Business
Full Year Results for the year ended 31 Dec 2020
Full Year Results for the year ended 31 Dec 2020.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 3721V\n Futura Medical PLC\n 14 April 2021\n \n \n \n \n Full Year Results for the year ended 31 December 2020\n \n \n \n \n \n Futura Medical plc (AIM: FUM) (\"Futura\" or the \"Company\"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology and currently focused on sexual health and pain, is pleased to announce its audited results for the year ended 31 December 2020.\n \n \n \n \n \n Key highlights\n \n \n \n \n \n Operational highlights\n \n \n \n \n \n \n MED3000\n \n - Topical fast acting treatment for erectile dysfunction (\"ED\")\n \n \n \n Significant progress made with recent recommendation by EU Notified Body1 for approval of MED3000 as a breakthrough, fast acting, clinically proven treatment for erectile dysfunction:\n \n \n \n In February 2020 formal proceedings commenced for approval as a medical device available throughout EU without the need of a doctor's prescription (\"OTC\").\n \n \n \n \n \n In July 2020, Futura submitted the Technical Dossier for MED3000 for marketing approval.\n \n \n \n \n \n \n \n In August 2020 positive audit opinion received for Futura's Quality Management Systems (\"QMS\").\n \n \n \n \n \n \n \n \n \n EU certificate expected before the end of May 2021 under Medical Device Regulation.\n \n \n \n \n \n \n \n \n \n \n \n \n \n De Novo medical device status for MED3000 confirmed by US Food and Drug Administration (\"FDA\") in February 2020 pre-submission meeting.\n \n \n \n Four pre-submission meetings held to determine design of small supplemental clinical trial (known as \"FM71\") and Human Factors study required by FDA for OTC marketing approval in USA. \n \n \n \n \n \n Detailed planning and preparatory activities for FM71 following receipt of final minutes from FDA.\n \n \n \n \n \n \n \n \n \n \n \n Specialist corporate advisors retained in July 2020 to progress commercialisation of MED3000:\n \n \n \n Joint collaboration agreement for China and South East Asia with 50/50 share of profits signed in March 2021 with expected additional R&D costs of up to £4 million being fully met by Asian partner.\n \n \n \n \n \n Discussions progressing with a number of other parties for licensing rights for MED3000 in other countries.\n \n \n...