Fum30 Apr 2021 15:23
30 April 2021
Futura Medical Receives Approval from EU Notified Body for MED3000
Breakthrough, fast acting topical gel formulation MED3000 becomes Europe's first approved clinically proven, topical treatment for erectile dysfunction available without the need of a doctor's prescription
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, today announces that further to the announcement of 19 March 2021, the Company has now received its MDR EU Quality Management Certificate for the placing on the market of a Class II(b) medical device known as MED3000 ("CE mark approval").
Futura's breakthrough, fast acting topical gel formulation MED3000, is the first clinically proven, pan-European topical treatment for adult men with erectile dysfunction ("ED") available without a doctor's prescription ("OTC").
Studies have shown MED3000 to be an extremely effective treatment for ED with an excellent safety profile. MED3000 has a unique evaporative mode of action which the Company believes stimulates nerve endings in the glans ***** to cause an erection. MED3000 helps men get an erection within 10 minutes, substantially faster than oral tablet phosphodiesterase-5 inhibitors (PDE5i's), with significant benefits for spontaneous rather than pre-planned sexual intercourse.
The CE mark approval of MED3000 from the EU Notified Body paves the way for approval in many countries around the world, including in the Middle East, Africa, the Far East and Latin American regions which allow "fast-track" review based on recognition of the EU CE mark. Due to post-Brexit arrangements, the EU CE mark can be used to market the product in Great Britain until 30 June 2023 by which time a specific UKCA mark has to be obtained.