Last checked at 31 Oct 2022 07:00
31 October 2022
Advanced Medical Solutions Group plc
("AMS" or the "Group")
LiquiBandFix8® 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® 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® 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® 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® 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® 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® 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® 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."
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Advanced Medical Solutions Group plc | Tel: +44 (0) 1606 545508 |
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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 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.