Receives (510)k clearance
January 28 2004 - 2:00AM
UK Regulatory
RNS Number:7079U
Advanced Medical Solutions Grp PLC
28 January 2004
For Immediate Release 28 January 2004
Advanced Medical Solutions Group plc ("AMS" or the "Company")
Announces 510(k) marketing clearance for a liquid bandage for
treatment of minor wounds and a new supply agreement for Australia
Winsford, UK: Advanced Medical Solutions, (AIM: AMS), the global woundcare
technology company, today announces that it has received 510(k) clearance by the
US Food & Drug Administration ("FDA") for the marketing of a single-use sterile
liquid bandage based on superglue technology.
The FDA has given clearance for the product to be used to cover minor cuts and
scrapes and minor irritations of the skin and help protect them from infection.
The liquid bandage is painted onto the wound to provide a protective barrier
whilst healing occurs. It bonds to the skin to form a water-resistant flexible
covering that wears off naturally after a few days as the wound heals. Based on
AMS' MedLogic cyanoacrylate tissue adhesive technology, the product is aimed at
Consumer First Aid and has significant benefits over traditional plasters, which
can often be difficult to apply to certain parts of the body
The significance to AMS of receiving this 510(k) is that these products have now
been given clearance for sale in the world's largest market - the US. The
Consumer over the counter (OTC) First Aid plaster market in the US is worth $200
million. Of this, the liquid bandage sector is expanding rapidly, as consumers
respond to its benefits and convenience, and is currently valued at more than
$25 million.
Commenting on this announcement, Dr Don Evans, Chief Executive of AMS, stated:
"This approval demonstrates another milestone in exploiting our MedLogic
cyanoacrylate technology and moving it into the consumer area. It offers the
opportunity of bringing the first single-use liquid bandage product to market
with significant benefits to the consumer over current multi-use products. Now
that US regulatory approval has been obtained we will be actively seeking an
appropriate marketing partner to collaborate on the development of a commercial
product for introduction to the global Consumer OTC market in 2005."
In a separate announcement released today:-
AMS announces that it has entered into a supply agreement with InterPharma
Proprietary Limited ("InterPharma") for marketing and distribution of its
advanced woundcare range in Australia.
Under the terms of the agreement, AMS will supply a full range of its wound care
products including alginate, hydrocolloid, foam, film and gels for sale under
its ActivHealTM brand. InterPharma, a Sydney based marketing company, is looking
to expand its current presence in pharmaceuticals into the advanced wound care
market, which is currently valued in excess of A$50 million.
Commenting on this announcement, Dr Don Evans, Chief Executive of AMS, stated:
"The addition of InterPharma to our list of partners further strengthens the
global distribution of our advanced woundcare products by giving us entry into a
new market. I look forward to working with InterPharma to build the ActivHealTM
brand and our business in Australia."
David Gray, Managing Director of InterPharma, added:
"We look forward to broadening our product portfolio by the addition of AMS'
wound care range. InterPharma offers a wide range of expertise in healthcare
marketing, which fits well with our new partnership with AMS. In addition to our
other partners, including those specialising in pharmaceuticals, InterPharma now
offers a unique product offering to the healthcare sector in Australia."
- ENDS -
For further information, please contact:
Advanced Medical Solutions Group plc Tel : +44 (0) 1606 545508
Don Evans, Chief Executive
Mary Tavener, Finance Director
www.admedsol.com
Buchanan Communications Tel: +44 (0) 20 7466 5000
Mary-Jane Johnson / Mark Court
Notes to Editors:
Advanced Medical Solutions is a leading company in the development and
manufacture of products for the $15 billion global woundcare market.
Founded in 1991 and quoted on AIM, Advanced Medical Solutions is focused on the
design, development and manufacture of innovative and technologically advanced
products for woundcare and other medical applications.
In-house natural and synthetic polymer technology is used to provide advanced
wound dressings based on the moist healing principle. AMS' resources ensure a
unique position as a vertically integrated 'one stop shop' to provide all
categories of moist wound healing products. The Company has the capability to
move from product design and development through to production and delivery
ready for distribution into customer markets.
The acquisition of MedLogic in 2002 has brought AMS products and technology in
cyanoacrylate based tissue adhesives and sealants sold direct to A & E
departments or through distributors.
AMS' technology and products currently serve the majority of the key global
markets with strategic partners including 3M, Novartis, Johnson & Johnson,
Molnlycke Healthcare, Coloplast, Smith + Nephew and Beiersdorf.
This information is provided by RNS
The company news service from the London Stock Exchange
END
REAVDLFLZFBFBBD
x