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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Advanced Medical Solutions Group plc

(“AMS” or the “Group”)

US regulatory approval for LiquiBand^® XL

Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the world-leading specialist in tissue-healing technologies, is pleased to announce that it has received FDA 510(k) approval for LiquiBand^® XL, a new device that can close longer wounds than existing LiquiBand^® products. The device consists of a surgical mesh which is used to close the wound and LiquiBand^® glue which is used to strengthen the closure and prevent infection. Product launch into the US is expected in the third quarter of 2022.

The device has been used successfully on a variety of orthopaedic procedures in multiple territories since its European approval in 2021 and has received very positive feedback in terms ease of use, efficacy and reduced pain and scarring in comparison with other closure methods such as stapling.

The addition of LiquiBand^® XL to AMS’ Advanced Wound Closure portfolio is an important step in the development of this franchise. It provides access to a new $60m, long wound sealant market in the US but also increases the overall strength of the LiquiBand^® portfolio, as it completes the range of applications available, significantly improving the company’s ability to win new contracts and bundle products.

Chris Meredith, Chief Executive Officer of AMS, commented: “I am delighted to announce the FDA approval of LiquiBand^® XL in the US and the addition of this product to our highly successful US LiquiBand^® franchise. There is strong demand for the product from hospitals and our distribution partners and we are confident that it will make a significant impact in the market and will play a critical role in strengthening the market share of the entire LiquiBand^® franchise.”

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