FDA approval for two woundcare portfolio dressings

Aug 10, 2018

Advanced Medical Solutions Group plc
(“AMS” or the “Group”)

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: 44 (0) 1606 545508

 

Chris Meredith, Chief Executive Officer

Mary Tavener,  Chief Financial Officer


 



 

Consilium Strategic Communications

Tel: 44 (0) 20 3709 5700

 

Mary-Jane Elliott / Matthew Neal / Nicholas Brown / Olivia Manser

AMS@consilium-comms.com

 



 

Investec Bank PLC (NOMAD & Broker)

Tel: 44 (0) 20 7597 5970

 

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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For further information, please contact:

Advanced Medical Solutions Group plc

Tel: 44 (0) 1606 545508

Chris Meredith, Chief Executive Officer

Eddie Johnson, Chief Financial Officer

Michael King, Investor Relations

Consilium Strategic Communications

Tel: 44 (0) 20 3709 5700

Matthew Neal / Lucy Featherstone

Investec Bank PLC (NOMAD & Broker)

Tel: 44 (0) 20 7597 5970

Gary Clarence / David Anderson

HSBC Bank PLC (Broker)

Tel: 44 (0) 20 7991 8888

Sam McLennan / Joe Weaving / Stephanie Cornish

About Advanced Medical Solutions Group plc

AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8® and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made five acquisitions: Sealantis, an Israeli developer of innovative internal sealants; Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business and Connexicon, an Irish tissue adhesives specialist.

AMS's products, manufactured in the UK, Germany, France, the Netherlands, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 800 employees. For more information, please see admedsol.com.

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