Advanced Medical Solutions Group Regulatory News (AMS)

16 December 2021

Advanced Medical Solutions Group plc

("AMS" or the "Group")

Full Year Trading Update

Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the world-leading specialist in tissue-healing technologies, today issued a trading update for the year ended 31 December 2021 (the "Period"). The Group expects to announce its preliminary results on 16 March 2022.

Strong recovery in trading

The Group is pleased to report that FY 2021 results are expected to be in line with market expectations.

Both Business Units reported significant growth against the comparative period as trading recovered in line with expectations and levels of elective surgery continued to rebuild towards pre-pandemic levels.

The volume of product shipped increased significantly and the improvement in operational leverage reported in the first half has continued, with stronger margins for both Business Units during the Full Year compared with 2020.

The Group's financial position remains strong in spite of the disruption caused by the pandemic. AMS will have generated strong cash flows during the Period supporting the increased final 2020 and interim 2021 dividend payments and continued investment in new products.

Regulatory and clinical progress

Patient enrolment for the Seal-G® and Seal-G® MIST clinical study continues to progress well with about 20 per cent of patients now recruited. In addition to three clinical sites operating in Israel, patient recruitment will also begin at five sites across the UK and Italy in H1 2022. The final results from this initial study are on track to be released mid-2022 and this will be used to market the technology during the full commercial launch. As part of the soft launch to Key Opinion Leaders, initial sales of the product were made in December 2021.

As previously reported, recruitment for the US clinical trial of LiquiBandFix8® has now been completed and the Premarket Approval (PMA) filing remains on track for 2022 once all the patients have completed their 12-month follow up.

Having submitted the 510(k) filing for LiquiBand®XL in the first half of 2021, final questions from the FDA were received later than anticipated and our R&D staff are currently working to submit our responses. We remain confident about the outcome, however, we now expect final approval to be granted in H1 2022.

We are pleased to report that the filing for AMS' innovative high gelling product with anti-biofilm activity has been submitted for 510(k) approval and the product is on track for a US launch in 2022.

Chris Meredith, Chief Executive Officer of AMS, commented: "I am extremely proud of AMS' financial performance this year and of the significant progress we have made in building our portfolio of new, innovative products. I would like to thank all our staff, partners, customers and clinicians who work tirelessly to ensure that patients continue to receive the best possible care throughout the pandemic. AMS remains committed to developing and marketing new tissue-healing technologies that address unmet clinical needs and ensuring that the Group continues to deliver significant and robust long-term growth."

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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 three 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 and Raleigh, a UK leading coater and converter of materials predominately for woundcare and bio-diagnostics products.

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, 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.