US Adhesives Reclassification

Advanced Medical Solutions Grp PLC
08 May 2008


For Immediate Release                                                 8 May 2008





Advanced Medical Solutions Group plc

                            ('AMS' or 'the Company')


                             Reclassification Order

                 Tissue adhesive for topical skin approximation



Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the global
medical technology company, today announces that the Center for Devices and
Radiological Health (CDRH) of the Food and Drug Administration (FDA) has
completed its review of a petition submitted by Regulatory and Clinical Research
Institute, Inc. (RCRI) of Minneapolis, on behalf of AMS' MedLogic Wound Closure
Division, for reclassification of tissue adhesives for topical approximation of
skin.


The FDA has concluded that these devices and substantially equivalent devices of
these generic types should be reclassified from Class III into Class II.


This means that tissue adhesives will now be cleared for commercial distribution
via a Premarket Notification 510(k) submission rather than a Premarket Approval
Application (PMA).


This order reclassifies tissue adhesives for topical skin approximation, and
substantial equivalent devices of these generic types into Class II under the
generic name 'Tissue Adhesive for Topical Skin Approximation,' effective
immediately.  This order also identifies the special controls applicable to the
device as the FDA guidance document entitled 'Class II Special Controls Guidance
Document : Tissue Adhesive for the Topical Approximation of Skin, Guidance for
Industry and FDA Staff.'


FDA identifies this generic type of device, the subject of this
reclassification, as follows:


Identification. A tissue adhesive for the topical approximation of skin is a
device intended for topical closure of surgical incisions, including
laparoscopic incisions, and simple traumatic lacerations that have easily
approximated skin edges.  Tissue adhesives for the topical approximation of skin
may be used in conjunction with, but not in place of, deep dermal stitches.


Classification.  Class II (special controls).  The special control for this
device is FDA's 'Class II Special Controls Guidance Document : Tissue Adhesive
for the Topical Approximation of Skin.'


At a public meeting held on 25 August 2006, following review of the petition
presented by RCRI and AMS MedLogic, the General and Plastic Surgery Devices
Panel, unanimously recommended reclassification of tissue adhesive for the
topical approximation of skin from Class III into Class II and that a guidance
document which includes several voluntary consensus standards be the special
control for the device.


FDA agreed with the panels' recommendation and after periods of review and
public comment, this Reclassification Order has been granted and a notice
announcing this will be published in the Federal Register.


Commenting on this announcement, Dr. Don Evans, Chief Executive of AMS, stated:


'This Reclassification Order by the FDA is of enormous significance for AMS.
The US is the major part of the global topical tissue adhesives market,
estimated to be $150 million.  AMS has a strong competitive position with these
products within Europe and has been working to obtain approval to enter the US.
Based on this decision, 510(k)'s will now be submitted.  The introduction of
AMS' tissue adhesive technology to this key market is expected to start in 2009
via a major marketing and distribution partner.'



For further information, please contact:


Advanced Medical Solutions Group plc
Don Evans, Chief Executive Officer
Mary Tavener, Finance Director                         Tel: [phone]
www.admedsol.com


Buchanan Communications                                Tel: [phone]
Mark Court, Mary-Jane Johnson


Landsbanki Securities (UK) Ltd                         Tel: [phone]
Shaun Dobson, Claes Spang




Notes to Editors:


Advanced Medical Solutions is a leading company in the development, manufacture
and sale of products into 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 products for advanced
woundcare and wound closure.


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 a product from design and development through to production and delivery
ready for distribution into customer markets.


AMS' technology in cyanoacrylate based tissue adhesives is used either for the
closure of small cuts and trauma wounds through to large surgical incisions, or
for protecting or sealing skin to prevent breakdown or infection.


AMS' products currently serve the majority of the key global markets sold either
direct or through strategic partners or distributors.


Regulatory and Clinical Research Institute, Inc. (RCRI) is a leading Contract
Research Organization for the medical device, IVD, and biologics industries
worldwide.  RCRI is ISO 9001:2000 certified and specializes in regulatory
affairs, clinical trial management, biostatistics, quality systems and
compliance, reimbursement, and venture capital due diligence.


For further information on RCRI, please contact:


Dr. Tierney Norsted or Juli Denny              Tel : [phone]
www.rcri-inc.com



                      This information is provided by RNS
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