EU Market Launch Clearance

EU

Futura Medical (AIM: FUM), the consumer healthcare Group behind Eroxon®, that specialises in the development and global commercialisation of innovative, clinically proven sexual health products, is pleased to announce that its new Eroxon® formulation, which delivers a demonstrably stronger sensation (Eroxon® Intense) has now been cleared for launch across the European Economic Area ("EEA") and the UK.

This follows the successful completion of all design, validation and pre-market regulatory activities required to support commercial launch under the Company's existing CE certification in accordance with the EU Medical Device Regulation (MDR 2017/745), together with UKCA (UK Conformity Assessed) certification.

As previously announced, the Company is focused on strengthening the Eroxon® brand proposition, including updated consumer messaging designed to create a more targeted positioning for consumers. Cooper Consumer Health, the Company's commercial partner for Eroxon® in the EEA and UK, will now be offered the opportunity to launch Eroxon® Intense within its licensed territories.

The Company continues to expect US FDA clearance during the second half of 2026. Following clearance, it will work alongside its new US commercial partner, MPG, to prepare for the planned US launch in 2027.

Eroxon® Intense overview:

Eroxon® Intense is a new formulation of Eroxon® which is designed to have a faster and stronger sensorial action. Marketing feedback with Eroxon® has shown that whilst many men are satisfied with the current sensorial effect of the product, a faster, stronger sensation with a more rapid onset of action would be beneficial.

In March 2026, the Company announced positive results following the Home User Test conducted on the current Eroxon® product and new product Eroxon® Intense. The Test on 223 men delivered positive results, demonstrating strong efficacy, high user satisfaction and improved outcomes compared with Futura's original Phase 3 study. Participants reported satisfactory erection hardness in around 70% of sexual encounters and successful intercourse in approximately 85% of encounters, with outcomes enhanced when the product was applied by a partner. The study also confirmed Eroxon® Intense's enhanced sensorial experience versus Eroxon®, while both products received favourable user ratings and more than half of participants indicated they would be likely to purchase the products.

Alex Duggan, CEO of Futura, commented:

"Receiving EEA and UK market clearance for Eroxon® Intense is a significant milestone for Futura and an important step in broadening the Eroxon® franchise. This approval follows a series of positive studies demonstrating strong consumer acceptance, ease of use and real-world performance, providing further validation of our proprietary formulation science and reinforcing our confidence in the product's commercial potential.

Eroxon® Intense has the potential to address the needs of a broad range of consumers seeking a more intensive erectile dysfunction treatment option, while further strengthening the Eroxon® brand. By expanding the Eroxon® portfolio with a differentiated product offering, we believe we can provide our commercial partners with additional opportunities to grow the brand, broaden consumer appeal and further increase market penetration. We look forward to working closely with our partners to bring Eroxon® Intense to consumers across Europe and, subject to FDA clearance, in the United States."