Advanced Medical Solutions Grp PLC
29 August 2006
For immediate release 29 August 2006
Advanced Medical Solutions Group plc
('AMS' or 'the Company')
Positive reclassification of topical tissue adhesives
recommended by FDA
Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the global
woundcare technology company, today announces that the General and Plastic
Surgery Devices Panel of the FDA Medical Devices Advisory Committee has
recommended that topical cyanoacrylate tissue adhesives be reclassified from
Class III to Class II devices. This means that the regulatory approval route for
sale into the US market will be by demonstrating substantial equivalence to
existing devices via a 510 (k) submission rather than requiring Pre-Market
Approval (PMA).
The panel's decision, which was unanimous, followed review of a petition
recommending reclassification presented by AMS' MedLogic wound closure division,
and hearing presentations opposing the reclassification from United States
Surgical (Division of Tyco Healthcare) and Closure Medical Corporation, the
holders of the two existing PMAs.
Commenting on this announcement Dr. Don Evans, Chief Executive of AMS, stated:
'This decision is of enormous significance for AMS. The US is the major part of
the global topical cyanoacrylate tissue adhesives market, estimated to be $100
million. AMS has a strong competitive position with these products within Europe
and has been working through the PMA route to obtain approval to enter the US.
This decision is expected to accelerate the regulatory approval process and the
introduction of the well-proven AMS wound closure product portfolio to this key
market.'
The Company will announce its interim results on Tuesday 5th September 2006
where more detail surrounding this announcement will be given.
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) 207466 5000
Mark Court, Mary-Jane Johnson
Notes for 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' 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' 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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