Advanced Medical Solutions Grp PLC LiquiBandFix8(R) PMA application accepted by FDA (5730E)
31 Octobre 2022 - 8:00AM
UK Regulatory
TIDMAMS
RNS Number : 5730E
Advanced Medical Solutions Grp PLC
31 October 2022
31 October 2022
Advanced Medical Solutions Group plc
("AMS" or the "Group")
LiquiBandFix8(R) PMA application accepted by the FDA
Winsford, UK : Advanced Medical Solutions Group plc (AIM: AMS),
the world-leading specialist in tissue-healing technologies, today
announces it has filed its PMA (Pre-Market Approval) application
for LiquiBandFix8(R) and that the submission has been accepted by
the FDA. AMS expects that US approval for the product will be
granted around the end of 2023.
LiquiBandFix8(R) uses drops of cyanoacrylate adhesive instead of
sharp tacks to fix hernia mesh to tissue inside the body. The
approval of this PMA would herald a significant step forward in the
treatment of hernias in the US, benefiting surgeons and patients
through its ease of use, less invasive application versus tacks and
the resulting potential to reduce pain and improve recovery
time.
The PMA application includes clinical data from 160 patients
followed up for 12 months to demonstrate the effective use of the
product. These patients are the first cohort of a larger clinical
trial of 284 patients which completed in December 2021 and whose 12
month follow up will conclude December 2022. The clinical study was
conducted across 10 US sites comparing the direct performance of
LiquiBandFix8(R) with a market leading tacker device, the data from
which will be used to market the product. The PMA application
covers a laparascopic and open version of the device.
AMS is currently evaluating a number of potential
commercialisation strategies in the US for LiquiBandFix8(R) and a
US launch would present the Group with a significant opportunity to
access a large new addressable market, estimated to be greater than
$250m.
LiquiBandFix8(R) is already being commercialised in Europe and
other non-US markets, and AMS recently reported encouraging growth
in the first half of 2022 as volumes of hernia repair procedures
continue to recover from the COVID-19 pandemic.
Chris Meredith, Chief Executive Officer of AMS, commented : "I
am pleased to be able to confirm that the PMA for LiquiBandFix8(R)
has been accepted by the FDA . To have reached this milestone is a
credit to the drive and energy of the R&D, Clinical and
Regulatory teams at AMS. LiquiBandFix8(R) is one of a number of
significant new technologies being developed within the Group that
we expect to augment our product offering over the coming 12-24
months. Today's news further validates our strategy and commitment
to increased R&D investment, enabling us to launch innovative
products which we believe will drive significant, long-term revenue
growth for the business."
- 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
Michael King, Investor Relations
Consilium Strategic Communications Tel: +44 (0) 20 3709
5700
Mary-Jane Elliott / Matthew Neal/ Matthew
Cole
Investec Bank PLC (NOMAD & Broker) Tel: +44 (0) 20 7597
5970
Daniel Adams / Gary Clarence
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(R) , RESORBA(R) , LiquiBandFix8(R) and Seal-G(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. Since 2019, the Group has made four acquisitions:
Sealantis, an Israeli medical device company with a
patent-protected sealant technology platform; Biomatlante, an
established French developer and manufacturer of innovative
surgical biomaterial technologies, Raleigh, a UK leading coater and
converter of materials predominately for woundcare and
bio-diagnostics products and AFS Medical an Austrian a specialist
surgical business with a focus on minimally invasive
procedures.
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, 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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END
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