8th May 2008 07:01
Advanced Medical Solutions Grp PLC08 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 globalmedical technology company, today announces that the Center for Devices andRadiological Health (CDRH) of the Food and Drug Administration (FDA) hascompleted its review of a petition submitted by Regulatory and Clinical ResearchInstitute, Inc. (RCRI) of Minneapolis, on behalf of AMS' MedLogic Wound ClosureDivision, for reclassification of tissue adhesives for topical approximation ofskin. The FDA has concluded that these devices and substantially equivalent devices ofthese generic types should be reclassified from Class III into Class II. This means that tissue adhesives will now be cleared for commercial distributionvia a Premarket Notification 510(k) submission rather than a Premarket ApprovalApplication (PMA). This order reclassifies tissue adhesives for topical skin approximation, andsubstantial equivalent devices of these generic types into Class II under thegeneric name "Tissue Adhesive for Topical Skin Approximation," effectiveimmediately. This order also identifies the special controls applicable to thedevice as the FDA guidance document entitled "Class II Special Controls GuidanceDocument : Tissue Adhesive for the Topical Approximation of Skin, Guidance forIndustry and FDA Staff." FDA identifies this generic type of device, the subject of thisreclassification, as follows: Identification. A tissue adhesive for the topical approximation of skin is adevice intended for topical closure of surgical incisions, includinglaparoscopic incisions, and simple traumatic lacerations that have easilyapproximated skin edges. Tissue adhesives for the topical approximation of skinmay be used in conjunction with, but not in place of, deep dermal stitches. Classification. Class II (special controls). The special control for thisdevice is FDA's "Class II Special Controls Guidance Document : Tissue Adhesivefor the Topical Approximation of Skin." At a public meeting held on 25 August 2006, following review of the petitionpresented by RCRI and AMS MedLogic, the General and Plastic Surgery DevicesPanel, unanimously recommended reclassification of tissue adhesive for thetopical approximation of skin from Class III into Class II and that a guidancedocument which includes several voluntary consensus standards be the specialcontrol for the device. FDA agreed with the panels' recommendation and after periods of review andpublic comment, this Reclassification Order has been granted and a noticeannouncing 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 theseproducts 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 ofAMS' tissue adhesive technology to this key market is expected to start in 2009via a major marketing and distribution partner." For further information, please contact: Advanced Medical Solutions Group plcDon Evans, Chief Executive OfficerMary Tavener, Finance Director Tel: +44 (0) 1606 545508www.admedsol.com Buchanan Communications Tel: +44 (0) 20 7466 5000Mark Court, Mary-Jane Johnson Landsbanki Securities (UK) Ltd Tel: +44 (0) 20 7426 9000Shaun Dobson, Claes Spang Notes to Editors: Advanced Medical Solutions is a leading company in the development, manufactureand sale of products into the $15 billion global woundcare market. Founded in 1991 and quoted on AIM, Advanced Medical Solutions is focused on thedesign, development and manufacture of innovative products for advancedwoundcare and wound closure. In-house natural and synthetic polymer technology is used to provide advancedwound dressings based on the moist healing principle. AMS' resources ensure aunique position as a vertically integrated 'one stop shop' to provide allcategories of moist wound healing products. The Company has the capability tomove a product from design and development through to production and deliveryready for distribution into customer markets. AMS' technology in cyanoacrylate based tissue adhesives is used either for theclosure of small cuts and trauma wounds through to large surgical incisions, orfor protecting or sealing skin to prevent breakdown or infection. AMS' products currently serve the majority of the key global markets sold eitherdirect or through strategic partners or distributors. Regulatory and Clinical Research Institute, Inc. (RCRI) is a leading ContractResearch Organization for the medical device, IVD, and biologics industriesworldwide. RCRI is ISO 9001:2000 certified and specializes in regulatoryaffairs, clinical trial management, biostatistics, quality systems andcompliance, reimbursement, and venture capital due diligence. For further information on RCRI, please contact: Dr. Tierney Norsted or Juli Denny Tel : 001 952-224-2263www.rcri-inc.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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