Business
FDA Approval
FDA Approval.
About this update from Advanced Medical Solutions Group Plc
[{"type":"text","content":"\n \nRNS Number : 1336G Advanced Medical Solutions Grp PLC 03 June 2013 \n \n\n\n\n\n\n\n\n\n3 June 2013\n\n\n\n\n \nAdvanced Medical Solutions Group plc\n(\"AMS\" or the \"Group\")\n \nFDA approval for 2-octyl cyanoacrylate tissue adhesive in US\n \nWinsford, 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. \n \nThis 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. \n \nWith 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.\n \nThis 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. \n \nChris Meredith, Chief Executive Officer of AMS commented:\n \n\"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. \n \nSince 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, ...