UK-based Advanced Medical Solutions Group announced last week that it has secured the U.S. Food and Drug Administration (FDA) 510(k) clearance for its two wound care products, Silver High Performance Dressing and Silicone PHMB Foam Dressing. With this latest development, Advanced Medical is cleared to sell and distribute these two wound care products in the U.S. market.
The company’s Silver High Performance Dressing utilizes antimicrobial gelling fiber technology for chronic wounds such as post-operative surgical wounds, graft and donor sites, diabetic foot ulcers and other ulcers. The products is made of ionic silver, which can offer antimicrobial protection for up to seven days.
Advanced Medical’s Silicone PHMB Foam Dressing is an atraumatic adhesive dressing intended for use on chronic or post-surgical wounds including diabetic ulcers, burns and pressure sores. The dressing is made of polyurethane foam infused with polyhexamethylene biguanide, and the company has demonstrated its effectiveness against methicillin-resistant Staphylococcus aureus (MRSA) and multiple microbes.
The approval of these two products for the U.S. market boosts Advanced Medicals existing available product line. In particular, the company expects that the introduction of their Silicone PHMB Foam Dressing will augment their existing PHMB Foam range and help improve their share of the estimated $100 million U.S. antimicrobial foam market.
Announcing the FDA clearance, Advanced Medical CEO Chris Meredith stated that “these two additional approvals significantly strengthen AMS’s U.S. advanced wound care portfolio and support for the Group’s wound care partners and end users…they also demonstrate the value generated by AMS’s R&D and regulatory capabilities, which are a key pillar of our strategy to drive organic growth.”
Advanced Medical plans to use its existing network of wound care partners and distributors to bring their Silver High Performance Dressing and Silicone PHMB Foam Dressing to customers in FDA-approved markets.
The announcement of U.S. approval for these products comes as Advanced Medical continues to work towards European marketing authorization for the Silicone PHMB Foam Dressing; the company expects to receive the CE-Mark approval, the European equivalent to the FDA’s 510(k) clearance, in the first half of next year.