FDA approval for two advanced woundcare ranges
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30 July 2019 |
Advanced Medical Solutions Group plc
("AMS", the "Company" or the "Group")
FDA approval for two further advanced woundcare ranges
Winsford, 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.
Silver 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.
As 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.
Chris Meredith, Chief Executive Officer of Advanced Medical Solutions, said: "These two additional approvals significantly strengthen AMS's US advanced woundcare portfolio and support for the Group's woundcare 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."
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For further information, please contact:
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Advanced Medical Solutions Group plc |
Tel: +44 (0) 1606 545508 |
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Chris Meredith, Chief Executive Officer Eddie Johnson, Chief Financial Officer |
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Consilium Strategic Communications |
Tel: +44 (0) 20 3709 5700 |
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Mary-Jane Elliott / Matthew Neal / Nicholas Brown / Olivia Manser |
AMS@consilium-comms.com |
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Investec Bank PLC (NOMAD & Broker) |
Tel: +44 (0) 20 7597 5970 |
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Daniel Adams / Patrick Robb / Gary Clarence |
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About Advanced Medical Solutions Group plc
AMS is a world-leading independent developer and manufacturer of innovative and technologically advanced products for the global surgical and wound care markets, focused on quality outcomes for patients and value for payers. AMS has a wide range of products that include tissue adhesives, sutures, haemostats, internal fixation devices, silver alginates, alginates and foams, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8® and ActivHeal® as well as supplying under white label.
AMS's products, manufactured out of two sites in the UK, one in the Netherlands, two in Germany and one in the Czech Republic, are sold in 77 countries via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, the Czech Republic and Russia. Established in 1991, the Group has approximately 650 employees. For more information please see www.admedsol.com.
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