US regulatory approval granted for LiquiBandFix8®
5 June 2023
Advanced Medical Solutions Group plc
("AMS" or the "Group")
US regulatory market approval granted ahead of schedule for LiquiBandFix8®
- Commercial launch expected in H2 2023
Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the world-leading specialist in tissue-healing technologies, is pleased to announce it has received approval from the US Food and Drug Administration (FDA) for the Pre-Market Approval (PMA) of LiquiBandFix8® for use in hernia surgery. The authorisation was granted ahead of schedule and seven months after submission, a significant achievement for the company's first PMA application, reflecting the quality of the submission and emphasising the benefits that the product provides to patients.
LiquiBandFix8® uses drops of cyanoacrylate adhesive instead of sharp tacks to fix mesh to tissue inside the body during hernia surgery. The approval covers two devices, one for use in open surgery and one for laparoscopic use, the first products of their kind in the US which will benefit patients as the less invasive application is expected to reduce pain and other post-operative complications. In addition to its use in securing mesh during hernia repair, LiquiBandFix8® has also been approved for use in closing the peritoneum, the membrane surrounding the abdominal cavity, further extending its application and the the clinical benefits it can provide. Overall, this represents a significant commercial opportunity for AMS to enter a new addressable market estimated at $200 million.
A 284-patient Randomised Control Trial (RCT) has been conducted with top hernia surgeons in five clinical sites across the US, comparing the direct performance of LiquiBandFix8® with a market leading tacker device. Clinical data from the trial was submitted as part of the PMA application and will be used to market the product.
LiquiBandFix8® is already being commercialised in Europe and other non-US markets and AMS reported strong growth in product sales during 2022, supported by the recent recommendation from the UK National Institute for Clinical Excellence (NICE) to consider the use of cyanoacrylate adhesives in place of invasive tackers.
The company is currently in late stage negotiations with a number of potential commercial partners in the US and expects to be able to announce its final decision on partner and marketing strategy shortly. Following this significant approval for AMS, the company will now focus on rolling out the launch of this exciting new product range across the US during H2 2023.
Chris Meredith, Chief Executive Officer of AMS, commented: "I am delighted to be able to announce the approval of LiquiBandFix8® in the US which represents a significant milestone for AMS, further validating the R&D investment we have made and demonstrating our commitment to develop high-quality, innovative products that satisfy unmet patient needs and provide significant commercial opportunities. The speed of the approval following our PMA application in October 2022, is a testament to the quality of product and the benefits it offers to patients, as well as the strength of our PMA submission. I would like to take this opportunity to thank our R&D, Regulatory and Clinical teams that have worked so hard on this project. Now that we have the FDA approval, I am confident that we can conclude our discussions with potential partners and embark on a successful US launch in H2 2023 and that LiquiBandFix8® in the US will be a meaningful contributor to achieving our stated aim of delivering sustainable double digit organic growth."
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For further information, please contact:
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Advanced Medical Solutions Group plc |
Tel: +44 (0) 1606 545508 |
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Chris Meredith, Chief Executive Officer Eddie Johnson, Chief Financial Officer Michael King, Investor Relations |
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Consilium Strategic Communications |
Tel: +44 (0) 20 3709 5700 |
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Investec Bank PLC (NOMAD & Broker) |
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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 five acquisitions: Sealantis, an Israeli developer of innovative internal sealants; Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business and Connexicon, an Irish tissue adhesives specialist.
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, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 800 employees. For more information, please see www.admedsol.com.
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