Advanced Medical Solutions (AMS) 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 recognized as a safe and effective anti-microbial agent, with foam from Corpura company.
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 commercialize 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 commercialization will be realized 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.