Advanced Medical Solutions Group plc, announced that it has received 510(k) approval from the Food and Drug Administration (FDA) to market its newly developed silver PU anti-bacterial foam dressings in the US.
AMS developed the dressings by combining silver, which is widely recognised as a safe and effective anti-microbial agent, with foam from Corpura, the company in which AMS acquired 49.4% ownership of in May 2008. Foam is one of the largest and fastest growing segments of the $3.2 billion advanced woundcare market and is an ideal material for the treatment of medium to high exudate chronic wounds. This 510(k) approval builds upon other approvals AMS has for products including silver.
These silver PU anti-bacterial foam dressings have gained 510(k) approval for the management of light to moderate exuding, partial to full thickness wounds including pressure sores, diabetic ulcers, leg ulcers, graft and donor sites, lacerations and abrasions, first and second degree burns, trauma wounds and post-operative surgical wounds.
AMS is working to identify a suitable partner to commercialise the launch of these products in the US. Approval for these products will take longer in Europe than in the US and the full benefits of commercialisation will be realised when European approval has been obtained.
Commenting on this announcement, Dr Don Evans, Chief Executive Officer of Advanced Medical Solutions, stated:
This 510(k) approval for silver PU anti-bacterial foam dressings extends the AMS portfolio of materials incorporating silver and underlines the benefits of our acquisition last year of an interest in Corpura. This approval marks the first success of an innovative development programme to combine actives into Corpura’s polyurethane foam technology and we look forward to further progress from this programme.