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FDA approval for two advanced woundcare ranges
FDA approval for two advanced woundcare ranges.
About this update from Advanced Medical Solutions Group Plc
[{"type":"text","content":"\n \nRNS Number : 1111H Advanced Medical Solutions Grp PLC 30 July 2019 \n\n\n\n\n\n \n\n\n30 July 2019\n\n\n\n\nAdvanced Medical Solutions Group plc\n(\"AMS\", the \"Company\" or the \"Group\")\n \n FDA approval for two further advanced woundcare ranges\n \nWinsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the surgical and advanced wound care specialist company, today announces that it has received 510(k) approvals from the US FDA (\"Food and Drug Administration\") for the Group's Silver High Performance Dressing and Silicone PHMB Foam Dressing. Both products will be commercialised via AMS's network of woundcare partners and distributors in FDA approved markets. \n \nSilver High Performance Dressing is the Group's next generation antimicrobial gelling fibre technology with excellent performance and patent protected construction. The dressing comprises ionic silver which delivers sustained antimicrobial activity for up to seven days and the dressing is indicated for chronic wounds such as ulcers, diabetic foot ulcers, post-operative surgical wounds, and graft and donor sites. Silver High Performance Dressing is the latest development in AMS's extensive portfolio of antimicrobial fibres, enabling the Group's partners to further access the gelling fibres segment in the US. \n \nAs an atraumatic adhesive dressing, Silicone PHMB significantly augments AMS's existing PHMB Foam range and gives AMS and its commercial partners greater access to the attractive atraumatic antimicrobial foam market in the US, which is worth in excess of $100m and is growing at 6% year-on-year. The PHMB Foam Dressing is polyurethane foam impregnated with Polyhexamethylene Biguanide that is indicated for use in the management of various chronic and post-surgical wounds including pressure sores, diabetic ulcers, and burns. The PHMB Foam dressing has also been shown to be effective against MRSA and a broad spectrum of microbes. Alongside the FDA approval being announced today, AMS has begun the process to gain CE mark approval in Europe for Silicone PHMB which is expected to be completed in H1 2020. \n \nChris Meredith, Chief Executive Officer of Advanced Medical Solutions, said: \"These two additional approvals significa...