FDA 510(k) Clearance
Advanced Medical Solutions Grp PLC
28 November 2006
For immediate release 28 November 2006
Advanced Medical Solutions Group plc
('AMS' or 'the Company')
FDA clears extended wear silver alginate dressing
Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the global
medical technology company, today announces that the Food & Drug Administration
(FDA) has granted 510(k) clearance for an AMS silver alginate wound dressing for
use over a period of up to 21 days, allowing it to be marketed in the US.
Silver is well recognised as a safe and effective anti-microbial agent for
control of infection from a wide range of micro-organisms such as MRSA. Wound
dressings containing silver are widely used, and AMS has a strong competitive
position with a number of silver technologies and marketing partners in this
dynamic global market, currently estimated at more than $100m and growing in
excess of 25% per year.
The product approved by the FDA is indicated for use on moderate to heavily
exuding partial to full thickness wounds including:
• Post-operative wounds
• Trauma wounds
• Leg ulcers
• Pressure ulcers
• Diabetic ulcers
• Graft and donor sites
Approval for use for up to 21 days, combined with the inherent absorbancy of the
dressing, may reduce the frequency of having to change dressings thus reducing
the time and overall cost of treatment and providing a better opportunity for
healing to progress undisturbed.
A scientific poster presented at the recent Wounds UK Conference in Harrogate,
North Yorkshire, and a summary of which was announced in a Press Release on 14
November 2006, has shown that the AMS silver alginate product is effective
against a broad spectrum of micro-organisms for a full 21 days whereas the
anti-microbial action of a leading silver brand diminished significantly after
14 days.
Commenting on today's announcement Dr. Don Evans, Chief Executive of AMS,
stated:
'This regulatory clearance demonstrates our ability to continue to evolve our
technology to meet the needs of the marketplace. The market for silver
dressings continues to expand rapidly and AMS is well placed to benefit from
this trend.'
-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
Mark Court, Mary-Jane Johnson
Notes to Editors:
Advanced Medical Solutions is a leading company in the development and
manufacture of products for the $13 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 that offer benefits over sutures and
staples for closing wounds sold direct to hospitals or through distributors.
AMS's technology and products currently serve the majority of the key global
markets and strategic partners.
This information is provided by RNS
The company news service from the London Stock Exchange
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