MED3000, our lead product, is a topical gel which utilises our proprietary technology DermaSys®, developed specifically for the treatment of erectile dysfunction (“ED”). MED3000 is a fast-acting topical treatment which has the potential to be a 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 for the treatment of ED. Futura is expecting to submit the dossier to EU regulators by the end of July 2020 with the U.S. FDA providing optimism for submission for a medical De Novo device approval filing by end of Q3 2020.
Futura will submit its technical file for review by an 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.
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. The regulatory pathway for a medical device is expected to be faster. An EU Notified Body has confirmed that MED3000 is a medical device and the US FDA has confirmed that the classification for the filing of MED3000 is a De Novo medical device.
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.
MED3000 discussions are progressing well with regulators with an EU filing expected by the end of July 2020 and with positive dialogue with the US FDA providing optimism for a submission for a medical de novo device approval filing by the end of Q3 2020.
The recruitment for the European Phase 3 study (FM57) is now closed.
MED3000 achieved all co-primary clinical endpoints against baseline (before treatment). We are now pursuing regulatory filings as a medical device in the EU and US.