Clearance for Marketing
Advanced Medical Solutions Grp PLC
08 July 2003
For Immediate Release: 07:00, Tuesday, 8th July 2003
Advanced Medical Solutions Group plc ('AMS' or the 'Company')
announces 510(k) marketing clearance by US Food & Drug Administration ('FDA')
for anti-microbial alginate dressing
plus
new US woundcare distribution agreement
Winsford, UK: AMS, the global woundcare technology company, has today announced
that it has received 510(k) clearance for the marketing of its silver based
anti-microbial alginate dressing.
The FDA has given clearance for the device to be marketed as an effective
barrier to bacterial penetration. The barrier functions of the dressing may
help reduce infection in moderate to heavily exuding partial and full thickness
wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites,
traumatic and surgical wounds.
The significance to AMS of receiving this 510k is that these products have now
been given clearance for sale in the world's largest woundcare market - the US.
AMS recently announced that it had entered into a global exclusive supply
agreement with Johnson & Johnson Wound Management for a range of alginate
woundcare dressings containing silver, which will be launched into the
Professional woundcare market during Qtr.3 2003 following the appropriate
regulatory clearances. These products will be marketed by Johnson & Johnson
Wound Management under its SilverCelTM brand.
This 510(k) clearance now allows these products to be sold into the US market.
CE mark clearance for Europe is expected to follow shortly.
Commenting on this announcement, Dr Don Evans, CEO of AMS, stated:
'As well as accomplishing a critical step in the introduction of our new silver
alginate product to the market, this clearance is a key milestone for AMS in
delivering our stated strategy of moving to woundcare products containing
actives, such as anti-microbials. The FDA clearance endorses our ability to
develop and obtain regulatory clearance for the marketing of such higher value
products, which will form an increasing part of our portfolio going forward.'
Also announced today:
AMS has entered into a non-exclusive distribution agreement with a major US
based medical products distribution company for AMS to supply a range of
advanced woundcare products.
Under the terms of this agreement, the unnamed partner, who had global sales of
over $1 billion in 2002, will distribute a wide range of AMS' products under its
private label for sale into the $500 million US advanced woundcare market.
Commenting on this announcement, Don Evans stated:
'We are seeing more and more interest from major distributors to carry a range
of standard private label woundcare products alongside the leading brands. As a
focussed woundcare technology company with a full range of products and
materials, AMS is ideally placed to provide a one-stop shop for these
distributors, complementing its programme of supplying new differentiated
products to its major international partners under their brands'.
- ENDS -
For further information, please contact:
Advanced Medical Solutions Group plc Tel : +44 (0) 1606 863 500
Don Evans, Chief Executive
Mary Tavener, Finance Director
www.admedsol.com
Buchanan Communications Tel: +44 (0) 20 7466 5000
Nicola How / Tim Anderson
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 currently 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's 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's 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 WSDSESW
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