Business
IDE received for LiquiBand Fix8 in US
IDE received for LiquiBand Fix8 in US.
About this update from Advanced Medical Solutions Group Plc
[{"type":"text","content":"\n \nRNS Number : 8802Y Advanced Medical Solutions Grp PLC 14 May 2019 \n\n \nAdvanced Medical Solutions Group plc\n(\"AMS\", the \"Company\" or the \"Group\")\n \nIDE received for LiquiBand Fix8 in US\n- Clinical study to start imminently for LiquiBand® Fix8™ in the US\n \nWinsford, 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.\n \nIn 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.\n \nAn 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.\n \nCommenting 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.\"\n \n \n- End -\n \nFor further information, please visit www.admedsol.com or contact:\n \n\n\n\nAdvanced Medical Solutions Group plc\n\n\nTel: +44 (0) 1606 545508\n\n\n\n\nChris Meredith, Chief Executive Officer\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nConsilium Strategic Communications\n\n\nTel: +44 (0) 20 3709 5700\n\n\n\n\nMary-Jane Ellio...