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FWI FUTURAMEDICAL FUTURA MEDICAL PLC 29 SEPTEMBER 2021 INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2021 Futura Medical plc ( AIM : FUM ) ( " Futura " or the " Company " ) , a pharmaceutical company developing a portfolio of innovative products based on its proprietary , transdermal DermaSysⓇ drug delivery technology and currently focused on sexual health and pain , is pleased to announce its interim results for the six months ended 30 June 2021 . HIGHLIGHTS Europe • Significant progress made in Europe and the UK with the Company receiving its MDR EU Quality Management Certificate in April 2021 , for placing MED3000 on the market as a Class 2B medical device also known as European " CE mark approval " . . Futura's breakthrough , topical gel formulation MED3000 , will become the first pan - European topical treatment for erectile dysfunction ( " ED " ) available without the need of a doctor's prescription ( " OTC " ) . USA • • Further pre - submission meetings with the US Food and Drug Administration ( FDA ) held during the period to finalise the design of a small supplemental clinical trial ( known as " FM71 " ) to be conducted prior to formal regulatory submission as a DeNovo Medical Device and a Human Factors study required by FDA for OTC marketing approval of MED3000 in USA . In March 2021 the Company received official minutes from the FDA following the pre - submission meeting signifying agreement between FDA and Futura on the detailed clinical study design ( protocol ) for clinical study , FM71 . USA - Post period highlights • • In August 2021 Futura received final meeting minutes from a July 2021 pre - submission meeting with FDA that also confirmed the detail of the work required for OTC classification in the USA for MED3000 . • To enable OTC classification a non - clinical , Human Factors Study will test the ability of subjects to self - diagnose their ED , correctly select the product based on label information and test their ability to correctly use the product without supervision of a doctor . The FDA has asked for a minimum of 15 subjects to complete the study . On 14 September 2021 the first patient was enrolled in the FM71 confirmatory clinical study . FIII FUTURAMEDICAL 1