Tristel (TSTL)

Sector:

Health Care

Index:

FTSE AIM 100

413.33p
   
  • Change Today:
    -6.67p
  • 52 Week High: 500.00
  • 52 Week Low: 350.00
  • Currency: UK Pounds
  • Shares Issued: 47.69m
  • Volume: 3,138
  • Market Cap: £197.13m
  • RiskGrade: 180

Tristel makes FDA submission for high-level disinfectant foam

By Josh White

Date: Thursday 12 Sep 2024

LONDON (ShareCast) - (Sharecast News) - Infection prevention products manufacturer Tristel announced the submission of a premarket notification 510(k) to the US Food and Drug Administration (FDA) on Thursday, for its high-level disinfectant (HLD) foam, Tristel OPH.
The AIM-traded firm said the product was designed specifically for ophthalmic medical devices, such as reusable tonometers, pachymeters, and lenses that come into contact with the cornea.

It said the FDA filing was based on Tristel ULT, a disinfectant cleared by the FDA in June last year for use on ultrasound probes and skin surface transducers.

Tristel said it believed that FDA clearance for Tristel OPH could "transform" disinfection practices for ophthalmic devices in North America.

Under the Spaulding classification, devices that come into contact with mucous membranes, such as ophthalmic instruments, are classified as semi-critical and require high-level disinfection.

However, many such devices in the US are currently disinfected using less effective methods, like alcohol wipes, or require time-consuming processes such as soaking in sodium hypochlorite or hydrogen peroxide.

Tristel said its OPH product was the only high-level disinfectant specifically developed for ophthalmic devices.

If the 510(k) submission succeeds, it would become the only FDA-cleared HLD for ophthalmic devices, offering a quicker, more efficient alternative with no need for chemical soaking.

That, the board said, could be a game changer for the approximate 16 million ophthalmic procedures annually in the US that require high-level disinfection, including those for glaucoma diagnosis and cataract surgeries.

The disinfectant was already approved by Health Canada as a class two medical device in 2021, setting a precedent for its safety and effectiveness.

"We are delighted to have completed our FDA 510(k) filing for Tristel OPH in line with the original US product development plan set out by the company in June last year," said chief executive officer Matt Sassone.

"We believe that our unique product designed specifically for high level disinfection of ophthalmic devices has the potential to transform infection prevention practices in the US.

"We continue to target FDA clearance by the end of 2024 and look forward to updating shareholders as we put in place a distribution agreement for the US later this year."

At 1125 BST, shares in Tristel were down 0.35% at 431p.

Reporting by Josh White for Sharecast.com.

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Note 1: Prices and trades are provided by Digital Look Corporate Solutions and are delayed by at least 15 minutes.

Note 2: RiskGrade figures are provided by RiskMetrics.

 

Tristel Market Data

Currency UK Pounds
Share Price 413.33p
Change Today -6.67p
% Change -1.59 %
52 Week High 500.00
52 Week Low 350.00
Volume 3,138
Shares Issued 47.69m
Market Cap £197.13m
RiskGrade 180

Tristel Star Ratings

Compare performance with the sector and the market.
more star ratings
Key: vs Market vs Sector
Value
97.23% below the market average97.23% below the market average97.23% below the market average97.23% below the market average97.23% below the market average
94.29% below the sector average94.29% below the sector average94.29% below the sector average94.29% below the sector average94.29% below the sector average
Price Trend
26.37% above the market average26.37% above the market average26.37% above the market average26.37% above the market average26.37% above the market average
62.16% above the sector average62.16% above the sector average62.16% above the sector average62.16% above the sector average62.16% above the sector average
Income
18.97% below the market average18.97% below the market average18.97% below the market average18.97% below the market average18.97% below the market average
100.00% above the sector average100.00% above the sector average100.00% above the sector average100.00% above the sector average100.00% above the sector average
Growth
77.93% above the market average77.93% above the market average77.93% above the market average77.93% above the market average77.93% above the market average
94.44% above the sector average94.44% above the sector average94.44% above the sector average94.44% above the sector average94.44% above the sector average

What The Brokers Say

Strong Buy 1
Buy 1
Neutral 2
Sell 0
Strong Sell 0
Total 4
buy
Broker recommendations should not be taken as investment advice, and are provided by the authorised brokers listed on this page.

Tristel Dividends

  Latest Previous
  Final Interim
Ex-Div 28-Nov-24 21-Mar-24
Paid 20-Dec-24 12-Apr-24
Amount 8.28p 5.24p

Trades for 03-Dec-2024

Time Volume / Share Price
10:18 10 @ 420.00p
10:18 11 @ 410.00p
09:51 3,070 @ 411.50p
08:05 47 @ 419.80p

Tristel Key Personnel

Finance Director Elizabeth Dixon
CEO Matthew (Matt) Giovanni Sassone

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