FDA approval for two woundcare portfolio dressings

RNS Number : 4012X

Advanced Medical Solutions Grp PLC

10 August 2018

 

10 August 2018

Advanced Medical Solutions Group plc

("AMS", the "Company" or the "Group")

FDA approval for two woundcare portfolio dressings

US launches expected in Q4 18

Winsford, UK, 9 August 2018: Advanced Medical Solutions Group plc (AIM: AMS), the surgical and advanced wound care specialist company, today announces that it has received notice from the FDA ("Food and Drug Administration") in the US, of Premarket 510(k) approvals for the Group's Surgical Silver Post Operative Dressing and for PHMB Foam Dressing.

These new approvals will allow AMS and its distribution partners to offer clinicians advanced woundcare dressings that help prevent and treat infection and accelerate the healing of chronic and high risk surgical wounds, saving time and cost burden to the payors. It is expected that both of these products will be launched in the US in the fourth quarter of 2018. 

The Surgical Silver Post Operative Dressing is indicated for use in the management of post-operative surgical wounds and consists of two skin-friendly layers of hydrocolloid securing a silver-containing absorbent antibacterial alginate dressing. It has been shown to be effective against Methicillin-Resistant S. aureus (MRSA) as well as a broad spectrum of microbes including other antibiotic resistant strains.

The PHMB Foam Dressing is a polyurethane foam impregnated with Polyhexamethylene Biguanide (PHMB) 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.

Chris Meredith, Chief Executive Officer of Advanced Medical Solutions, said: "These most recent approvals strengthen our advanced woundcare portfolio in the US and provide further significant products to support our OEM customers and end users. We are particularly pleased to be able to demonstrate the value of our 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 visit www.admedsol.com or contact:

Advanced Medical Solutions Group plc		Tel: [phone]
Chris Meredith, Chief Executive Officer Mary Tavener,  Chief Financial Officer
Consilium Strategic Communications		Tel: [phone]
Mary-Jane Elliott / Matthew Neal / Nicholas Brown / Olivia Manser		[e-mail]
Investec Bank PLC (NOMAD & Broker)		Tel: [phone]
Daniel Adams / Gary Clarence / Patrick Robb

About Advanced Medical Solutions Group plc - see www.admedsol.com

AMS is a world-leading independent developer and manufacturer of innovative and technologically advanced products for the global surgical, wound care and wound closure markets, focused on quality outcomes for patients and value for payors. AMS has a wide range of products that include silver alginates, alginates, foams, tissue adhesives, sutures and haemostats, which it markets under its brands; ActivHeal^®, LiquiBand^® and RESORBA^® 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 more than 75 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 600 employees.  For more information, please see www.admedsol.com.

 

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