Advanced Medical Solutions Group Regulatory News (AMS)

18 September 2023

Advanced Medical Solutions Group plc

("AMS" or the "Group")

AMS signs agreement with TELA Bio, Inc. to commercialise LiquiBand Fix8® in the US under the brand name LIQUIFIX™

US launch of LIQUIFIX™ at American Hernia Society Annual Meeting on 21 September

Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the world-leading specialist in tissue-healing technologies, today announces that it has signed an agreement to commercialise LiquiBandFix8® in the US with TELA Bio, Inc. ("TELA Bio"), a specialist medical technology designer and developer of innovative soft-tissue reconstruction solutions that optimise clinical outcomes, (NASDAQ: TELA).

Under the terms of the agreement, TELA Bio will market and distribute LiquiBandFix8® under the brand name LIQUIFIX™ via its direct specialist sales team across the United States with official launch at the American Hernia Society Annual Meeting, taking place from 21-23 September. This represents a significant commercial opportunity for AMS and TELA Bio as they enter a new addressable market estimated at $200 million.

Headquartered in Malvern, Pennsylvania, TELA Bio has an established and fast-growing footprint in the US market with products that focus on addressing the shortcomings of existing reinforcement materials in hernia repair, abdominal wall reconstruction and plastic reconstructive surgery. To service its growing product portfolio, TELA Bio has projected that its salesforce is expected to reach 75-80 representatives by the end of 2023. TELA Bio generated revenues of $41.4 million (+41%) in 2022 and $26.4 million (+42%) in H1 2023, with full year 2023 guidance of $60-65 million.

The signing of this agreement concludes a comprehensive selection process involving a number of potential partners with a broad range of strengths and marketing strategies. The outcome of this process made it clear that TELA Bio brings the right combination of strengths and attributes, with a vision and ambition that is closely aligned with and complements AMS' strategy and aspirations. 

LiquiBandFix8®/LIQUIFIX™ is already marketed in Europe and other non-US territories and delivered strong growth in these markets in 2021, 2022 and 2023 year to date. AMS' experience in commercialising the product in these markets has emphasised the importance of using specialist sales operations. TELA Bio is an ideal partner for LiquiBandFix8®/LIQUIFIX™ in the US with its hernia repair specialism, its focus on education and training, and its commitment to improving patient outcomes through new technologies that address the shortcomings of existing devices.

In June 2023, LiquiBandFix8®/LIQUIFIX™ was granted Pre-Market Approval (PMA) by the US Food and Drug Administration (FDA) for its use in hernia repair surgery. The device uses drops of cyanoacrylate adhesive instead of sharp tacks to fix mesh to tissue inside the body during open and laparoscopic hernia surgery. It is the first product of its kind to be approved in the US and will benefit patients as the less invasive application is expected to reduce pain and other post-operative complications.

Chris Meredith, Chief Executive Officer of AMS, commented: "TELA Bio's rapidly growing sales presence in the US hernia repair market and its focus on new technologies complement AMS' strengths and aspirations to improve quality outcomes for patients and value for payers, making it the perfect partner to launch and commercialise LIQUIFIX™ in the US. The launch of LIQUIFIX™ is a significant milestone and commercial opportunity for AMS and we are very pleased to be working with a US partner that shares our vision and commitment to the benefits that the product can provide. In this respect we believe that both companies are strongly aligned and we look forward to a long and successful partnership together, starting with the preparations for the launch in Q4 of this year." 

Antony Koblish, Co-founder, President and Chief Executive Officer of TELA Bio, commented: "LIQUIFIX™ has already gained significant adoption in Europe and is demonstrating a clear benefit to patients while providing novel fixation and tacking alternatives for surgeons. We believe this technology is well aligned with our commercial strategy to deliver innovative and effective solutions for soft-tissue repair and reconstruction. We look forward to working closely with the AMS team to commercialise the product across the US market."

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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®, LIQUIFIX™ 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.

About TELA Bio, Inc.

TELA Bio, Inc. (NASDAQ: TELA) is a commercial-stage medical technology company focused on providing innovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient's own anatomy. The Company is committed to providing surgeons with advanced, economically effective soft-tissue reconstruction solutions that leverage the patient's natural healing response while minimizing long-term exposure to permanent synthetic materials. For more information, visit www.telabio.com.