Futura Medical PLC (LON:FUM) told investors the EU is to certificate Futura’s MED3000 as a Class 2B approved medical device.
Once the certificate is received, Futura's topical gel formulation MED3000 will become the first pan-European topical treatment for erectile dysfunction available without the need for a doctor's prescription.
WATCH: Futura's head of R&D explains final administrative stages of EU approval for MED3000
EU certification and the resultant CE mark will make it easier for Futura to gain approval for MED3000 in other parts of the world, as many jurisdictions "fast-track" their reviews if a product has an EU CE mark.
The CE marking will also be recognised in Great Britain until June 30, 2023, and in the period leading up to this, the company will secure the new post-Brexit UKCA mark. This will be a streamlined process since it is understood the UK application can bridge to the EU approval.
Meanwhile, Futura continues to march towards receiving marketing approval for MED3000 in the US for use as a non-prescription, clinically proven treatment of erectile dysfunction.
The company also revealed it has been working with retained specialised corporate advisers on active commercial discussions with potential licensing and marketing partners.
Following the company's recent announcement of a collaboration agreement for the China and the South East Asia region, partnering discussions for other countries continue in line with the agreed process being managed by Futura's corporate advisers.
READ: Futura Medical shares rise 21% after it makes significant commercial and financial headway
The company has received initial offers from several parties and believes the EU approval of MED3000 will assist the company in its objective of delivering long-term, sustainable value through the licensing of MED3000.
"The recommendation to approve MED3000 in Europe is a huge milestone for Futura in the development of MED3000. We look forward with excitement to bringing MED3000 to patients in Europe as the first, clinically proven treatment for erectile dysfunction that is highly differentiated with its rapid speed of onset. Once the certificate is issued, MED3000 may be marketed throughout the EU without the need of a doctor's prescription subject to any national marketing restrictions. This will represent a significant commercial opportunity," said James Barder, the chief executive of Futura Medical.
Shares in Futura were up 64% at 29.5p in early deals.