Advanced Medical Solutions Group Regulatory News (AMS)

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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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.