Advanced Medical Solutions Group plc
(“AMS”, the “Company” or the “Group”)
IDE received for LiquiBand Fix8 in US
– Clinical study to start imminently for LiquiBand® Fix8™ in the US
Winsford, UK, 14 May 2019: Advanced Medical Solutions Group plc (AIM: AMS), the surgical and advanced wound care specialist company, today announces that the Company has received Investigational Device Exemption (IDE) for the LiquiBand® Fix8™ device in the US. This exemption by the FDA now allows AMS to begin the planned patient clinical trial, with first patient enrolment before the end of May, in line with previous guidance at the time of the full year results.
In the clinical study, LiquiBand® Fix8™ will be used in laparoscopic hernia repair treatments and 284 patients are due to be enrolled with the last patient expected by the end of 2019. The study will close after the final patient has received 12 months follow up and the Company intends to report on this data thereafter.
An IDE allows an investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA). The approval process in the US for LiquiBand® Fix8™ is expected to complete by the second half of 2020.
Commenting on the announcement, Chris Meredith, CEO of AMS, said: “LiquiBand® Fix8™has been growing sales strongly and receiving very positive feedback from surgeons in the European market and we are delighted that we can now start a study with our proprietary device that could benefit patients in the US market. Innovation is at the heart of AMS and this is just one example of our devices that helps patients, surgeons and healthcare payors. We look forward to reporting on further development with LiquiBand® Fix8™ as it grows sales and receives further approvals.”
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For further information, please visit www.admedsol.com or contact:
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Advanced Medical Solutions Group plc |
Tel: 44 (0) 1606 545508 |
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Chris Meredith, Chief Executive Officer |
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Consilium Strategic Communications |
Tel: 44 (0) 20 3709 5700 |
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Mary-Jane Elliott / Matthew Neal / Nicholas Brown / Olivia Manser |
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Investec Bank PLC (NOMAD & Broker) |
Tel: 44 (0) 20 7597 5970 |
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Daniel Adams / Patrick Robb / Gary Clarence |
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About Advanced Medical Solutions Group plc – see www.admedsol.com
AMS is a world-leading independent developer and manufacturer of innovative and technologically advanced products for the global surgical and woundcare markets, focused on quality outcomes for patients and value for payors. AMS has a wide range of products that include tissue adhesives, sutures, biosurgical devices, internal sealants, silver alginates, alginates and foams, which it markets under its brands; LiquiBand®, LiquiBand® Fix 8™, RESORBA® and ActivHeal® as well as supplying under white label.
AMS’s products, manufactured out of two sites in the UK, one in the Netherlands, two in Germany and one in the Czech Republic, are sold in more than 75 countries 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. Established in 1991, the Group has approximately 630 employees. For more information, please see www.admedsol.com
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