FDA Approval

RNS Number : 1336G

Advanced Medical Solutions Grp PLC

03 June 2013

 



3 June 2013

Advanced Medical Solutions Group plc

("AMS" or the "Group")

FDA approval for 2-octyl cyanoacrylate tissue adhesive in US

Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS.L), the global medical technology company, today announces that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market a newly developed 2-octyl cyanoacrylate topical skin adhesive in the US.

This new topical skin adhesive augments AMS's existing LiquiBand^®range of tissue adhesive products which are designed for the fast closure of wounds. Octyl-based formulations of cyanoacrylate are more flexible and film-forming than AMS's current butyl-based cyanoacrylates and are frequently used in the operating room to both close and protect wounds, or in conjunction with sutures or staples simply to protect surgical incisions.

With the approval of the octyl-based formulation alongside our existing butyl-based formulation, AMS is now able to provide a complete solution to users of topical skin adhesives requiring either the fast setting and precise wound closure implementation offered by butyl or the more flexible, film-forming properties of octyl.

This new topical skin adhesive will be marketed and distributed in the second half of 2013 by a major, acute care focused, US partner to extend distribution in this sector, which is comprised of more than 3,000 hospitals and attached care centres and represents over 80% of the total US market.

Chris Meredith, Chief Executive Officer of AMS commented:

"We are very pleased with yet another new product clearance into the US market as well as the agreement we have reached with a major partner. This expands our range of topical adhesive products for the benefit of both patients and providers, and is an important part of our strategy to increase our market share in the acute care sector of the US market.

Since we launched our LiquiBand^® range of tissue adhesives into the US market in December 2010 we have established a 13% market share in the alternate site sector. This new product will allow us to compete even more effectively in the acute care sector where we have a 4% market share, with a significant partner and a wider range of wound closure products. We look forward to updating the market further with progress in due course."

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For further information, please visit www.admedsol.comor contact:

Advanced Medical Solutions Group plc	Tel: [phone]
Chris Meredith, Chief Executive Officer Mary Tavener, Group Finance Director
Tavistock Communications	Tel: [phone]
John West / Chris Munden / Andrew Dunn
Investec Bank plc	Tel: [phone]
Gary Clarence / Daniel Adams / Patrick Robb

About Advanced Medical Solutions Group plc - see www.admedsol.com 

Founded in 1991, AMS is a leader in the development and manufacture of innovative and technologically advanced products for the US$15 billion global wound care market. Through a mix of organic development and a number of acquisitions, AMS now has a wide range of products based on technologies that include alginates, silver alginates, foams, collagens, cyanoacrylate adhesives and sutures.

AMS manufactures wound care products for an extensive list of Original Equipment Manufacturer ("OEM") customers around the world, but the majority of the Group's revenues now come from its own brands - ActivHeal^® wound care products in the UK to the NHS, LiquiBand^® cyanoacrylate products primarily in the UK, Europe and the USA, and RESORBA^® sutures and collagen wound care products primarily in Europe. AMS develops innovative products from its R&D pipeline which it commercialises globally either directly or through partnerships with its OEM customers.

AMS's products are sold globally via a network of regional or multinational partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, the Czech Republic and Russia.

With 450 employees operating under four distinct business units (Branded Direct, Branded Distributed, OEM and Bulk Materials) that match its multiple products and routes-to-market, AMS's products are manufactured from two sites in the UK, one in the Netherlands, two in Germany and one in the Czech Republic.

 

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