MED3000, our lead product, is a topical gel which utilises our proprietary technology DermaSys®, developed specifically for the treatment of erectile dysfunction (“ED”). MED3000 has the potential to be a highly differentiated product by addressing significant unmet needs in the ED market.
MED3000 has the potential to be highly differentiated product by addressing significant unmet needs in the ED market.
MED3000 is now the codename for a formulation of DermaSys® developed specifically for the treatment of ED. MED3000 is a unique formulation of DermaSys® using volatile solvent components tailored for the treatment of ED.
MED3000 is a topical gel applied directly to the head (glans) of the penis for the treatment of ED.
MED3000 works through an evaporative and unique mode of action. MED3000’s combination of volatile solvent components creates an evaporative and novel action that stimulates nerve sensors in the highly innervated glans penis rapidly, leading to smooth muscle relaxation, tumescence and erection.
Futura now plans to pursue the medical device regulatory pathway for MED3000. Futura has commenced formal proceedings for MED3000 as a clinically proven treatment for ED to be approved as a medical device and will target mid 2020 for both regulatory the submissions in the US and EU.
Futura will submit its technical file for review by EU Notified Body (Notified Bodies are the regulatory authorities that oversees the approval of medical devices within the EU for all EU countries including the UK), including the full clinical study report for FM57 and the Company’s Quality Management System in mid-2020.
A medical device is described within the EU as a product which does not achieve its principal intended action on the human body by pharmacological, immunological or metabolic means.
These regulatory positions are the consensus from a number of regulatory experts consulted by Futura, nevertheless the Company is meeting with respective regulators ahead of regulatory filings.
Unfortunately, under the current regulations, Futura Medical are not able to provide samples.