to the US market will be a
significant inflection point for the Company.

 

The Company has already established a manufacturing base in North America and
has put in place nationwide distribution in anticipation of FDA clearance.

 

Paul Swinney, Chief Executive of Tristel, said: "We have been on a five-year
journey to gain FDA approval and submitting this last data set is an important
milestone for the Company. If we are successful in June, we will be able to
introduce an innovative and lower cost decontamination product to the United
States healthcare market, significantly increasing our future global revenue
and profit potential."

 

 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

 

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