Advanced Medical Solutions Grp PLC Seal-G CE Mark Approval (9581V)
April 20 2021 - 1:00AM
UK Regulatory
TIDMAMS
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 (R) 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(R) MIST. In
addition, the existing CE mark for the Seal-G(R) 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
(R) and Seal-G (R) 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 (R) and Seal-G
MIST (R) . 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(R) and Seal-G(R)
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."
- End -
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
Tel: +44 (0) 20
Investec Bank plc (NOMAD & Broker) 7597 5970
Daniel Adams / Patrick Robb / Gary Clarence
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(R) , RESORBA(R) , and LiquiBandFix8(R) . AMS also
supplies wound care dressings such as silver alginates, alginates
and foams through its ActivHeal(R) 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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