Positive Eroxon® & Eroxon® “Intense” HUT results

Futura Medical plc (AIM: FUM), the consumer healthcare company behind Eroxon® and that specialises in the development and global commercialisation of innovative and clinically proven sexual health products, is pleased to report the results of the Home User Test ("HUT") conducted on the current Eroxon® product and prototype product Eroxon® 'Intense' ("Intense").

The results of the HUT are positive (with an overall improvement on the original Phase 3 study for Eroxon®) and give the Company confidence that the Intense formula gives a statistically significant greater sensorial effect over the current Eroxon® formulation especially in the first two minutes after application.

Home User Test results summary

The study compared the new Intense formula with current Eroxon® over 4 weeks in 223 subjects (112 tested Eroxon® and 111 tested Intense). Subjects were based in the United Kingdom and were recruited on-line. Each subject was individually interviewed to assess their suitability for inclusion into the study. Subjects were male, 18-59 years of age and 94% assessed as suffering from mild to moderate erectile dysfunction ("ED").

In this selected demographic, both Eroxon® and Intense were judged to have high efficacy rates. Subjects stated that they were satisfied with the hardness of their erection in 70% and 71% of their sexual encounters using Eroxon® or Intense, respectively. Subjects also recorded that their erections lasted long enough to have sexual intercourse in 84% and 85% of encounters, respectively.

Using the clinically validated and most widely used measure of erection functionality (the IIEF-EF scale*), subjects in both groups showed a highly significant and clinically important improvement in their erectile function. The improvement versus baseline (pre-treatment) was at least as good as reported in the Phase 3 clinical study FM71, which was used to obtain regulatory approval in the US.

The study also showed that when either Eroxon® or Intense was applied onto the study participant by their partner it increased effectiveness and showed significantly higher erection maintenance.

The study confirmed the sensorial enhancement of Intense over Eroxon® with statistically significant greater intensity during the first two minutes after application.

Additionally, both products were well tolerated in men and their female partners.

Both formulations received favourable 4- or 5-star ratings in 49% and 53% of subjects for Eroxon® and the Intense formula respectively. Over 50% of study participants said they would be somewhat or very likely to purchase either product.

In summary, the HUT study confirmed that a more targeted approach of marketing to consumers under 60 years of age with mild to moderate ED will likely lead to higher efficacy and satisfaction rates and thus higher in-market repeat purchase rates. Encouraging users to use the product with their partners as part of foreplay will likely also improve the overall product experience. The Intense formula will appeal to those consumers seeking a more rapid or stronger sensorial effect, especially in younger age groups. Detailed work is now underway to assess and update optimal brand positioning. Meanwhile, data necessary to support regulatory filings for Eroxon® Intense in Europe and USA has been generated and a "Special" 510K submission has been filed with the US FDA. Regulatory authorisation in the US and Europe is expected in H1 2026.

* Rosen, Riley, Wagner, Osterloh, Kirkpatrick and Mishra. Urology. Volume 49, Issue 6, June 1997, pages 822-830

Ken James, Executive Director and Head of R&D commented: "We are very pleased to report this positive data for Eroxon® and Eroxon® Intense, and ease of use in a real‑world setting. These findings provide further validation of our formulation science and give us confidence as we progress Eroxon® Intense through regulatory authorisation and build an optimal brand position."

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