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
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