510(k) for LiquiBand

Feb 18, 2009

Advanced Medical Solutions Group plc
(“AMS” or the “Group”)

RNS Number : 4835N
Advanced Medical Solutions Grp PLC
18 February 2009

For Immediate Release 

18 February 2009

Advanced Medical Solutions Group plc 

(“AMS” or “the Company”)

510(k) clearance for LiquiBand Topical Skin Adhesive

Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the global medical technology company, today announces that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for one of its LiquiBand Topical Skin Adhesive formulations.

The US market constitutes the major part of the global topical tissue adhesives market, which has an estimated value of $200 million annually. AMS commercial strategy has therefore been focused on obtaining US approval for a product range that  is already sold successfully in Europe.  

In May 2008, following review of a petition submitted on behalf of AMS’ MedLogic Wound Closure Division, the FDA concluded that tissue adhesives for topical approximation of skin should be reclassified from Class III to Class II.  This meant that these devices will now be cleared for commercial distribution via a Pre-Market Notification 510(k) submission rather than a Pre-Market Approval (PMA) application. AMS has subsequently submitted 510(k) applications covering its tissue adhesive product range.

The initial product cleared for sale by the FDA, LiquiBand Topical Skin Adhesive, is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma induced lacerations in areas of low skin tension that are simple, thoroughly cleansed and have easily approximated edges.

This particular product has been sold successfully for many years in Europe and has allowed AMS to establish a leadership position in the use of tissue adhesives for closing wounds in the Accident & Emergency (A&E) arena.

Clearance is also being sought for additional products that will provide a comprehensive range of topical skin adhesives covering both the A&E and Operating Room market in the US.

Dr. Don Evans, Chief Executive of  Advanced Medical Solutions Group plc, commented:

I am delighted that we have received this initial clearance on the back of which we will be finalising commercial arrangements for the introduction of our tissue adhesive technology to this key strategic market during 2009 via marketing and distribution partners.


For further information, please contact:

Advanced Medical Solutions Group plc

Don Evans, Chief Executive Officer

Mary Tavener, Finance Director



   Tel: +44 (0) 1606 545508

Buchanan Communications

Tel: +44 (0) 20 7466 5000

Mark Court / Mary-Jane Johnson / Stasa Filiplic


Shaun Dobson / Claes Spang

Tel: +44 (0) 20 7426 9000

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 quoted on AIM, Advanced Medical Solutions is focused on the design, development and manufacture of innovative and technologically advanced woundcare products.

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 for distribution and sale into customer markets.

The acquisition of 49.4% of Corpura BV in May 2008 strengthened AMS’ position in hydrophilic polyurethane foam – the largest and fastest growing segment of the advanced woundcare market

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.

This information is provided by RNS
The company news service from the London Stock Exchange

For further information, please contact:

Advanced Medical Solutions Group plc

Tel: 44 (0) 1606 545508

Chris Meredith, Chief Executive Officer

Eddie Johnson, Chief Financial Officer

Michael King, Investor Relations

Consilium Strategic Communications

Tel: 44 (0) 20 3709 5700

Matthew Neal / Lucy Featherstone

Investec Bank PLC (NOMAD & Broker)

Tel: 44 (0) 20 7597 5970

Gary Clarence / David Anderson

HSBC Bank PLC (Broker)

Tel: 44 (0) 20 7991 8888

Sam McLennan / Joe Weaving / Stephanie Cornish

About Advanced Medical Solutions Group plc

AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8® and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made five acquisitions: Sealantis, an Israeli developer of innovative internal sealants; Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business and Connexicon, an Irish tissue adhesives specialist.

AMS's products, manufactured in the UK, Germany, France, the Netherlands, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 800 employees. For more information, please see admedsol.com.

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