Seal-G CE Mark Approval

Apr 20, 2021

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

RNS Number : 9581V
Advanced Medical Solutions Grp PLC
20 April 2021
 

 

20 April 2021

            Advanced Medical Solutions Group plc

(“AMS”, the “Company” or the “Group”)

 

            Seal-G® CE Mark Approval 

–     Strengthened commercial product offering for AMS’s innovative range of GI sealants

–     Differentiated product to enter new $1 billion market and fulfil a significant unmet need

Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the surgical and advanced wound care specialist company, today announces it has received CE mark approval for its laparoscopic gastrointestinal (“GI”) sealant device, Seal-G® MIST. In addition, the existing CE mark for the Seal-G® open device has been extended to include a blue colourant that aids visibility for the surgeon during product usage.

 

Patient enrolment for the first human clinical study of Seal-G® and Seal-G® MIST began in Israel in February 2021 with a small number of patient procedures and successful follow-ups already completed. The 160-patient study will also recruit patients in the UK and Italy with final study results expected in early 2022. The open-label trial will collect clinical evidence on the usage, safety, performance and usability of Seal-G® and Seal-G MIST®. Successful study results would provide additional momentum for the full commercial European launch planned for 2022.

 

In 2020, AMS completed commercial research activity with European Key Opinion Leaders (“KOLs”) on Seal-G® and Seal-G® MIST. Positive feedback was received, including recognition that the device is a potential solution to the high unmet need for an effective GI sealant.

 

Chris Meredith, Chief Executive Officer of Advanced Medical Solutions, said: “Having invested in these innovative products since acquiring Sealantis in January 2019, we are busy preparing to enter the global $1 billion internal sealants market with a differentiated commercial product range. These market approvals and the initiation of patient enrolment are important milestones for the Group as we continue to build our commercial activity through 2021, in anticipation of full commercial launch in 2022.” 

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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

 

 

 

Consilium Strategic Communications

Tel: 44 (0) 20 3709 5700

Mary-Jane Elliott / Matthew Neal / Olivia Manser

 

Investec Bank plc (NOMAD & Broker)

Daniel Adams / Patrick Robb / Gary Clarence

 

 

Tel: 44 (0) 20 7597 5970

 

 

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 woundcare markets, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, and internal fixation devices, which it markets under its brands LiquiBand®, RESORBA®, and LiquiBandFix8®. AMS also supplies wound care dressings such as silver alginates, alginates and foams through its ActivHeal® brand as well as under white label. In 2019, the Group made two acquisitions: Sealantis, an Israeli medical device company with a patent-protected sealant technology platform; and Biomatlante, an established developer and manufacturer of innovative surgical biomaterial technologies based in France. In 2020, the Group acquired Raleigh Adhesive Coatings, a leading coater and converter of materials predominately for woundcare and bio-diagnostics products based in the UK.

AMS’s products, manufactured in the UK, Germany, France, Israel, the Netherlands, and the Czech Republic, 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, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Germany, France and Israel. Established in 1991, the Group has more than 700 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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com. RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.