Advanced Medical Solutions Grp PLC IDE received for LiquiBand Fix8 in US (8802Y)
May 14 2019 - 1:00AM
UK Regulatory
TIDMAMS
RNS Number : 8802Y
Advanced Medical Solutions Grp PLC
14 May 2019
Advanced Medical Solutions Group plc
("AMS", the "Company" or the "Group")
IDE received for LiquiBand Fix8 in US
- Clinical study to start imminently for LiquiBand(R) Fix8(TM) in the US
Winsford, UK, 14 May 2019: Advanced Medical Solutions Group plc
(AIM: AMS), the surgical and advanced wound care specialist
company, today announces that the Company has received
Investigational Device Exemption (IDE) for the LiquiBand(R)
Fix8(TM) device in the US. This exemption by the FDA now allows AMS
to begin the planned patient clinical trial, with first patient
enrolment before the end of May, in line with previous guidance at
the time of the full year results.
In the clinical study, LiquiBand(R) Fix8(TM) will be used in
laparoscopic hernia repair treatments and 284 patients are due to
be enrolled with the last patient expected by the end of 2019. The
study will close after the final patient has received 12 months
follow up and the Company intends to report on this data
thereafter.
An IDE allows an investigational device to be used in order to
collect safety and effectiveness data required to support a
premarket approval (PMA). The approval process in the US for
LiquiBand(R) Fix8(TM) is expected to complete by the second half of
2020.
Commenting on the announcement, Chris Meredith, CEO of AMS,
said: "LiquiBand(R) Fix8(TM)has been growing sales strongly and
receiving very positive feedback from surgeons in the European
market and we are delighted that we can now start a study with our
proprietary device that could benefit patients in the US market.
Innovation is at the heart of AMS and this is just one example of
our devices that helps patients, surgeons and healthcare payors. We
look forward to reporting on further development with LiquiBand(R)
Fix8(TM) as it grows sales and receives further approvals."
- End -
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
Consilium Strategic Communications Tel: +44 (0) 20 3709
5700
Mary-Jane Elliott / Matthew Neal / Nicholas
Brown / Olivia Manser
Investec Bank PLC (NOMAD & Broker) Tel: +44 (0) 20 7597
5970
Daniel Adams / Patrick Robb / Gary Clarence
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 and woundcare markets, focused on quality outcomes for
patients and value for payors. AMS has a wide range of products
that include tissue adhesives, sutures, biosurgical devices,
internal sealants, silver alginates, alginates and foams, which it
markets under its brands; LiquiBand(R) , LiquiBand(R) Fix 8(TM),
RESORBA(R) and ActivHeal(R) 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 630 employees. For
more information, please see www.admedsol.com
This information is provided by RNS, the news service of the
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Authority to act as a Primary Information Provider in the United
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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