UK-based Advanced Medical Solutions Group (AMS) has received the US Food and Drug Administration (FDA) 510(k) clearance for its wound care products, Silver High Performance Dressing and Silicone PHMB Foam Dressing.
Silver High Performance Dressing is an antimicrobial gelling fibre technology meant to address chronic wounds, including ulcers, post-operative surgical wounds, diabetic foot ulcers and graft and donor sites.
It is made of ionic silver, which is said to provide antimicrobial activity for up to seven days. The product expands the company’s antimicrobial fibres portfolio.
Silicone PHMB Foam Dressing is an atraumatic adhesive dressing intended for chronic and post-surgical wounds such as pressure sores, diabetic ulcers and burns.
This dressing consists of polyurethane foam infused with polyhexamethylene biguanide. The company added that the product was found to be effective against methicillin-resistant Staphylococcus aureus (MRSA) and multiple microbes.
Silicone PHMB boosts Advanced Medical’s existing PHMB Foam range and is expected to improve access to the US antimicrobial foam market, which is estimated to be worth $100m.
The company is further working to seek European marketing authorisation for Silicone PHMB. The CE-Mark approval is expected in the first half of next year.
Advanced Medical Solutions CEO Chris Meredith said: “These two additional approvals significantly strengthen AMS’s US 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.”
The company plans to commercialise Silver High Performance Dressing and Silicone PHMB Foam Dressing in FDA-approved markets through its network of wound care partners and distributors.
Advanced Medical works in the development of surgical and wound care products. Its portfolio includes tissue adhesives, internal fixation devices, sutures, silver alginates, haemostats, alginates and foams.