Futura Medical (AIM:FUM), the AIM-listed developer of the Eroxon erectile dysfunction gel, said its new Eroxon Intense formulation has cleared all design, validation and pre-market regulatory steps needed for launch across the European Economic Area and UK.
The clearance sits under Futura's existing CE certification against the EU Medical Device Regulation, alongside UKCA certification.
Cooper Consumer Health, Futura's commercial partner for Eroxon across the EEA and UK, will now be offered the chance to launch the new formulation within its licensed territories.
Eroxon Intense is designed to act faster and deliver a stronger sensation than the original product, addressing feedback that some men wanted a more rapid, intense onset.
A Home User Test on 223 men, reported in March, found satisfactory erection hardness in around 70% of sexual encounters and successful intercourse in approximately 85%, with both products rated favourably and more than half of participants indicating they would likely buy.
Futura still expects US Food and Drug Administration clearance for Eroxon in the second half of the year, after which it plans to work with new US partner MPG toward a 2027 launch.
"This approval follows a series of positive studies demonstrating strong consumer acceptance, ease of use and real-world performance," said chief executive Alex Duggan, adding the product could broaden the Eroxon franchise and give commercial partners further routes to grow the brand.
News Intelligence what this means for the company
Futura Medical has secured EU and UK regulatory clearance for Eroxon Intense, a faster-acting, higher-sensation variant of its erectile dysfunction gel, under its existing CE and UKCA certifications. The move unlocks commercial launch opportunity for partner Cooper Consumer Health across the EEA and UK, while US FDA clearance remains on track for H2 2026, positioning the company to broaden its Eroxon franchise and extend revenue runway beyond its near-term cash position.
- Cooper Consumer Health now holds the commercial decision to launch Eroxon Intense in its licensed EEA and UK territories; uptake and timing will determine near-term revenue contribution.
- US FDA clearance in H2 2026 would trigger MPG activation for a 2027 US launch, materially expanding addressable market and revenue potential beyond current European footprint.
Regulatory clearance de-risks the product roadmap and validates the formulation strategy, but commercial traction depends on partner execution. The company's cash runway extended only to October 2026 as of late June; successful US and European launches will be critical to funding the next phase and justifying the AIM valuation.
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